louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05555069: The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
Official title: The Impact of Menthol Flavoring on Switching in Adult Menthol Smokers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Reduction
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-09-26
Enrollment: 800
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will compare the efficacy of menthol-flavored versus tobacco-flavored 4th generation nicotine salt-based pod-system e-cigarettes in facilitating a switch from combustible cigarettes to e-cigarettes in adult menthol smokers.

Detailed description: Menthol smokers (n=800), stratified by race, will be randomized 1:1 into a 12-week open label, non-inferiority trial comparing a 4th generation nicotine salt-based pod-system e-cigarette in menthol- versus tobacco-flavored e-liquid. Follow-up will continue through week 26. The primary outcome is rate of switching from combustible cigarettes to e-cigarettes at week 12.

Eligibility criteria: Inclusion Criteria:

* ≥ 21 years of age
* Smoke ≥ 5 cigarettes per day (CPD)
* Smoke menthol cigarettes for ≥ 6 months
* Verified smoker (CO \>5ppm)
* Functioning telephone
* Interested in switching to E-cigarettes

Exclusion Criteria:

* Interested in quitting smoking
* Use of other tobacco products in past 30 days (i.e. cigarillos, cigars, hookah, smokeless tobacco, pipes)
* E-cigarette use on ≥ 4 of the past 30 days
* Uncontrolled hypertension: BP ≥ 180(systolic) or ≥ 105 (diastolic)
* Use of smoking cessation pharmacotherapy in the month prior to enrollment
* Pregnant, contemplating getting pregnant, or breastfeeding
* Plans to move from Kansas City during the treatment and follow-up phase
* Another household member enrolled in the study

Primary outcomes:
measure: Number of participants who switch from cigarettes to electronic cigarettes at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: Assessment of respiratory symptoms using spirometry
timeFrame: Week 12
measure: Amount of e-liquid consumed
timeFrame: Week 12
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Missouri
Study officials:
affiliation: University of Kanas Medical Center
name: Nicole Nollen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02776969: A Gene Hunting Study for Familial Papillary Thyroid Cancer
Official title: A Strategy to Search for Genes Predisposing to Papillary Carcinoma of the Thyroid When Mutated
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid
Keywords: Papillary Carcinoma
Gene Hunting
Familial
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 1200
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: Families with at least 4 living individuals with a diagnosis of papillary thyroid carcinoma

Brief summary: The aim of this project is to identify genetic risk factors associated with familial papillary thyroid carcinoma (PTC). Papillary thyroid cancer is a type of cancer that shows high heritability. However, the specific genetic factors that cause an increased risk have been elusive.

Detailed description: The aim of this project is to identify genetic risk factors associated with familial papillary thyroid carcinoma (PTC). This can be accomplished in several ways, including loss of heterozygosity studies as well as comparative gene expression analysis. When possible, linkage analysis on families with multiple individuals affected with PTC may also help identify the putative gene(s).

Study participants will be asked to:

1. Complete family history and medical history questionnaires
2. Sign a medical record release so that thyroid cancer pathology reports can be obtained
3. Supply a blood or saliva sample for genetic studies
4. Provide study related information to family members who are needed for family studies

Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of PTC and a family history of PTC in 3 or more living relatives
* Affected and unaffected family members of the proband\*

  * For familial cases (families with 4 or more cases of PTC), participation will be offered to all living family members with PTC or benign thyroid disease as well as selected unaffected first and second degree relatives. Participation may also be offered to spouses when needed for analyzing parent/offspring samples.

Exclusion Criteria:

* Known germline predisposition (ex: pathogenic PTEN variant)
* Non-English speaking

Primary outcomes:
measure: Genetic variants associated with familial papillary thyroid cancer as assessed by multiple genetic testing methodologies
timeFrame: Up to 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Matthew Ringel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00481169: Study Evaluating TSE-424/Placebo/Raloxifene in Preventing Osteoporosis in Postmenopausal Women
Official title: A Multicenter, Double Blind, Randomized, Placebo and Raloxifene Controlled Study to Assess Safety and Efficacy of TSE-424 (Bazedoxifene Acetate) in the Prevention of Postmenopausal Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoporosis
Keywords: Postmenopausal Osteoporosis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-06-01
Enrollment: 1742
Sex: FEMALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether TSE-424 (bazedoxifene acetate), an investigational drug, is safe and effective in the prevention of osteoporosis in postmenopausal women.

Detailed description: Primary objective: To evaluate the safety and efficacy of 3 doses of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with those of placebo and raloxifene in preventing osteoporosis in postmenopausal women.

Secondary objective: To evaluate the effect of TSE-424 (bazedoxifene acetate), an investigational drug, in comparison with that of placebo and raloxifene on endometrium, metabolic parameters, vasomotor symptoms, adverse events, and quality of life. Samples will be collected for population pharmacokinetic (PK) analysis.

Eligibility criteria: Inclusion Criteria:

* Generally healthy women 45 years of age or older who are at least 1 year postmenopausal.
* Subjects must qualify for one of the following categories (a or b): a) Greater than 1 year but less than 5 years postmenopausal with at least one of the osteoporosis risk factors. b) Greater than 5 years postmenopausal with BMD T-score at lumbar spine or femoral neck between -1 and -2.5 (inclusive) with at least one osteoporosis risk factor.

Exclusion Criteria:

* One (1) or more osteoporotic vertebral fractures (T4-L4).
* Diseases that may affect bone metabolism.
* Past history or active nontraumatic venous thromboembolic events, including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis.

Primary outcomes:
measure: The percent change from baseline in lumbar spine bone mineral density (BMD) after 24 months.
timeFrame: 24 months
Secondary outcomes:
measure: Additional BMD evaluation including total hip, femoral neck and trochanter at months 6, 12, 18 and 24. Serum bone markers at months 3, 6, 9, 12, 18 and 24. Lipid panel at months 3, 6, 12, 18 and 24.
timeFrame: Up to 24 months
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04823169: Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method
Official title: Painful and Barometric Dynamic Monitoring in the Aftermath of Foot Surgery Using the Distal Metatarsal Mini-invasive Osteotomy (DMMO) Method.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Distal Metatarsal Mini-invasive Osteotomy (DMMO)
Keywords: Distal Metatarsal Mini-invasive Osteotomy
DMMO
Podobarometry
Lead sponsor: Centre Hospitalier le Mans
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 70
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 definitive treatment of disabling metatarsalgia requires surgery. In recent years, a percutaneous technique has been developed, the "Distal Metatarsal Mini-invasive Osteotomy" (DMMO). It consists of performing extra-articular osteotomies that are not osteosynthesized and maintained during the time of bone consolidation by a dressing and specific offloading footwear.The patient is encouraged to resume walking immediately after the procedure, as full plantar support is an integral part of the surgical concept. The goal is to actively modify the distribution of all metatarsal supports by the pressure exerted on the ground during walking and by tendon tensions, in order to reduce forefoot deformities.

DMMO offers many advantages over traditional techniques, but it remains a painful forefoot surgery in the short term despite the systematic use of analgesics and the wearing of a dedicated therapeutic shoe.

The study will seek to identify the predictive character of podobarometric parameters at walking (D+7 and D+30 post-op), between patients who will require a palliative solution versus those who will not (D+90)


Eligibility criteria: Inclusion Criteria:

* Adult person
* Affiliated or beneficiary of a statutory social insurance scheme
* Free ans informed consent
* Following foot surgery like DMMO only or DMMO and hallux valgus

Exclusion Criteria:

* Minor or legally protect adult
* Amputation disturbing the natural course of the step
* Osteoarticular diseases/sequelae affecting walking and/or balance
* Neuromuscular diseases/sequelae affecting walking and/or balance
* Vestibular disorders affecting balance
* Patients requiring a walking aid (e.g., walker)
* Pregnant woman
* Patient with dementia who are unable to follow verbal instructions

Primary outcomes:
measure: podobarographic parameters (plantar pressures) predictive of the need for a palliative foot orthosis
timeFrame: 90 days after surgery
Secondary outcomes:
measure: Compare daily walk pain kinetics over one month postoperatively in patients requesting palliative solutions at 3 months (requesters) versus those not requesting them (non-requesters)
timeFrame: 90 days after surgery
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Centre Hospitalier Du Mans
Study officials:
References:
Clinical trial NCT02480569: Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter
Official title: Trial to Compare FFR Measurement With a Non-Side-Hole Guide Catheter Vs. a Side-Hole Guide Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: North Texas Veterans Healthcare System
Sponsor class: FED
First posted: 2015-06-24
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The investigators propose a single center prospective study that will assess two different strategies for measuring Fractional Flow Reserve (FFR) in patients undergoing clinically-indicated coronary angiography in whom FFR measurement is indicated. FFR will be measured with a non-side hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) and with a side-hole guide catheter (with the guide catheter both engaged and disengaged from the coronary ostium) to determine, whether measurements obtained with an engaged side-hole guide catheter are more accurate as compared with those obtained with the engaged non-side hole catheter.


Eligibility criteria: Inclusion Criteria:

* Undergoing a clinically indicated coronary catheterization
* Need FFR of a coronary artery lesion
* Agree to participate and able to provide informed consent

Exclusion Criteria:

* Significant difficulty advancing the pressure measuring guidewire into the coronary artery
* Severe chronic obstructive pulmonary disease
* Severe ostial disease (\>70% diameter stenosis within 5 mm from the coronary artery ostium)

Primary outcomes:
measure: FFR measurement using a guide catheter with and without side holes
timeFrame: Less than 1 hour during the coronary angiography
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
Study officials:
References:
Clinical trial NCT03397069: Midazolam Additive to Local Anesthetic in Peribulbar Block
Official title: Efficacy of Midazolam Addition to Local Anesthetic in Peribulbar Block. Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Cataract
Local Anaesthetic Complication
Midazolam
Keywords: peribubar block - midazolam
Lead sponsor: Al Jedaani Hospital
Sponsor class: OTHER
First posted: 2018-01-11
Enrollment: 90
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Regional eye blocks are usually preferred for ophthalmic procedures. Peribulbar block (PBB) is a safe alternative for patients undergoing cataract surgery. Many studies tried to solve this issue by means of prolonging the duration of action of the local anesthetics used. Several drugs were tried as adjuncts to local anesthetics, and their effects have been studied. Midazolam added to the list of adjuvant used in the subarachnoid or epidural block can produce analgesia, probably mediated by the benzodiazepine-Gamma Amino-Butyric Acid(GABA) receptor complex.

The investigators hypothesized that the addition of midazolam to lidocaine will improve the quality of the peribulbar block; fasten the onset and prolonging its anesthetic and analgesic duration.


Eligibility criteria: Inclusion Criteria:

* 90 adult patients with ASA physical status I to III
* Aged 40-70 years
* Scheduled for elective extracapsular or phacoemulsification cataract surgery with peribulbar block
* No history of allergy to local anesthetics
* Axial length less than 28 mm.

Exclusion Criteria:

* Patient's refusal to share in the study
* communication barrier (e.g. impaired hearing, disturbed conscious level, impaired mental status)
* uncontrolled tremors
* morbidly obese patients
* allergy to lidocaine
* coagulation abnormalities
* glaucoma
* recent surgical procedure on the same eye.

Primary outcomes:
measure: Quality of the sensory and motor block
timeFrame: 6 hours
Secondary outcomes:
measure: Onset and duration of block
timeFrame: 6 hours
measure: Analgesia
timeFrame: 4 hours postoperative
measure: local or systemic complications
timeFrame: 6 hours
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: Al Jedaani group of hospitals
state: Meccah
Study officials:
References:
citation: Ibrahim M, Gomaa E. Efficacy of midazolam addition to local anesthetic in peribulbar block : Randomized controlled trial. Anaesthesist. 2019 Mar;68(3):143-151. doi: 10.1007/s00101-018-0525-3. Epub 2019 Jan 9.
Clinical trial NCT01859169: Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma
Official title: Longterm Outcome of Photodynamic Therapy Compared With Biliary Drainage Alone in Patients With Unresectable Cholangiocarcinoma
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Cholangiocarcinoma
Keywords: bili duct neoplasms
bile duct cancer
photodynamic therapy
biliary drainage
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2013-05-21
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with bile duct cancer

Brief summary: This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through T-tube compared with biliary drainage alone in patients presenting with unresectable bile duct cancer.


Eligibility criteria: Inclusion Criteria:

* 1.Patients with bile duct cancer 2.Patients are willing to join in this clinical trial.

Exclusion Criteria:

* 1.Patients with bile duct carcinoma can not suffer PDT procedure. 2.Allergy to photosensitizer

Primary outcomes:
measure: Survival rate
timeFrame: one month
Secondary outcomes:
measure: Quality of life
timeFrame: one month
Other outcomes:
measure: Complication of therapy
timeFrame: one month
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
References:
citation: Kahaleh M, Mishra R, Shami VM, Northup PG, Berg CL, Bashlor P, Jones P, Ellen K, Weiss GR, Brenin CM, Kurth BE, Rich TA, Adams RB, Yeaton P. Unresectable cholangiocarcinoma: comparison of survival in biliary stenting alone versus stenting with photodynamic therapy. Clin Gastroenterol Hepatol. 2008 Mar;6(3):290-7. doi: 10.1016/j.cgh.2007.12.004. Epub 2008 Feb 6.
Clinical trial NCT00257569: Study Of Atopic Dermatitis In Pediatrics
Official title: Evaluation of the Efficacy and Safety of Cetirizine Dry Syrup in Children -Suffering From Atopic Dermatitis-
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dermatitis, Atopic
Keywords: Atopic
Pediatric
Dermatitis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2005-11-23
Enrollment: 278
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To verify of cetirizine dry syrup to ketotifen dry syrup in the change in the severity of pruritus of the treatment period.


Eligibility criteria: Inclusion Criteria:

* Children diagnosed as atopic dermatitis
* Giving informed consent
* Children who have 2 grades or more pruritus score.
* Children who require the treatment with external steroid preparation other than face and head.
* Children with a pruritus severity of 2.
* Mild or severe on the fist day of the treatment period.

Exclusion criteria:

* have spastic disease such as epilepsy
* have a history of drug hypersensitivity
* are lactating or possibly pregnant female Children
* have a skin infection, or with zooparasite such as scabies and pediculosis
* cannot avoid the use of external steroid classified into strong, strongest or very strong
* have eczematous otitis externa with perforation in the eardrum
* have dermal ulcer, or profound heat burn or frostbite of the severity higher than the grade 2
* have asthma that requires the treatment with corticosteroid
* have pruritus only on face and head
* have inappropriate complication of dermal disorder that may influence on the evaluation of the study drug
* are undergoing specific desensitization therapy or immunomodulation therapy or phototherapy.

Primary outcomes:
measure: change in the severity of pruritus
Secondary outcomes:
measure: -changes in the total pruritus score -daily main pruritus score -improvement of area with pruritus -patient global improvement -Cetirizine serum concentrations -Adverse events
Other outcomes:
Locations:
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03790969: Minimizing Pain Experience In Trigger Finger Steroid Injection.
Official title: Minimizing Pain Experience In Trigger Finger Steroid Injection.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Trigger Finger
Keywords: steroid injection
pain
needle gauge
trigger finger
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
First posted: 2019-01-02
Enrollment: 112
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: To study the pain experience of trigger finger steroid injection with 26 gauge needle as compared to 23 gauge needle.

Detailed description: compare pain experience of trigger finger steroid injection between 26 gauge needle and 23 gauge needle.

Eligibility criteria: Inclusion Criteria:

* Age above 18 year old
* Male or female(non-pregnant)
* Single trigger finger
* Clinically diagnosed trigger finger- Green classification Grade I or II
* No prior surgery to the involved finger
* Subject is able to provide voluntary, written informed consent

Exclusion Criteria:

* Age less than 18 year old
* Allergy to lignocaine or corticosteroid
* Trigger finger with Green classification grade III or IV
* Previous surgery on the affected finger
* Any wound, neurovascular injury, or skin disease at injection site
* Concomitant ipsilateral fingers/wrist/forearm/arm injury
* Preexisting congenital/acquired deformities of hand (such as rheumatoid arthritis, contracture)
* Insensate hand

Primary outcomes:
measure: Visual analog scale-pain
timeFrame: one minute after injection
Secondary outcomes:
Other outcomes:
Locations:
city: Cheras
country: Malaysia
facility: Chuah Sion Keat
state: Kuala Lumpur
Study officials:
name: Chuah Sion Keat
role: PRINCIPAL_INVESTIGATOR
References: