louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06584019: The Effect of Range of Motion (ROM) exercıses on Comfort Level and vıtal sıgns
Official title: The Effect of Range of Motion (ROM) Exercises Applied to Oncology Patients in the 6-12 Years Group on the Comfort Level and Vital Signs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children With Cancer
Keywords: Range Of Motion exercises
cancer
pediatrics
comfort
Lead sponsor: Istanbul Medipol University Hospital
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 30
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This experimental study aims to examine the effects of ROM (Range of Motion) exercises on comfort level and vital signs in children diagnosed with cancer.

Detailed description: The sample of the study consisted of a total of 60 oncology patient children, 30 in the experimental group and 30 in the control group, between the ages of 6-12, who were hospitalized in the Pediatric Bone Marrow Transplant Unit and Pediatric Hematology Oncology Service of a state hospital. The data of the study were collected with the "Data Collection Form", "Life Findings Table" and "Comfort Scale in Children". Range of motion exercise applications continued once a day for 5 days a week for approximately 20 minutes. Fever, pulse, respiration, blood pressure, pain and comfort levels of the children were measured before and after the exercise. In the study, it was investigated whether Range of motion exercises have an effect on vital signs and comfort levels of children with cancer.

Eligibility criteria: Inclusion Criteria:

* Individuals between 6 and 12 years of age.
* Patients diagnosed with oncology.
* Patients who agreed to participate in the study and whose consent was obtained from their parents.
* Patients who can communicate and are conscious.

Exclusion Criteria:

* Patients with fractures or orthopedic conditions that may limit exercise.
* Patients with serious cardiac problems that may prevent exercise.

Primary outcomes:
measure: Body temperature
timeFrame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
measure: Pulse
timeFrame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
measure: Respiration
timeFrame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
measure: Blood pressure
timeFrame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
measure: Comfort
timeFrame: For 5 days/ 2 times a day/ before and after a 20 minute range of motion.
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Medipol University
state: Beykoz
Study officials:
affiliation: Istanbul Medipol University faculty member
name: Aysel Kokcu Dogan, Asst. Prof.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03066219: Safety and Efficacy of BRM421 for Dry Eye Syndrome
Official title: A Multi-Center, Randomized, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of BRM421 Ophthalmic Solution in Subjects With Dry Eye Using a Controlled Adverse Environment (CAE®) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dry Eye Syndrome
Lead sponsor: BRIM Biotechnology Inc.
Sponsor class: INDUSTRY
First posted: 2017-02-28
Enrollment: 157
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: The objective of this study is to compare the safety and efficacy of BRM421 Ophthalmic Solution to placebo for the treatment of the signs and symptoms of dry eye.

Detailed description: This is a multi-center, double-masked, randomized, vehicle-controlled, phase 2 study in approximately 150 subjects. (75 per treatment arm).

Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age;
* Provide written informed consent;
* Have a reported history of dry eye for at least 6 months prior to enrollment;
* Have a history of use of eye drops

Exclusion Criteria:

* Have any clinically significant slit lamp findings at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters;
* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal), or active ocular inflammation at Visit 1;
* Have worn contact lenses within 7 days of Visit 1 or anticipate using contact lenses during the study;
* Have used any eye drops within 2 hours of Visit 1;
* Have previously had laser-assisted in situ keratomileusis (LASIK) surgery within the last 12 months;
* Be a woman of childbearing potential who is not using an acceptable means of birth control; acceptable methods of contraception

Primary outcomes:
measure: Sign: Corneal fluorescein staining score
timeFrame: Up to 4 weeks
measure: Symptom: Ocular discomfort score
timeFrame: Up to 4 weeks
Secondary outcomes:
measure: Tear film break-up time
timeFrame: Up to 4 weeks
measure: Conjunctival Redness
timeFrame: Up to 4 weeks
measure: Ocular Surface Disease Index (OSDI)©
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Lewiston
country: United States
facility: Central Maine Eye Care
state: Maine
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
Study officials:
References:
Clinical trial NCT01176318: Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Erdosteine for Treatment of Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Double Blind, Placebo Controlled Multicentre Study of the Effects of Standard Care Plus Erdosteine (Erdotin) Versus Standard Care Plus Placebo on Cough in Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: cough
exacerbation
quality of life
Lead sponsor: Hull University Teaching Hospitals NHS Trust
Sponsor class: OTHER_GOV
Collaborators: name: Galen Limited
First posted: 2010-08-06
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a parallel group, double-blind, placebo controlled, multi-centre, randomised trial.

60 patients to be included who are adult patients admitted to hospital with a clinical diagnosis of acute exacerbation of Chronic Obstructive Pulmonary Disease (COPD). Acute exacerbation of COPD will be defined as sustained worsening of the patient's condition with an increase in cough and one or more of dyspnoea, sputum volume or sputum purulence, necessitating a change in regular medication.

The primary objective of this study is to evaluate the effectiveness of standard care plus erdosteine in reducing hourly cough (24 hour cough recording using automated cough recorder) measured from baseline (Day 0) and at Day 5 of treatment, compared with standard care plus placebo.


Eligibility criteria: Inclusion Criteria:

* Male/females aged between 40-80 years
* Previous diagnosis of COPD
* Acute exacerbation of COPD requiring treatment with antibiotics and/or corticosteroids
* Symptoms of increased breathlessness, cough, sputum volume or sputum purulence
* Acute exacerbation of COPD hospitalised within 24hrs of study participation.
* On a stable therapeutic regimen for COPD for 8 weeks prior to inclusion
* Known history of cigarette smoking at least 10 pack yrs
* Willing and able to comply with study procedures
* Able to provide written informed consent to participate

Exclusion Criteria:

* Acute exacerbation of COPD within 8 weeks prior to inclusion
* Arterial blood gas on admission \< pH 7.26
* Currently on treatment with mucolytics
* Patients suffering from post nasal drip, or gastro-oesophageal reflux disease
* Clinically significant or unstable concurrent disease e.g. left ventricular failure, diabetes mellitus
* On long-term oxygen therapy
* Known or suspected hypersensitivity to erdosteine

Primary outcomes:
measure: 24 hr cough recording
timeFrame: 5 days
Secondary outcomes:
measure: Quality of life questionnaire
timeFrame: 10 days
Other outcomes:
Locations:
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
state: East Yorkshire
Study officials:
affiliation: Hull and east Yorkshire NHS trust
name: Alyn H Morice, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01492218: Observational Study With Mixtard® 30 NovoLet® to Assess Patient Satisfaction
Official title: A Prospective, Open-labelled, Non-controlled Observational Study to Assess Patient Satisfaction, Physician Acceptability and Safety of Mixtard® 30 NovoLet® for the Treatment of Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2011-12-14
Enrollment: 1330
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with type 1 or type 2 diabetes mellitus and are not presently using Mixtard® 30 NovoLet®

Brief summary: This study is conducted in Asia. The aim of this study is to assess patient satisfaction after switching to biphasic human insulin 30 treatment using the NovoLet® insulin device as treatment for diabetes mellitus under normal clinical practice setting.


Eligibility criteria: Inclusion Criteria:

* Diabetes mellitus (type 1 or type 2)
* Patient not presently using Mixtard® 30 NovoLet®

Primary outcomes:
measure: Change in Diabetes Treatment Satisfaction Questionnaire (DTSQ) score
Secondary outcomes:
measure: Adverse events
measure: Technical complaints of NovoLet® device
Other outcomes:
Locations:
city: Manilla
country: Philippines
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR,1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03643718: Web-based International Register of Emergency Surgery and Trauma
Official title: Web-based International Register of Emergency Surgery and Trauma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Appendicitis
Acute Cholecystitis
Acute Diverticulitis
Post-operative Complications
Acute Pancreatitis
Perforated Gastro-duodenal Ulcers
Adhesive Small Bowell Occlusion
Colonic Neoplastic Emergencies
Gynecological Emergencies
Vascular Emergencies
Intestinal Ischemia
Abdominal Wall Hernia
Foreign Bodies
Caustic Ingestion
Trauma
Lead sponsor: A.O. Ospedale Papa Giovanni XXIII
Sponsor class: OTHER
Collaborators: name: World Society of Emergency Surgery
name: University of Pisa
First posted: 2018-08-23
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients affected by an acute surgical disease and/or who may require to be undergone to the emergency surgeon attention to be managed either with an operative or a non-operative approach.

Brief summary: The WIRES-T project (Web-based International Registry of Emergency General Surgery and Trauma) has been set up to allow to all the EGS (Emergency General Surgery) and Trauma surgeons to register their activity and to obtain a worldwide register of traumatic and non traumatic surgical emergencies. This will give the opportunity to evaluate results on a macro-data basis and to give index allowing stratifying, evaluating and improving the outcomes.


Eligibility criteria: Inclusion Criteria:

* Patients affected by an acute surgical disease
* Patients with indication to be referred to the emergency surgeon attention
* Patients to be operated or to be treated with non-operative approach without surgical intervention

Exclusion Criteria:

* Patients not affected by an acute surgical disease
* Patients without indication to be referred to the emergency surgeon attention

Primary outcomes:
measure: Rate of patients treated with surgery
timeFrame: Until hospital discharge, approximately 2 weeks
measure: Rate of patients treated with conservative treatment
timeFrame: Until hospital discharge, approximately 2 weeks
Secondary outcomes:
measure: Mortality
timeFrame: Until hospital discharge, approximately 2 weeks
measure: Morbidity
timeFrame: Until hospital discharge, approximately 2 weeks
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: General, Emergency and Trauma surgery, University Hospital of Pisa
Study officials:
References:
Clinical trial NCT02189018: Activity To Improve Outcomes in Peripheral Arterial Disease
Official title: Activity To Improve Outcomes in Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Arterial Occlusive Disease
Keywords: Peripheral arterial disease
Endovascular
Exercise
Perfusion
Functional capacity
Lead sponsor: Baltimore VA Medical Center
Sponsor class: FED
First posted: 2014-07-14
Enrollment: 208
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Peripheral artery disease (PAD) results in blockages of arteries (blood vessels) in the legs and decreased blood flow to the legs. This may cause difficulty or pain with walking or other activities that use leg muscles. Exercise may help improve blood flow in the legs and improve the ability to walk. This research project is being implemented in adults with PAD to examine the effects of exercise or weight loss programs on lower extremity blood flow, health, and physical function.

Detailed description: This pilot study seeks to gather data on different exercise interventions in PAD. Collectively, the proposed studies will gather data on the role of novel exercise interventions in those with PAD who are receiving conservative treatment as well as those who have undergone an endovascular intervention for lower extremity arterial disease.

We hypothesize that patients who undergo an exercise intervention will: A) show improved lower extremity perfusion and B) improve their functional ability, compared to a standard care control group over 6 months of follow-up. We further hypothesize that these improvements are mediated through angiogenesis and increased perfusion of the lower limb, as well as improvements in muscle strength, mass, and function.

Eligibility criteria: Inclusion Criteria:

* Age 21-90 years
* Ankle brachial index \< 0.9

Exclusion Criteria:

* Cancer under active treatment, except prostate, skin, and hematologic cancers
* Planned for open lower extremity bypass surgery
* Body mass index \>45
* Lower extremity gangrene

Primary outcomes:
measure: Lower extremity perfusion
timeFrame: 6 months
Secondary outcomes:
measure: Functional capacity
timeFrame: 6 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VAMC
state: Maryland
Study officials:
affiliation: Baltimore VAMC, University of Maryland School of Medicine
name: Brajesh K Lal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00171418: Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
Official title: Assessment of the Effects of Tegaserod in the Management of Gastroesophageal Reflux Disease (GERD) in Patients With Incomplete Response to Proton Pump Inhibitors (PPIs).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: GERD
PPI
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study to assess the effects of adding tegaserod to PPI therapy results in clinically meaningful improvement of GERD symptoms in patients with incomplete relief of symptoms on daily PPI therapy alone.


Eligibility criteria: Inclusion Criteria:

* GERD symptoms for at least 6 months
* PPI therapy for at least 4 weeks
* Incomplete symptom relief on daily PPI therapy
* No erosive disease as evidenced in EGD/no change in symptom severity

Exclusion Criteria:

* Evidence of structural abnormality of the gastrointestinal tract or disease/conditions
* Previous gastrointestinal surgery that may influence esophageal motor function
* Known primary esophageal motor disorder other than Inefficient Esophageal Motor Disorder
* Evidence of cathartic colon or a history of laxative use

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: To determine the effect of 4 weeks of tegaserod treatment in addition to PPI on clinically meaningful incremental gain in improvement of overall GERD symptoms, based on weekly binary questions.
Secondary outcomes:
measure: To evaluate the sensitivity of three global symptom assessments, including two binary scales and a Likert-type scale along with a composite symptom index (end of treatment compared to baseline)
measure: To evaluate frequency, severity and bothersomeness of individual GERD symptoms (daily assessments)
measure: Safety assessment
Other outcomes:
Locations:
city: Metairie
country: United States
facility: Drug Research Services, Inc
state: Louisiana
city: Oklahoma City
country: United States
facility: The Oklahoma Foundation for Digestive Research
state: Oklahoma
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT02543918: A Study of the Immune Response to Vaccines and Ixekizumab (LY2439821) in Healthy Participants
Official title: Vaccination Response Following Administration of Ixekizumab to Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2015-09-07
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to compare the body's immune response when vaccines are given alone versus when vaccines are given along with the study drug called ixekizumab. The vaccines protect against pneumonia and tetanus. This study will last about 6 weeks with follow-up at 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Healthy males and females without compromised immune system
* Have a body mass Index of 18 to 32 kilograms per square meter (kg/m²)

Exclusion Criteria:

* Previously completed or withdrawn from an ixekizumab study or a study investigating interleukin-17 (IL-17) antagonists
* Have participated, within the last 30 days, in a clinical trial involving an investigational product. If the previous investigational product has a long half-life, 3 months or 5 half-lives (whichever is longer) should have passed
* Have known allergy or hypersensitivity to any biologic therapy
* Past vaccination allergy or Arthus-type hypersensitivity
* Received a tetanus toxoid-containing vaccine within the last 5 years
* Severe allergic reaction to Boostrix
* Allergic to latex
* Have been immunized with pneumococcal vaccine
* Known hypogammaglobulinemia
* History of Guillain-Barre Syndrome
* Active infectious disease
* Had a live vaccination within 1 year prior to screening, or intend to have a live vaccination during the course of the study
* Evidence of a significant uncontrolled neuropsychiatric disorder -
* Have a score of 3 on Item 12 of the Quick Inventory of Depressive Symptomatology-Self Report (16 Items) at screening
* Evidence of Human Immunodeficiency Virus infection, Hepatitis C, B
* Had symptomatic herpes zoster within 3 months of screening
* Women who are lactating

Primary outcomes:
measure: Percentage of Participants With an Immune Response to Tetanus and Pneumococcal Vaccinations
timeFrame: Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance
state: Florida
city: Evansville
country: United States
facility: Covance
state: Indiana
city: Dallas
country: United States
facility: Covance
state: Texas
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Gomez EV, Bishop JL, Jackson K, Muram TM, Phillips D. Response to Tetanus and Pneumococcal Vaccination Following Administration of Ixekizumab in Healthy Participants. BioDrugs. 2017 Dec;31(6):545-554. doi: 10.1007/s40259-017-0249-y.
Clinical trial NCT02090218: I-Gel in Out-of-hospital Cardiac Arrest in Norway
Official title: I-Gel Versus Current Practice in Out-of-hospital Cardiac Arrest by Paramedics in Norway - a Prospective Stepped Wedge Crossover Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Out of Hospital Cardiac Arrest
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
Collaborators: name: Sykehuset Innlandet HF
name: Helse Midt-Norge
name: Helse Fonna
First posted: 2014-03-18
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main objective of this trial is to compare the effectiveness of a newer supraglottic airway method (the i-Gel), compared to current airway management practice in out-of-hospital cardiac arrests treated by Norwegian ambulance services.


Eligibility criteria: Inclusion Criteria:

* Out-of-hospital cardiac arrest patients requiring and receiving advanced airway management on ambulance missions. Advanced airway management is defined as the attempted insertion of an airway adjunct (I-Gel, laryngeal tube or ETI) or the administration of ventilatory assistance/support (including bag-mask ventilation (BMV) or other ventilatory support.
* Adult patients (\> 18 years).

Exclusion Criteria:

* Non-adult patients / minors (\< 18 years).
* Traumatic cardiac arrest.

Primary outcomes:
measure: ventilation success
timeFrame: up to 24 hours
Secondary outcomes:
measure: survival to hospital discharge / 30-day survival
timeFrame: up to 30 days
measure: levels of ETCO2 related to the presence and quality of bystander CPR
timeFrame: up to 24 hours
measure: cerebral function assessed by Glascow Outcome Score at discharge from hospital
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 4 weeks
measure: insertion related complications
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Brumunddal
country: Norway
facility: Innlandet Sykehus HF
city: Haugesund
country: Norway
facility: Helse Fonna HF
city: Trondheim
country: Norway
facility: Ambulanse Midt-Norge HF
Study officials:
affiliation: Haukeland University Hospital
name: Geir A Sunde, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haukeland University Hospital
name: Jon-Kenneth Heltne, MD, PhD
role: STUDY_CHAIR
affiliation: Haukeland University Hospital
name: Guttorm Brattebø, MD
role: STUDY_CHAIR
affiliation: Haukeland University Hospital
name: Hanne Klausen, MD
role: STUDY_DIRECTOR
References: