louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02243410: Visual Analogue Scale - a Quality Assurance Study
Official title: Visual Analogue Scale (VAS) - a Quality Assurance Research Study to Assess the Quality of the VAS as a Means for Measuring Postoperative Pain.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Surgery
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2014-09-17
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All participants will be postoperative patients of Department of Surgery, Department of Gynecology and Department of Orthopaedic Surgery, all based at Herlev Hospital.

Brief summary: It has come to our attention that there is not a general consensus of how to apply Visual Analogue Scale (VAS) as a tool in measuring pain amongst postoperative patients in Denmark.

The assumption is that patients will grade the level of pain differently dependent on how VAS is presented.

Detailed description: To ensure the data is valid for the study it has been decided to base the research material on four different VAS usage, as it is most often used in clinical practise in Denmark. Which in this case implies VAS horizontal, with and without endpoint, and VAS vertical, with and without endpoint. Every participant will grade their pain on each of the listed VAS representations. Furthermore, as a guideline, the participant will be asked to grade the pain on a Numerical Ranking Scale (NRS).

The ordering of VAS lines will be subject to randomization, for each participant

Eligibility criteria: Inclusion Criteria:

* Patient must have undergone surgery within the last five days
* The patient must be able and willing to participate in the study
* Must be at 18 years of age or older
* A patient can only participate one time.

Exclusion Criteria:

* Previously included patients
* Medically treated patients Linguistic difficulties
* Mentally or physically exhausted

Primary outcomes:
measure: agreement in VAS values with horizontal vs vertical and with and without stop lines
timeFrame: First five days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Herlev Hospital
Study officials:
affiliation: Professor
name: Jacob Rosenberg, MD
role: STUDY_CHAIR
References:
Clinical trial NCT06422910: Video Exercise Mobile Application for People With Knee Osteoarthritis
Official title: Development and Investigation of the Effectiveness of Video Exercise Mobile Application for People With Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Telerehabilitation
Osteoarthritis, Knee
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
Collaborators: name: The Scientific and Technological Research Council of Turkey
First posted: 2024-05-21
Enrollment: 52
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 aim of our study is to realize an exercise training and follow-up system that individuals with knee OA can easily adapt.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of primary knee osteoarthritis (OA) according to the American College of Rheumatology (ACR) criteria
* Be qualified to use the mobile application and agree to use the application

Exclusion Criteria:

* Individuals with poor cognitive function or inadequate reading skills
* Individuals with neurological disorders that may affect mobility skills
* Individuals who have undergone knee joint surgery and individuals with traumatic injuries

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Change from Baseline VAS at 8 weeks
measure: The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: Change from Baseline WOMAC at 8 weeks
measure: Satisfaction and expectation assessment
timeFrame: Change from Baseline Satisfaction and expectation assessment at 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Fethiye State Hospital
state: Fethiye
Study officials:
affiliation: Muğla Sıtkı Koçman University
name: Fatih Özden, PhD
role: STUDY_CHAIR
affiliation: Muğla Sıtkı Koçman University
name: Baki Umut Tuğay, PhD
role: STUDY_DIRECTOR
affiliation: Muğla Sıtkı Koçman University
name: Barış Ethem Süzek, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sanko University
name: Nazan Tuğay, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Marmara University
name: Zübeyir Sarı, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Haliç University
name: İrem Çetinkaya, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: İstanbul Medeniyet University
name: Gülser Cinbaz, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04901910: Social Media Intervention - Physical Activity
Official title: Social Media Intervention for Cannabis Use and Physical Activity in Emerging Adults - Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Keywords: social media
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2021-05-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to develop and test social media interventions to help young people increase well-being and reduce risky behaviors. The study will help us learn about ways to deliver wellness information in a way that is appealing and helpful to young people that use social media.

Eligible participants will be enrolled after baseline survey is completed. Participants will be involved with the secret social media group they are assigned to for 8 weeks. In addition, surveys will be completed at various times during and after the 8 week social media group.


Eligibility criteria: Inclusion Criteria:

* self-report using cannabis at least 3 times per week or more often in the past month
* active Facebook profile

Exclusion Criteria:

* participants who cannot read English will be informally excluded
* if participants fail identity verification based on:

  * Internet Protocol (IP) addresses
  * survey time completion
  * repeat attempts
  * survey responses
  * photo identification from a time stamped self picture sent to the research team
* cannot safely engage in moderate to vigorous physical activity \[assessed at screening\]
* participated in previous Project Verdi waves

Primary outcomes:
measure: Acceptability of intervention (i.e., ratings of e-coaches, )
timeFrame: 3 months (after baseline)
measure: Acceptability of intervention (i.e., helpfulness of peer interaction)
timeFrame: 3 months (after baseline)
measure: Feasibility of intervention as evidenced by metrics of key activities (accepting group invitation)
timeFrame: 8 weeks post-group start
measure: Feasibility of intervention as evidenced by metrics of key activities (engaging in the group)
timeFrame: 8 weeks post-group start
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Erina Bonar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02084810: Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven® in Healthy Male Subjects
Official title: A Single Centre, Randomised, Double-blind, Two-way Crossover Trial in Healthy Male Subjects Investigating the Bioequivalence of Eptacog Alfa A 6 mg and NovoSeven®
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia A With Inhibitors
Haemophilia B
Haemophilia B With Inhibitors
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-03-12
Enrollment: 0
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of the trial is to investigate the bioequivalence of eptacog alfa A 6 mg and NovoSeven® in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* Male, age 18-55 years, both inclusive, at the time of signing informed consent
* Body Mass Index (BMI) 18.5-30 kg/m\^2, both inclusive
* Good general health based on assessment of medical history, vital signs, physical examination, ECG (electrocardiogram), and laboratory data at screening, as judged by the investigator

Exclusion Criteria:

* Known history of thromboembolic event(s) or potential thromboembolic risk as judged by the investigator

Primary outcomes:
measure: Area under the curve
timeFrame: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
measure: Maximum concentration
timeFrame: After a single i.v. injection based on FVIIa activity assessments up to 36 hours post dose
Secondary outcomes:
measure: Frequency of adverse events (including serious adverse events)
timeFrame: Assessed up to 7 weeks following first trial product administration
measure: Incidence of antibodies
timeFrame: Assessed up to 7 weeks following first trial product administration
Other outcomes:
Locations:
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01676610: Infant Pulse Oximetry in Pakistan Study
Official title: Infant Pulse Oximetry in Pakistan (iPOP) Study: Utility and Feasibility of Integrating Pulse Oximetry Into the Routine Assessment of Young Infants at First-level Clinics in Karachi, Pakistan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypoxemia
Neonatal Sepsis
Pneumonia
Keywords: Pulse Oximetry
Pediatrics
Pakistan
Hypoxemia
Neonatal Sepsis
Pneumonia
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2012-08-31
Enrollment: 3149
Sex: ALL
Minimum age (years): 1
Maximum age (years): 59
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young infants, aged 0-59 days.

Brief summary: Hypoxemia is an abnormally low concentration of oxygen in the blood, and is an important sign of cardio-respiratory compromise in acutely ill patients. Pulse oximetry (PO) is a rapid, portable, non-invasive and accurate method of measuring arterial hemoglobin oxygenation (Sp02), and can therefore be readily implemented to detect hypoxemia in the clinical setting. In this research study, we propose to test the hypothesis that the use of pulse oximetry to detect hypoxemia by first-level health workers' in Karachi, Pakistan is useful and feasible for the identification of the infants most urgently in need of medical care. We will enroll 1,400 infants 0-59 days of age who present to one of two primary health centers in Karachi. Infants will undergo brief clinical assessment by a community health worker (CHW) based on the WHO/UNICEF Integrated Management of Neonatal and Child Illness (IMNCI) algorithm, assessment by two pulse oximetry devices, and examination by a physician. The primary outcomes include prevalence of hypoxemia, feasibility of PO (e.g., time to obtain measurement, number of infants for who repeat measurements are required), and concordance between paired measurements on separate devices.


Eligibility criteria: Inclusion Criteria:

* Infant presenting to the Bilal or Bhains PHC in Karachi, Pakistan
* Age 0 - 59 days

Exclusion Criteria:

* Clinic visit is for scheduled injectable antibiotic administration (e.g., SAT trial)

Primary outcomes:
measure: Prevalence of hypoxemia
timeFrame: Over the duration of hopsital stay, on average 24 hours
Secondary outcomes:
measure: Validity of PO
timeFrame: Baseline, +2 hours
measure: Comparison of PO Measurements
timeFrame: Baseline, +2 hours
measure: Operational Feasibility
timeFrame: Baseline, +2 hours
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Karachi
country: Pakistan
facility: Aga Khan University
Study officials:
affiliation: The Hospital for Sick Children
name: Daniel Roth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02665910: Multiple Doses Escalation Study of SHR0302 in Rheumatoid Arthritis (RA) Patients
Official title: A Phase I, Randomized, Placebo-Controlled, Multiple Doses Escalation Study to Investigate Safety, Pharmacokinetics and Pharmacodynamics of SHR0302 in Patients With RA
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Rheumatoid Arthritis
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-01-28
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Condition: Rheumatoid Arthritis Intervention: Drug: SHR0302; Drug: SHR0302 placebo comparator Phase: Phase 1 Study Type: Interventional Study Design: Treatment, Parallel Assignment, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Randomized


Eligibility criteria: Inclusion Criteria:

* Male or female subjects who are 18\~70 years of age on the day of signing informed consent,
* Have a diagnosis of RA meeting the 1987 ACR/EULAR criteria of RA and ACR functional class I-III,
* Body mass index (BMI = weight/height squared (kg/m2)) within the range of 19 to 30,
* Have agreed to not use any anti- rheumatic drug except for study drugs during the study period.

Exclusion Criteria:

* Current therapy with any disease modifying anti-rheumatic drug (DMARD), with the exception of Methotrexate (MTX), Leflunomide, sulfasalazine, antimalarials, gold preparations, penicillamine, which must have discontinued for a period of at least 7 t1/2s prior to dosing,
* Previous RA treatment with DMARDs or drugs with strong immunosuppressive effect in 3 months prior to dosing (12 months for rituximab or other B cell depleting agents),
* Previous therapy with NSAIDs or oral glucocorticoids in 2 weeks before dosing,
* Any parenteral (intramuscular or intravenous injection) or intra-articular corticosteroids therapy in 4 weeks before dosing,
* Previous treatment with interferons in 4 weeks before dosing.

Primary outcomes:
measure: Adverse events and the number of volunteers with adverse events as a measure of safety and tolerability.
timeFrame: up to 48 hrs postdose
Secondary outcomes:
measure: The maximum plasma concentration (Cmax) of SHR0302
timeFrame: At protocol-specified times up to 48 hrs postdose
measure: The area under the plasma concentration-time curve (AUC) of SHR0302
timeFrame: At protocol-specified times up to 48 hrs postdose
measure: t1/2 of SHR0302
timeFrame: At protocol-specified times up to 48 hrs postdose
Other outcomes:
measure: Pharmacodynamics (PD) parameters of percent and actual change from baseline for a panel of JAK dependent biomarkers
timeFrame: At protocol-specified times up to 24 hrs postdose
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Pei Hu, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Xiaofeng Zeng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00509210: Study of Telaprevir in Subjects With Hepatic Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Insufficiency
Keywords: Liver Disease
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2007-07-31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to assess the safety and pharmacokinetics of Telaprevir following administration of multiple oral doses to subjects with moderate and severe hepatic impairment.


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with Child Pugh score of 7-9 or greater than 10
* Women of non-childbearing age

Exclusion Criteria:

* Tested positive for HIV, Hepatitis C, Hepatitis B

Primary outcomes:
measure: Pharmacokinetics
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University, Department of Medicine,Division of Gastroenterology / Hepatology
state: Indiana
Study officials:
affiliation: Indiana University, Department of Medicine, Division of Gastroenterology/Hepatology
name: Paul Y Kwo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00825110: SS-GCC1- Screening Study of Genetic Changes in Colorectal Cancer
Official title: SS-GCC1- Screening Study of Genetic Changes in Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Keywords: colorectal
cancer
gene expression
biomarker
genomic mismatch repair
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2009-01-19
Enrollment: 3750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients at the Royal Marsden with a diagnosis of colorectal cancer will be eligible to enter this study.

Adults who have a terminal illness

Brief summary: the principal research objective is to form a database of tissue samples from patients with colorectal (bowel) cancer. The tissue samples that will be used for this research will have already been taken for diagnostic or therapeutic reasons. We will also be asking for consent for a research blood sample. The database will be used to improve our understanding of the molecular genetics and gene expression patterns in colorectal cancer.

Detailed description: All patients at the Royal Marsden with a diagnosis of colorectal cancer will be eligible to enter this study. This will include patients both with early and advanced disease, provided they give informed consent. They will give written consent to participate, to include consent for analysis of existing tumour tissue and consent for collection of demographic and clinicopathological data relating to their case and its future outcome, and consent for a blood sample to be taken for research purposes. Additionally, old samples of material surplus to clinical requirements may be collected without specific consent if there is no possibility that it would affect the patient's interest (eg the patient has died).

Eligibility criteria: Inclusion Criteria:

* adults who have a terminal illness
* 18 and over
* confirmed diagnosis of colorectal carcinoma
* ability to give informed consent
* paraffin embedded histological material available for analysis

Exclusion Criteria:

* medical or psychiatric conditions
* impairing ability to give informed consent

Primary outcomes:
measure: the primary endpoint is the identification of cases with evidence of loss of the product of one of the four main MMR genes on tumour histology.
Secondary outcomes:
measure: Secondary outcome measure is the survival and response to treatment of the identified cases.
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Prof Cunningham, David
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02716610: Dose-Response and Variability of Inhaled Insulin in Type 2 Diabetes
Official title: Samba-02: An Investigation of the Dose-Response and Subject Variability of Inhaled Insulin in Subjects With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Dance Biopharm Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-23
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: Pharmacokinetic (PK) and Pharmacodynamic (PD) dose-response investigation of Dance-501 inhaled human insulin

Detailed description: This study investigated the pharmacokinetic (PK) and pharmacodynamic (PD) properties of Dance-501, a novel inhaled human insulin liquid formulation (INH) and device. Twenty-four subjects with type 2 diabetes (T2DM) received 3 INH doses: low (69 units), medium (139 units) and high (208 units) and 1 equivalent medium dose (18 units) of subcutaneous insulin lispro (LIS).

The medium dose was repeated to determine within subject variability. PD was investigated during a 12 hour euglycemic clamp.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus treated with insulin injections at a total daily dose less than 1.2 U/kg/day.
* Body mass index 25-40 kg/m2
* Hemoglobin A1c 6.5-9.5%
* Forced vital capacity and forced expiratory volume in 1 second at least 75% of predicted normal values.
* Fasting c-peptide less than 1 nmol/L

Exclusion Criteria:

* Any condition possibly affecting drug absorption from the lung, in particular subjects with decreased lung function or subjects taking bronchodilators or subjects who smoke.
* Active or chronic pulmonary disease.
* Any major disorder other than type 2 diabetes.
* Decompensated heart failure or myocardial infarction at any time or angina pectoris within the last 12 months.
* Proliferative retinopathy or maculopathy or severe neuropathy.

Primary outcomes:
measure: Area under the curve for insulin from 0-8 hours (AUCins0-8h)
timeFrame: 0 to 8 hours following each dose
measure: Maximum concentration of insulin (CMaxIns)
timeFrame: up to 12 hours following each dose
measure: Area under the curve for glucose infusion rate from 0-12 hours (AUGgir0-12h)
timeFrame: 0 to 8 hours following each dose
measure: Maximum glucose infusion rate (GIRmax)
timeFrame: up to 12 hours following each dose
Secondary outcomes:
measure: Bioavailability
timeFrame: 0 to 8 hours following each dose
Other outcomes:
Locations:
Study officials:
affiliation: Profil Institut für Stoffwechselforschung GmbH
name: Tim Heise, MD
role: PRINCIPAL_INVESTIGATOR
References: