louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03400241: Pharmacokinetic Study Comparing Tiotropium Easyhaler and Spiriva Handihaler
Official title: Pharmacokinetic Pilot Study Comparing Absorption of Inhaled Tiotropium Between Tiotropium Easyhaler® Products and Spiriva® Capsules Delivered Via HandiHaler®
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Subjects
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2018-01-17
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Absorption of inhaled tiotropium is compared between three Tiotropium Easyhaler products and Spiriva capsules inhaled via HandiHaler. All subjects will receive all products as a single dose.


Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects
* 18-60 years old
* Body mass index \>19 and \<30 kg/m2
* Weight at least 50 kg
* Written informed consent obtained

Exclusion Criteria:

* Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
* Any condition requiring regular concomitant treatment.
* Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator may interfere with the interpretation of study results or constitute a health risk for the subject.
* Known hypersensitivity to tiotropium bromide, atropine or its derivatives, or lactose.
* Pregnant or lactating females and females of childbearing potential not using proper contraception.
* Blood donation, loss of a significant amount of blood or administration of another investigational medicinal product within 90 days before the first study treatment administration

Primary outcomes:
measure: Peak plasma concentration (Cmax) of tiotropium
timeFrame: between 0-72 hours after dosing
measure: Area under the concentration-time curve (AUC) of tiotropium from time zero to 72 h after the study treatment administration
timeFrame: 0-72 hours after dosing
measure: Truncated area under the concentration-time curve (AUC) of tiotropium from time zero to 30 min after study treatment administration
timeFrame: 0-30 minutes after dosing
Secondary outcomes:
measure: Time to reach peak concentration in plasma (tmax) of tiotropium
timeFrame: between 0-72 hours after dosing
Other outcomes:
measure: Adverse events
timeFrame: throughout the study, an average of 10 weeks
Locations:
city: Espoo
country: Finland
facility: Clinical Pharmacology Unit
Study officials:
affiliation: Orion Corporation, Orion Pharma
name: Ulla Sairanen, MSc
role: STUDY_DIRECTOR
References:
Clinical trial NCT04916041: Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses
Official title: Visual Function in Subjects Implanted With Advanced Technology Intraocular Lenses
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lenses, Intraocular
Lead sponsor: Clínica Rementería
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have undergone bilateral cataract surgery between three and nine months prior to study procedures, with bilateral implantation of one of the intraocular lens models included in the study

Brief summary: Multiple intraocular lens are nowadays available for implantation after cataract surgery. They use different technology to try to improve patient spectacle independence. It is necessary to better characterise the performence of each type of lens, as well as to define how they are affected by residual refractive errors. The purpose of this study is to evaluate visual function in patients implanted with different lenses (advanced monofocals, trifocals) in order to be able to recommend the best type of lens for each patient.


Eligibility criteria: Inclusion Criteria: Bilateral cataract surgery Bilateral implantation of one of the intraocular lens models included in the study

Exclusion Criteria:

Intrasurgical complications Postsurgical complications Ophthalmological disease that limits visual potential as estimated by investigator

Primary outcomes:
measure: Intermediate binocular uncorrected visual acuity
timeFrame: 3-9 months after cataract surgery
Secondary outcomes:
measure: Distance binocular uncorrected visual acuity
timeFrame: 3-9 months after cataract surgery
measure: Near binocular uncorrected visual acuity
timeFrame: 3-9 months after cataract surgery
measure: Binocular contrast sensitivity
timeFrame: 3-9 months after cataract surgery
measure: Halo perception
timeFrame: 3-9 months after cataract surgery
measure: Self-reported visual function questionnaires
timeFrame: 3-9 months after cataract surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clínica Rementería
Study officials:
References:
Clinical trial NCT00574041: How Side Effects of Avonex Are Affected by Gradually Increasing to Full Dose vs Starting at Full Dose
Official title: An Open-Label Study to Examine the Difference in Tolerability Associated With Titration Of Dose on Initiation of Avonex therapY (TODAY)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Relapsing Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
Avonex
side effects
flu like symptoms
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2007-12-14
Enrollment: 19
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 is to find out if starting at low dose Avonex and slowly increasing to full dose will improve flu like symptoms as a side effect of Avonex treatment.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of clinically-definite relapsing-remitting multiple sclerosis

Exclusion Criteria:

* Any Product Information-specified contraindications to interferon-beta therapy, or other medical factors which, in the opinion of the investigator, make the subject unsuitable for interferon-beta therapy
* Use of AVONEX, but not other interferon therapies, in the 3 months prior to randomisation into the study
* A clinically significant infectious illness (e.g., cellulitis, abscess, pneumonia, septicemia) within 30 days prior to randomisation.
* History of seizure in the 3 months prior to randomisation
* History of suicidal ideation or severe depression within the 3 months prior to randomisation.
* Other inclusion and exclusion criteria may apply per study protocol

Primary outcomes:
measure: To assess the mean severity of episodes of FLS during the 4 week titration phase
timeFrame: 4 weeks
Secondary outcomes:
measure: To assess the mean severity and duration of FLS episodes in post-titration phase
timeFrame: throughout study
Other outcomes:
Locations:
city: Malvern
country: Australia
facility: Coordinating Research Site
state: Victoria
Study officials:
affiliation: Biogen
name: Biogen-Idec Investigator
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00254241: Safety and Efficacy of Seroquel in First Episode Schizophrenia
Official title: Safety and Efficacy of Seroquel in First Episode Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Schizophrenia
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-11-16
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode schizophrenia


Eligibility criteria: Inclusion Criteria:

* Age 18-35 years Meet ICD-10 criteria for schizophrenia No abnormaility on clinical examination No previous episode of psychosis No previous antipsychotics of any kind in last 3 months

Exclusion Criteria:

* Have received a course of antipsychotics drug treatment prior to entry which may introduce risk factors or interfere with study procedures Have received anticholinergics within 10 days of baseline aseessment Have received mood stabilizers or anti depressants within 2 weeks

Primary outcomes:
measure: The proportion of patients developing clinically significant EPS at any point between baseline (day 1) and final assessment
Secondary outcomes:
measure: CGI severity of illness
measure: CGI global improvement
measure: PANSS total score and subscales)
measure: Abnormal Involuntary Movement Scale (AIMS)
measure: Dose of anti cholinergic medication
measure: Serum prolactin levels
measure: Proportion of patients discontinuing treatment due to reasons of lack of efficacy or adverse effects
measure: Proportion of patients experiencing relapse.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZenenca
name: AstraZeneca Seroquel Medical Science Director, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01523041: Comparison of Two Formulations of Biphasic Insulin Aspart 70
Official title: A Randomised, Double Blind, Single Centre, Three Period Crossover Trial Testing the Bioequivalence of Two Formulations of Biphasic Insulin Aspart 70 and Characterising the Pharmacokinetics of Biphasic Insulin Aspart 50 in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-02-01
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to compare two formulations of biphasic insulin aspart 70 and characterise the pharmacokinetics of biphasic insulin aspart 50 and biphasic insulin aspart 70 in healthy male subjects.

Detailed description: Each subject participated in three treatment periods, and were randomly assigned to each of the six treatment sequences in varying order

Eligibility criteria: Inclusion Criteria:

* Caucasian
* Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
* Body mass index (BMI) between 19-27 kg/m\^2
* Fasting plasma glucose between 3.8-6.0 mmol/L

Exclusion Criteria:

* Participation in any other clinical trial involving other investigational products within the last three months
* Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
* Any serious systemic infectious disease that occurred in the 4 weeks prior to the first dose of test drug

Primary outcomes:
measure: Area under the insulin aspart curve in the interval from 0-24 hours
Secondary outcomes:
measure: Cmax, maximum insulin aspart concentration
measure: tmax, the time to maximum insulin aspart concentration
measure: t½, terminal half-life
measure: Cmin, minimum glucose concentration
measure: tmin, time to minimum concentration
Other outcomes:
Locations:
city: Leeds
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT03354741: Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children
Official title: Stimulation of Acupuncture Points by Athermic Laser Therapy for the Prevention of Chemotherapy Induced Nausea and Vomiting in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Children
Chemotherapy-induced Nausea and Vomiting
Malignant Tumor
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2017-11-28
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Poor control of chemotherapy-induced nausea and vomiting has a major clinical and psychological impact in patients treated with chemotherapy. Metabolic, nutritional and mechanical complications, as well as psychological repercussions, complicate the therapeutic management of the patient and can lead to poor compliance, a deterioration in the general condition or even prolongation of hospitalizations and a delay in the implementation of chemotherapy cures. The control of induced chemo- and radio-induced nausea and vomiting rests above all on their prevention. At present and in most centers, the prevention of nausea and vomiting in the pediatric onco-hematology department of the CHU de Nice is based exclusively on drug treatments, according to a protocol established according to the emetogenic risk of the chemotherapy received.

We propose a study evaluating the effectiveness of the stimulation of acupuncture points by low frequency laser therapy associated with antiemetics in the management of chemotherapy induced nausea and vomiting in patients of 2 to 20 years followed in the service of analgesics. pediatric onco-hematology.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of malignant pathology with indication of chemotherapy with moderate to severe emetogenic potential
* Indication of at least three identical chemotherapy cures
* Age between 2 and 20 years
* Prescription of an anti emetic protocol
* Karnosky / Lansky Index\> 60%

Exclusion Criteria:

* Proven laser contraindication
* Vomiting in the 24 hours before starting treatment
* Presenting a brain lesion responsible for nausea and vomiting
* Pelvic abdominal irradiation the week before the start of treatment
* Treatment with benzodiazepines or opioids the week before treatment
* Pregnant women

Primary outcomes:
measure: The complete response to the preventive treatment of nausea and vomiting
timeFrame: Hours 72 after the end of chemotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Dr Marilyne POIREE
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Marilyne POIREE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02676141: Responsiveness of the German Version of the Neck Disability Index (NDI-G)
Official title: Responsiveness of the German Version of the Neck Disability Index (NDI-G)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neck Pain Chronic
Lead sponsor: Balgrist University Hospital
Sponsor class: OTHER
Collaborators: name: Maastricht University
First posted: 2016-02-08
Enrollment: 50
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: Patients with chronic neck pain.

Brief summary: This study evaluates if the German Version of the NDI is sensitive to change over time.

Detailed description: Chronic neck pain patients will be asked to participate in the study.

The participants are asked to fill out the NDI at the beginning of the study and after seven weeks. Additionally the participants will fill out the PGIC.

Eligibility criteria: Inclusion Criteria:

* Chronic neck pain
* over 18 years old
* informed consent
* able to speak, write and read German.

Exclusion Criteria:

* Any problems that may exclude Manual Therapy treatment of the cervical spine e.g fractures

Primary outcomes:
measure: Change of the German Version of the Neck Disability Index (NDI-G)
timeFrame: Change from Baseline to seven weeks
Secondary outcomes:
measure: Patient's Global Impression of Change Scale (PGIC)
timeFrame: Seven weeks after the baseline measurement
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Balgrist University Hospital
Study officials:
affiliation: Balgrist University Hospital
name: Jaap Swanenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Langenfeld A, Gassner AP, Wirth B, Muhlemann MB, Nyiro L, Bastiaenen C, Swanenburg J. Responsiveness of the German version of the Neck Disability Index in chronic neck pain patients: a prospective cohort study with a seven-week follow-up. Arch Physiother. 2022 Oct 17;12(1):23. doi: 10.1186/s40945-022-00149-y.
Clinical trial NCT06573541: Use of Ultrasound in the Initial Management of Patients in Shock in the Nancy Emergency Department
Official title: Use of Ultrasound in the Initial Management of Patients in Shock in the Nancy Emergency Department - Retrospective Descriptive Analysis
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Shock
Keywords: shock
ultrasound
emergency department
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults in shock at the Nancy ED

Brief summary: Context: shock is a serious pathology where diagnostic and therapeutic speed determines the prognosis, ultrasound can be a valuable aid for the emergency physician to differentiate the different types of shock and allow appropriate treatment.

Hypothesis: what are the uses of ultrasound in the initial diagnostic and therapeutic management of patients in shock at the Emergency Department of Nancy? Main outcome: Describe the use of ultrasound in the initial diagnostic and therapeutic management of patients in shock at the Nancy Emergency Department Secondary outcome: Study the contribution of the use of different ultrasound techniques in the initial diagnostic and therapeutic management of patients depending on the type of shock state


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Shock (MAP \< 65 mmHg + lactate ≥ 2 mmol/l)
* Admission to the Nancy ED between 01/01/2023 and 12/31/2023
* ICD-10 output coding: R57: shock, not elsewhere classified; R570: cardiogenic shock; R571: hypovolemic shock; R572: septic shock; R578: other shocks; R579: shock, unspecified; T794: traumatic shock; T782: anaphylactic shock, unspecified; or diagnosis of entry into intensive care including the word "shock"

Exclusion Criteria:

* Age \< 18 years old
* Absence of shock
* No passage through the Nancy ED
* Patient whose initial treatment was carried out in another emergency department
* State of shock occurring after going to the emergency department

Primary outcomes:
measure: rate of ultrasound use
timeFrame: Day 0
Secondary outcomes:
measure: rate of patients with care changes
timeFrame: Day 0
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU
Study officials:
References:
Clinical trial NCT00449241: Acupuncture Treatment in Adults Undergoing Diagnostic OGD : A Double-Blind Placebo Controlled Randomized Trial
Official title: Acupuncture Treatment in Adults Undergoing Diagnostic Upper Gastrintestinal Endoscopy: A Double-Blind Placebo Controlled Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anxiety
Keywords: Acupuncture, Endoscopy
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2007-03-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To find out how the application of acupuncture needles to the proposed acupuncture points: Heart 7 (HT 7) and Pericardium 6 (PC 6) for reducing anxiety during Esophago-gastro-duodenoscopy (EGD)

Detailed description: Acupuncture is being used as one part of Chinese medicine for more than 2,500 years in treating diseases. Recent functional magnetic resonance imaging demonstrated that acupuncture can suppress the "pain" area in the brain so as to reduce the pain that felt by human subjects. Western medicine proposed the acupuncture mechanisms as to "provoke the release of endogenous substances" from central nervous system so in reducing pain. Many studies had been done using acupuncture in reducing pain for post-operation period, however, most of them were not very systematic and even some of them are leak of control group. Furthermore, to our knowledge, the use of acupuncture for reducing anxiety during EGD has not been previously investigated.

Eligibility criteria: Inclusion Criteria:

* 18-70 undergoing elective unsedatant diagnostic EGD
* belonging to American Society of Anesthesia (ASA) classes 1 to 2

Exclusion Criteria:

* History of gastrectomy, esophagectomy, Whipple's operation and other gastrointestinal operations
* ASA class 3 to 4
* Pregnancy
* Allergy to acupuncture needles
* Request sedation
* Previous experiences of EGD

Primary outcomes:
measure: Anxiety elicited during EGD
Secondary outcomes:
measure: Overall tolerance, overall satisfaction, patient's willingness to repeat procedure and recovery time
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Combined Endoscopy Centre, Alices Ho Miu Ling Netherole Hospital
Study officials:
affiliation: Department of Surgery, CUHK
name: Wing Wa Leung, Master
role: PRINCIPAL_INVESTIGATOR
References: