louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00246935: Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)
Official title: A Long-term Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Phosphodiesterase 4 inhibitor
Roflumilast
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Mitsubishi Tanabe Pharma Corporation
First posted: 2005-11-01
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with chronic obstructive pulmonary disease (COPD) who completed the 24-week evaluation of study APTA-2217-06. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is an extension of the 24-week study APTA-2217-06 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.


Eligibility criteria: Main inclusion criteria:

* Patients with chronic obstructive pulmonary disease (COPD)
* Written informed consent
* Patients who completed the 24-week evaluation of study APTA-2217-06

Main exclusion criteria:

* If patients required hospitalization or received emergency care for COPD exacerbation by the investigator (or sub-investigator) between the informed consent day and the starting day
* Patients with long-term oxygen therapy
* Serious diseases

Primary outcomes:
measure: Long-term safety after 28 weeks treatment of Roflumilast (total 52 weeks, 24 weeks of study APTA-2217-06 followed by 28 weeks) .
Secondary outcomes:
measure: Efficacy.
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Nycomed in Japan and Mitsubishi Tanabe Pharma Corporation
Study officials:
affiliation: AstraZeneca
name: AstraZeneca AstraZeneca
role: STUDY_DIRECTOR
References:
Clinical trial NCT03832335: A New Measurement of Anseikonia Tolerance
Official title: Can we Measure Aniseikonia Tolerance in a Normal Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Aniseikonia
Anisometropia and Aniseikonia
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2019-02-06
Enrollment: 31
Sex: ALL
Minimum age (years): 60
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: group 1: eyehealthy pahkic individuls group 2: eyehalthy phakic patients awainting cataratc surgery

Brief summary: Population 1:

Measure the effect of size glasses from1-9% on stereopsis

Population 2:

Measure the effect of size glasses from 1-9% on stereopsis in two settings:

* before and after cataract surgery
* after dilation of the eye

Detailed description: Population 1:

21 eye healthy phakic individuals. Measurements: baseline stereopsis and stereopsis after size glass (1-9%) is added in front of the right eye and in front og the left eye. This measurement provides details on how much size difference a person can endure without impairing stereopsis.

Population 2:

11 phakic eye healthy individuals awaiting cataract operation on both eyes. Measurements are the same as population 1 but this study group is also measured after dilating the eyes. This is to see if accommodation affects the measurement. A postoperative measurement six weeks after cataract operation is also performed to examine if cataract operation affects the measurement.

Eligibility criteria: Inclusion Criteria:

* No previous eye history
* cataract grade \<= 1
* visual acuity above 0.8

Exclusion Criteria:

* lack of cooperation
* amblyopia
* axial anisometropia
* ametropia

Primary outcomes:
measure: Aniseikonia tolerance
timeFrame: baseline
measure: Change of Aniseikonia tolerance after surgery
timeFrame: six weeks after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Rigshospitalet-glostrup
state: Danmark
Study officials:
References:
Clinical trial NCT05933135: Factor XIII Activity in Gastrointestinal Bleedings
Official title: Influence of Factor XIII Activity on the Outcome of Gastrointestinal Bleedings
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastro Intestinal Bleeding
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2023-07-06
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients were retrospectively recruited if they suffered an episode of a gastrointestinal bleeding and factor XIII was measured.

Brief summary: The aim of this retrospective study is to investigate the relationship between factor XIII activity and the outcome of gastrointestinal bleedings. Since factor XIII is of great importance in haemostasis and plays a key role in stabilizing the fibrin clot, it can be assumed that a deficiency of factor XIII leads to an unfavorable course of gastrointestinal bleedings. Our hypothesis is that early detection of such a deficiency can prevent a more severe course and that substitution of factor XIII contributes to faster cessation of bleeding, improves patient outcome and reduces the number of red cell concentrates required.


Eligibility criteria: Inclusion Criteria:

* Age over 18 years
* Confirmed diagnosis of gastrointestinal bleeding
* Assessment of factor XIII activity during the gastrointestinal bleeding episode

Exclusion Criteria:

* Age under 18 years
* Diagnosis of hemophilia A or B or other congenital coagulation disorders

Primary outcomes:
measure: Red cell concentrates
timeFrame: 1 year
Secondary outcomes:
measure: Hospitalization
timeFrame: 1 year
measure: Interventions
timeFrame: 1 year
measure: Mortality
timeFrame: 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
state: Styria
Study officials:
affiliation: Medical University of Graz
name: Christoph Hoegenauer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02238535: Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
Official title: Use of Ventavis in Patients With Postembolic Residual Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Residual Pulmonary Hypertension
Lead sponsor: Meshalkin Research Institute of Pathology of Circulation
Sponsor class: NETWORK
First posted: 2014-09-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effectiveness of the synthetic analogue of prostacyclin in postembolic residual pulmonary hypertension.


Eligibility criteria: Inclusion Criteria:

* Patients with pulmonary embolism after undergone surgical treatment (intravascular thrombolysis, catheter thrombus fragmentation)
* Patients with preserved thromboembolism in the pulmonary circulation system and mean pressure in the pulmonary artery of more than 25 mm Hg

Exclusion Criteria:

* Patient did not sign the informed consent.
* Mean pulmonary artery pressure after surgical treatment less than 25 mm Hg
* Age above 75 years.
* Patients with an increased risk of bleeding - including gastric ulcer and 12 duodenal ulcer in acute, hemorrhagic stroke.
* Severe coronary artery disease (unstable angina, myocardial infarction within the last 6 months).
* Acute heart failure or CHF IV in NYHA.
* Severe arrhythmias.
* Pregnancy, lactation.
* The presence of severe diseases of other organ systems that may result in death during the first year after surgery.

Primary outcomes:
measure: Pulmonary hypertension
timeFrame: 6 months
Secondary outcomes:
measure: Number of deaths
timeFrame: 6 months
measure: Number of recurrent pulmonary embolisms
timeFrame: 6 months
measure: Number of venous thromboembolisms
timeFrame: 6 months
Other outcomes:
Locations:
city: Novosibirsk
country: Russian Federation
facility: State Research Institute of Circulation Pathology
Study officials:
References:
Clinical trial NCT04696835: fNIRS in Pediatric Hearing Aids
Official title: Use of Near-infrared Functional Spectroscopy (fNIRS) in the Evaluation of Hearing Rehabilitation in Children With Hearing Aid(s)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hearing Loss
Keywords: NIRS
hearing aid
pediatrics
cochlear implant
rehabilitation
neuroimaging
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
Collaborators: name: Fondation William Demant
First posted: 2021-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Pilot phase. Monocentric, non-controlled, non-randomized, open-label study evaluating the capacity of the functional near-infrared functional neuroimaging (fNIRS) technique to translate temporal cortical activity in response to a speech stimulus in normo-hearing and deaf children with cochlear implants.

Hemodynamic changes are expected to be observed that indicate brain activity following the stimuli, resulting in a change in the concentration of oxygenated hemoglobin (HbO) and deoxygenated hemoglobin (HbR) recorded by the fNIRS.

The use of the FNIRS in the evaluation of hearing aid effectiveness could contribute to a more adapted management of childhood hearing loss since conventional methods in young children are not adapted to the needs of children with hearing loss.


Eligibility criteria: Inclusion Criteria:

* Group A: Infants and toddlers 3-18 months of age who are normal hearing.
* Group B: Infants and toddlers aged 3 to 18 months with sensorineural hearing loss fitted with a unilateral or bilateral hearing aid with optimized adjustments by the hearing healthcare professional.
* Socially insured subject
* Parents or guardians who have given their consent to participate in the study

Exclusion Criteria:

* Medical condition that does not allow for research compliance.

Primary outcomes:
measure: Oxygenated haemoglobin concentration (HbO)
timeFrame: Baseline (at inclusion)
Secondary outcomes:
measure: Deoxygenated haemoglobin concentration (HbR)
timeFrame: Baseline (at inclusion)
measure: HbO Concentration
timeFrame: At 3 months, 6 months, 12 months and 24 months
measure: HbR Concentration
timeFrame: At 3 months, 6 months, 12 months and 24 months
Other outcomes:
Locations:
city: Lille
country: France
facility: Hopital Roger Salengro, CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Christophe VINCENT, PU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01156935: Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients in a Oncologic Clinic Setting.
Official title: Effects of Laugh-yoga Intervention on Mood and Quality of Life Among Oncologic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neoplasms
Keywords: Neoplasm
Laugh-Yoga
Mood
Quality of life
Lead sponsor: Wolfson Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-07-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Previous studies report low levels of mood and of quality of life among cancer patients. Laugh has been proved to improve mood and immune system function. The investigators propose to assess in a prospective randomised case-control study the affects of laugh-yoga intervention on mood levels and quality of life among cancer patients in a cancer clinic. The main hypothesis is that patients in laugh-yoga group will report higher mood and quality o life levels after intervention in comparison with no-intervention group. The second hypothesis is that immune system is the mediator of the effects of laugh-yoga intervention on mood and quality of life.


Eligibility criteria: Inclusion Criteria:

* oncologic patients treated in oncologic clinic in Wolfson MC,
* must be able to participate in Laugh Yoga session

Exclusion Criteria:

* psychiatric or cognitive impairment,
* deterioration in physical status,
* treatment discontinuation

Primary outcomes:
measure: Quality of Life Questionnaire - QLQ-C30 & Positive-Negative Affect
timeFrame: Participants will fill QLQ-C30 & Positive -Negative Affect will be assessed before intervention and after three laugh - yoga sessions (that is after three weeks)
Secondary outcomes:
measure: Blood analysis for WBC, CRP, T&B Lymphocytes
timeFrame: Before intervention and after three laugh-yoga interventions, that is after three weeks.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02003235: Assessment of Device for Treatment of Amblyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Keywords: Amblyopia
Lead sponsor: Visior Technologies Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-06
Enrollment: 35
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The study will evaluate the effect of Reviview™, a dichoptic video display device for administrating a novel treatment protocol for Amblyopia (lazy eye) in kids.

The effect of the treatment will be measured by the change from baseline in Visual acuity and in Stereoscopic Vision; and to assess the ease of use of and compliance by the patients.


Eligibility criteria: Inclusion Criteria:

Refractive or Strabismic Amblyopia, with best corrected visual acuity.

(1) Refractive Amblyopia, visual acuity score \<6:15 (worse then)

* or (2) Strabismic Amblyopia, visual acuity score between 6:15 and 6:30

Exclusion Criteria:

Diagnosed with epilepsy, recently treated with occlusion or penalization therapy

Primary outcomes:
measure: Improvement in VA in amblyopic eye
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tel-Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Tel-Aviv Sourasky Medical Center
name: Haim Stolovitch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05796635: An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores
Official title: An Investigation Into the Efficacy of Herpecin L at Reducing the Frequency and Severity of Cold Sores
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cold Sores
Lead sponsor: Focus Consumer Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2023-04-03
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Focus Consumer Healthcare has developed Herpecin L. Herpecin L combines many different ingredients hypothesized to promote quick healing and symptom reduction from cold sores.


Eligibility criteria: Inclusion Criteria:

* Male Female between 18-60 years of age.
* Must be in good health with no significant chronic conditions and a BMI under 35.
* Must experience regular cold sores or fever blisters
* Must agree to avoid daily lip balm or another product designed to alleviate their cold sore (e.g., Abreva or other over-the-counter cold sore products).

Exclusion Criteria:

* Suffers from pre-existing conditions that would prevent them from adhering to the protocol including chronic conditions such as oncological or psychiatric disorders.
* Anyone with known severe allergic reactions.
* Unwilling to follow the study protocol.
* Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study.

Primary outcomes:
measure: The primary aim of this research is to understand the changes in cold sore severity.
timeFrame: 12 weeks
Secondary outcomes:
measure: The secondary objective of this trial is to examine differences in cold sore frequency between the two groups.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References:
Clinical trial NCT05647486: Predictors of 30-day Postoperative Outcome After Elective EVAR
Official title: Predictors of 30-day Postoperative Outcome After Elective Endovascular Abdominal Aortic Aneurysm Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Complications
Lead sponsor: University of Thessaly
Sponsor class: OTHER
First posted: 2022-12-12
Enrollment: 322
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: The study included consecutive AAA patients treated electively by EVAR

Brief summary: This study investigated the 30-day postoperative outcome after elective EVAR and the role of possible predictors among patients' baseline characteristics

Detailed description: The study included 322 consecutive AAA patients treated electively with EVAR from March 2016 to February 2019 at a tertiary referral center.

Early follow-up with clinical and laboratory evaluation took place at the 30rd day post-operatively. Any adverse event, such as major adverse cardiovascular events (MACE), post-implantation syndrome (PIS), acute kidney injury (AKI), and deaths of any cause were recorded.

Eligibility criteria: Inclusion Criteria:

* Only patients managed with EVAR using standard bifurcated devices in elective setting were included.

Exclusion Criteria:

* Patients treated for ruptured, symptomatic, inflammatory or infectious AAA were excluded. Furthermore, any patient needing complex endovascular repair of the proximal landing zone was considered ineligible. Additional exclusion criteria were the presence of any trauma or surgery within two months before EVAR, any autoimmune or systemic inflammatory disease and any malignancy. Of note, any patient with clinical or laboratory signs of infection before the scheduled operation was not offered an EVAR until a complete resolution of the infection was confirmed via a clinical, laboratory and/or imaging evaluation.

Primary outcomes:
measure: Number of patients with major adverse cardiovascular events
timeFrame: 30rd day post-operatively
measure: Number of patients with acute kidney injury
timeFrame: 30rd day post-operatively
measure: Number of patients with post-implantation syndrome
timeFrame: 30rd day post-operatively
measure: Deaths of any cause
timeFrame: 30rd day post-operatively
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital of Larissa
state: Thessaly
Study officials:
affiliation: University of Thessaly
name: Eleni Arnaoutoglou, Professor
role: STUDY_CHAIR
References:
Clinical trial NCT00420186: A Phase I Study of BMS-690514 in Combination With Paclitaxel and Carboplatin
Official title: A Phase I Study to Determine the Safety, Pharmacokinetics and Pharmacodynamics of BMS-690514 in Combination With Paclitaxel and Carboplatin for Patients With Advanced or Metastatic Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cancer (Solid Tumors)
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-01-09
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical research is to assess the safety and tolerability of BMS-690514 when given in combination with paclitaxel and carboplatin. Paclitaxel and carboplatin will be administered on a standard regimen every 3 weeks at standard doses. BMS-690514 will be given in the interval at escalating doses until the maximum tolerated dose (MTD) is identified. An additional cohort of subjects will be treated with BMS-690514 at the MTD in combination with Paclitaxel and carboplatin


Eligibility criteria: Inclusion Criteria:

* Patients with advanced or metastatic solid tumors for whom paclitaxel/carboplatin is considered an appropriate therapy
* Centrally located squamous cell carcinoma of the lung is permitted
* ECOG performance status of 0-1
* Life expectancy of at least 3 months
* Men and women age 18 and above

Exclusion Criteria:

* Symptomatic brain metastases. Patients with signs for symptoms of brain metastases are ineligible unless brain metastases are ruled out by CT or MRI
* Peripheral neuropathy ≥Grade 1 for any reason
* History of thromboembolic disease or bleeding diatheses within the last 6 months
* Women of child bearing potential without adequate contraception, breastfeeding, or pregnant
* Serious, uncontrolled medical disorder or active infection
* Uncontrolled or significant cardiac disease
* Uncontrolled hypertension (150/100)
* Allergy to Cremophor EL®

Primary outcomes:
measure: To assess safety and tolerability and to identify a dose for BMS-690514 in combination with paclitaxel/carboplatin for Phase II evaluation
timeFrame: upon occurrence
Secondary outcomes:
measure: Describe anti-tumor activity
timeFrame: upon occurence
measure: Obtain blood, plasma and fresh and/or archived tumor tissue for exploratory research
timeFrame: upon occurence
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Ottawa
country: Canada
facility: Local Institution
state: Ontario
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: