louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00128245: Safety and Efficacy of Pimecrolimus Ophthalmic Suspension in Patients With Moderate to Severe Keratoconjunctivitis Sicca
Official title: A 24-week Randomized, Double-blind, Multicenter, Parallel-group, Placebo-controlled Evaluation of the Safety and Efficacy of 0.3% and 1% Pimecrolimus Ophthalmic Suspensions Used Twice Daily in Patients With Moderate to Severe Keratoconjunctivitis Sicca
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Keratoconjunctivitis Sicca
Keywords: KCS
dry eye
pimecrolimus
Keratoconjunctivitis sicca (dry eye syndrome)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-09
Enrollment: 440
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 study evaluates the efficacy and safety of 2 doses of pimecrolimus (0.3% and 1%) ophthalmic suspension in a moderate to severe population of keratoconjunctivitis sicca (KCS, dry eye syndrome) patients.


Eligibility criteria: Inclusion Criteria:

* History of artificial tear use
* Moderate to severe signs of dry eye
* Moderate to severe ocular discomfort

Exclusion Criteria:

* Patients with uncontrolled systemic or ocular diseases.
* Have any history of refractive surgery
* Use any topical ocular medications other than those dispensed for the study, during the study

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: 12 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)in one sign and one symptom
measure: change from baseline in fluorescein corneal staining and ocular discomfort(worst symptom,VAS)
Secondary outcomes:
measure: 24 week's treatment with 2 concentrations of pimecrolimus (0.3% and 1 %)on all signs and symptoms
measure: Global assessment of efficacy and tolerability
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis
state: New Jersey
Study officials:
affiliation: University of Louisville, USA
name: Gary Foulks, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04865445: Drug-drug Interaction Study of Midazolam and AT-527 (R07496998)
Official title: A Phase 1 Open-Label Study to Evaluate the Interaction Potential Between AT 527 and Midazolam in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer Study
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Hoffmann-La Roche
First posted: 2021-04-29
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Drug-drug interaction study of midazolam and AT-527 (R07496998)


Eligibility criteria: Inclusion Criteria:

* Must agree to use two methods of birth control from Screening through 90 days after administration of the last dose of study drug
* Females must have a negative pregnancy test at Screening and prior to dosing
* Minimum body weight of 50 kg and body mass index (BMI) of 18-29 kg/m2
* Willing to comply with the study requirements and to provide written informed consent

Exclusion Criteria:

* Infected with hepatitis B virus, hepatitis C virus, HIV or SARS-CoV-2
* Abuse of alcohol or drugs
* Use of other investigational drugs within 28 days of dosing
* Concomitant use of prescription medications, or systemic over-the-counter medications
* Other clinically significant medical conditions or laboratory abnormalities

Primary outcomes:
measure: Pharmacokinetics (PK) of midazolam
timeFrame: Day 1, Day 3, Day 7
Secondary outcomes:
measure: Pharmacokinetics (PK) of AT-527
timeFrame: Day 3, Day 7
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Atea Study Site
state: Montreal, Quebec
Study officials:
References:
Clinical trial NCT03512145: Clinical Evaluation of the VIPUN Balloon Catheter 0.2 in Critically Ill Patients
Official title: A Prospective Evaluation of the VIPUN Balloon Catheter 0.2: an Investigational Medical Device for the Monitoring of Gastric Motility in Adult Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Critical Illness
Intolerance; Nutritional
Delayed Gastric Emptying
Gastric Motor Dysfunction
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: An open label, non-randomized, monocentric, interventional investigation in a cohort of adult critically ill patients


Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Of adult age (18 years or older)
* ICU patients in which enteral nutrition is planned to be initiated and are expected to stay at least 1 day in ICU on enteral feeding.
* Patients should be mechanically ventilated or have an endotracheal tube or tracheostomy in place.

Exclusion Criteria:

* Contra-indication for (re-) placement of nasogastric feeding catheters.
* History of gastric or esophageal surgery
* Any gastrointestinal surgery or trauma that could significantly increase the risk related to the investigational medical device in the opinion of the investigator
* Fed by mouth or enterally prior to inclusion
* Patient is moribund
* Known pregnancy or breastfeeding women
* Receives gastroprokinetic medication (e.g., erythromycin, metoclopramide, domperidone)

Primary outcomes:
measure: Gastric motility
timeFrame: 10 hours
measure: gastric emptying rate
timeFrame: 6 hours
Secondary outcomes:
measure: Success rate placement and removal balloon catheter
timeFrame: Day 0 until day 1 (<24 h)
measure: Safety parameters potentially related to the use of the investigational medical device
timeFrame: Day 0 until day 30
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Vlaams-Brabant
Study officials:
References:
Clinical trial NCT01967745: Laparoscopic Versus Open Appendectomy
Official title: Laparoscopic vs. Open Surgical Procedure in Management of Acute Appendicitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Appendicitis
Keywords: open appendectomy
laparoscopic appendectomy
appendicitis
Lead sponsor: Varazdin General Hospital
Sponsor class: OTHER
First posted: 2013-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with clinical, laboratory, and radiologic signs of acute appendicitis

Brief summary: Comparison of open and laparoscopic appendectomy

Detailed description: Adult patients with presumptive diagnosis of acute appendicitis were were operated by laparoscopic appendectomy or open appendectomy group during a three-year period (between 2007 and 2009).

Eligibility criteria: Inclusion Criteria:

* patients older than 16 years with presumptive diagnosis of acute appendicitis

Exclusion Criteria:Appendectomy performed during diagnostic laparoscopy and incidental appendectomies patients with:

* cirrhosis
* ascites
* coagulation disorder
* diffuse peritonitis
* shock on admission
* large ventral hernia. Appendectomy performed during diagnostic laparoscopy and incidental appendectomies were also excluded

Primary outcomes:
measure: Cost of hospitalization based on the final hospital bills
timeFrame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
Secondary outcomes:
measure: Analgesia demands
timeFrame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
measure: Complications
timeFrame: during first 4 weeks after the surgery
measure: Length of hospital stay
timeFrame: from the beginning of the surgery till discharge from hospital (an expected average of 8 days, maximmum 20 days)
measure: Time until resumption of clear liquid and regular diet
timeFrame: from the beginning of the surgery to the resumption (an expected average 2 days after the surgery)
Other outcomes:
Locations:
city: Varazdin
country: Croatia
facility: Varazdin General Hospital
Study officials:
affiliation: Varazdin General Hospital
name: Ranko Stare, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00576745: A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery
Official title: Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Wound Infection
Keywords: Sutures
Lead sponsor: American Heart Association
Sponsor class: OTHER
First posted: 2007-12-19
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Following closure of surgical incisions, wounds may develop redness, swelling, and drainage which may result in increased pain and infection. This study will test to hypothesis that using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness, swelling, and infections in a group of patients undergoing a mediastinotomy incision used for open heart surgical procedures.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing mediastinotomy for cardiac surgical procedures

Exclusion Criteria:

Patients with:

* Allergies to skin adhesives
* Known keloid formation
* Prior sternotomies
* Conditions making them not candidates for vicryl skin closure

Primary outcomes:
measure: Incidence of erythema
timeFrame: 30 days following surgery
Secondary outcomes:
measure: Incidence of infection
timeFrame: 30 days following surgery
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Harold L Lazar MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lazar HL, McCann J, Fitzgerald CA, Cabral HJ. Adhesive strips versus subcuticular suture for mediansternotomy wound closure. J Card Surg. 2011 Jul;26(4):344-7. doi: 10.1111/j.1540-8191.2011.01257.x. Epub 2011 May 9.
Clinical trial NCT00380445: Effect of Vildagliptin on Fat and Muscle Metabolism in Patients With Type 2 Diabetes
Official title: Effect of Vildagliptin on Adipose Tissue and Skeletal Muscle Metabolism in Obese Patients With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: Vildagliptin, Type 2 diabetes
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-09-26
Enrollment: 21
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Please note this study is not being conducted in the United States. The purpose of this study is to test the hypothesis that acute DPP-4 inhibition with vildagliptin improves fat and muscle metabolism in patients with type 2 diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Must be able to complete a 3-week wash-out of current anti-diabetic medication
* Cannot take any medications which may alter gastric motility except for cardiac medication at a stable dose
* Must discontinue beta-blockers and lipid lowering drugs
* Blood glucose criteria must be met
* BMI in the range 30-35

Exclusion Criteria:

* History of type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
* Need for insulin within 3 months or patients on thiazolidinediones
* Patients taking a sulfonylurea or metformin who cannot safely discontinue medication for the duration of the study
* Significant concomitant disease or complications of diabetes
* Patients with any history of gastrointestinal surgery or positive gastrointestinal symptons
* High tryglycerides as defined by the protocol
* Smokers who cannot abstain from smoking during the treatment periods

Primary outcomes:
measure: To explore whether vildagliptin augments insulin mediated inhibition of adipose tissue lipid mobilization following a mixed meal in patients with type 2 diabetes
Secondary outcomes:
measure: To measure the effects of vildagliptin on tissue carbohydrate metabolism (skeletal muscle)
Other outcomes:
Locations:
city: East Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
city: Investigative Centers
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Boschmann M, Engeli S, Dobberstein K, Budziarek P, Strauss A, Boehnke J, Sweep FC, Luft FC, He Y, Foley JE, Jordan J. Dipeptidyl-peptidase-IV inhibition augments postprandial lipid mobilization and oxidation in type 2 diabetic patients. J Clin Endocrinol Metab. 2009 Mar;94(3):846-52. doi: 10.1210/jc.2008-1400. Epub 2008 Dec 16.
Clinical trial NCT05944445: The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT
Official title: The Incidence of Linezolid-induced Thrombocytopenia (LIT) in Critically Ill Patients, the Risk Factors for LIT and Time to Events (LIT, Recovery)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thrombocytopenia; Drugs
Keywords: Linezolid
Thrombocytopenia
Lead sponsor: Helwan University
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult critically ill patients admitted to ICU for different indications

Brief summary: * To identify the incidence of LIT among critically ill patients, as limited studies have only addressed this population.
* To evaluate the impact of several factors on the incidence of LIT, the time to onset of LIT, and the time to recovery of platelets.
* To study the effect of concurrent medications (enoxaparin, unfractinated heparin, piperacillin, carbapenems, tigecycline, fluconazole or voriconazole, digoxin, amiodarone, acetaminophen, tirofiban, statins, and antiepileptics) frequently used in critically ill patients on the incidence of LIT.
* To investigate the impact of possible medications with an antioxidant effect on the prevention of LIT.
* To assess the impact of LIT on composite end point (mortality, bleeding, and length of stay)


Eligibility criteria: Inclusion Criteria:

* All adult patients, age \> or = 18 years old, admitted to the ICU with different indications.
* candidates for intravenous linezolid therapy for \> or =1 day.

Exclusion Criteria:

* Taking any myelosuppressive drug.
* Baseline platelets \< 50000.
* Patients with hematological malignancy.
* COVID-19 patients.
* Patients with immune thrombocytopenia

Primary outcomes:
measure: Incidence of Linezolid-induced thrombocytopenia (LIT) thrombocytopenia
timeFrame: One year
Secondary outcomes:
measure: Time to the onset of LIT
timeFrame: One year
measure: time to platelet recovery
timeFrame: One year
measure: Incidence of clinical outcomes
timeFrame: One year
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: 15 May hospital
Study officials:
affiliation: Helwan University, faculty of pharmacy
name: Abdelhameed I Ebid
role: STUDY_DIRECTOR
affiliation: Helwan University, faculty of pharmacy
name: Mahmoud I Mostafa
role: STUDY_DIRECTOR
References:
Clinical trial NCT00047645: A Study of the Safety and Efficacy Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of the Safety and Efficacy of Subcutaneous Recombinant Interferon-Gamma 1b in Patients With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: lung
IPF
Lead sponsor: InterMune
Sponsor class: INDUSTRY
First posted: 2002-10-11
Enrollment: 330
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study GIPF-001 is phase 3 study designed to determine the safety and efficacy of IFN-g 1b administered by subcutaneous injection; compared to placebo in patients with IPF who are unresponsive to steroids. 330 patients have been enrolled and were assigned to either a IFN-g 1b group or a placebo group.


Eligibility criteria: Male or Female, 20-79 years old

Primary outcomes:
measure: Progression-free survival time
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: InterMune
name: Javier Szwarcberg, MD
role: STUDY_DIRECTOR
References:
citation: Cottin V, Hansell DM, Sverzellati N, Weycker D, Antoniou KM, Atwood M, Oster G, Kirchgaessler KU, Collard HR, Wells AU. Effect of Emphysema Extent on Serial Lung Function in Patients with Idiopathic Pulmonary Fibrosis. Am J Respir Crit Care Med. 2017 Nov 1;196(9):1162-1171. doi: 10.1164/rccm.201612-2492OC.
Clinical trial NCT06954545: Outcomes of a Game-based Educational Intervention: Healthy Kids
Official title: Effectiveness of a Role-play Based School Intervention in Primary School Students: a Non-randomized Cluster Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Child Health
Physical Activity
Keywords: educational intervention
prevention of obesity
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2025-05-01
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: intervention group with healthy kids programme, control group
Primary purpose: PREVENTION

Brief summary: 235 / 5.000 Investigators aimed to reduce the risk of obesity by trying a new intervention method that is role-play based, interactive and fun with age-appropriate play materials, considering that learning through play is more efficient.

Detailed description: It was aimed to reduce the risk of obesity by trying a new intervention method based on role-play, interactive and fun with age-appropriate game materials, considering that learning through play is more efficient.

Two schools were determined as control and intervention groups. An 8-week interactive-game-based intervention program will be applied to children in the intervention group who are at risk for obesity. The program was shaped by a physician-dietician-psychologist and a professional theater actor.

Family Nutrition and Physical Activity (FNPA) score, Food index (FI) score and BMI will be grouped for each child and a risk score will be calculated based on the total score they receive. It will be checked whether there is a decrease in this score after the training.

Eligibility criteria: Inclusion Criteria:

* All participants who do not meet the criteria of whether or not they agree to participate in the study will be included in the study.

Exclusion Criteria:

* neurodevelopmental delays
* metabolic disorders potentially leading to obesity
* physical disabilities
* those whose parents or guardians declined participation.

Primary outcomes:
measure: BMI (body mass index)
timeFrame: All measurements will be collected at 0, 3 and 6 months
Secondary outcomes:
measure: FNPA scores
timeFrame: All measurements will be collected at 0, 3 and 6 months
measure: FI Scores
timeFrame: All measurements will be collected at 0, 3 and 6 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University
state: Pendik
Study officials:
affiliation: Marmara University
name: Arzu uzuner
role: STUDY_DIRECTOR
References:
Clinical trial NCT00896545: Early Childhood Prevention of Childhood Overweight
Official title: Development of an Early Intervention for the Prevention of Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2009-05-11
Enrollment: 100
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: You are invited to participate in a research study to understand more about childhood obesity and how to prevent it. We hope to learn how families influence each others eating habits.

Detailed description: This study aims to understand more about childhood obesity and how to prevent it. Two different methods of prevention will be tested and participants will be allocated at random to one of these methods. The investigators hope to learn how families influence each others eating habits.

Participants in this study will attend a series of five classes, once a week for five weeks, on the topic of child feeding. The aim of the classes is to learn how to feed your child so as to prevent future eating and weight problems. The research component includes filling out some surveys before classes begin and at the end of the last class. Classes are small and interactive so that parents have a chance to voice concerns and get feedback.

Eligibility criteria: Inclusion Criteria:

* One or both parents with BMI \> or = to 27.5
* Healthy child ages 2-4 years

Exclusion criteria.

- Inadequate understanding of the English language

Primary outcomes:
measure: Parental control of feeding
timeFrame: 5-weeks
Secondary outcomes:
measure: Daily patterns of child and family meals
timeFrame: 1-week
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: William Stewart Agras
role: PRINCIPAL_INVESTIGATOR
References: