louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00152412: Open Study to Evaluate the Safety of Levocetirizine in Young Children (2 - 6 Years) Suffering From Allergic Rhinitis
Official title: A 4 Week Open, Multi-center Study Evaluating the Safety of Levocetirizine 1.25 mg b.i.d. Given as 0.5 mg/mL Oral Solution in 2 to 6 Year-old Children Suffering From Allergic Rhinitis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Keywords: Allergic Rhinitis, safety, levocetirizine, children
Xyzal
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 30
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: 4 week open study to evaluate the safety of levocetirizine in young children (2 - 6 years) suffering from allergic rhinitis. As secondary objective, this study will assess the efficacy of the treatment by means of the T4SS (Total 4 symptoms scores of allergic rhinitis) and each of the 4 individual rhinitis symptom scores


Eligibility criteria: Inclusion Criteria:

* At Visit 1:

  * Male or female outpatients aged 2 to 6 years old.
  * Subjects suffering from allergic rhinitis (perennial and/or seasonal) and symptomatic as attested by the Daily Record Card (DRC).
* At Visit 2:

  * Respected wash-out periods for the forbidden medication.

Exclusion Criteria:

* • Presence of asthma requiring treatment by inhaled corticosteroids.

  * Atopic dermatitis or urticaria requiring antihistamine treatment or the administration of oral or topical corticosteroids, or any other disease requiring the administration of oral or topical corticosteroids, immunomodulatory drugs, anti-inflammatory, or cytotoxic drugs.
  * Use during the course of the study, or during the specific wash-out periods, of any of the following medications: intranasal or systemic corticosteroids (within 7 days), ketotifen (within 7 days), nedocromil or cromoglicate (within 7 days), loratadine and desloratadine (within 7 days), other antihistamines (within 3 days) or decongestants (per os, nasal spray, or drops - within 3 days), or any other concomitant medications that, in the opinion of the Investigator, interfered with the study.
  * Initiation or change of dose of an immunotherapy regimen during the course of the study.

Primary outcomes:
measure: To assess safety of levocetirizine 1.25 mg bid given as 0.5 mg/mL oral solution in 2 to 6 years old children suffering from allergic rhinitis over 4 weeks of treatment
Secondary outcomes:
measure: To assess efficacy of 1.25 mg levocetirizine 0.5 mg/mL oral solution bid in 2 to 6 years old children suffering from allergic rhinitis over 4 weeks by means of the T4SS and each of the 4 individual rhinitis
measure: To describe the serum concentration of levocetirizine after 1,3 and 6 hours following the last treatment intake
Other outcomes:
Locations:
Study officials:
affiliation: UCB Pharma
name: UCB Clinical Trial Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05217212: Do Markers of Systemic Inflammatory Response and Tumor Metabolism Indicate Radioresistance in Head and Neck Cancer?
Official title: Do Markers of Systemic Inflammatory Response and Tumor Metabolism Indicate Radioresistance in Head and Neck Cancer?
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Head and Neck Squamous Cell Carcinoma
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: Universität Luzern
First posted: 2022-02-01
Enrollment: 100
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 undergoing primary radio(chemo)therapy for oral, oropharyngeal, epipharyngeal, hypopharyngeal or laryngeal squamous cell carcinoma at Cantonal Hospital Lucerne, Switzerland

Brief summary: The aim of the study is to prospectively evaluate whether markers of a patient's systemic inflammatory response in addition to FDG-PET/CT metabolic parameters of the primary tumor or of nodal metastases can predict radioresistance and survival before primary radiochemotherapy in advanced head and neck cancer patients.

Detailed description: This study prospectively investigates pretherapeutic markers of systemic inflammatory response (including neutrophil-to-lymphocyte ratio, platelet-to-lymphocyte ratio, lymphocyte-to-monocyte ratio, systemic inflammation response index, and systemic immune-inflammation) and FDG-PET/CT-derived metabolic parameters of tumor and nodal metastases (including maximum standardized uptake value, metabolic tumor volume, and total lesion glycolysis) and their potential prognostic value in head and neck cancer patients prior to primary radiochemotherapy.

Eligibility criteria: Inclusion Criteria:

* histopathologic diagnosis of squamous cell carcinoma of the head and neck
* primary radio(chemo)therapy with curative intent
* available pretherapeutic FDG-PET/CT imaging
* available pretherapeutic differential blood analysis

Exclusion Criteria:

* other tumor entities of the head and neck including cutaneous squamous cell carcinoma
* primary surgical treatment
* ongoing infections or other inflammatory diseases at the time of diagnosis
* patients not completing a course of irradiation with at least 66 Gray locally

Primary outcomes:
measure: Survival
timeFrame: Prospective analysis of various measures of survival up to 5 years after completion of the therapy. Events such as tumor recurrence or death will be recorded continually.
Secondary outcomes:
Other outcomes:
measure: Correlation Analysis
timeFrame: At diagnosis
Locations:
city: Lucerne
country: Switzerland
facility: Department of Otorhinolaryngology - Head and Neck Surgery, Cantonal Hospital Lucerne
Study officials:
References:
Clinical trial NCT04825912: Resilience Measurement in Older Adults With Late-Stage Lung Cancer
Official title: Resilience Measurement, Prediction, and Its Role in Older Adults With Late-Stage Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Cancer Stage III
Lung Cancer Stage IV
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Wake Forest University Health Sciences
First posted: 2021-04-01
Enrollment: 18
Sex: ALL
Minimum age (years): 65
Maximum age (years): 100
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study to test measures of physical and psychological resilience while using Self-System therapy (SST), to treat depression and lung-cancer-related distress in older adults (65 years and older).

Detailed description: The investigator will examine the feasibility of delivering measures of psychological and physical resilience while delivering the SST intervention. The investigator will also examine whether participation in SST can help alleviate symptoms of depression and distress while helping improve overall physical functioning in older adults with advanced lung cancer.

Eligibility criteria: Inclusion Criteria:

* Age 65 or older
* English-speaking
* The patient has a diagnosis of late-stage (III-IV) lung cancer and is living at his/her home.

Exclusion Criteria:

* Unable to provide informed consent
* Visual or hearing impairments that preclude participation
* Serious mental illness

Primary outcomes:
measure: Confidence in Behavior as Measured by the Cancer Behavior Inventory
timeFrame: Baseline, 8 weeks, 10 weeks
Secondary outcomes:
measure: Coping Skills Related to Stress as Measured by the Brief COPE (Coping Orientation to Problems Experienced)
timeFrame: Baseline, 8 weeks, 10 weeks
measure: Resilience as Measured by the CD-RISC-25 (Connor-Davidson Resilience Scale)
timeFrame: Baseline, 8 weeks, 10 weeks
measure: Depression as Measured by the Beck Depression Inventory (BDI-II)
timeFrame: Baseline, 8 weeks, 10 weeks
measure: Positive Affect as Measured by the PANAS (Positive and Negative Scale)
timeFrame: Baseline, 8 weeks, 10 weeks
measure: Negative Affect as Measured by the PANAS (Positive and Negative Scale)
timeFrame: Baseline, 8 weeks, 10 weeks
measure: Physical Activity as Measured by the PASE (Physical Activity Scale for the Elderly)
timeFrame: Baseline, 8 weeks, 10 weeks
measure: Pain Interference as Measured by the PROMIS PI (Patient-Reported Outcomes Measurement Information System Pain Interference)
timeFrame: Baseline, 8 weeks, 10 weeks
measure: Number of Participants Who Completed the QUALE (Quality of Life at the End of Life)
timeFrame: Baseline, 8 weeks, 10 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Katherine Ramos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00714012: Evaluation of Information Displays-A Paper, Computer and Simulator Based Study
Official title: Evaluation of Information Displays-A Paper, Computer and Simulator Based Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Display development
Intuitive display use
visualizations are intuitive
Lead sponsor: University of Utah
Sponsor class: OTHER
Collaborators: name: Applied Medical Visualizations
First posted: 2008-07-14
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: projected end users of the domain specific visualizations. experts and novice users of the domain specific information.

Brief summary: Our objective is to develop intuitive, meaningful and ergonomically efficient informative displays specific to the user's domain.

Detailed description: Typically information monitors present numeric values, waveforms, alarms and informative sounds in a single sensor single indicator manner (5). In an effort to improve the situational awareness of the end user (6), we design and develop various visual metaphors and audible representations of information to communicate the past, present, and future status of a complex system. Our studies will identify the visual and auditory elements that optimize the presentation of critical domain specific information in an intuitive, meaningful manner as well as communicate critical events efficiently and saliently as they arise.

Eligibility criteria: Inclusion Criteria:

* projected end users of the domain specific visualizations.
* experts and novice users of the domain specific information.

Exclusion Criteria:

* Subjects having been exposed to a particular visualization prior to testing.

Primary outcomes:
measure: Subjects will be able to identify components of the visualization from predetermined lists of answers.
timeFrame: At time of observation
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Dwayne Westenskow
role: PRINCIPAL_INVESTIGATOR
References:
citation: Koch SH, Weir C, Westenskow D, Gondan M, Agutter J, Haar M, Liu D, Gorges M, Staggers N. Evaluation of the effect of information integration in displays for ICU nurses on situation awareness and task completion time: A prospective randomized controlled study. Int J Med Inform. 2013 Aug;82(8):665-75. doi: 10.1016/j.ijmedinf.2012.10.002. Epub 2013 Jan 26.
Clinical trial NCT03163212: Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
Official title: Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Safety Issues
Tolerance
Very Low Birth Weight Infant
Keywords: Lactoferrin/FOS Supplementation
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: The Gerber Foundation
First posted: 2017-05-22
Enrollment: 20
Sex: ALL
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Dose escalation design
Primary purpose: TREATMENT

Brief summary: This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. It also has antimicrobial and immunomodulation activities.

Detailed description: Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants

1. Lactoferrin/FOS related adverse events and serious adverse events
2. Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day)
3. Episodes of not receiving enteral feedings for \> 24 hours once feeding is initiated

Aim 2: To evaluate lactoferrin/FOS absorption and excretion

1. Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool
2. Examine lactoferrin levels in materal and human donor milk

Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure

Eligibility criteria: Inclusion Criteria:

* \< 15 days of age and receiving enteral feedings
* \< 1500 grams birth weight
* \< 37 weeks gestation

Exclusion Criteria:

* Congenital bowel obstruction (esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
* Known necrotizing enterocolitis or bowel perforation

Primary outcomes:
measure: Definitely related study solution serious adverse event
timeFrame: 30 days while receiving study solution
Secondary outcomes:
measure: Day after birth to reach 120ml/kg of enteral feeds
timeFrame: 30 days while receiving study solution
measure: Number of days not receiving any feedings after lactoferrin/FOS administration
timeFrame: 30 days while receiving study solution
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03207412: Human Amniotic Epithelial Cells Treatment for Ovarian Insufficiency
Official title: Clinical Study of Minimally Invasive Implantation of Human Amniotic Epithelial Cells in the Treatment of Premature Ovarian Insufficiency
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Premature Ovarian Failure
Lead sponsor: The Second Affiliated Hospital of Chongqing Medical University
Sponsor class: OTHER
Collaborators: name: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
First posted: 2017-07-02
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project will investigate the safety and effectiveness of human amniotic epithelial cells in primary ovarian insufficiency patients and provide a new cell therapy against infertility.

Detailed description: Premature ovarian insufficiency (POI) refers to women before the 40 years of age who suffer clinical manifestations of ovarian recession. Now, there is no exact and effective treatment to restore ovarian function. Human amniotic Epithelial cells (hAECs) are derived from human amniotic epithelium. hAECs retain the characteristics of embryonic stem cells, as well as a strong differentiation potential and plasticity. Experiments show that the fertility of mice is significantly improved after amniotic epithelial cells implantation. In order to further study the role of hAECs in POI treatment, this project will conduct minimally invasive implantation with hAECs in 20 cases of POI patients, and evaluate the changes of ovarian function and the safety of hAECs implantation. hAECs is prepared by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of POI, excluding genetic disease caused by patients; POI diagnostic criteria: Patients that \<40 years of age, oligomenorrhea for 4 months,FSH\> 25 IU/L.
2. Have fertility requirements;
3. Agree to sign the designed consent for the study.

Exclusion Criteria:

1. Breast cancer, ovarian cancer and other cancer/tumor;
2. Contraindications for pregnancy;
3. Coagulation disorder and other abnormal physical conditions.

Primary outcomes:
measure: Changes of follicle stimulating hormone(FSH)
timeFrame: 1 year
measure: antral follicle count (AFC)
timeFrame: 1 year
Secondary outcomes:
measure: Menstrual situation
timeFrame: 1 year
measure: Luteinizing Hormone(LH)
timeFrame: 1 year
measure: estrogen 2(E2)
timeFrame: 1 year
measure: Anti Mullerian Hormone(AMH)
timeFrame: 1 year
measure: Ovarian volume
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: The Second Affiliated Hospital of Chongqing Medical University
name: Chanyu Zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01609712: Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation
Official title: Osteoporotic Vertebral Compression Fractures: Can Kyphoplasty Improve Lung Function? A Prospective Evaluation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporotic Vertebral Compression Fractures
Lung Function
Keywords: Improvement of lung function (FEV1, PEF)
Visual Analog Scale
Oswestry Disability Index
Radiographs pre and post Op
Lead sponsor: University Hospital, Bonn
Sponsor class: OTHER
First posted: 2012-06-01
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with osteoporotic compression fractures, mostly elderly females

Brief summary: Patients with vertebral fractures often have problems to straighten and as a consequence of impaired lung ventilation that leads to a impaired lung function. Furthermore, it comes to the sintering of the vertebra and a so-called hunchback. This also contributes to the poorer expansion of the lung. Pain is also caused by respiratory excursions of the chest which hinder the patients to use their entire lung volume.

Kyphoplasty is designed to counter all these consequences of vertebral fractures by bringing stability to the fracture.

In order to prove the thesis the results of lung function test (FEV1, PEF) are assessed.


Eligibility criteria: Inclusion Criteria:

* over 50 years
* VAS over 49, ODI over 29
* radiographic evidence of A 1.1, 1.2, 1.3 fractures
* patients mentally capable to sign informed consent

Exclusion Criteria:

* high-energy trauma
* known tumor involvement
* osteonecrotic fractures
* burst fractures or pedicle fractures
* previous surgical treatment for a vertebral body compression fracture
* patient has paget's disease
* BMI \> 35
* uncontrolled diabetes HbAc1c \> 7%
* severe cardiopulmonary disease
* Myelopathy
* long-time steroid therapy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bonn
country: Germany
facility: Orthopädie und Unfallchirurgie Universitätsklinikum Bonn
state: NRW
Study officials:
affiliation: Orthopädie und Unfallchirurgie, Universitätsklinkum Bonn
name: Robert Pflugmacher, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02233712: Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.
Official title: An Open-label, Dose-finding, Schedule-changing, Multi-center Study to Determine the Antibody Response to G17DT Treatment of Patients With Gastric Cancer.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Gastric Cancer
Keywords: gastric cancer, stomach neoplasms,
Lead sponsor: Cancer Advances Inc.
Sponsor class: INDUSTRY
First posted: 2014-09-08
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial
* Male or female and over 18 years of age
* Must have a life expectancy of at least three months
* World Health Organization Performance Status of 0 to 1
* Given written conformed consent

Exclusion Criteria:

* Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study
* History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix
* Previous use within the last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
* Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
* Females who pregnant, planning to become pregnant or lactating
* Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study
* Previously received G17DT treatment
* Haemoglobin (Hb) \< 10.0 g/dL White blood cell count (WBC) \< 4.0 x 10\^9/L Platelets \< 100 x 10\^9/L

Primary outcomes:
measure: Antibody Levels
timeFrame: Up to Week 24
measure: Injection Site Reaction
timeFrame: Up to Week 12
measure: World Health Organization (WHO) Performance Status
timeFrame: Up to Week 12
measure: Diptheria Toxoid Antibody Levels
timeFrame: Up to Week 12
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to Week 24
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital Aintree
name: Peter G McCulloch, MB, ChB
role: PRINCIPAL_INVESTIGATOR
References: