louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05557214: Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers
Official title: Reducing Unnecessary Antibiotic Prescriptions in Primary Healthcare in Saskatchewan by Identifying High Prescribers
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Upper Respiratory Tract Infections
Keywords: audit and feedback
antimicrobials
primary healthcare
Lead sponsor: Saskatchewan Health Authority - Regina Area
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Approximately 90% of antibiotics are prescribed in primary healthcare (PHC) in Canada (Public Health Agency of Canada, 2020), making this an important sector for antimicrobial stewardship. Upper respiratory tract infections (URTIs) represent a common indication in PHC for which antibiotics are often prescribed unnecessarily (Leis et al, 2020; Schwartz et al., 2020). Reducing unnecessary antibiotic treatment in this sector is a vital part of contributing to minimizing the global burden of antibiotic resistance.

The goal of this research project is to reduce the number of antibiotic prescriptions among family physicians identified as high prescribers in Saskatchewan. To achieve this, the investigators will send letters to the top 25th percentile of high prescribers in PHC. The letters will contain data indicating the prescribers high antimicrobial usage as well as guidance for reducing unnecessary prescriptions and promoting appropriate lengths of prescriptions for upper respiratory tract infections.


Eligibility criteria: Inclusion Criteria:

* must be a practicing family physician in Saskatchewan
* top 25th percentile of antimicrobial prescribers

Exclusion Criteria:

* fewer than 12 months of historical prescribing data available

Primary outcomes:
measure: Total Antibiotic Prescriptions
timeFrame: 12 months
Secondary outcomes:
measure: Total Prolonged-Duration Prescription
timeFrame: 12 months
measure: Total Days of Therapy
timeFrame: 12 months
measure: Antibiotic Cost
timeFrame: 12 months
measure: Total Specific Antibiotic Prescriptions
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: Leis JA, Born KB, Ostrow O, Moser A, Grill A. Prescriber-led practice changes that can bolster antimicrobial stewardship in community health care settings. Can Commun Dis Rep. 2020 Jan 2;46(1):1-5. doi: 10.14745/ccdr.v46i01a01. eCollection 2020 Jan 2.
citation: Schwartz KL, Langford BJ, Daneman N, Chen B, Brown KA, McIsaac W, Tu K, Candido E, Johnstone J, Leung V, Hwee J, Silverman M, Wu JHC, Garber G. Unnecessary antibiotic prescribing in a Canadian primary care setting: a descriptive analysis using routinely collected electronic medical record data. CMAJ Open. 2020 May 7;8(2):E360-E369. doi: 10.9778/cmajo.20190175. Print 2020 Apr-Jun.
Clinical trial NCT04675814: Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA)
Official title: Prospective Evaluation of the Impact on Patients' Quality of Life of a 12-Week Adapted Physical Activity Program (APA) at Institut de Cancerologie de l'Ouest (ICO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sports Physical Therapy
Keywords: Adapted Physical Activity program (APA)
kinesiophobia
Fatigue
Quality of life
Lead sponsor: Institut Cancerologie de l'Ouest
Sponsor class: OTHER
First posted: 2020-12-19
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects participating in the ICO's APA program during the enrolment period regardless of the type of cancer and the type of treatment in progress (chemotherapy, radiotherapy, hormone therapy, immunotherapy) who accept to participate to the study.

Brief summary: The objective of this study is to evaluate the effects of regular physical practice on fatigue, quality of life and kinesiophobia in patients treated at the ICO in Angers, regardless of the type of cancer and the type of treatment.

Detailed description: The objective of this study is to evaluate the effects of regular physical practice on fatigue, quality of life and kinesiophobia in patients treated at the ICO in Angers, regardless of the type of cancer and the type of treatment.

A 12-week Adapted Physical Activity program (APA) is proposed to patients included in the study with an assessment of fatigue, quality of life, level of physical activity and kinesiophobia (fear of movement) at the beginning of the study.

A second assessment of fatigue and quality of life will be done during the 6-week management.

At the end of the program, a final evaluation of fatigue, quality of life and kinesiophobia will be done.

Eligibility criteria: Inclusion Criteria:

1. Oncological care at the ICO
2. All types of cancer
3. Regardless of the type of treatment (chemotherapy, radiotherapy, hormone therapy, immunotherapy)
4. Age \> 18 years old
5. Follow the APA program at the ICO
6. Subject informed of the study

Exclusion Criteria:

1. Contraindication to the practice of sport
2. APA Program outside the ICO
3. Subject opposing the use of his data
4. Minor or adult patient under guardianship or curatorship
5. Pregnant woman
6. Altered general condition

Primary outcomes:
measure: quality of life of patients participating in the 12-week adapted physical activity program.
timeFrame: 12 weeks
Secondary outcomes:
measure: Describe attendance at the APA program.
timeFrame: 12 weeks
measure: Measure the evolution of Kinesiophobia (fear of movement).
timeFrame: 12 weeks
measure: Measure physical activity at the initiation of the APA program.
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Angers
country: France
facility: Institu de Cancérologie de L'Ouest
Study officials:
References:
Clinical trial NCT00000314: M-CPP and Fenfluramine in Cocaine Addicts - 3
Official title: To Study Predictive Values of M-CPP and Fenfluramine in Cocaine Addicts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cocaine-Related Disorders
Keywords: cocaine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
Collaborators: name: VA Office of Research and Development
First posted: 1999-09-21
Enrollment: 0
Sex: MALE
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate predictive value of M-CPP and fenfluramine challenges for outcome.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Drug use
measure: Hospitalization, arrests, jail, employment, psychiataric symptoms
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: VA Medical Center
state: New York
Study officials:
affiliation: VA Medical Center
name: Laure Buydens-Branchey, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ulmann G, Jouinot A, Tlemsani C, Curis E, Kousignian I, Neveux N, Durand JP, Goldwasser F, Cynober L, De Bandt JP. Lean Body Mass and Endocrine Status But Not Age Are Determinants of Resting Energy Expenditure in Patients with Non-Small Cell Lung Cancer. Ann Nutr Metab. 2019;75(4):223-230. doi: 10.1159/000504874. Epub 2019 Dec 19.
Clinical trial NCT00979095: Genetic Examination of Patients With Primary Multiple Hernia
Official title: Genetic Differences Between Patients With Multiple Hernia and a Healthy Control Group
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Multiple Hernia
Keywords: multiple hernia
Lead sponsor: Herlev Hospital
Sponsor class: OTHER
First posted: 2009-09-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Danish citizens. Data have been retracted from The Danish Hernia Database.

Brief summary: The investigators are performing a genetic study of patients with multiple hernias (at least 3 primary hernias) versus a healthy control group. This genetic information is compared with circulating and subcutaneously biomarkers such as matrix-metalloproteinases (MMP's).

The hypothesis is that patients with multiple hernias have different expression of specific genes compared to the healthy control group.

Detailed description: Other examinations performed on the patients enrolled in this study:

* Ultrasound (US) examination of the abdominal aorta to discover possible abdominal aortic aneurysms.
* Beightons score to evaluate the degree of joint hypermobility.

Eligibility criteria: Inclusion Criteria:

* Patients with minimum 3 primary hernias

Exclusion Criteria:

* Patients under 18 years

Primary outcomes:
measure: Genetic expression of relevant genes between the groups
timeFrame: 12 months
Secondary outcomes:
measure: Amount of serological biomarkers (MMP's) correlated to gene expression
timeFrame: 12 months
Other outcomes:
Locations:
city: Herlev Hospital
country: Denmark
facility: Jacob Rosenberg
state: Herev
Study officials:
affiliation: Herlev Hospital
name: Jacob Rosenberg, Prof. MD
role: STUDY_DIRECTOR
affiliation: Herlev Hospital
name: Jakob Burcharth, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00656695: Comparisone of Iminoral Versus Neoral in Prevention of Acute Rejection in Renal Transplantation
Official title: The Comparison Between Clinical and Paraclinical Effect of Iminoral Vs Neoral in Prevention of Acute Rejection in the First Year Afer Transplantation in De Novo Renal Transplant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End Stage Renal Disease
Renal Transplantation
Keywords: Iminoral
Neoral
Acute renal transplant rejection
Lead sponsor: Imam Khomeini Hospital
Sponsor class: OTHER
First posted: 2008-04-11
Enrollment: 208
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: Cyclosporine is the key drug in organ transplantation. In Iran the investigators have more than 2500 new renal transplantation each year and because of this the government pay a huge amount of money for subsiding the imported cyclosporine in the form of Neoral. Recently an Iranian drug company introduced this drug in the name of Iminoral which has been approved by different authorities in Iran and abroad, (including the Ministry of Health in Iran and also European Directorate for the Quality of Medicines Certification Unit and FDA(Department of Health and Human Services,Center for Drug Evaluation and Research)). The investigators study is the first clinical trial to compare the effect of Iminoral versus Neoral in preventing acute rejection in renal transplantation and also to compare the side effects of these two drugs.


Eligibility criteria: Inclusion Criteria:

1. renal transplantation candidates
2. written consent
3. not taking participate in any other clinical trial in last 3 months

Exclusion Criteria:

1. primary FSGS
2. hyperoxaluria
3. age under 18
4. multi organ transplantation
5. any malignancy in 5 years
6. PRA \> 25%
7. use of Tacrolimus
8. hyper acute rejection

Primary outcomes:
measure: transplanted kidney acute rejection
timeFrame: one year
Secondary outcomes:
measure: cyclosporine side effects
timeFrame: one year
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Imam Khomeini Hospital
Study officials:
affiliation: Imam Khomeini Hospital
name: Mohammad R Khatami, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khatami SM, Taheri S, Azmandian J, Sagheb MM, Nazemian F, Razeghi E, Shahidi S, Sadri F, Shamshiri AR, Sayyah M. One-Year Multicenter Double-Blind Randomized Clinical Trial on the Efficacy and Safety of Generic Cyclosporine (Iminoral) in De Novo Kidney Transplant Recipients. Exp Clin Transplant. 2015 Jun;13(3):233-8.
Clinical trial NCT06445595: The Relationship Between Obesity and Chronic Headache
Official title: Investigation of the Effectiveness of Obesity in the Development of Chronic Headache After Traumatic Brain Injury
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Lead sponsor: Karaman Training and Research Hospital
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: individuals over the age of 18 who suffered a head injury

Brief summary: The relationship between obesity and the development of chronic headache after traumatic brain injury will be investigated.

Detailed description: Traumatic brain injury (TBI) can be defined as an injury caused by an external force, particularly a direct blow to the head or exposure to a shock wave. In addition to the well-known consequences of TBI, including cognitive changes, motor deficits and sensory abnormalities, available evidence suggests that acute and chronic pain is also common after TBI. Obesity and TBI can be considered as public health problems with their increasing prevalence in recent years. Chronic pain adds to the already enormous clinical, psychological, social and economic burden of obesity. Developing mechanisms to prevent the development of pain after TBI has attracted the attention of researchers. Obesity is a preventable and modifiable clinical condition. The extent to which obesity may create adverse conditions after TBI remains unclear.

Eligibility criteria: Inclusion Criteria:

* Individuals over the age of 18 who suffered a head injury

Exclusion Criteria:

* People with severe head trauma
* Those who do not speak Turkish
* Those with a history of chronic opioid user
* Those with alcohol and drug addiction

Primary outcomes:
measure: The relationship between Bady Mass Index (BMI) and the development of chronic headache
timeFrame: Postoperative 3 month.
Secondary outcomes:
measure: The relationship between the nature of trauma and the development of chronic headache
timeFrame: Postoperative 3 month.
measure: The relationship between patients' education levels and chronic headache
timeFrame: Postoperative 3 month
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karaman Training and Research Hospital
state: Merkez
Study officials:
References:
Clinical trial NCT00734695: Comparing the Use of Vitamin c (Ascorbic Acid) in Eye Burn in Subconjunctival Injection to Topical or Oral Treatment.
Official title: The Effect of Subconjunctival Vitamin c on Recovery Rate and End Result From Eye Burn.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Burn
Keywords: BURN
EYE
VITAMIN C
ASCORBIC ACID
Lead sponsor: The Baruch Padeh Medical Center, Poriya
Sponsor class: OTHER_GOV
Collaborators: name: Rambam Health Care Campus
name: Soroka University Medical Center
First posted: 2008-08-14
Enrollment: 20
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Eye burns may cause a severe permanent damage. One kind of treatment is the use of vitamin C (Ascorbic acid). This study will compare between subconjunctival topical and/or systemic route of administration and topical and/or systemic administration.

Detailed description: In order to prevent permanent and severe damage to the eye after eye burn early treatment is mandatory. It is well known and published that the use of Vitamin c may contribute to the healing process of such burns, including burns from chemicals or heat. We believe that the route pf administration of the medicine is as important as the kind of medicine and that subconjunctival injection will have better effect and will influence in a favorable manner on the the end result as well as on the time of the healing.

In order to be able to compare between cases we made a new definition of the severity of the burn according to the extension of the damage on the cornea, conjunctiva and limbus, and according to the severity and depth of the ischemia.

In 3 medical centers 3 protocols of treatment and followup will be compared while only in Baruch Pade Medical Center the main route of administration will be subconjunctival on top of the topical treatment.

Eligibility criteria: Inclusion Criteria:

* Eyes clinic patients presented with acute chemical or thermal burn.

Exclusion Criteria:other disease

Primary outcomes:
measure: EXTENSION OF FLORSCEIN PAINT ON THE CORNEA AND CONJUNCTIVA
timeFrame: BID
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: Movshovitz Ina
city: Tiberia
country: Israel
facility: Naftali Modi
Study officials:
affiliation: Baruch Pade medical center
name: naftali modi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05328895: Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease
Official title: Transcutaneous Auricular Vagus Nerve Stimulation for Meniere Disease: Randomized Trial Controlled
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meniere Disease
Keywords: Meniere Disease
taVNS
RCT
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 92
Sex: ALL
Minimum age (years): 20
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the effect of Transcutaneous auricular vagus nerve stimulation for the patients Meniere disease. Methods: We enrolled 88 patients at Beijing TongRen Hospital. All treatments were self-administered by the patients at home after training at the hospital. Patients completed questionnaires at baseline and after 4 weeks, 8 weeks, 12 weeks. Tinnitus Handicap Inventory (THI), Dizziness Handicap Inventory (DHI), Pure Tone Audiometry, visual scale of ear stuffiness and SF-36 were performed to evaluate the therapeutic effects. A difference of P \< 0.05 was considered statistically significant.


Eligibility criteria: Inclusion Criteria:

1. Age \>=18 and Age \<=70.
2. Clinical diagnosis of meniere disease.

Exclusion Criteria:

1. History of depression, tumors, thyroid disease, diabetes, cardiac diseases.
2. History of Otorhinolaryngology surgery.
3. Pregnant or lactating women.

Primary outcomes:
measure: Tinnitus Handicap Inventory (THI)
timeFrame: Change from Baseline scores of THI at 12-weeks post-therapy.
measure: Dizziness Handicap Inventory (DHI)
timeFrame: Change from Baseline scores of DHI at 12-weeks post-therapy.
measure: Pure tone thresholds.
timeFrame: Change from Baseline level of Pure tone thresholds at 12-weeks post-therapy.
measure: Visual analogue scale (VAS)
timeFrame: Change from Baseline scores of VAS of aural fullness at 12-weeks post-therapy.
Secondary outcomes:
measure: The Short Form Health Survey (SF36)
timeFrame: Change from Baseline scores of SF-36 at 12-weeks post-therapy.
measure: Video head impulse test (vHIT)
timeFrame: Change from Baseline number of pathological saccades and values of vHIT at 12-weeks post-therapy.
measure: The caloric test
timeFrame: Change from Baseline number of abnormal Unilateral Weakness (UW) at 12-weeks post-therapy.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing TongRen Hospital, Capital Medical University
Study officials:
References:
Clinical trial NCT01352195: Extended Self-Help for Smoking Cessation
Official title: Extended Self-Help for Smoking Cessation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: Forever Free
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-05-11
Enrollment: 2124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is smoking cessation. The investigators are conducting a research study to learn how well the information from the program helps participants to quit smoking and remain smoke-free.

Detailed description: The investigators propose a randomized 3-arm design, with 660 smokers recruited into each condition. The three conditions will include: (1) Usual care (UC), which will comprise a single smoking cessation booklet developed by NCI; (2) Standard Repeated Mailings (Stand-RM), which will be the same 8 Forever Free booklets (edited for cessation) distributed over 12 months as in our preliminary studies; and (3) Intensive Repeated Mailings (Inten-RM), which will add two additional booklets to extend the intervention out to 18 months, plus additional monthly contacts. Assessments will occur at six-month intervals, through 30 months. An overview of the design is depicted in Table 4, which will be referenced throughout the remainder of this proposal.

Eligibility criteria: Participants:

* Planned Participants: 1980 daily smokers (for a final sample of at least 1584 after attrition), recruited via multimedia advertisements (daily and weekly newspapers, radio, cable television, public transit ads, etc.), public service announcements, and direct community engagement.

Inclusion Criteria:

* smoking at least five cigarette per day over the past year
* not currently enrolled in a face-to-face smoking cessation program
* able to speak and read English
* desire to quit smoking, as indicated by a score of at least 5 ("Think I should quit, but not quite ready") on the Contemplation Ladder (Biener \& Abrams, 1991)

Exclusion Criteria:

* number of participants from the same street address limited to 1
* no more than 2 referrals per participant

Primary outcomes:
measure: 7-Day Point-Prevalence Abstinence at Each Follow-up Point
timeFrame: 30 months per participant
Secondary outcomes:
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Thomas Brandon, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brandon TH, Simmons VN, Sutton SK, Unrod M, Harrell PT, Meade CD, Craig BM, Lee JH, Meltzer LR. Extended Self-Help for Smoking Cessation: A Randomized Controlled Trial. Am J Prev Med. 2016 Jul;51(1):54-62. doi: 10.1016/j.amepre.2015.12.016. Epub 2016 Feb 8.