louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00845195: Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Seasonal Allergic Rhinitis
Keywords: Rhinitis
Allergy
Nasal Spray
Antihistamine
Intranasal Corticosteroid
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-02-18
Enrollment: 150
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Able to provide consent/assent
* History of spring/summer allergic rhinitis
* Positive skin prick and/or intradermal test
* Absence of significant anatomic abnormalities, infection, bleeding, and mucosal ulcerations
* Non-pregnant (where applicable)
* Able to complete daily diary

Exclusion Criteria:

* Smoker
* Concurrent disease such as rhinitis medicamentosa or large obstructive nasal polyps
* History of current chronic sinusitis
* Asthma
* Use of anti-allergy immunotherapy, corticosteroids, chronic use of long acting antihistamines
* History of severe, unstable, or uncontrolled cardiovascular, hepatic, renal and/or other diseases/illnesses
* History or evidence of nasolacrimal drainage system malfunction

Primary outcomes:
measure: Mean Change in Reflective Total Nasal Symptom Score (rTNSS) From Baseline
timeFrame: 14 days minus baseline
measure: Mean Change in Reflective Total Ocular Symptom Scores (rTOSS) From Baseline
timeFrame: 14 days minus baseline
measure: Mean Change in Instantaneous Total Nasal Symptom Scores (iTNSS) From Baseline
timeFrame: 14 days minus baseline
measure: Mean Change in Instantaneous Total Ocular Symptom Scores (iTOSS) From Baseline
timeFrame: 14 days minus baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Alcon Call Center for Trial Locations
state: Texas
Study officials:
References:
Clinical trial NCT00056381: Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children Ages 2-17
Official title: Phase I/II Study of the Safety, Tolerance and Pharmacokinetics of Anidulafungin in Immunocompromised Children With Fever and Neutropenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Neutropenia
Keywords: neutropenia
fever
febrile neutropenia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Vicuron Pharmaceuticals
First posted: 2003-03-12
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Anidulafungin is a medicine being developed for treatment of adults with certain kinds of fungal infections. This study is evaluating anidulafungin in children and adolescents who have fever and a low white blood cell count (neutropenia).

Detailed description: Anidulafungin is an investigational drug being developed as an intravenous treatment for esophageal candidiasis, candidemia and other invasive fungal infections. Anidulafungin is an antifungal agent of the echinocandin class, which targets the fungal cell wall of yeast and other filamentous fungi.

Eligibility criteria: * Children ages 2-17 years with fever and neutropenia.
* The expected duration of neutropenia should be 10 days and due to cytotoxic chemotherapy or aplastic anemia.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: King of Prussia
country: United States
facility: Versicor
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05793281: An Observational Study to Learn More About NTRK Gene Fusion Positive in Solid Tumor in Japan
Official title: A Retrospective Observational Study to Investigate the Prevalence of NTRK Gene Fusion Positive in Solid Tumor in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced or Recurrent Solid Tumor Harboring an NTRK Gene Fusion
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2023-03-31
Enrollment: 46621
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with any solid tumor and genome profiling results

Brief summary: This is an observational study in which data from the past of people with solid tumors harboring an NTRK gene fusion in Japan are studied. In observational studies, only observations are made without specified advice or interventions.

Advanced or recurrent solid tumor harboring an NTRK gene fusion is a rare type of solid cancer caused by specific changes in the genes called NTRK gene fusion, and which has spread to nearby tissues and/or lymph nodes or has returned. Due to this change in the gene, an altered protein known as a TRK fusion protein is made, which can cause cancer cells to grow and survive.

The main purpose of this study is to learn more about NTRK gene fusion in people in Japan. To do this, researchers will collect information on the number or percentage of Japanese people with NTRK gene fusion in any solid tumor.

The data will come from the national database called C-CAT. They will cover the period from June 2019 until January 2023.

Besides this data collection, no further tests or examinations are planned, and no visits are required in this study.


Eligibility criteria: Inclusion Criteria:

* Patients with any solid tumor and genome profiling results

Exclusion Criteria:

* None

Primary outcomes:
measure: Prevalence of patients with NTRK gene fusions by patient characteristic categories, such as tumor types
timeFrame: Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)
measure: Distribution of cancer types in patients with NTRK fusion positive among all, adult and pediatric
timeFrame: Retrospective data analysis from June 2019 to the latest data available (planned end of February 2023)
Secondary outcomes:
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Many Locations
Study officials:
References:
Clinical trial NCT00441181: Effects of Travoprost on Neovascular Glaucoma
Official title: Effects of Travoprost on Neovascular Glaucoma
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Neovascular Glaucoma
Keywords: Neovascular glaucoma
Travoprost
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2007-02-28
Enrollment: 40
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: Prostaglandin analogues have not been used in the treatment of neovascular glaucoma because of suspicious lack of efficacy. This study aims at assessing the effect of travoprost on neovascular glaucoma.


Eligibility criteria: Inclusion Criteria:

* Neovascular glaucoma of known cause
* Older than 18 years
* Previously submitted to retinal photocoagulation
* Under medical treatment to glaucoma

Exclusion Criteria:

* Need of antiglaucomatous surgery
* Previous ocular surgery in the last 6 months
* Pregnancy

Primary outcomes:
measure: Intraocular pressure
Secondary outcomes:
measure: Inflammation
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Federal University of São Paulo
Study officials:
affiliation: Federal University of São Paulo
name: Luiz A Melo Jr, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00932581: Bradykinesia Subscale Administered Alone Versus Regular Administration: Psychometric Properties
Official title: Investigation of the Psychometric Properties of the Bradykinesia Subscale When Administered Alone Versus as a Component of the Entire Motor Examination Section of the Unified Parkinson's Disease Rating Scale
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Parkinson's Disease
Movement Disorders
Unified Parkinson's Disease Rating Scale
Short Parkinson's Evaluation Scale
Scales for Outcomes in Parkinson's Disease
Motor Evaluation
Schwab and England activities of daily living
Bradykinesia
psychometrics
order effects
hoehn yahr aging
assessments
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2009-07-03
Enrollment: 110
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of idiopathic Parkinsons disease (PD) who also presented with bradykinesia and one other cardinal sign at the time of assessment.

Brief summary: The purpose of this study is to examine whether scores on questionnaires that rate how much Parkinson's Disease (PD) has slowed movements of the body differ when the order of the questions are changed. The consistency and accuracy of the questionnaires will also be examined. It is hypothesized that there will not be a difference.


Eligibility criteria: Inclusion Criteria:

1. Male or Female at least 30 years of age
2. Willing to be assessed using the motor examination section of the UPDRS and the SPES/SCOPA motor evaluation
3. Patients must be willing and able to give written informed consent prior to performing an study procedures
4. Be in the "ON" State (only for patients who fluctuate between "ON" and "OFF" states)

Exclusion Criteria:

1. Absence of bradykinesia at the time of assessment
2. Hoehn and Yahr stage not available from patient's chart or not assessed between 3 and 180 days prior to clinic visit
3. Has received and experimental drug within the last thirty (30) days

Primary outcomes:
measure: Scores on the UPDRS motor evaluation subscale are equivalent.
timeFrame: 4 months
Secondary outcomes:
measure: Correlations between the UPDRS motor examination bradykinesis subscale and the remaining UPDRS motor examination items, Hoeh and Yahr stage, Schwab and England scale, and SPES/SCOPA motor evaluation.
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Teva Neuroscience, Inc.
name: Philip Buck, PhD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT05417581: Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition
Official title: Mitochondrial Oxygraphy on Subcutaneous and Peri-visceral Adipose Tissue: Influence of Body Composition
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Digestive Organs--Cancer
Bariatric Surgery Candidate
Parietal Region Trauma
Keywords: Mitochondria
Oxygraphy
Adipose Tissue
Body Mass Index
Digestive surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2022-06-14
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: all participants receive the same intervention
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to adapt the oxygraphy technique on human adipocytes and to characterize respiration measurements according to patients' body mass index and white adipose tissue localization (subcutaneous vs visceral).

Detailed description: During digestive surgery: oncological and bariatric surgery, it is possible to collect a small volume of subcutaneous and epiplonic adipose tissue (10-20 cc). We wish to collect these samples in order to develop the technique of oxygenography on permeabilized adipocytes. In order to characterize these measurements, they will be related to the clinical data of the patients usually collected in the framework of the preoperative assessment including the body mass index (BMI). The measured adipocyte data will thus be normalized to three BMI classes: ≤ 20, \> to 20 \< 30, and ≥ to 30 kg∙m-2.

Primary end point is to validate the measurement of mitochondrial respiration under oxidophosphorylating conditions by determining indicators of the distribution of mitochondrial respiration values (mean, standard deviation, skewness, kurtosis, coefficient of variation) as a function of patients' body mass index.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing oncological, bariatric, parietal surgery
* Patients able to give an informed consent
* Patients affiliated to an Health Care insurance
* Patients aged over 18

Exclusion Criteria:

* Patients under guardianship, curatorship or deprived of freedom
* Pregnant or breastfeeding women
* Participation refusal
* Patients under chemotherapy
* Patients with peritonitis and infectious parietal processes

Primary outcomes:
measure: Evaluation of mitochondrial respiration on adipose tissue by oxygraphy
timeFrame: day 1
Secondary outcomes:
measure: mitochondrial respiration values depending on patients BMI by oxygraphy
timeFrame: day 1
measure: comparing mitochondrial respiration values depending on tissue location by oxygraphy
timeFrame: day 1
measure: comparing mitochondrial respiration values depending on anthropometric data by oxygraphy
timeFrame: day 1
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU clermont-ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Ruddy RICHARD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04147481: Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery
Official title: Effects of Abdominal Nerve Block on Postoperative Recovery in Patients Undergoing Gastrointestinal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Rectal Cancer
Gastric Cancer
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the effect of general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) on the recovery of patients with gastrointestinal tumor after surgical treatment.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 to 80 years.
2. ASA 1-3.
3. Clinical diagnosis of gastric carcinoma and colorectal cancer without metastasis.
4. Surgery for gastrointestinal surgery.

Exclusion Criteria:

1. Patients and their family members refuse to accept the clinical trial;
2. Complicated with acute cholangitis, gastrointestinal bleeding or ascites, etc.;
3. Hepatic encephalopathy, psychosis or neuropathy;
4. Body weight for acid-base and electrolyte imbalances, endotoxemia, and cachexia decreased by more than 2% or 5% in the past 2 months or 6 months.
5. Uncontrolled hypertentsion, coronary heart disease, diabetes.

Primary outcomes:
measure: Incidence of postoperative chronic pain
timeFrame: 6 month after operation
Secondary outcomes:
measure: Bedridden time
timeFrame: The postoperative duration up to 15 days
measure: Fasting time
timeFrame: The postoperative duration up to 15 days
measure: Gastrointestinal decompression
timeFrame: The postoperative duration up to 15 days
Other outcomes:
measure: The numeric rating scale of postoperative pain
timeFrame: Within 7 days after surgery
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Haidian
Study officials:
affiliation: the Chinese PLA General Hospital
name: Yi Liu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04530981: A Drug-Drug Interaction Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate in Patients with Advanced GIST
Official title: A Phase 1 Open-label, Multicenter Study to Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Probe Substrate (Repaglinide) in Patients with Advanced Gastrointestinal Stromal Tumors (GIST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: GIST - Gastrointestinal Stromal Tumor
Lead sponsor: Deciphera Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2020-08-28
Enrollment: 13
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: Evaluate the Effect of Ripretinib on the Pharmacokinetics of a CYP2C8 Substrate


Eligibility criteria: Inclusion Criteria:

1. Patients ≥18 years of age.
2. Patients must have a histologic diagnosis of GIST.
3. Patients must have GIST that has progressed on or have intolerance to at least 2 lines of prior TKI therapies.
4. Patients must have an Eastern Cooperative Oncology Group performance score of ≤ 2.
5. If a female of childbearing potential, must have a negative pregnancy test prior to enrollment and agree to follow the contraception requirements.
6. Adequate organ and bone marrow function.

Exclusion Criteria:

1. Received prior anticancer or other investigational therapy within 28 days or 5× the half-life prior to the first dose.
2. Prior treatment with ripretinib.
3. Patients who have had prior repaglinide treatment within 14 days prior to Cycle 1 Day 1.
4. History or presence of clinically relevant cardiovascular abnormalities.
5. Gastrointestinal abnormalities including but not limited to:

   * inability to take oral medication,
   * malabsorption syndromes,
   * requirement for intravenous alimentation.
6. Patients who have type 1 or type 2 diabetes.

Primary outcomes:
measure: Maximum Observed Plasma Concentration for Repaglinide
timeFrame: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
measure: Area under the concentration-time curve (AUC) from time 0 up to time t (AUC0-t) for Repaglinide
timeFrame: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
measure: AUC from time 0 and extrapolated to infinity (AUC0-∞)
timeFrame: Cycle 1 Day 1 and Cycle 1 Day 15 (pre-dose and at multiple time points [up to 24 hours] post-dose). Each cycle is 28 days.
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: Cycle 1 through study completion (~ 12 months). Each cycle is 28 days.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Miami
country: United States
facility: Sylvester Comprehensive Cancer Center
state: Florida
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT03337581: Pharmacodynamics and Pharmacokinetics of Dexmedetomidine in Pediatric
Official title: The Safety、Efficacy and Pharmacokinetics of Dexmedetomidine Administered Through Different Routes in Pediatric
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pediatrics
Dexmedetomidine
Pharmacodynamics
Pharmacokinetics
Keywords: Dexmedetomidine
pediatrics
Pharmacodynamics
Pharmacokinetics
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2017-11-09
Enrollment: 187
Sex: ALL
Minimum age (years): 3
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 1. Acute Hemodynamic and respiratory Changes After Rapid Intravenous different doses of Dexmedetomidine in Pediatric.
2. Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric.
3. Pharmacokinetics after a single dose of Dexmedetomidine administered as a nasal spray in Pediatric.


Eligibility criteria: Inclusion Criteria:

* selective operation of inguinal hernia repair、orthopedics operation or general surgery operation in children
* aged 3-9 years
* ASA I - II
* enter the operating room by himself without parents
* normal liver and kidney function
* no history of anesthesia medication allergy.

Exclusion Criteria:

* allergic to dexmedetomidine, similar active ingredients or excipients
* G-6-PD deficiency
* a history of arrhythmia, bronchial and cardiovascular diseases, abnormal liver function and so on
* a history of use of alpha 2 receptor agonists or antagonists.

Primary outcomes:
measure: Acute Hemodynamic and respiratory Changes After Rapid Intravenous of Dexmedetomidine
timeFrame: up to 4 months
measure: Pharmacokinetics after a single Rapid Intravenous dose of Dexmedetomidine in Pediatric
timeFrame: up to 6 months
measure: Pharmacokinetics of Dexmedetomidine administered as a nasal spray
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
name: Huacheng Liu
role: STUDY_DIRECTOR
References:
Clinical trial NCT06301581: Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Official title: Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cochlear Hearing Loss
Lead sponsor: Advanced Bionics AG
Sponsor class: INDUSTRY
First posted: 2024-03-08
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The studied population consists of all CI users implanted with a HiRes Ultra Version V2 or HiRes Ultra 3D Version V2 CI at the Medical University of Hannover in Germany (MHH).

Brief summary: This is a retrospective study designed to collect speech perception results for HiRes Ultra CI and HiRes Ultra 3D CI users as measured in the clinical routine and to confirm the performance of these devices.


Eligibility criteria: Inclusion Criteria:

* Unilateral or bilateral HiRes Ultra CI or HiRes Ultra 3D CI users including

  * Ultra Version V2 newly implanted on this side (Group 1)
  * Ultra Version V2 users implanted following an Ultra Version V1 device failure in the same ear (Group 2)
* Informed consent signed

Exclusion Criteria:

* no exclusion criteria

Primary outcomes:
measure: Freiburger monosyllabic word recognition score in quiet in the implanted ear
timeFrame: 12 months after device activation
Secondary outcomes:
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
Study officials:
affiliation: Hannover Medical School
name: Andreas Büchner
role: PRINCIPAL_INVESTIGATOR
References: