louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01368016: Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Therapy and Nicotine Gum
Official title: Nicotine Pharmacodynamics With a New Oral Nicotine Replacement Product and Nicotine Gum 4 mg. A Study in Healthy Smokers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Dependence
Keywords: Smoking Cessation
Nicotine Pharmacodynamics
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2011-06-07
Enrollment: 346
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: A comparison of two products for oral nicotine replacement with respect to relief of urges to smoke after single doses of nicotine.

Detailed description: This study will be performed at two sites and two-hundred and fifty (250) healthy male and female subjects will be included. Treatments comprise single doses of an experimental Nicotine Replacement Therapy (NRT) and Nicorette Freshfruit gum 4 mg, which are chewed during 30 minutes. All subjects will be given both treatments in a crossover setting. The length of the time interval separating treatment visits, and during which no NRT must be used, will be at least 36 hours.

The subjects will abstain from smoking from 8 pm the evening before until the end of each visit. The subjects will take the gums according to instructions from the study personnel. After chewing, used gums will be collected for nicotine analysis.

Electronic diaries will be used to collect data. Urges to smoke will be scored on a 100 mm visual analogue scale (VAS) before the start of treatment and during 5 hours thereafter. Subjects will also be monitored to capture any adverse events that may occur.

Eligibility criteria: Inclusion Criteria:

* Healthy subjects, smoking more than 20 cigarettes daily during at least one year preceding inclusion.
* Body Mass Index (BMI) between 17.5 and 32.0 kg/m2 and a total body weight of at least 55.0 kg.
* Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
* A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Pregnancy, lactation or intended pregnancy.
* Treatment with an investigational product within one month preceding the first dose of study medication.

Primary outcomes:
measure: Area Under the Curve (AUC): Urges to Smoke-vs-Time
timeFrame: During 5 hours post-dose
Secondary outcomes:
measure: Amount of Nicotine Released
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Clinical Pharmacology, McNeil AB
city: Stockholm
country: Sweden
facility: Karolinska Trial Alliance (KTA), University Hospital Huddinge
Study officials:
affiliation: McNeil AB
name: Elisabeth Kruse, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03280316: Efficacy Comparison Between Different Management Strategies for Consistent OAB in Patients With SVMs After Surgery
Official title: Efficacy Comparison Between Different Management Strategies for Consistent Overactive Bladder (OAB) in Patients With Spinal Vascular Malformations After Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Spinal Vascular Disorder Nos
Overactive Bladder
Keywords: Spinal Vascular Disorder
Overactive Bladder
Lead sponsor: Xuanwu Hospital, Beijing
Sponsor class: OTHER
First posted: 2017-09-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB in patients with SVMs after surgery.

Detailed description: Spinal Vascular malformations (SVMs) are complex neurosurgical lesions and account for 3%-4% of all intradural spinal cord mass lesions, which can influence the function of bladder. The investigators' goal is to compare the efficacy of three different management strategies (sacral neuromodulation, botulinum toxin, M receptor antagonist) in treating consistent OAB (Overactive Bladder) in patients with SVMs after surgery.

Eligibility criteria: Inclusion Criteria:

* •Patient diagnosed with spinal vascular diseases including Intradural arteriovenous malformation,Intradural arteriovenous fistula,Dural arteriovenous fistula,Extradural arteriovenous malformation,Paravertebral arteriovenous malformation,Paravertebral arteriovenous fistula,cobbs' syndrome,and other spinal arteriovenous metameric syndromes involve the spinal cord.

  * patient not received surgical or interventional treatment before
  * patient with normal cardiac, renal and hepatic function
  * patient capable of understanding the content of the patient information / Informed Consent Form
  * patient willing and able to participate in the registry
  * patients have consistent OAB after surgery

Exclusion Criteria:

* •patient received surgical treatment or interventional treatment before

  * patient is pregnant
  * patient allergic to iodine
  * patient unable to complete follow-up
  * patient with cerebral lesions
  * patient with other spinal lesions
  * patient with cardiac, renal or hepatic dysfunction

Primary outcomes:
measure: bladder function
timeFrame: 3 months and 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Xuanwu Hospital, Beijing
name: tongwen ou, M.D
role: STUDY_DIRECTOR
References:
Clinical trial NCT04679116: Laparoscopic vs Open Bilateral Inguinal Hernia Repair
Official title: Laparoscopic vs Open Bilateral Inguinal Hernia Repair
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Inguinal Hernia Bilateral
Keywords: bilateral inguinal hernia repair
Lead sponsor: General Hospital of Larissa
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective, non randomised
Primary purpose: TREATMENT

Brief summary: The European Hernia Society Guidelines of 2018 suggest that laparoscopic surgery should be preferred over open surgery for bilateral inguinal hernia repair even though scientific evidence are scarce. We will conduct a prospective, non randomise control trial, to investigate the superiority of one technique over the other.


Eligibility criteria: Inclusion Criteria:

* bilateral inguinal hernia

Exclusion Criteria:

* American Society of Anaesthesiology score \>3
* complicated inguinal hernias

Primary outcomes:
measure: Post operative Pain
timeFrame: 24 hours post surgery
Secondary outcomes:
measure: days of hospitalization
timeFrame: 30 days
measure: urinary retention
timeFrame: 8 hours
measure: complications
timeFrame: 30 days
measure: recurrence
timeFrame: 1 year
measure: chronic pain
timeFrame: 1 year
measure: foreign body sensation to the inguinal area
timeFrame: 1 year
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: General Hospital Of Larissa
Study officials:
affiliation: General Hospital of Larissa
name: Georgios D Koukoulis, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: HerniaSurge Group. International guidelines for groin hernia management. Hernia. 2018 Feb;22(1):1-165. doi: 10.1007/s10029-017-1668-x. Epub 2018 Jan 12.
Clinical trial NCT06027216: Multiplexing Prism Fitting for Field Expansion of Monocular Vision
Official title: Monocular Visual Confusion for Field Expansion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: One Eye Blindness
Blind Left Eye
Blind Right Eye
Keywords: Field expansion
Collision detection
Walking
Response time
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2023-09-07
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Individuals with Acquired Monocular Vision/ Blindness in One Eye
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators are testing a simplified design and fitting protocol to provide field expansion for individuals with acquired monocular vision.


Eligibility criteria: Inclusion Criteria:

* No medical health issues such as seizures, motor movements problem
* Loss of vision in one eye (less than 20/200) for \>1 year)
* Visual acuity of the seeing eye: Better than 20/32 visual acuity with correction
* No visual field defect in the seeing eye (nasal field of at least \>45degree)
* No medical health issues such as seizures, motor movements problem

Exclusion Criteria:

* Patients with any physical or mental disabilities, including cognitive dysfunction, balance problems, or other deficits that could impair their ability to respond to the stimuli presented in this study will be excluded
* Any person with motor movements problem (e.g., unable to use extremities)

Primary outcomes:
measure: Gain in Visual Field With the Multiplexing Prism
timeFrame: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
Secondary outcomes:
measure: Maximum Extent of Nasal Visual Field With the Multiplexing Prism
timeFrame: Visit 2 of Study (approximately 2-3 weeks after 1st Visit)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Schepens Eye Research Institute
state: Massachusetts
Study officials:
affiliation: Schepens Eye Research Institute
name: Eli Peli, OD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jung JH, Peli E. Field Expansion for Acquired Monocular Vision Using a Multiplexing Prism. Optom Vis Sci. 2018 Sep;95(9):814-828. doi: 10.1097/OPX.0000000000001277.
citation: Jung JH, Peli E. No Useful Field Expansion with Full-field Prisms. Optom Vis Sci. 2018 Sep;95(9):805-813. doi: 10.1097/OPX.0000000000001271.
citation: Peli E, Jung JH. Multiplexing Prisms for Field Expansion. Optom Vis Sci. 2017 Aug;94(8):817-829. doi: 10.1097/OPX.0000000000001102.
Clinical trial NCT01317316: Causes and Characteristics of Occupational Eye Injuries in Western Turkey
Official title: Causes and Characteristics of Occupational Eye Injuries in Western Turkey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Other and Unspecified Superficial Injuries of Eye
Lead sponsor: Pamukkale University
Sponsor class: OTHER
First posted: 2011-03-17
Enrollment: 816
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with WREI admitted to the center in the four-year period were enrolled in this prospective study. Institutional Review Board approval was obtained before commencement of the study. A special data recording system was developed for the study. The study sample comprised only the casualties occurred at workplace and while working de facto.

Brief summary: Patients with work-related eye injuries (WREI) admitted to the center in the four-year period were enrolled in this prospective study. Institutional Review Board approval was obtained before commencement of the study. A special data recording system was developed for the study. The study sample comprised only the casualties occurred at workplace and while working de facto. The data were abstracted via face to face contact in the emergency department (ED). The data sheets comprised sociodemographic and injury-related information brought together in 15-item questionnaire. Causes of occupational injuries as reported by the victims were assigned to either of two groups: "Worker-related causes" and "workplace-related causes".

Since workers are known to be pressured by the workplace to work in unsafe ways, an isolated room in the ED was used for this purpose in order to prevent bias and the patients were not accompanied by any person other than the medical personnel in charge of due medical care. The patients were also assured that the information obtained by the survey are to be used for research purposes only and no feedback is to be given to employers or related persons.

Patients who did not give consent for the study, fatal accidents and patients younger than 15 years of age were excluded from the analysis.

Detailed description: All data obtained in the study were recorded in and analyzed using the Statistical Package for Social Sciences for Windows, Version 17. Numerical variables were given as mean and standard deviation (SD), while categorical variables were given as frequencies (n) and percentages.

Eligibility criteria: Inclusion Criteria:

* The study sample comprised only the casualties occurred at workplace and while working de facto

Exclusion Criteria:

* Other

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pamukkale University
name: mustafa serinken, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06467916: The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home
Official title: The Development of PATH, a Program to Support NICU Parent Mental Health Through the Transition From Hospital to Home
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Mental Health
Keywords: neonatal intensive care unit
perinatal mental health
perinatal depression
perinatal anxiety
posttraumatic stress disorder
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Oregon Health and Science University
name: National Institute of Mental Health (NIMH)
First posted: 2024-06-21
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective of this study is to develop and pilot test a telehealth-based mental health screening and engagement program that supports parents as their infants transition home from the NICU. The program will use a stepped-care approach to screen parents for depression, anxiety, and PTSD; provide a brief behavioral intervention to those who screen as having at least a low risk of these conditions; and provide a warm hand-off to community mental health services for those at medium to high risk.


Eligibility criteria: Inclusion Criteria:

* NICU parents: Participants will be parents of currently hospitalized preterm infants from either the OHSU NICU or the UCH NICU. We will include parents of live preterm infants who have been admitted in the NICU for at least 2 weeks. Parents must speak English or Spanish. Parents can be of any age.
* NICU stakeholders: Participants will be stakeholders from either the OHSU NICU or the UCH NICU. Stakeholders will be social workers, mental health providers responsible for providing more intensive mental health support for NICU parents, nurses, neonatologists, and hospital administrators.

Primary outcomes:
measure: Mental health self-efficacy scale
timeFrame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Secondary outcomes:
measure: City Mental Illness Stigma Scale
timeFrame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
measure: Parenting Sense of Self Confidence Scale
timeFrame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Other outcomes:
measure: Edinburgh Postnatal Depression Scale (EDPS)
timeFrame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
measure: GAD-7
timeFrame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
measure: Post-Traumatic Stress Disorder Questionnaire (PPQ)
timeFrame: ~2 weeks prior to discharge; 2 weeks post-discharge; 6 weeks post-discharge
Locations:
city: Aurora
country: United States
facility: University of Colorado Hospital
state: Colorado
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
References:
Clinical trial NCT05704816: The Effect of Different Types of Spinal Needles on the Success of the Procedure
Official title: The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spinal Needle Diameter and Design, Click Feeling
Lead sponsor: Zonguldak Bulent Ecevit University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 213

Brief summary: The effects of spinal needles with different tip designs on the success of the application and the number of attempts required to get the spinal click feeling.


Eligibility criteria: Inclusion Criteria:

* Elective lower abdomen/extremity surgery planned,
* American Society of Anesthesiologists (ASA) I-II risk group,
* without bleeding diathesis
* patients with written consent

Exclusion Criteria:

* Patients for whom spinal anesthesia is contraindicated,
* morbidly obese,
* pregnant
* Patients with a history of allergic reactions to the drugs used in the study.

Primary outcomes:
measure: The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
timeFrame: Spinal anesthesia procedure time
measure: The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
timeFrame: Spinal anesthesia procedure time
Secondary outcomes:
measure: The Effect of Different Types of Spinal Needles Used by First-year Anesthesia Residents on Procedural Success and Click Sensation: A Prospective, Observational Study
timeFrame: Spinal anesthesia procedure time
Other outcomes:
Locations:
city: Zonguldak
country: Turkey
facility: Gamze Küçükosman
Study officials:
References:
Clinical trial NCT06744816: Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study
Official title: Exploring the Benefit of Topical Capsaicin in Treating Pain From Chemo-induced Peripheral Neuropathy: a Longitudinal Single Center Pilot Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Peripheral Neuropathy Due to Chemotherapy
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: Averitas Pharma, Inc.
First posted: 2024-12-20
Enrollment: 20
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: To learn if topical capsaicin can help relieve pain from CIPN and improve gait (the pattern of walking) in patients.

Detailed description: Primary Objectives

• To assess changes in Gait (specifically looking at velocity) before and after use of topical capsaicin.

Secondary Objectives

* To assess Pain intensity numerical rating scale (NRS) scores in chemotherapy induced peripheral neuropathy (CIPN) participants before and after use of capsaicin 8% topical patch.
* To assess changes in quantitative sensory testing (QST) before and after use of topical capsaicin.
* To assess skin punch biopsy to compare the integrity of epidermal nerve fibers and Meissner's corpuscles (MC) in CIPN patients before and after use of topical capsaicin (optional).
* To assess pain tumor related neuropathy assessment scale (TNAS) before and after topical capsaicin
* To assess pain interference using the Brief Pain Inventory (BPI), before and after topical capsaicin
* To assess Patient Global Impression of Change (PGIC)
* To assess the rate of adverse events and tolerability of topical capsaicin as reported by participants

Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with pain of the lower extremity from chronic (\>90 days duration) CIPN (due to either vinca alkaloids, taxanes, bortezomib, thalidomide, platinum-based compounds), seen at MD Anderson Cancer Center
* Participants reporting baseline pain ≥ 4 (0-10 scale, NRS)
* Participants age 18+
* Participants who have completed chemotherapy within the last year at the time of enrollment.

Exclusion Criteria:

* Participants with cognitive dysfunction
* Participants with recent history (\<6 months) of drug or alcohol abuse
* Participants with open skin lesion or undergoing antibiotic therapy for local for systemic infection
* Participants with allergies to capsaicin or adhesives
* Pregnant participants

Primary outcomes:
measure: Safety and adverse events (AE)s
timeFrame: Through study completion; an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Saba Javed, MD
role: PRINCIPAL_INVESTIGATOR
References: