louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00241111: Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis
Official title: Assessment of the Efficacy, Tolerability and Pharmaco-economic Impact of Zoledronic Acid Treatment in Prostate Cancer With Bone Metastasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostate Cancer With Bone Metastasis
Keywords: Prostate
cancer
bone metastasis
zoledronic acid
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-18
Enrollment: 148
Sex: MALE
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: Study to determine effectiveness and safety of zoledronic acid and whether it has a pharmaco-economic impact in prostate cancer with bone metastasis.


Eligibility criteria: Inclusion Criteria:

* Aged ≥18 years.
* Written informed consent.
* With histologically-proven prostate carcinoma.
* ECOG performance status ≤ 2
* Life expectancy \> 12 months
* Current or previously documented diagnosis of at least 1 bone metastasis due to prostate cancer (patient could be hormono naif, Hormono sensible or hormono refractory)
* Patients with partners of childbearing potential should use a barrier method of contraception throughout the study.

Exclusion Criteria:

* ECOG performans status \>3
* Prior treatment with bisphosphonates IV within the last 3 month to the study
* Renal insufficiency (serum creatinine \> 265 micromol/L or \> 3.0 mg/dL)
* Liver function tests \> 2.5 ULN
* Patients with another nonmalignant disease which would confuse the evaluation of primary endpoints or prevent the patient from complying with the protocol.
* History of concomitant disease with influence on bone metabolism such as Paget's disease or primary hyperparathyroidism
* Disabling or non controlled concomitant disease likely to alter the quality of life
* Patient unable to fill in a questionnaire: senile dementia, psychiatric or neurological disease, illiterate or partially sighted patient
* Known hypersensitivity to zoledronic acid or other bisphosphonates

Other protocol-defined inclusion / exclusion criteria may apply.

Primary outcomes:
measure: to assess the effectiveness of Zol in prevention of SREs in stratified groups (hormonal treatment)
timeFrame: at 15 months & at end of study
Secondary outcomes:
measure: to assess the effectiveness of Zol in improving pain and QoL in prostate cancer patients with bone metastases
timeFrame: V1, V2, V3, V5
measure: to assess the safety of ZOL treatment
timeFrame: V1, V2, V3, V5
measure: to assess resources consumption
timeFrame: V1, V2, V3, V5
measure: to assess BM
timeFrame: V1 et V5
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT00880711: Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer (BC)
Official title: Faslodex International Observational Non-Interventional Study in Advanced Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Fiona
Faslodex
Advanced Breast Cancer
Real life data
Collect real life data in clinical practice across Austria
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-04-14
Enrollment: 57
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitals, office based specialists

Brief summary: The purpose is to collect real life data on the use of fulvestrant in normal clinical practice in Austria and document the clinical benefit of fulvestrant treatment.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal women with hormone receptor-positive locally advanced or metastatic breast cancer
* Ability to read and write and complete questionnaires
* Provision of written informed consent
* Patients who already received a prescription for fulvestrant

Exclusion Criteria:

* A subject who does not fulfil all the above mentioned inclusion criteria is not allowed to participate in this NIS

Primary outcomes:
measure: Clinical Benefit, defined as the development of at least one of the following stages and holding on for at least 6 month: Complete response, partial response or stable disease
timeFrame: Baseline, after 3, 6, 9 month
Secondary outcomes:
measure: Tolerability
timeFrame: After 3, 6, 9 month (as per usual clinical practice)
measure: Quality of Life
timeFrame: Baseline, after 3, 6, 9 month (as per usual clinical practice)
measure: Performance status (Karnofsky Index)
timeFrame: Baseline, after 3, 6, 9 month (as per usual clinical practice)
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Research Site
city: Innsbruck
country: Austria
facility: Research Site
city: Klagenfurt
country: Austria
facility: Research Site
city: Leoben
country: Austria
facility: Research Site
city: Linz
country: Austria
facility: Research Site
city: Oberpullendorf
country: Austria
facility: Research Site
city: Rankweil
country: Austria
facility: Research Site
city: Rottenmann
country: Austria
facility: Research Site
city: Salzburg
country: Austria
facility: Research Site
city: St. Veit
country: Austria
facility: Research Site
city: Steyr
country: Austria
facility: Research Site
city: Vienna
country: Austria
facility: Research Site
city: Wr. Neustadt
country: Austria
facility: Research Site
Study officials:
affiliation: Medical University of Vienna
name: Guenther Steger, Univ Prof. Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT04480411: Use of Technology and Telemedicine to Improve Quality of Care in COVID 19 Patients
Official title: Use of Technology and Telemedicine to Improve Quality of Care in COVID 19 Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diagnoses Disease
Covid19
Keywords: Telemedicine
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-07-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to assess the use of technology including remote vital sign monitoring in improving quality of patient care, decreasing hospital admissions and re-admissions, decreasing hospital length of stay and decreasing use of personal protective equipment.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patient with COVID 19 or outpatient under investigation for or diagnosed with COVID 19
* Clinically stable (on 4L O2 or less, non ICU)
* Demonstrates ability to be trained in use of digital stethoscope technology

Exclusion Criteria:

* Pregnancy
* Delirium

Primary outcomes:
measure: Patient provider experience survey score
timeFrame: Once after completion of device use (up to 15 minutes to complete the survey)
measure: Provider experience survey score
timeFrame: Once after completion of device use (up to 15 minutes to complete the survey)
measure: Use of personal protective improvement
timeFrame: 6 months
measure: Number of in-patient encounters with COVID patients as a measure of provider exposure to high risk illness
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Ritu Parikh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Julieta M Gabiola, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Nicholas Scoulios, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Lisa Shieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04232111: Effect of AVACEN 100 on Brachial Artery Blood Flow
Official title: Effect of AVACEN 100 on Brachial Artery Blood Flow
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Blood Flow
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2020-01-18
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Determine effect of AVACEN 100 on brachial artery blood flow

Detailed description: Blood flow measured via ultrasound doppler

Eligibility criteria: Inclusion Criteria:

* anyone within specified age

Exclusion Criteria:

* anyone outside specified age

Primary outcomes:
measure: brachial artery blood flow via ultrasound doppler
timeFrame: 10 min
measure: brachial artery blood flow via ultrasound doppler
timeFrame: 20 min
measure: brachial artery blood flow via ultrasound doppler
timeFrame: 30 min
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04928911: Expectations About the COVID-19 Vaccines
Official title: Expectations About the COVID-19 Vaccines
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vaccine Adverse Reaction
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2021-06-16
Enrollment: 1176
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults signed up to receive a COVID-19 vaccine in Denmark, who are also participating in the ENFORCE study

Brief summary: This study collects information on expectations and attitudes towards the COVID-19 vaccines in participants about to receive a COVID-19 vaccine. This information will be linked to data on side effect occurrence collected in an independent study.

Detailed description: General hypothesis: Negative expectations and attitudes towards the vaccine are associated with a higher risk of side effects

Eligibility criteria: Inclusion Criteria:

* Must have signed up to receive a COVID-19 vaccine in Denmark
* Participants are also a part of the ENFORCE study from which outcome data is obtained
* Must be able to read and understand Danish

Primary outcomes:
measure: Rate of local and systemic reactions (self-report)
timeFrame: 7 days after vaccination
measure: Rate of local and systemic reactions (self-report)
timeFrame: 14 days after vaccination
Secondary outcomes:
measure: Grade 1-4 and serious adverse events
timeFrame: 3-6 months after vaccination
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University
Study officials:
affiliation: University of Aarhus
name: Lene Vase
role: STUDY_CHAIR
References:
Clinical trial NCT00533611: Effect of MK0524A on Flushing Caused by Niacin (0524A-056)
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Tolerability and Effect of MK0524A on Niacin-Induced Acute Flushing in Lipid Clinic Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Flushing
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-09-21
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to assess the effects of MK0524A in reducing flushing associated with niacin.


Eligibility criteria: Inclusion Criteria:

* Patient is male or female between 18 and 70 years of age
* Females of reproductive potential must agree to take acceptable contraceptive precautions for the duration of the study

Exclusion Criteria:

* Patient has a history of hypersensitivity to niacin or niacin-containing products
* Patient is currently experiencing menopausal hot flashes
* Patient consumes more than 2 alcoholic beverages per day
* Patient has poorly controlled Type 1 or Type 2 diabetes mellitus
* Patient engages in vigorous exercise or an aggressive diet regimen

Primary outcomes:
measure: MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by maximum Global Flushing Severity Score (GFSS) categorized as none/mild, moderate, severe, extreme.
timeFrame: Over 1 week
Secondary outcomes:
measure: MK-0524A produces less flushing during the acute dosing period than niacin extended-release as measured by (a) maximum daily GFSS; and (b) percentage of patients with a maximum GFSS =4 (moderate or greater).
timeFrame: Daily
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Kush D, Hu DY, Ye P, Kim HS, Chen E, Sirah W, McCrary Sisk C, Paolini JF, Maccubbin D. Flushing profile of extended-release niacin/laropiprant at initiation of therapy in Asian lipid clinic patients. Cardiology. 2009;114(3):192-8. doi: 10.1159/000228585. Epub 2009 Jul 15.
Clinical trial NCT04776928: Testing a Provider-Level Feedback Intervention to Optimize Postoperative Prescribing
Official title: Testing a Provider-Level Feedback Intervention to Optimize Postoperative Prescribing - Aim 3 Phase 1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Prescribing
Keywords: Surgery
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2021-03-02
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this project is to leverage the Michigan Surgical Quality Collaborative's (MSQC) existing network and surgeon performance feedback platform to improve opioid prescribing practices for surgeons within the network found to be prescribing in a manner discordant with published guidelines and to inform best practices for future surgical quality improvement initiatives.

The study is being completed to learn more about the effectiveness, feasibility, and acceptability and that the goal is both to evaluate how effective this intervention and mechanism are for changing surgeon opioid prescribing behavior and to inform best practices for future quality initiatives. The study hypothesizes that provider-level feedback will allow clinicians to tailor postoperative prescribing more closely to patient consumption, and reduce excess postoperative prescribing.

The cohort of surgeons which have been identified as outliers by the Michigan Surgical Quality Collaborative (MSQC) will be be invited to participate in this trial. The study team will send surgeons belonging to sites that signed the Exhibit B-1 form the provider-level push notifications (98 participants). In this study de-identified prescribing data will also be analyzed for sites that do not sign the Exhibit B-1 form (105 participants).

The study team will approach 98 surgeons receiving the provider-level push notifications in one wave.


Eligibility criteria: Inclusion Criteria:

* Surgeons already participating in and sharing data with the Michigan Surgical Quality Collaborative (MSQC) who perform procedures of interest
* Surgeons within MSQC who have median prescribing \> 1 pill equivalents over the published recommendation
* Surgeons within MSQC who perform surgeries at a hospital that have agreed to participate in this research

Exclusion Criteria:

* Surgeons not identified in the MSQC data as having a valid National Provider Identifier (NPI)

Primary outcomes:
measure: Change in Opioid Prescribed Following the Intervention
timeFrame: up to 5 months from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Jennifer F Waljee, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02795728: Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial
Official title: Fuji Type VII Sealants Versus Resin Based Sealants. A Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dental Caries
Lead sponsor: Kamineni Institute of Dental Sciences
Sponsor class: OTHER
First posted: 2016-06-10
Enrollment: 120
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design ,a double blind randomized controlled clinical trial was conducted to compare the retention and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass ionomer sealant (FUJI). The study comprised of 120 government school children of 7-9 years age group. The glass-ionomer sealant and resin-based sealant were applied randomly on either side of the first mandibular permanent molars. They were recalled for assessment of sealant retention at intervals of 3, 6 and 12 months.


Eligibility criteria: Inclusion Criteria:

* Children with a fully erupted contra lateral permanent mandibular first molars with well-defined deep pits and fissures and molars free of mucosal tissue are included in the study.

Exclusion Criteria:

* Molars with developmental anomalies, hypoplastic teeth were promptly excluded

Primary outcomes:
measure: Retention of the sealant
timeFrame: Baseline to 1 year
Secondary outcomes:
measure: Caries incidence
timeFrame: Baseline to 1 year
Other outcomes:
Locations:
city: Vikarabad
country: India
facility: Sri Sai college of Dental surgery
state: Telangana
Study officials:
affiliation: Sri Sai college of Dental surgery
name: Prathibha Rao, MDS
role: STUDY_DIRECTOR
References:
Clinical trial NCT01753128: Efficacy of Imipramine for Treatment of Patients With Esophageal Hypersensitivity/ Functional Heartburn
Official title: Efficacy of Imipramine for Treatment of Patients With Esophageal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastroesophageal Reflux Disease
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2012-12-20
Enrollment: 83
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: Esophageal hypersensitivity/Functional heartburn are common among non-erosive reflux disease (NERD) patients who do not response to proton pump inhibitors. Whether tricyclic antidepressant improves NERD patient's symptoms remains unknown

Aim of this randomized controlled trial study is to determine the efficacy of imipramine, which could increase esophageal pain thresholds in healthy volunteers, in comparison with placebo for treatment patients with esophageal hypersensitivity or functional heartburn evaluated by improvement of specific-symptom score and quality of life


Eligibility criteria: Inclusion Criteria:

* patient with typical reflux symptoms (heartburn and/or regurgitation) more than 3 times per week in at least last 3 months
* Age more than 18 years
* Upper GI endoscopy showed no esophageal mucosal breaks
* MII-pH monitoring was not showed abnormal both acid and non-acid reflux
* symptoms was not improved after received standard dose proton pump inhibitor for at least 1 month

Exclusion Criteria:

* history of thoracic, esophagus, or stomach surgery
* severe esophageal motility disorder eg. Achalasia, scleroderma, autonomic/peripheral neuropathy/myopathy
* patient who was indicated to receive proton pump inhibitor
* pregnant women
* patient who was allergy to imipramine
* patient who received tricyclic antidepressant or SSRI with in 3 month of enrollment

Primary outcomes:
measure: improvement of GERD score
timeFrame: 6 months
Secondary outcomes:
measure: improve quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Medical Institue; Siriraj Hospital
Study officials:
affiliation: Mahidol University
name: Julajak Limsrivilai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04871828: The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19)
Official title: The Efficacy of Leukotriene Inhibitor in Adult Patients With Moderate SARS-COV-2 Symptoms (COVID19): (Randomized Clinical Trial)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Moderate Covid19
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2021-05-04
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized placebo-controlled double-blinded clinical trial
Primary purpose: TREATMENT

Brief summary: There is an urgent need to explore therapeutic options for SARS-CoV-2 in order to face the pandemic. The selected intervention was based on that zafirlukast will have dual effect; first it will block the virus replication through inhibiting the COVID19 helicase that is involved in virus replication and secondly by reducing the inflammation through antagonizing the leukotriene receptor.

The purpose of this study is to evaluate the clinical efficacy and safety of Leukotriene receptor antagonist in the treatment of moderate cases of COVID-19 patients.


Eligibility criteria: Inclusion Criteria:

1. Age of 18 years or above
2. Diagnosed with COVID-19 by PCR confirmed SARS-coV-2 viral infection.
3. Able to sign the consent form and agree to clinical samples collection
4. Moderate symptomatic COVID-19 patients, (any or all of the followings: fever or cough or SOB)
5. Admitted to the hospital (outside the ICU)
6. Patients had to be enrolled within 10 days of symptoms onset.
7. willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

1. Asthmatic patient using antiasthma medications
2. Being in the hospital or in home isolation for more than 72 hours before the start of the study drug.
3. Known sensitivity/allergy to the study drug
4. Pregnancy
5. Patient refused
6. Chronic liver disease
7. Severe mental disorder
8. Unstable patients requiring ICU admission
9. Participating in other clinical trial

Primary outcomes:
measure: Time to clinical improvement,
timeFrame: 28Day
Secondary outcomes:
measure: Escalate therapy.
timeFrame: 28Day
measure: PCR test
timeFrame: Day14
measure: Length of hospital stay.
timeFrame: 28Day
measure: Duration of fever
timeFrame: 28Day
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Abdulaziz Medical city, MNGHA
Study officials:
References: