louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00482963: A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
Official title: A Pilot Study of the Pharmacokinetic Interactions Between the Hormonal Emergency Contraception, Plan B, and Efavirenz
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Contraception
Pharmacokinetics
Keywords: HIV
Contraception
Antiretroviral agents
Pharmacokinetics
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: The Miriam Hospital
name: University of Washington
name: Bristol-Myers Squibb
First posted: 2007-06-06
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if blood levels of the hormonal emergency contraceptive agent, Plan B, are altered by concomitant use with the HIV medication, efavirenz.

Detailed description: The use of hormonal contraceptive pills in women with HIV is complex due to potential interactions between these agents and HIV medications. HIV-infected women taking efavirenz have an even greater need for effective birth control as this medication may cause severe brain damage to a developing fetus. The use of an emergency contraceptive agent in cases of unprotected sex or condom failure can prevent pregnancy. This study seeks to establish that Plan B can be used effectively and safely in women taking efavirenz.

Eligibility criteria: Inclusion Criteria:

* Healthy, HIV-1 seronegative women of child-bearing age.

Exclusion Criteria:

* Current use of hormonal contraception
* Pregnancy/Breast Feeding
* Post-menopausal status
* Obesity
* Hepatitis B or C
* Psychiatric illness
* Active Substance Abuse

Primary outcomes:
measure: The change in Plan B (levonorgestrel) Area under the Concentration Time Curve (AUC12) prior to and during steady state efavirenz
timeFrame: 12 hour pharmacokinetic study
Secondary outcomes:
measure: Pharmacokinetic parameters of levonorgestrel prior to and during steady state efavirenz
timeFrame: 12 hour pharmacokinetic study
measure: Frequency of common levonorgestrel-associated adverse events prior to and during steady-state efavirenz
timeFrame: 3 weeks
measure: Changes in liver function tests before and during efavirenz
timeFrame: 3 weeks
measure: The efavirenz Area Under the Concentration Time Curve (AUC 24) in setting of levonorgestrel compared to historical controls
timeFrame: 12 hour pharmacokinetic study
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: University of Colorado, Denver
name: Monica L Carten, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01522963: Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms
Official title: Medicinal Nicotine for Preventing Stress Induced Craving and Withdrawal Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-02-01
Enrollment: 98
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: OTHER

Brief summary: The purpose of this study is to determine the timeframe (relative to a stress task) that is most effective at attenuating the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with stressful situations.


Eligibility criteria: Inclusion Criteria:

* Smoking an average of at least 10 cigarette per day
* General good health

Exclusion Criteria:

* unstable medical or psychiatric conditions
* history of severe motion sickness
* women who are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not participate

Primary outcomes:
measure: Craving
timeFrame: Baseline, 6 months
measure: Nicotine Withdrawal Symptoms
timeFrame: 5 to 35 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Clinical and Translational Sciences Institute
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Michael Kotlyar, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kotlyar M, Lindgren BR, Vuchetich JP, Le C, Mills AM, Amiot E, Hatsukami DK. Timing of nicotine lozenge administration to minimize trigger induced craving and withdrawal symptoms. Addict Behav. 2017 Aug;71:18-24. doi: 10.1016/j.addbeh.2017.02.018. Epub 2017 Feb 10.
Clinical trial NCT06995963: Impact of TURP on Quality of Life in Patients With Benign Prostatic Hyperplasia: A Retrospective Study
Official title: Impact of TURP on Quality of Life in Patients With Benign Prostatic Hyperplasia: A Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostatic Hyperplasia
Prostatectomy
Transurethral Resection of Prostate
Quality of Life
Urinary Tract Symptoms
Treatment Outcome
Lead sponsor: Centre Hospitalier de Gonesse
Sponsor class: OTHER
First posted: 2025-05-30
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population consists of adult male patients diagnosed with benign prostatic hyperplasia (BPH) who underwent transurethral resection of the prostate (TURP) at a single medical center. Participants will be selected retrospectively from medical records of patients treated between February and April. All included patients must have urinary symptoms related to prostatic obstruction and complete pre- and post-operative data available, including IPSS scores.

Brief summary: This study looks at how a common surgery called TURP (Transurethral Resection of the Prostate) affects the quality of life in men with benign prostatic hyperplasia (BPH), a non-cancerous enlargement of the prostate. By reviewing past medical records of patients who had this surgery, researchers will evaluate how urinary symptoms and overall well-being changed after the procedure.


Eligibility criteria: Inclusion Criteria:

* Male patients with urinary symptoms related to prostatic obstruction
* Patients who underwent transurethral resection of the prostate (TURP)
* Availability of pre- and post-operative data (including IPSS)

Exclusion Criteria:

* Patients with urinary symptoms not related to prostatic obstruction
* Patients who did not undergo TURP
* Incomplete or missing clinical data required for analysis

Primary outcomes:
measure: Change in urinary symptoms after TURP, measured by the IPSS
timeFrame: From baseline (pre-surgery) to 1-3 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Gonesse
country: France
facility: France
Study officials:
References:
Clinical trial NCT05573763: Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
Official title: Evaluation of the F&P Toffee Nasal Pillows Mask, US, 2022
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Fisher and Paykel Healthcare
Sponsor class: INDUSTRY
First posted: 2022-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this clinical investigation is to evaluate the performance and safety of the F\&P Toffee nasal pillows mask in a home environment.


Eligibility criteria: Inclusion Criteria:

* Persons who are ≥22 years of age
* Persons who weigh ≥66 pounds
* Persons who have been prescribed PAP therapy by a physician
* Persons who are existing nasal pillows mask users with at ≥3 months of use prior to enrolment in the clinical trial
* Persons who are compliant with PAP therapy for ≥4 hours per night for ≥70% of nights for a 14-day period within 30 days prior to enrolment in the clinical trial
* Persons who are fluent in spoken and written English
* Persons who possess the capacity to provide informed consent

Exclusion Criteria:

* Persons who are intolerant to PAP therapy
* Persons who possess, or suffer from, anatomical or physiological conditions which make PAP therapy inappropriate
* Persons who are required to use PAP therapy for \>12 hours per day or for extensive periods, not including sleep or naps
* Persons who are trying to get pregnant, are pregnant, or think they may be pregnant
* Persons who have an IPAP pressure of \>25 cmH2O if on BPAP
* Persons who use a PAP therapy device for the delivery of medicines, except supplemental O2
* Persons who use a PAP therapy device that does not possess data recording capabilities to capture AHI and a numerical indicator of leak that is accessible to the investigation site

Primary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: 14±5 days
measure: Epworth Sleepiness Scale
timeFrame: 14±5 days
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio Sleep Medicine Institute
state: Ohio
Study officials:
References:
Clinical trial NCT03410563: The Analgesic Effect of Auditory Inputs and Its Relation to Psychological and Neurobiological Mechanisms
Official title: The Analgesic Effect of Auditory Inputs and Its Relation to Psychological and Neurobiological Mechanisms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Analgesia
Keywords: Pain
Auditory inputs
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2018-01-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy participants

Brief summary: The study investigates the analgesic effect of different auditory inputs. Employing a within-subject design, the study includes healthy participants that are exposed to thermal stimuli while listening to three different auditory inputs. By repeating this on separate test days, the involvement of bodily processes is investigated.


Eligibility criteria: Inclusion Criteria:

* Healthy participants with normal hearing

Exclusion Criteria:

* Chronic pain conditions
* Other medical, psychiatric or neurological disorders
* Use of pain-relieving medication 24 hours prior to testing

Primary outcomes:
measure: Visual analogue scales
timeFrame: An average of 3 weeks (Participants are tested at three different test days across an average of 3 weeks; the primary outcome measure will be assessed after each thermal stimulus at the three test days)
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus C
country: Denmark
facility: Department of Psychology and Behavioural Sciences
Study officials:
References:
citation: Lunde SJ, Vuust P, Garza-Villarreal EA, Kirsch I, Moller A, Vase L. Music-Induced Analgesia in Healthy Participants Is Associated With Expected Pain Levels but Not Opioid or Dopamine-Dependent Mechanisms. Front Pain Res (Lausanne). 2022 Apr 4;3:734999. doi: 10.3389/fpain.2022.734999. eCollection 2022.
Clinical trial NCT01750463: Comparing Validity of Non-Invasive Hemoglobin Monitoring to Laboratory Results in Critically Ill Children
Official title: Verifying the Accuracy of the Masimo Pronto Non-Invasive Hemoglobin (Hb) Monitor and Associated Rainbow Probes Compared to Measured Laboratory Values in Critically Ill Pediatric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemoglobin Results
Keywords: Pediatric critically ill
Masimo
hemoglobin
monitoring
UNC
PICU
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2012-12-17
Enrollment: 65
Sex: ALL
Minimum age (years): 30
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients admitted to the PICU requiring hemoglobin monitoring

Brief summary: This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children.

Detailed description: This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin concentration in critically ill children. Data from at least 30 patients admitted to the Pediatric Intensive Care Unit (PICU) over a period of 2 months will be collected and analyzed for this study.

Note, that this device would not lead to deviations in routine patient care; specifically, the non-invasive monitor placed on the patient's finger is FDA approved. The proposed monitors are identical macroscopically to monitors, which are currently used to measure oxygen saturation at this institution. Clinical decisions, additional blood draws or alterations to the plan of care will not be made based on study data. The objective is to compare the validity of the hemoglobin values determined from non-invasive technology with measured laboratory values for hemoglobin utilized as standard of care.

Eligibility criteria: Inclusion Criteria:

* Patient has been admitted to Pediatric Intensive Care Unit
* Patient age is ≥ 30 days old and ≤ 18 years old
* Patient weight ≥ 3 Kg.
* Patient requires hemoglobin monitoring

Exclusion Criteria:

* Patient does not have exposed fingers/toes,due to congenital anomalies wound dressing or injury.
* Patient weight is less than 3 Kg
* Patient is less than 30 days old

Primary outcomes:
measure: Comparison of standard hemoglobin monitoring vs. the MASIO non-invasive hemoglobin monitor
timeFrame: up to 48 hours, post PICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Pediatric Intensive Care Unit, University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina,Chapel Hill, NC
name: Michael Phillips, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03506763: Effect of Pre-medication in Pain Measures on Office Hysteroscopy
Official title: Effect of Pre-medication in Pain Measures on Office Hysteroscopy - Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pain
Keywords: office hysteroscopy, pain measure
Lead sponsor: Hospital de Clinicas de Porto Alegre
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 231
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: RCT
Primary purpose: TREATMENT

Brief summary: Will be perform a RCT to compare pain measure on office hysteroscopy after pre-medication with oral analgesic. Patients will be alocate to oral sodic diclofenac, scopolamin or placebo. We will compare visual analog score of pain after the procedure.

Patients: patients with indication of office hysteroscopy to evaluate uterine intracavitary abnormality.

Interventions Group 1 (control) The patients will receive about 2 h prior to the procedure 2 placebo tablets.

Group 2 (diclofenac + scopolamine) The patients will receive about 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of scopolamine 2 mg.

Group 3 (diclofenac only). Patients will receive approximately 2 h prior to the procedure 1 tablet of diclofenac sodium 50 mg and 1 tablet of placebo.

Detailed description: Pain during and 30 minutes after a hysteroscopy will be measured through the visual analog pain scale of 10 centimeters, considering 0 (no pain) and 10 (unbearable pain or the greatest pain ever experienced). Acceptance of the procedure and assessed through the Likert 5-point scale: 1) totally disagree; 2) disagree; 3) I do not agree or disagree; 4) I agree and 5) I totally agree.There will also be a need for analgesia after the procedure, the time spent in the observation room and the onset of vagal symptoms such as dizziness, malaise, nausea, vomiting or syncope

Eligibility criteria: Inclusion Criteria:

1. indication of intrauterine evaluation
2. Abnormal uterine bleeding
3. post-menopause uterine bleeding
4. infertility
5. recurrent miscarriage

Exclusion Criteria:

1. stenosis of the external cervical orifice,
2. pelvic inflammatory disease,
3. suspected gestation or pregnancy,
4. active bleeding at the time of examination
5. contraindication to the use of the study medication, diclofenac sodium and scopolamine,

Primary outcomes:
measure: Pain measure
timeFrame: until 1 hour after exam
Secondary outcomes:
measure: Likert scale
timeFrame: until 1 hour after exam
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: Rio Grande Do Sul
Study officials:
affiliation: HCPA- Professor
name: Joao Sabino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05747235: The Role of Computed Tomography in the Phenotyping of COPD Patients
Official title: The Role of Computed Tomography in the Phenotyping of COPD Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: • All stable COPD patients that lastly confirmed to have the disease based on spirometry and past clinical history according to GOLD (2022).and able to perform MSCT

Brief summary: Chronic obstructive pulmonary disease (COPD) is a common, preventable, and treatable disease that is characterized by respiratory symptoms and airflow limitation that is due to airway and/or alveolar abnormalities usually caused by significant exposure to noxious particles or gases. the CT was used for classification of COPD patients into different phenotypes: phenotype A that has minimal emphysema with or without airway disease, phenotype E that has emphysema without airway disease, and finally phenotype M as a mixed form. The investigators aimed to to identify the phenotypes of COPD using radiologic data obtained by computed tomography. Moreover, this study will be designed to answer the questions about possible correlation between pulmonary function parameters and CT.


Eligibility criteria: Inclusion Criteria:

* All stable COPD patients that lastly confirmed to have the disease based on spirometry and past clinical history according to GOLD (2022).
* Age above 18 years.

Exclusion Criteria:

* COPD patients associated with other chest diseases as collapse
* COPD patients associated with consolidation
* COPD patients unable to perform spirometry

Primary outcomes:
measure: Identifying the different phenotypes of COPD using HRCT
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Islam Galal Sayed
Study officials:
References:
citation: Fan L, Xia Y, Guan Y, Zhang TF, Liu SY. Characteristic features of pulmonary function test, CT volume analysis and MR perfusion imaging in COPD patients with different HRCT phenotypes. Clin Respir J. 2014 Jan;8(1):45-54. doi: 10.1111/crj.12033. Epub 2013 Jul 31.
Clinical trial NCT05582863: Effects of a 12-week VR Intervention on the Functional Fitness of Adults of Different Age Ranges
Official title: Effects of a 12-week Virtual Reality-based Fitness Intervention on the Functional Fitness of Adults of Different Age Ranges
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Functional Fitness
Virtual Reality
Keywords: Virtual reality
Exercise
Old adults
Lead sponsor: National Taiwan Normal University
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 86
Sex: ALL
Minimum age (years): 65
Maximum age (years): 84
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study aimed to evaluate the effects of a 12-week VR fitness intervention on the functional fitness of adults of different age ranges.

Detailed description: Previous studies have shown age-related decreases in physical activity and functional fitness among older adults. Virtual Reality (VR) exercise programs are currently used in leisure and entertainment to improve the physical health of older adults. However, VR exercise in assessing physical health or functional fitness in older adults of different age ranges is rare. To fill this research gap, VR exercise was to assess functional fitness improvement in young and middle-aged participants.

Eligibility criteria: Inclusion Criteria:

* aged more 65 and less 84 years
* with no listening/vision impairments
* who did not have any history of illness based on their response to the Physical Activity Readiness Questionnaire (PAR-Q)
* interested in the virtual reality exercise

Exclusion Criteria:

* age less than 65 or more than 84 years
* disability and unable to live independently

Primary outcomes:
measure: Senior Fitness Test
timeFrame: Senior Functional fitness to specify a period "change" is being assessed. The time points for assessment were week 1 (pre-test), and 12 (post-test).
Secondary outcomes:
measure: Weight and Kilograms test
timeFrame: Not assessing change.The test was only a one-time measure at week 1(pre-test).
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: NTNU
Study officials:
affiliation: Research Ethics Committee, National Taiwan University
name: Lee Szu-Hsien
role: STUDY_DIRECTOR
References: