louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04107857: Electronic Health Record-Enabled Evidence-Based Smoking Cessation Quality Improvement Implementation Program
Official title: Electronic Health Record-Enabled Evidence-based Smoking Cessation Quality Improvement Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2019-09-27
Enrollment: 1000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 18 years of age or older

Brief summary: The goal of this quality improvement program is to implement, evaluate, and sustain an evidence-based smoking cessation treatment program with a population-based approach so that all patients at the Siteman Cancer Center, Washington University, Barnes-Jewish Hospital, BJC Healthcare, and satellite locations receive assessment of smoking and all smokers receive treatment support.


Eligibility criteria: Inclusion Criteria:

-Patients seen at Siteman Cancer Center, Washington University, Barnes-Jewish Hospital, BJC Healthcare, or any of the satellite locations

Exclusion Criteria:

-None

Primary outcomes:
measure: Clinic level percentage of patients receiving brief counseling
timeFrame: From 6 months pre-intervention through 6 months post-intervention
measure: Clinic level percentage of smokers offered referral to additional counseling
timeFrame: From 6 months pre-intervention through 6 months post-intervention
measure: Clinic level percentage of smokers offered medication
timeFrame: From 6 months pre-intervention through 6 months post-intervention
Secondary outcomes:
measure: Clinic level percentage of patients receiving brief counseling
timeFrame: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
measure: Clinic level percentage of smokers offered referral to additional counseling
timeFrame: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
measure: Clinic level percentage of smokers offered medication
timeFrame: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
measure: Clinic level percentage of smokers receiving smoking assessment
timeFrame: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
measure: Clinic level percentage of smokers receiving cessation medication
timeFrame: Estimated to be 12 months pre-intervention and 12, 24, 36, and 48 months post-intervention
measure: Number of patients who have abstained from smoking
timeFrame: Estimated to be 6 months post-intervention
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Li-Shiun Chen, M.D., ScD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00432757: Evaluation of Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens in Allergic Conjunctivitis
Official title: A Multi-Center, Randomized, Double-Masked, Placebo-Controlled Evaluation of the Efficacy and Safety of an Anti-Allergy Drug With a Contact Lens as Compared to Placebo in the Prevention of Allergic Conjunctivitis in a Population of Allergic Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Keywords: allergic conjunctivitis, ophthalmology, multicenter, controlled
Lead sponsor: Vistakon Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2007-02-08
Enrollment: 120
Sex: ALL
Minimum age (years): 8
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 evaluate the efficacy and safety of an anti-allergy drug with a contact lens compared to placebo in preventing ocular itching associated with allergic conjunctivitis


Eligibility criteria: Inclusion Criteria:

* history of ocular allergies and a positive skin test reaction to cat hair, cat dander, grasses, ragweed, and/or trees within the past 24 months; successful soft contact lens wearer who has frequently worn contact lenses for at least one month or more

Exclusion Criteria:

* active ocular infection; clinically significant blepharitis; follicular conjunctivitis; pterygium; narrow angle glaucoma; dry eye syndrome; ocular surgery within past 6 months; pregnancy or lactation

Primary outcomes:
measure: Ocular itching
Secondary outcomes:
measure: Conjunctival, ciliary, and episcleral redness; chemosis and mucous discharge; tearing and lid swelling
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Charlotte
country: United States
state: North Carolina
city: Memphis
country: United States
state: Tennessee
Study officials:
affiliation: Vistakon Pharmaceuticals
name: Brian Pall, OD, MS, FAAO
role: STUDY_DIRECTOR
References:
Clinical trial NCT00995657: Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma
Official title: Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: University of Dundee
Sponsor class: OTHER
First posted: 2009-10-15
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Asthma is a chronic disease, which means that it cannot be cured, but the investigators can use inhalers and tablets to control the symptoms. In asthma, the airways become inflamed and irritated which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in asthma. Doctors have different ways to measure the inflammation in the airways. One way is to measure a gas called nitric oxide (NO) on the breath. This is made by the lungs when asthmatic inflammation is present. The investigators have been using NO as a test in research labs for many years, but there are still unanswered questions about how it changes between morning and night and how quickly medicines work on it. In most asthmatics, even small doses of inhaled steroids (preventers) can reduce the NO levels to normal, but in some people this does not seem to happen. The investigators now have portable NO machines that are designed for patients to use in the home. The investigators want to follow NO readings in patients with high levels to measure how they respond to different doses of steroid inhalers. The investigators hope this will help the investigators better understand asthma inflammation and treatments.


Eligibility criteria: Inclusion Criteria:

* Diagnosis os asthma, taking 200-1000mcg budesonide or equivalent per day
* FENO greater than 30ppb on treatment

Exclusion Criteria:

* Recent RTI or prednisolone
* Smoking within 1 year or 10 pack years
* ABPA, COPD, bronchiectasis

Primary outcomes:
measure: Change in FENO
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Asthma and Allergy Research Group, University of Dundee
state: Tayside
Study officials:
affiliation: University of Dundee
name: Peter A Williamson, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: Anderson WJ, Short PM, Williamson PA, Lipworth BJ. Inhaled corticosteroid dose response using domiciliary exhaled nitric oxide in persistent asthma: the FENOtype trial. Chest. 2012 Dec;142(6):1553-1561. doi: 10.1378/chest.12-1310.
citation: Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3.
Clinical trial NCT00625157: Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Discoid Lupus Erythematosus (DLE) Lesions (2)
Official title: Efficacy and Safety of ASF-1096 Cream 0.5% in the Treatment of Patients With Newly Developed Discoid Lupus Erythematosus (DLE) Lesions. An International Multi-Centre Clinical Phase 2, Placebo Controlled and Double Blind Proof of Concept Study (2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Discoid Lupus Erythematosus
Lead sponsor: Astion Pharma A/S
Sponsor class: INDUSTRY
First posted: 2008-02-28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: Lupus Erythematosus (LE) is an autoimmune disorder that includes a broad spectrum of clinical forms. One of these forms, Discoid Lupus Erythematosus (DLE) is a chronic disfiguring disease confined to the skin.

The aim of this pivotal trial is to investigate the efficacy and safety of ASF-1096 cream 0.5% in the treatment of patients with DLE or SLE presenting newly developed discoid lesions.


Eligibility criteria: Inclusion Criteria:

* A clinical diagnosis of either DLE or SLE
* Histological results from biopsy confirming the diagnosis (biopsy can be taken at screening)
* Is prepared to grant authorised persons access to the medical records
* Has signed informed consent

Exclusion Criteria:

* Has an active skin disease other than DLE or another progressive or serious disease that interferes with the study outcome
* Has scarring at the target lesion
* Systemic treatment of SLE

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Roskilde Hospital
country: Denmark
facility: Gregor Jemec
Study officials:
References:
Clinical trial NCT04608357: Integrated Patient Avatars for Guiding Systemic Therapy Treatments in Metastatic Breast Cancer Patients
Official title: Integrated Patient Avatars for Guiding Systemic Therapy Treatments: "Intuition-Free" Decisions in Metastatic Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Breast Neoplasms
Metastatic Breast Cancer
Cancer, Breast
Keywords: metastatic breast cancer
systemic therapy
needle core biopsy
PDXovo
feasibility study
tumor take rate
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: AFP Innovation Fund
First posted: 2020-10-29
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic breast cancer irrespective of subtype prior to receiving either front-line or subsequent line systemic therapy

Brief summary: The investigators propose to use clinically validated patient avatar technology ("PDXovo") that can test multiple drugs against patients' cancers to identify the most promising systemic therapy for each individual.

Detailed description: The primary goal of this feasibility study is to determine the percentage of patients for whom PDXs are successfully generated within 7-10 days. This will give the investigators an indication of the success rate for providing patients with actionable information if this PDX technology were to be implemented in the clinic. Since the PDXs will also receive the same drug as the patient, there is an opportunity to assess the agreement between the clinical response and the PDX response.

As a secondary goal, the response of PDXs will be compared to the patient's response to systemic therapy, as measured using the objective response rate at 12 weeks +/- 4 weeks (ORR, measured using RECIST 1.1 criteria).

Eligibility criteria: Inclusion Criteria:

1. Age 18+.
2. Metastatic breast cancer irrespective of subtype.
3. Measurable disease as per RECIST 1.1 criteria.
4. Metastatic disease involving the lymph nodes and/or visceral organs is required.
5. Willingness to undergo a biopsy prior to the start of planned systemic therapy.

Exclusion Criteria:

1. Lack of feasibility to obtain a core biopsy of a metastatic site other than the bone (e.g. a metastatic lesion cannot be safely sampled due to proximity to vasculature).
2. Inability to provide informed consent.

Primary outcomes:
measure: Determine the tumor take rate in PDX
timeFrame: 7-10 days
Secondary outcomes:
measure: Compare response rates of PDXs & with that of the patient from whom the PDX was derived
timeFrame: 8 to 16 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
Study officials:
affiliation: Sunnybrook Health Sciences Centre
name: Katarzyna J Jerzak, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04984057: Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome
Official title: Optimal Dose of Surfactant for Preterm Infants With Respiratory Distress Syndrome(RDS)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Distress Syndrome, Newborn
Patent Ductus Arteriosus
Bronchopulmonary Dysplasia
Preterm
Lead sponsor: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Chongqing Medical University
First posted: 2021-07-30
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In preterm infants with neonatal respiratory distress syndrome (RDS), exogenous pulmonary surfactant(PS) replacement therapy is one of the most important therapeutic breakthrough to reduce neonatal incidences of bronchopulmonary dysplasia(BPD) and/or death. But not all preterm infants with RDS can be beneficial. Otherwise, the international neonatal acute RDS (NARDS) collaborative group provides the first consensus definition for NARDS in 2017. And whether or not PS being beneficial in preterm infants with NARDS remains unknown.

Detailed description: To date, the optimal dose of PS is inconsistent, although the recommended dose of PS is given in the 2019 update guideline. PS is not recommended to adult and pediatric ARDS. Systematic review indicates that PS does not reduce the incidences of BPD and death in infants with meconium aspiration syndrome(MAS, a subtype of NARDS). A reasonable speculation is that preterm infants with NARDS do not benefit from PS. And the speculation can explain why not all preterm infants with RDS can be beneficial from PS. In the era of pre-NARDS, the preterm infants fulfilling the definition of NARDS may have been considered as RDS in the first three days after birth.

Meantime, the dose of PS given to infants with NARDS remains unknown. the aim of the present study is to assess the optimal dose of PS. the control group: PS is given according to the European RDS management guideline in 2019 edition. The study group: PS is stopped when the pressure is equal between before patent ductus arteriosus(bPDA) and after PDA(aPDA). the primary outcomes are the closure rate of PDA within 7 days, the incidence of BPD and/or death.

Eligibility criteria: Inclusion Criteria:

* gestation age less than or equal to 32 weeks
* PS is needed

Exclusion Criteria:

* main congenital abnormalities
* parents' refusal or quit

Primary outcomes:
measure: the size of PDA
timeFrame: within 7 days after birth
measure: BPD and/or death
timeFrame: at 36 week's gestational age
Secondary outcomes:
Other outcomes:
Locations:
city: Chongqing
country: China
facility: Children's Hospital of Chongqing Medical University
Study officials:
References:
Clinical trial NCT05432557: External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block in Supra-umbilical Surgical Incisions
Official title: External Oblique Intercostal Plane Block Versus Subcostal Transversus Abdominis Plane Block in Supra-umbilical Surgical Incisions; Randomized Controlled Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-06-27
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Various newer techniques have been proposed to enhance analgesia in upper abdominal region. The subcostal transverse abdominis plane (SCTAP) block is the deposition of local anesthetic in the transverse abdominis plane inferior and parallel to the costal margin. There is a growing consensus that the SCTAP block provides better analgesia for upper abdominal incisions than the traditional transverse abdominis plane block.

The External oblique intercostal plane (EOIP) block is a novel technique reported by Hamilton et al. performed EOPB by administering LA superior or deep of the external oblique muscle from the sixth intercostal space leading to the blockage of thoracoabdominal nerves at T6-T10. It has several attractive aspects such as easy sono-anatomy ribs one strip of muscle so easy to demonstrate even in obese patients, there is a bony backstop, easy expandable fascial plane that can accommodate a catheter and it is shallow block with no big vessels nearby.


Eligibility criteria: Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) physical status grade I -II,
2. Scheduled to undergo elective supra-umbilical surgeries under GA (epigastric herniotomy- gastrectomy- open cholecystectomy- nephrectomy).

Exclusion Criteria:

1. Allergy to local anesthetics,
2. Infection at the site of injection,
3. Coagulopathy,
4. Chronic pain syndromes,
5. Prolonged opioid medication,
6. Patients who received any analgesic 24 h before surgery.
7. Chronic liver disease, chronic renal disease, and cognitive impairment.

Primary outcomes:
measure: amount of postoperative morphine consumed
timeFrame: 24 hours postoperatively
measure: First postoperative analgesics request
timeFrame: 24 hours postoperatively
Secondary outcomes:
measure: Postoperative pain score
timeFrame: at 1, 2,4 , 8, 16 and 24 hours postoperatively
measure: Incidence of Postoperative nausea & vomiting (PONV)
timeFrame: 24 hours postoperatively
measure: incidence of complications related to the block
timeFrame: 24 hours postoperatively
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Samar Rafik Amin
state: Qalubia
Study officials:
References:
Clinical trial NCT01485757: Prospective L-arginine Study
Official title: Effect of Chronic Oral L-arginine Supplementation on Peripheral Endothelial Function and Exercise Tolerance in a Population of Young Heart Transplant Patients.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Heart Transplant
Keywords: patients
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2011-12-05
Enrollment: 3
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: HYPOTHESIS The investigators primary hypothesis is that peripheral endothelial function and exercise tolerance will be abnormal in the population of young heart transplant patients at baseline, and that each will show a trend towards improvement following a 12 week course of oral L-arginine, with regression towards the baseline following the 12 week washout period.


Eligibility criteria: Inclusion Criteria:

* University of Michigan Pediatric Heart Transplant Clinic patient.
* Greater than or equal to 8 years of age.
* Heart transplant between 1 and 8 years prior to enrollment in the study

Exclusion Criteria:

* Relative hypotension for age
* Refusal to participate
* Inability to cooperate with Endo-PAT testing
* Pregnant or nursing women.
* Insulin dependent diabetes

Primary outcomes:
measure: Change in peripheral endothelial function from baseline following 12 week treatment course of L-arginine.
timeFrame: baseline and 12 weeks
Secondary outcomes:
measure: Change from baseline in serum levels of oxidative stress markers
timeFrame: baseline and 12 weeks
measure: Change in exercise tolerance from baseline following a 12 week treatment course of L-arginine
timeFrame: baseline and 12 weeks
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Pediatric Heart Transplant Clinic
state: Michigan
Study officials:
References:
Clinical trial NCT03274557: Radiofrequence Microtenotomy for Treatment of Achilles Tendinose
Official title: Treatment of Achilles Tendinose
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Achilles Pain
Keywords: Achilles, tendinose, tendinopathy, pain
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2017-09-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: To evaluate improvement of VAS and functionality before and after treatment of Achilles tendinosis using radiofrequency-plasma based microtenotomy in comparison to traditional physical therapy.
Primary purpose: TREATMENT

Brief summary: Prospective randomized controlled study using radio-frequency microtenotomy or physical therapy (eccentric training) for treatment of Achilles tendinose

Detailed description: Achilless tendinosis is a major clinical problem. There is a need for new studies to map the effectiveness of treatment. This study will compare treatment effectiveness between traditional physical therapy with surgical treatment using (RFM). The tendinosis grade will be evaluated using MRI and /or ultrasound before and after intervention. The outcome measurment include VAS and function using ( FAOS FOOT \& ANKLE SURVEY) at 6,12 weeks and 6, 12 months after intervention.

Eligibility criteria: Inclusion Criteria:

* Patients with pain in Achilles tendon for at least 6 weeks.
* MR / ultrasound confirms diagnosis tendinose.
* Pain in sport and daily activities

Exclusion Criteria:

Other co-morbidity that constitutes contraindication for surgery, serious illness, bad compliance

Primary outcomes:
measure: Pain reduction
timeFrame: 6.12 weeks and 6,12 months
Secondary outcomes:
measure: Function
timeFrame: 6.12 weeks and 6,12 months
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
References:
citation: Al-Ani Z, Meknas D, Kartus JT, Lyngedal O, Meknas K. Radiofrequency Microtenotomy or Physical Therapy for Achilles Tendinopathy: Results of a Randomized Clinical Trial. Orthop J Sports Med. 2021 Dec 20;9(12):23259671211062555. doi: 10.1177/23259671211062555. eCollection 2021 Dec.