louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01145911: The Study of Ocular Hemodynamics With Glaucoma Progression
Official title: The Study of Ocular Hemodynamics With Glaucoma Progression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Keywords: Glaucoma
Blood Flow
Progression
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 123
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glaucoma patients

Brief summary: To determine the relationships between ocular hemodynamics and glaucomatous optic neuropathy progression.

Detailed description: 1. To determine whether baseline ocular blood flow values are predictive of glaucomatous progression as determined by visual field analysis.
2. To determine how changes in ocular blood flow are related to visual field progression.
3. To determine how changes in ocular blood flow are related to changes in optic nerve structure and topographic change over time.

Eligibility criteria: Inclusion Criteria:

Patients will meet all of the following inclusion criteria to enter the study:

1. Age: 30 years or older.
2. Diagnosis: confirmed open-angle glaucoma in at least one eye:

   1. glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
   2. glaucomatous optic disc cupping
   3. agreement between two baseline exams for reliability
3. Best corrected visual acuity at least 20/60 in at least one eye.
4. Prior Humphrey visual fields demonstrate acceptable reliability standards (see below).

Exclusion Criteria:

1. Extensive Humphrey visual field damage consisting of either a mean deviation (MD) \< -15 decibels or a clinically determined threat to fixation in both hemifields.
2. Evidence of exfoliation or pigment dispersion.
3. History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
4. History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
5. History or signs of intraocular trauma.
6. Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
7. Any abnormality preventing reliable applanation tonometry.
8. Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
9. Cataract surgery within the past year.
10. Resting pulse \< 50 beats per minute.
11. Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.

Primary outcomes:
measure: Ocular Blood Flow
timeFrame: various
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine, Department of Ophthalmology
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Alon Harris, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00376311: Effects of Oral Salmon Calcitonin in Human Osteoarthritis
Official title: Phase IIa Study of the Effects of a New Oral Formulation of Salmon Calcitonin in Human Osteoarthritis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Osteoarthritis
Keywords: Lequesne's algo-functional score
Biomarkers of joint metabolism
Lead sponsor: Université Catholique de Louvain
Sponsor class: OTHER
Collaborators: name: Novartis
First posted: 2006-09-14
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the safety, tolerability and clinical efficacy of oral salmon calcitonin in patients suffering from osteoarthritis

Detailed description: Osteoarthritis (OA) is a difficult condition to manage and, thus far, we have no simple, effective interventions for this common cause of pain and disability.

Because parenteral salmon calcitonin (sCT) has positive effects in canine experimental OA, this phase IIa, randomized,placebo-controlled, double-blind trial evaluates the safety, tolerance and clinical efficacy of an oral formulation of sCT in patients with OA.

Patients receive a tablet containing either a placebo, 0.5 mg sCT or 1 mg sCT that they have to take every day in the morning 15 minutes before breakfast for 3 months.

Eligibility criteria: Inclusion Criteria:

* radiographic OA according to the criteria of the American College of Rheumatology;
* morning joint stiffness between 15 and 30 minutes;
* pain on weight bearing and motion reported greater than 40 mm on a 0-100 mm visual analogue scale;
* normal liver and kidney function tests;
* serum CRP levels \< 10 mg/l

Exclusion Criteria:

* previous or ongoing treatment with anti-resorptive drugs such as bisphosphonates, estrogen or raloxifene
* crystal deposition diseases
* known hereditary or congenital defects
* clinically significant hepatic, renal, cardiovascular, psychiatric, endocrine and/or hematological diseases
* intra-articular injections of either corticosteroids (previous 3 months) or hyaluronan (previous 6 months)

Primary outcomes:
measure: Lequesne's algofunctional index
measure: Biomarkers of joint metabolism
Secondary outcomes:
measure: Safety and tolerance
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: St Luc University Hospital, Department of Rheumatology, Université Catholique de Louvain
Study officials:
affiliation: Department of Rheumatology, University hospital St Luc, Brussels, Belgium
name: Daniel H Manicourt, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05521711: TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
Official title: TRADE Trial - Tree Nut Immunotherapy Route Development and Evaluation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Tree Nut Allergy
Food Allergy
Keywords: Immunotherapy
Randomized Controlled Trial (RCT)
Lead sponsor: Hamilton Health Sciences Corporation
Sponsor class: OTHER
Collaborators: name: AAAAI Foundation
First posted: 2022-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tree nut immunotherapy Route Assessment and DEvelopment (TRADE) is a randomized controlled trial that evaluates the efficacy and safety of sublingual immunotherapy and lower, more tolerable, doses of oral immunotherapy than currently in use.


Eligibility criteria: Inclusion Criteria:

* Allergic to tree nut with baseline threshold of 444 mg protein or less and provides consent, and where applicable, assent.

Exclusion Criteria:

1. History of anaphylaxis to tree nut severe enough to cause shock, syncope, or intubation
2. Eosinophilic or other inflammatory gastrointestinal disease within the past 2 years
3. Severe (GINA severity class 5) or uncontrolled asthma including exacerbation within past 6 months
4. Use of biologics, other food immunotherapy or experimental treatment in past 6 months.
5. Ongoing other allergic diseases severe enough to preclude discontinuing antihistamines for 7 days prior to assessment visits
6. Pregnancy or significant medical condition (e.g., liver, kidney, gastrointestinal, cardiovascular, hematologic, or pulmonary disease; allergy to the oat-based placebo) which would put the participant at excessive risk for food allergic reactions as judged by local investigator

Primary outcomes:
measure: Eliciting dose thresholds to food challenge
timeFrame: 1 year
Secondary outcomes:
measure: Quality of life
timeFrame: 1 Year
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University Medical Centre
state: Ontario
Study officials:
affiliation: Hamilton Health Sciences & McMaster University
name: Derek Chu, MD PhD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02806011: Long-term Follow-up Study of Livercellgram in Alcoholic LC Patients Who Completed Livercellgram Phase 2 Study
Official title: Long-term Follow-up Study of Livercellgram in Alcoholic Liver Cirrhosis Patients Who Completed Livercellgram Phase 2 Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alcoholic Liver Cirrhosis
Lead sponsor: Pharmicell Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-06-20
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have completed the Livercellgram phase 2 study and can agree to participate in the long term observation study by oneself.

Brief summary: This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).

Detailed description: This is a 5-year (+30 days) long term follow up study to evaluate the safety of Livercellgram in subject who participated in and completed the Livercellgram Phase 2 trials (refer to ClinicalTrials.gov.Identifier: NCT01875081).

This trial is planned to evaluate the safety of Livercellgram in patients with alcoholic liver cirrhosis. Subjects who signed this follow-up observation informed consent form will participate in a safety assessment (tumor marker test, occurrence of adverse events and serious adverse events, clinical laboratory tests, vital sign, physical examinations.).

Eligibility criteria: Inclusion Criteria:

1. Subjects who treated with Livercellgram and completed the Livercellgram phase 2 study.
2. Subjects who can agree to participate in the long term observation study by oneself.

Exclusion Criteria:

* Not Applicable

Primary outcomes:
measure: Safety Evaluation assessed by Tumor Marker Test, Adverse Events and Serious Adverse Events, Clinical Laboratory Tests, Vital Signs, and Physical Examinations
timeFrame: 5-year(+30 days)
Secondary outcomes:
Other outcomes:
Locations:
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Wonju Severance Christian Hospital
name: Soon Koo Baik, M.D.,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03748511: Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease
Official title: Identification of Microbial Properties Predicting a Worsening Course of Fatty Liver Disease
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Patients With Fatty Liver Disease
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2018-11-21
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients with fatty liver disease

Brief summary: This study investigates the relation between the gastrointestinal tract bacteria and the progression of fatty liver disease .

Detailed description: In the gastrointestinal (GI) tract live wide spectrum of bacteria, in this study we are trying to find if there is a relation between the GI tract bacteria and the development of non alcoholic fatty liver disease, the results of the this study may help us identify the stage of liver disease in noninvasive means and enables us to adopt methods to reduce morbodity.

Eligibility criteria: Inclusion Criteria:

* patients with non alcoholic fatty liver disese.
* patients who give approval to participate in the study

Exclusion Criteria:

* liver failure
* acute or chronic kidney failure
* heart failure ( NYHA 3-4)
* active cancer
* fatty liver due to non alcoholic etiology.
* patients who consume drugs from the estrogen/methotrexate family, or chloroquine.
* history of hypothyrodism or cushing.
* patients who used TPA in the last 6 months .
* pathients with chronic liver disease like A1AT, hemochromatosis, wilson, toxic damage and autoimmunity .
* special population like - children, pregnant women and patients who lack the ability to make judgment.
* infectious liver disease - viral hepatitis or HIV.
* inflammatory bowel disease.
* patients who underwent surgery of the gastrointestinal trant.

Primary outcomes:
measure: Transient Elastography Test
timeFrame: up to 2 hours
Secondary outcomes:
measure: Gastrointestinal Microbiome test
timeFrame: up to 1 month
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Liver Init
Study officials:
References:
Clinical trial NCT06800911: Metacognitive Beliefs in Obese Patients
Official title: Metacognitive Beliefs, Emotional Regulation in Obese Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Keywords: Metabeliefs
Metacognition
Rumination
Dysfunctional lifestyle
Rehabilitation
Lead sponsor: Istituto Auxologico Italiano
Sponsor class: OTHER
First posted: 2025-01-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 90 patients aged between 18 and 65, of both sexes, of Italian nationality, suffering from obesity (Body Mass Index, BMI: kg/m2 ≥ 35, according to the criteria of the World Health Organization WHO).

Brief summary: The study aims to investigate the presence of metacognitive beliefs, emotional regulation, and emotional eating in obese patients and their possible relationships.


Eligibility criteria: Inclusion Criteria:

* Age: between 18 and 65 years
* Italian nationality
* Body Mass Index ≥ 35 kg/m2

Exclusion Criteria:

* Psychiatric pathologies
* Severe cognitive deficits that could compromise the completion of the questionnaires
* Absence of signed informed consent

Primary outcomes:
measure: Metacognitive beliefs
timeFrame: Baseline
measure: Rumination
timeFrame: Baseline
measure: Anger Rumination
timeFrame: Baseline
measure: Emotional dysregulation
timeFrame: Baseline
measure: Emotional eating
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Oggebbio
country: Italy
facility: Istituto Auxologico Italiano IRCCS, Site Piancavallo
state: Verbania
Study officials:
References:
Clinical trial NCT02530528: Pilot Trial of Preoperative Chlorhexidine Gluconate (CHG) Skin Preparation
Official title: Pilot Trial Assessment of the Antimicrobial Efficacy of Medline 2% CHG Cloth Preoperative Skin Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Surgery
Keywords: Surgical Skin Preparation
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2015-08-21
Enrollment: 27
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Pilot study to evaluate and compare activity of investigational preoperative preparation (2% CHG) with comparator (2% CHG).

Detailed description: Evaluate and compare similar preoperative surgical preparations in healthy volunteers. Various application times were evaluated. Efficacy was assess using the Tentative Final Monograph (TFM) criteria.

Eligibility criteria: Inclusion Criteria:

* Healthy
* No dermatological conditions

Exclusion Criteria:

* Sensitivity to CHG
* Sensitivity to natural latex rubber or adhesive skin products

Primary outcomes:
measure: Log Reduction of Bacterial Flora on Abdomen and Groin Sites
timeFrame: 10 min, 6 hr and 8 hr
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Microbac Laboratories
name: Bashir M Hamid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01173328: Effects of Pursed-lip Breathing on Exercise Tolerance and Dynamic Hyperinflation in COPD
Official title: Effects of Pursed-lip Breathing on Exercise Tolerance and Dynamic Hyperinflation in Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: exercise tolerance
dynamic hyperinflation
respiratory mechanics
Lead sponsor: Universidade Federal do Rio de Janeiro
Sponsor class: OTHER
First posted: 2010-08-02
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Pursed-lip breathing (PLB) has been advocated to reduce respiratory rate and improve oxygen saturation in patients with chronic obstructive pulmonary disease (COPD) at rest. Although PLB is a strategy that potentially reduces expiratory flow limitation, there are only few studies addressing its effects on exercise.

This study aimed to assess the ability of PLB to change the breathing pattern, degree of dynamic hyperinflation (DH) and arterial oxygenation in COPD patients during exercise. Exercise tolerance was evaluated by endurance time and respiratory mechanics was evaluated by forced oscillation technique.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of chronic obstructive pulmonary disease (COPD)
* Regular treatment at Clementino Fraga Filho University Hospital (UFRJ)

Exclusion Criteria:

* Exacerbation in the preceding 4 weeks
* SpO2\<85% at peak exercise
* Other diseases that may contribute to dyspnea and exercise intolerance

Primary outcomes:
measure: Endurance time
timeFrame: within the first 01 hour
Secondary outcomes:
measure: inspiratory capacity
timeFrame: within the first 01 hour
measure: oxygen saturation
timeFrame: within the first 01 hour
measure: dyspnea
timeFrame: within the first 01 hour
measure: forced oscillation variables
timeFrame: within the first 01 hour
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Clementino Fraga Filho University Hospital
Study officials:
affiliation: Universidade Federal do Rio de Janeiro
name: Fernando S Guimarães, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04916028: Clinical Characteristics of Patients Referred to a Substance Abuse Liaison Department in an Academic Hospital, France
Official title: Clinical Characteristics of Patients Referred to a Substance Abuse Liaison Department in an Academic Hospital, France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Substance Abuse
Emergencies
Personality Disorders
Substance Use Disorders
Keywords: Substance abuse liaison-department
Emergencies
Academic Hospital
Personality Disorders
Substance Use Disorders
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 700
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients consecutively admitted for addictive behaviors in the emergency department and in the Medicine or Surgery departments of the Amiens University Hospital Center, France.

Brief summary: The Coalition on Psychiatric Emergencies (CPE) stressed in 2016 that emergency providers were increasingly recognizing the important role of the Emergency Department (ED) in reducing adverse outcomes associated with untreated with substance abuse liaison department (SUDs). Additional research is required to close identified knowledge gaps and improve care of ED patients with SUD. Of the more than 4.5 million ED visits in 2009 in US for drug-related causes,34-32% involved alcohol use alone or in combination with other drugs. Few studies investigated the clinical characteristics of patients referred to an addiction liaison department in a general hospital. The present study will be retrospective in a sample of 700 patients consecutively admitted for addictive behaviors in the emergency department and in the Medicine or Surgery departments of the Amiens University Hospital Center, France.


Eligibility criteria: Inclusion Criteria:

* patient addressed to University Hospital Emergency Department and consecutively referred to a substance abuse liaison department in the Amiens Academic Hospital, France between 2017 and 2020.
* Patients must be able to speak French

Exclusion Criteria:

* Neurological disorders
* patients who are not able to speak French

Primary outcomes:
measure: sociodemographic characteristics of patients referred to an addiction liaison department in a Academic general hospital
timeFrame: one month
measure: clinical characteristics of patients referred to an addiction liaison department in a Academic general hospital
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
References:
Clinical trial NCT01870128: Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial
Official title: Comparison of Three Different Treatment Regimes in Early Rheumatoid Arthritis: A Randomized Open-labelled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis
Steroid
Lead sponsor: All India Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of various treatment regimens in early RA. Methods: This is a randomized open-labeled trial. Patients were randomised into three groups. In group A, patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.

Detailed description: Many studies have been conducted to evaluate the role of pulse steroids in early rheumatoid arthritis (RA) but no consensus exists. The aim of this study is to study the efficacy of various treatment regimens in early RA. Patients were divided into three groups. In group A, patients were treated with single drug (methotrexate 15 mg/wk). The patients in Group B were treated with a combination of DMARDS (Methotrexate, sulfasalazine and hydroxychloroquine). The patients in Group C received combination therapy as in group B and 3 pulses of methylprednisolone intravenously.

Eligibility criteria: Inclusion Criteria:

1. Rheumatoid Arthritis diagnosed on the basis of revised American college of rheumatology criteria,1987
2. Age \>18 years
3. Early Rheumatoid Arthritis i.e. less than 2 years duration
4. Patient giving consent to participate in study
5. Disease Modifying Anti-Rheumatic Drugs naive -

Exclusion Criteria:

1. Pregnant and lactating patient or planning to conceive in next year
2. Patient who had joint surgery in last 6 months
3. Co morbidities such as liver disease, kidney disease, hematological malignancies
4. Uncontrolled hypertension, diabetes mellitus
5. Coronary artery disease -

Primary outcomes:
measure: Response to treatment
timeFrame: 22 months
Secondary outcomes:
measure: Disease activity score (DAS28)
timeFrame: 22 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: AIIMS
state: Delhi
Study officials:
affiliation: All India Institute of Medical Sciences
name: ATUL BATRA, MD
role: PRINCIPAL_INVESTIGATOR
References: