louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00756418: Montelukast Post-marketing Comparative Study With Theophyline Added to Inhaled Corticosteroid (0476-396)
Official title: A Randomized Open-Label Comparative Study of Montelukast Versus Theophylline Added to Inhaled Corticosteroid in Pediatric Patients With Bronchial Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Organon and Co
Sponsor class: INDUSTRY
First posted: 2008-09-22
Enrollment: 84
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A clinical study explores the safety and efficacy of montelukast and to compare the safety and efficacy of montelukast with those of theophylline in pediatric bronchial asthma patients when they are used in conjunction with inhaled steroids.


Eligibility criteria: Inclusion Criteria:

* Pediatric Bronchial Asthma Patients Aged 6 To 14 Years (At The Beginning Of The Treatment Period)
* The Severity Must Be Mild, Moderate Or Severe, Persistent Bronchial Asthma
* The Patient Must Have Symptoms That Can Be Used As Efficacy Variables (Such As Repeated Coughing And Mild Or Moderate Asthma Attacks) During The Observation Period, And Must Be Using Inhaled Steroids

Exclusion Criteria:

* Patient Using Anti-Asthma Treatment Or Therapy Including corticosteroids Or Oral Anti-Allergic Drugs
* Patient With Complications That Will Impair The Judgment Of Efficacy Of This Drug
* Patient With Convulsive Disorders Such As Epilepsy Or Such A History
* Patient With Liver Disease, Renal Impairment, Heart Disease Or Such Other Complication

Primary outcomes:
measure: Improvement of AM PEF over first 2 Weeks
timeFrame: Over first 2 Weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kondo N, Katsunuma T, Odajima Y, Morikawa A. A randomized open-label comparative study of montelukast versus theophylline added to inhaled corticosteroid in asthmatic children. Allergol Int. 2006 Sep;55(3):287-93. doi: 10.2332/allergolint.55.287.
Clinical trial NCT00817518: A Dose-Escalating Study of RO4987655 in Patients With Advanced Solid Tumors
Official title: An Open-label, Dose-escalation Study With Extension to Evaluate Safety, Pharmacokinetics and Anti-tumor Activity of RO4987655, a MEK Inhibitor, Administered Orally as Monotherapy in Patients With Advanced Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasms
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-01-06
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will determine the maximum tolerated dose and the dose-limiting toxicities of RO4987655 in patients with advanced and/or metastatic solid tumors. In the first part of the study, groups of patients will be sequentially enrolled to receive ascending oral doses of RO4987655 daily for 28 days. The starting dose of 1mg daily will be escalated in subsequent groups of patients after a successful assessment of the safety and tolerability of the previous dose. In Part 2 of the study, patients with metastatic or advanced malignant melanoma, or any other responsive tumor type, will be randomized to receive either the maximum tolerated dose or the optimal biological dose of RO4987655 daily. The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* advanced and/or metastatic cancer not amenable to standard therapy;
* any solid tumor type (Part 1); malignant melanoma or other responsive tumor type (Part 2);
* measurable and/or evaluable disease (Part 1); \>=1 measurable lesion (Part 2);
* ECOG performance status 0-2.

Exclusion Criteria:

* prior chemotherapy, radiotherapy or immunotherapy within 28 days of first receipt of study drug;
* prior corticosteroids as anti-cancer therapy within 14 days of first receipt of study drug;
* active CNS lesions;
* acute or chronic infection.

Primary outcomes:
measure: Maximum tolerated dose (Part 1)
timeFrame: Reviewed after each 4 week cycle
measure: Tumor assessments (Part 2)
timeFrame: Every 8 weeks
Secondary outcomes:
measure: Adverse events, laboratory parameters, PD parameters, optimal biological dose (Parts 1 and 2)
timeFrame: Reviewed after each 4 week cycle
Other outcomes:
Locations:
city: Marseille
country: France
city: Paris
country: France
city: Paris
country: France
city: Villejuif
country: France
city: Essen
country: Germany
city: Amsterdam
country: Netherlands
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Sevilla
country: Spain
city: Cambridge
country: United Kingdom
city: London
country: United Kingdom
city: Oxford
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05519618: Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus
Official title: Multi-modality Evaluation of Flow Rate, Pressure and Size of Spine Epidural Venous Plexus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neoplasms
Spine Tumor
Venous Hypertension
Keywords: Spine tumor
Venous pressure
Internal vertebral venous plexus
Epidural venous plexus
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2022-08-29
Enrollment: 32
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who are suspected to have spine tumor, and referred to the multi-discipline spine oncology team in the study institute, for evaluation of debulking surgery or en bloc resection of the spinal tumor.

Brief summary: Vertebra is one of the most common site of metastatic disease, which may cause severe pain or neurological deficit. Debulking surgery usually has better local control and survival benefit as compared with decompression or radiotherapy. However, debulking surgery often accompany with massive blood loss, which may cause hemorrhagic shock or death. The major bleeding point during operation including tumor parenchyma, arteries that are difficult to ligate, and epidural venous plexus. Vascularity of tumor parenchyma had been associated with increased intraoperative blood loss, on the other hand, there is a lack in the literature regarding to evaluation of the size, flow and pressure of epidural venous plexus, and their changes after embolization.


Eligibility criteria: Inclusion Criteria:

1. Patient who receive pre-operative angiography and possible embolization before debulking surgery or en bloc resection of the spinal tumor.
2. The tumor has to be located in thoracic or lumbar spine.

Exclusion Criteria:

1. Confirmed non-tumor diagnosis.
2. Patient who cannot tolerate the procedure due to severe pain.
3. Patients who cannot receive angiography or embolization due to contraindications, including poor renal function (Serum creatinine \>2.0 deciliter/mg or estimated glomerular filtration rate(eGFR)) \< 30ml/min) , severe allergy to contrast medium, uncorrectable coagulopathy and bleeding diathesis.
4. Patient who has severe neurological deficit that should receive emergent decompression.
5. Poor image quality.
6. Expected life expectancy \< 6 months.

Primary outcomes:
measure: Epidural venous pressure
timeFrame: During the embolization intervention.
measure: Epidural venous flow rate.
timeFrame: During the embolization intervention.
Secondary outcomes:
measure: Size of epidural venous plexus.
timeFrame: During the embolization intervention.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Radiology, National Taiwan University Hospital
name: YuCheng Huang, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04124718: VDR and TFIP11 Gene Polymorphism and Gene-environmental Interaction in Adults
Official title: Association Between Enamel Gene Variants and Dental Caries in Adults
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Caries Experience
High Caries Experience
Keywords: caries experience, VDR, TFIP11, enviromental risk factor
Lead sponsor: Recep Tayyip Erdogan University Training and Research Hospital
Sponsor class: OTHER
First posted: 2019-10-11
Enrollment: 160
Sex: ALL
Minimum age (years): 24
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 160 adult in the 24-40 age range living in Northeast Turkey will allowed in the study

Brief summary: VDR and TFIP11 Gene polymorphism and gene-environment interactions on caries etiology and susceptibility in adults.

Detailed description: To date, genes can be grouped into categories based on the factor influencing dental caries. The major candidate gene categories to date include enamel formation genes, immune response genes, genes related to saliva, and genes related to taste and dietary habits.

TFIP11 and VDR genes are related to enamel formation genes

Eligibility criteria: Inclusion Criteria:

* adult be between 24 and 40 years old
* subject has DMFT (Decayed, Missing, Filled, Permanent Tooth) DMFT≤4 , or, DMFT\>13.9

Exclusion Criteria:

* systemic or genetic disorders
* orthodontic appliances
* pregnant women

Primary outcomes:
measure: past caries experience
timeFrame: 3 weeks
Secondary outcomes:
measure: Plaque index
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Rize
country: Turkey
facility: Recep Tayyip Erdogan University Dentistry Faculty
Study officials:
affiliation: Recep Tayyip Erdogan University Dentistry Faculty
name: Gül Yıldız Telatar, dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cogulu D, Onay H, Ozdemir Y, Aslan GI, Ozkinay F, Eronat C. The Role of Vitamin D Receptor Polymorphisms on Dental Caries. J Clin Pediatr Dent. 2016;40(3):211-4. doi: 10.17796/1053-4628-40.3.211.
Clinical trial NCT00493818: Open-label Study to Investigate the Safety, Tolerability, PK, and Pharmacodynamics of the AKT Inhibitor GSK690693
Official title: An Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the AKT Inhibitor GSK690693 Given on Various Schedules in Subjects With Solid Tumors or Lymphoma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Cancer
Keywords: GSK690693,
Solid Tumors,
Lymphoma,
AKT
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2007-06-28
Enrollment: 70
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: This study is a first time in human, Phase I, open-label study to determine recommended doses and schedules, based on maximum tolerated doses and biologically active doses, for the AKT inhibitor GSK690693.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of solid tumor malignancy or lymphoma that is not responsive to standard therapies or for which there is no approved therapy
* Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control.

Exclusion Criteria:

* Prior anti-cancer therapy within the prior 28 days.
* History of diabetes.
* Coronary artery disease/myocardial infarction, acute coronary syndromes within the past 6 months.
* Use of theophylline and warfarin within 14 days prior to the first dose of study drug.
* Current use of oral corticosteroids (note: Inhaled corticosteroids are permitted.)
* Participation in an investigational study within the prior 28 days.
* Pregnant or breast-feeding.

Primary outcomes:
measure: To determine the maximum tolerated dose of GSK690693 given weekly or twice weekly over 1 - 4 hours.
timeFrame: given weekly or twice weekly over 1 - 4 hours
Secondary outcomes:
measure: Blood pressure and heart rate every 8 hours.
timeFrame: every 8 hours.
measure: 12-lead ECGs will be conducted at 4, 8, 10, 12, 14, 24hrs
timeFrame: 4, 8, 10, 12, 14, 24hrs
measure: Pharmacokinetics and Pharmacodynamics via blood draws before, during, and after the infusion.
timeFrame: draws before, during, and after the infusion
measure: Urinalysis samples while the patient is hospitalized
timeFrame: while the patient is hospitalized
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: GSK Investigational Site
state: Indiana
city: Detroit
country: United States
facility: GSK Investigational Site
state: Michigan
city: Durham
country: United States
facility: GSK Investigational Site
state: North Carolina
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04579718: A Study of Radiotherapy Planning System Software ---- Zeus Cloud
Official title: A Multicenter Study on the Feasibility of a Radiotherapy Treatment Planning System (TPS) Software---Zeus Cloud
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Radiotherapy
Keywords: Treatment Planning System
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Soochow University
name: The Affilicated Suzhou Science and Technology Town Hospital
First posted: 2020-10-08
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with confirmed brain glioma, nasopharyngeal carcinoma, lung cancer, esophageal cancer, gastric cancer, liver cancer, prostate cancer, cervical cancer and rectal cancer.

Brief summary: To evaluate the feasibility of Zeus Cloud TPS in the design of photon intensity modulated radiation therapy (IMRT) plan for tumors in various parts of the body.

Detailed description: This is a self-control, multi-center non-inferiority study. Subjects meeting inclusion criteria have radiation treatment plans designed by Zeus Cloud TPS and Eclipse treatment planning software from Varian, respectively. The qualities of two plans are compared.

This is a observational study as the two plans are not executed.

Eligibility criteria: Inclusion Criteria:

1. Patients with confirmed brain glioma, nasopharyngeal carcinoma, lung cancer, esophageal cancer, gastric cancer, liver cancer, prostate cancer, cervical cancer and rectal cancer;
2. The medical imaging data (CT) of the subjects were complete and available;
3. Between 18 and 75 years old, regardless of gender;

Exclusion Criteria:

1. The patients had metal implants;
2. Not suitable for clinical trials judged by investigators.

Primary outcomes:
measure: The qualification rate of treatment plans based on dosimetry
timeFrame: 2 months
Secondary outcomes:
measure: The conformability index of radiation dose to the target
timeFrame: 2 months
measure: single-field pass rate
timeFrame: 2 months
measure: composite-field pass rate
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
affiliation: Sun Yat-sen University
name: Hui Liu, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00001218: Development of Normative Ultrasound Databases of Tongue Surface Configuration
Official title: Development of Normative Ultrasound Databases of Tongue Surface Configuration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Speech Disorders
Keywords: Baseline Data
Curve Averaging
Curve Fitting
Movement Patterns
Normative Data
Polar Distribution
Tongue
Tongue Shape
Ultrasound
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2002-12-10
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

Brief summary: Our past ultrasound research has indicated a need for baseline normative tongue data against which to compare our disordered speech populations. Subjects with normal speech and hearing who represent different ages and sexes, will be studied with respect to tongue shape and movement patterns. Recently developed parameters such as curve fitting, curve averaging, and polar coordinates will be used to create baseline data categories. In addition, new parameters and improved instruments will be developed as previously to produce a data base which can be used across disciplines.

Detailed description: Our past ultrasound research has indicated a need for baseline normative tongue data against which to compare our disordered speech populations. Subjects with normal speech and hearing who represent different ages and sexes, will be studied with respect to tongue shape and movement patterns. Recently developed parameters such as curve fitting, curve averaging, and polar coordinates will be used to create baseline data categories. In addition, new parameters and improved instruments will be developed as previously to produce a data base which can be used across disciplines.

Eligibility criteria: Healthy normal subjects.

No reconstructive tongue surgery.

No radiation for head and neck malignancy.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: Warren G. Magnuson Clinical Center (CC)
state: Maryland
Study officials:
References:
citation: Sonies BC, Wang C, Sapper DJ. Evaluation of normal and abnormal hyoid bone movement during swallowing by use of ultrasound duplex-Doppler imaging. Ultrasound Med Biol. 1996;22(9):1169-75. doi: 10.1016/s0301-5629(96)00158-5.
Clinical trial NCT04040218: Trigger Point Dry Needling Practice in Colorado: Practitioner and Patient
Official title: Harms Associated With Dry Needling Provided During Patient Care in Colorado by Physical Therapists
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dry Needling
Harm
Keywords: dry needling
physical therapy
Lead sponsor: Regis University
Sponsor class: OTHER
First posted: 2019-07-31
Enrollment: 2607
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The target population for this study was a representative sample of PT providers that administer and patients that receive dry needling as a treatment modality in the state of Colorado. 440 PT's licensed in Colorado and 2167 patients were recruited for this study. Purposive sampling was implemented through convenience sampling methods; by which PT respondents were included through their association to APTA CO or Kinetacore@ (an education provider in DN) and patients through their PT provider. The PT survey was sent out to APTA CO members and via a Kinetacore email list; which included approximately 900 individuals trained by Kinetacore in CO. All respondents to the PT survey were requested to provide patients with a direct link to the patient survey. Invitation was promoted by APTA CO outside of their member portal to non-members and word of mouth was encouraged.
Primary purpose: TREATMENT

Brief summary: A retrospective analysis of responses following a descriptive survey to investigate the benefits and harms associated with dry needling as provided by a physical therapists in CO

Detailed description: Two surveys were completed to identify the reported harms by physical therapists in the provision of dry needling in Colorado, and by patients who received dry needling from physical therapists in Colorado in April 2017. Retrospective analysis of the data (de-identified) was completed to provide a representative reporting on harms associated with the dry needling provided and received for patients.

Eligibility criteria: Inclusion Criteria:

* Physical therapists providing dry needling to patients in Colorado
* Patients who had received dry needling from Physical Therapists in Colorado

Exclusion Criteria:

* None

Primary outcomes:
measure: Survey analysis of harm data
timeFrame: As reported during the four week survey time frame
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Regis University
state: Colorado
Study officials:
References:
Clinical trial NCT02295618: ETI During Intubation
Official title: Can the ETView VivaSight SL Rival the Macintosh Laryngoscopy With Conventional Tube During Adult Resuscitation by Novice Physicians: a Randomized Crossover Simulation Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intubation
Cardiac Arrest
Lead sponsor: International Institute of Rescue Research and Education
Sponsor class: OTHER
First posted: 2014-11-20
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to compared effectiveness of intubation using ETView VivaSight SL and standard tracheal tube during resuscitation performed by a novice-physicians.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* maximum 1 year of work experience in medicine
* maximum 10 clinical intubations

Exclusion Criteria:

* not meet the above criteria
* wrist or low back diseases

Primary outcomes:
measure: Time to intubation
timeFrame: 1 day
Secondary outcomes:
measure: Success of intubation
timeFrame: 1 day
measure: Cormack-Lehan scale
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: International Institute of Rescue Research and Education
state: Masovia
Study officials:
affiliation: Institute of Cardiology
name: Lukasz Szarpak
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kurowski A, Szarpak L, Truszewski Z, Czyzewski L. Can the ETView VivaSight SL Rival Conventional Intubation Using the Macintosh Laryngoscope During Adult Resuscitation by Novice Physicians?: A Randomized Crossover Manikin Study. Medicine (Baltimore). 2015 May;94(21):e850. doi: 10.1097/MD.0000000000000850.