louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06530186: Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters
Official title: Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Vaginal Infection
Vaginal Discharge
Vaginosis
Sexual Dysfunction
Keywords: vaginal odor
vaginal discharge
postcoital dripping
vaginal microbiome
Lead sponsor: Atlantic Health System
Sponsor class: OTHER
First posted: 2024-07-31
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: LiviWell has developed a product designed for postcoital semen absorption. Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption such as vaginal odor and discharge. This study will investigate the study device, Livi, in a broader clinical setting.

Detailed description: LiviWell's consumer hygiene device is a post-coital vaginal insert called "Livi". Livi is comprised of an applicator, with a medical-grade polyurethane foam and retrieval string. It is designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal. The result is a decrease in discharge/dripping and vaginal odor. The investigators also believe the device will lower vaginal pH, as the typical premenopausal vaginal pH is acidic (pH \~4), and semen has an alkaline pH (\~8). The resulting pH imbalance in sexually-active women not using male condoms had been shown to lead to vaginal odor, dripping, discomfort. Furthermore, the risk of bacterial vaginosis (BV) is higher in women who are sexually active and not using male condoms. The investigators have additional studies planned to evaluate if the product lowers the risk of BV.

The current study will be used to validate user needs requirements for the study device, understand pH changes after insertion, and evaluate change in symptoms of vaginal odor, discharge/dripping, and discomfort, common symptoms of vaginal microbiome disruption and bacterial vaginosis.

Eligibility criteria: Inclusion Criteria:

* Over 18 (for pH subset, 18-45)
* Sexually-active with biological men
* Willing and able to use product
* Resides in continental USA
* Understands, reads, writes, and speaks English

Exclusion Criteria:

* Currently Pregnant or are trying to conceive
* Unable to use device due to poor motor function
* Unable to sign informed consent

Primary outcomes:
measure: User Experience Questionnaire
timeFrame: 24 hours
Secondary outcomes:
measure: change in vaginal pH
timeFrame: 2-6 hours, and 10-14 hours after use
Other outcomes:
Locations:
city: Mountain Lakes
country: United States
facility: Garden State Urology
state: New Jersey
Study officials:
References:
Clinical trial NCT04265586: Sleep, Pain and Quality of Life in Chronic Pain Patients
Official title: Sleep, Pain and Health-related Quality of Life in Chronic Pain Patients. Interventional Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Insomnia
Keywords: Health-related Quality of Life
Anxiety
Pain intensity
Pain interference
Symptoms of insomnia
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Turku University Hospital
First posted: 2020-02-11
Enrollment: 554
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The interventional study will have two main aims. First, to compare two interventions aiming to improve sleep in chronic pain patients. And secondly, to study the associations of sleep, mood, chronic pain and quality of life. Half of participants will go through iCBT intervention for insomnia and the other half will receive sleep hygiene education. Additionally, the study will gather information which patients will benefit/will not benefit the tertiary pain clinic treatment when the outcome variable is the Health-related Quality of Life (HrQoL).

Detailed description: Sleep disturbances associates closely with chronic pain. It now seems that sleep problems usually precede and maintain persistent pain. Anxiety and worry frequently precede and associate with disturbed sleep and chronic pain. Depression is usually a consequence of chronic pain. Pain and depression disturb sleep further. These elements form a vicious circle where poor sleep is a critical driver.

Previous studies have shown that sleep disturbances are a major contributor to the poor health-related quality of life (HRQoL) of patients with chronic pain.

Eligibility criteria: Inclusion Criteria:

* fluency in Finnish

Exclusion Criteria:

* severe psychiatric conditions (e.g. scizopherenia)

Primary outcomes:
measure: Health-related Quality of Life (HrQoL) questionnaire (15D)
timeFrame: Change from Baseline HrQoL at 12 months
Secondary outcomes:
measure: Mood -BDI-II and STAI-Y
timeFrame: Change from Baseline mood at 12 months
measure: Pain related catastrophizing (PCS)
timeFrame: Change from Baseline pain related catatsrophizing at 12 months
measure: Stress and worrying tendency
timeFrame: Change from Baseline stress and worrying tendency at 12 months
measure: Brief Pain Inventory (BPI)
timeFrame: Change from Baseline pain intensity and interference at 12 months
measure: Insomnia Severity Index (ISI)
timeFrame: Change from Baseline symptoms of insomnia at 12 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: HUH Pain Clinic
city: Turku
country: Finland
facility: Turku University Hospitla Pain Clinic
Study officials:
affiliation: Helsinki University Hospital, University of Helsinki
name: Eija A Kalso, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04554186: Serratus Anterior Plane Block Versus Thoracic Paravertebral Block.
Official title: Ultrasound Guided Serratus Anterior Plane Block Versus Thoracic Paravertebral Block in Emergency Department Rib Fracture
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rib Fractures
Analgesia
Keywords: Fracture rib
TPVB
SAPB
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2020-09-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Compare between serratus anterior plane block and thoracic Paravertebral block in analgesia for patients with multiple rib fractures

Detailed description: The study will be conducted in a prospective randomised controlled. Patients will be allocated into three groups

Control group:

The patient will receive fentanyl patch 50 microgram

TPVB group:

The patient will receive thoracic vertebral plane lock 0.4ml/kg bupivacaine 0.1 25% will be administered. For continuous infusion catheter will be inserted . Then a rate of 7ml / hour to max 10 ml / hour of bupivacaine 0.0625%

SAPB group,:

Patient will receive serratus anterior plane block 0.4ml / kg bupivacaine 0.125% will be injected to open the space then a catheter will be advanced For continuous infusion of 0.0625 % bupivacaine at 7 ml / hour

Eligibility criteria: Inclusion Criteria:

* ASA 1_3 Age 18_60 Unilateral fracture ribs

Exclusion Criteria:

* Drug allergy Morbid obese Opioid dependence Patients refuse

Primary outcomes:
measure: VAS score
timeFrame: 24 hour
Secondary outcomes:
measure: Total analgesic consumption
timeFrame: 24 hour
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Minia university hospital
Study officials:
affiliation: Minia University Hospital
name: Amany K Aboelhassan
role: STUDY_CHAIR
References:
Clinical trial NCT06210386: Physiology of Helmet vs. Facemask Noninvasive Ventilation
Official title: Physiological Effects of Helmet vs. Facemask Noninvasive Ventilation in Acute Hypoxemic Respiratory Failure
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Hypoxemic Respiratory Failure
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2024-01-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Crossover randomized trial
Primary purpose: TREATMENT

Brief summary: The optimal noninvasive management of acute hypoxemic respiratory failure is debated. Helmet noninvasive ventilation may be more effective than facemask noninvasive ventilation for these patients. Putatitve benefits of helmet use are the possibility to apply significantly higher positive end-expiratory pressure without air leaks and with good patient's comfort.

In this randomized crossover study, the investigators will assess the physiological effects of helmet compared to facemask noninvasive ventilation, with the latter applied with different ventilator settings (similar to or different from helmet settings).


Eligibility criteria: Inclusion Criteria:

* Acute hypoxemic respiratory failure and PaO2/FiO2\<200 mmHg
* PaCO2\<45 mmHg
* Respiratory failure not caused by exacerbation of chronic pulmonary disease, cardiac failure or fluid overload

Exclusion Criteria:

* Pregnancy
* Contraindication to helmet or facemask noninvasive ventilation
* Contraindication to esophageal manometry
* Contraindication to electrical-impedance tomography monitoring
* Recent surgery involving the abdomen or the thorax
* Pneumothorax or documented barotrauma

Primary outcomes:
measure: Inspiratory effort
timeFrame: 1 hour
measure: End-expiratory lung impedance
timeFrame: 1 hour
Secondary outcomes:
measure: Tidal volume
timeFrame: 1 hour
measure: Work of breathing
timeFrame: 1 hour
measure: Respiratory rate
timeFrame: 1 hour
measure: Dynamic transpulmonary driving pressure
timeFrame: 1 hour
measure: Compliance
timeFrame: 1 hour
measure: Dyspnea
timeFrame: 1 hour
measure: Discomfort
timeFrame: 1 hour
measure: Oxygenation
timeFrame: 1 hour
measure: Pendelluft extent
timeFrame: 1 hour
measure: Corrected minute ventilation
timeFrame: 1 hour
measure: Arteria Carbon dioxide tension
timeFrame: 1 hour
measure: Tidal volume distribution
timeFrame: 1 hour
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitaro A. Gemelli IRCCS
Study officials:
affiliation: Fondazione Policlinico A. Gemelli IRCCS
name: Domenico L. Grieco, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01074086: Phase I Study in RAD 001 Patients With Relapse AML
Official title: Multicentric Study of GOELAMS Phase I Evaluation of RAD001 in Association With Aracytine and Daunorubicine in AML Treatment in Patients Less Than 65 Years in Relapse More Than One Year After First Complete Remission
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: AML
Keywords: RAD 001 in relapsed AML
Lead sponsor: French Innovative Leukemia Organisation
Sponsor class: OTHER
Collaborators: name: Novartis Pharmaceuticals
First posted: 2010-02-24
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: A phase I clinical study in evaluation of RAD 001 with aracytine and daunorubicine in AML treatment of patients older less than 65 years in relapse

Detailed description: The primary objective of the study is to determinate the maximal tolerate dose and evaluate the toxicity of RAD 001 in patients older less than 65 years in AML relapse in association with a conventional chemotherapy 5Aracytine and Daunorubicine) in an dose escalated phase I study.

Eligibility criteria: Inclusion Criteria:

* patients from 18 to 65 years old
* AML in relapse more than 1 year after CR
* inform consent signed

Exclusion Criteria:

* age more than 65
* cardiac insufficiency
* renal insufficiency
* hepatic disease
* other type of AML
* blastic MCL
* HIV positive serology
* other malignancy
* pulmonary infection

Primary outcomes:
measure: maximal dose tolerated
timeFrame: 40 days
Secondary outcomes:
measure: Biological study
timeFrame: Day 1 and day 7
measure: Biological study
timeFrame: Day 1 and Day 7
Other outcomes:
Locations:
city: Paris
country: France
facility: Sophie Park
Study officials:
affiliation: French Innovative Leukemia Organisation
name: Sophie PARK, MD MS
role: PRINCIPAL_INVESTIGATOR
affiliation: French Innovative Leukemia Organisation
name: Didier BOUSCArY, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Park S, Chapuis N, Saint Marcoux F, Recher C, Prebet T, Chevallier P, Cahn JY, Leguay T, Bories P, Witz F, Lamy T, Mayeux P, Lacombe C, Demur C, Tamburini J, Merlat A, Delepine R, Vey N, Dreyfus F, Bene MC, Ifrah N, Bouscary D; GOELAMS (Groupe Ouest Est d'Etude des Leucemies aigues et Autres Maladies du Sang). A phase Ib GOELAMS study of the mTOR inhibitor RAD001 in association with chemotherapy for AML patients in first relapse. Leukemia. 2013 Jul;27(7):1479-86. doi: 10.1038/leu.2013.17. Epub 2013 Jan 16.
Clinical trial NCT01330186: Predictive Value of FMISO-PET, FDG-PET-CT, DWI-MRI and DCE-MRI Scans for Patients With Anal Cancer Receiving Radiotherapy +/- Chemotherapy
Official title: 18F-FMISO-PET, 18F-FDG-PET/CT, DWI-MRI and DCE-MRI Scans as Predictors of Response to Radiotherapy +/- Chemotherapy in Patients With Anal Cancer.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anal Cancer
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2011-04-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with anal canal or perianal cancer

Brief summary: The purpose of the study is to evaluate the predictive value of 18F-fluoromisonidazol-PET (FMISO-PET), 2-18F-fluoro-2-deoxy-d-glukose-PET-CT (FDG-PET-CT), Diffusion-Weighted Magnetic Resonance Imaging (DWI-MRI) and Dynamic Contrast-Enhanced Magnetic Resonance Imaging (DCE-MRI) for patients with anal cancer receiving radiation therapy +/- chemotherapy (Cisplatin and 5-FU).

Detailed description: The study involves tree MRI sessions, two FDG-PET-CT sessions and one FMISO-PET session. The FMISO-PET session is presently not carried out because of delivery problems. The production of 18F-fluoromisonidazol at The Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Herlev, Denmark has not jet been approved by the Danish Medicines Agency.

Eligibility criteria: Inclusion Criteria:

* Histological confirmation of invasive primary squamous cell carcinoma of the anal canal or perianal region.
* TNM stage T1-4, N0-3, M0-1
* Treatment with curative intent
* Age \> 18 years
* Able to provide informed consent

Exclusion Criteria:

* Contraindication to MRI imaging
* Cardiac pacemaker
* Major obesity
* Serious claustrophobia
* Other malignant disease (except non-melanoma skin cancer) in a period of 5 years prior to imaging study
* Poorly regulated diabetes mellitus despite insulin
* Pregnancy
* Breast feeding
* Known allergy to iv contrast agent
* Major psychiatric illness which would prevent participation in the imaging study
* Infectious wounds on the legs
* Unacceptable kidney function
* Major language difficulties which would prevent participation in the imaging study

Primary outcomes:
measure: Tumor response
timeFrame: 6-8 weeks post radiation
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Oncology Herlev Hospital
Study officials:
References:
Clinical trial NCT03703986: Early Neurological Deterioration in Patients With Acute Ischemic Stroke
Official title: Explore the Causes and Predictors of Early Neurological Deterioration Occurred in Patients With Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Infarction
Keywords: deterioration
risk factors
predictors
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2018-10-12
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients admitted to First Affiliated Hospital of Nangjing Medical University from January 2015 to April 2018 were collected retrospectively.

Brief summary: This study set out to explore the risk factors of early neurological deterioration (END) occurred in patients with acute ischemic stroke and to investigate the corresponding predictors.

Detailed description: END refers to the illness aggravation occurred in the early stage of stroke and often indicates a poor outcome. Some clinical scales may play an important role in its diagnoses and treatments. Across the reviewed studies, the risk factors of END, which included biochemical parameters, neuroimaging, ect. were explored incompletely and the effective predictors of END is unknown. We aimed to explore the risk factors of END and investigate the predictive value of certain scales.

Eligibility criteria: Inclusion Criteria:

* Subjects with acute ischemic stroke
* Subjects with detailed progress notes

Exclusion Criteria:

* Subjects with thrombolysis therapy
* Subjects with transient ischemia attach
* Subjects complicated with seriously underlying diseases

Primary outcomes:
measure: National Institutes of Health Stroke Scale
timeFrame: 7 days
measure: Canadian Neurological Scale
timeFrame: 7 days
Secondary outcomes:
measure: Blood parameters
timeFrame: 7days
measure: Neuroimaging data
timeFrame: 7days
Other outcomes:
Locations:
city: Nanjing
country: China
facility: First Affiliated Hospital of Nanjing Medical University
Study officials:
References:
Clinical trial NCT05006586: Rectovaginal Fistula Repair
Official title: Rectovaginal Fistula Repair Predictors of Outcome and Results After Surgical Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fistula Vagina
Fistula;Rectal
Keywords: Rectovaginal fistula
Surgical repair
Quality-of-life
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2021-08-16
Enrollment: 55
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing RVF repair att Uppsala University Hospital. A quality-of-life follow-up is planned.

Brief summary: This study is a prospective evaluation of quality-of-life after rectovaginal fistula repair at our institution

Detailed description: All patient having undergone rectovaginal fistula repair at Uppsala University Hospital 2003-2018. An invitation to join the study was sent to all patients. Those who answered were then sent Rand 36/SF36 questionnaire as a follow-up together with some general questions concerning whether the rectovaginal fistula was healed or not.

Eligibility criteria: Inclusion Criteria:

* Undergone RVF repair at Uppsala University Hospital 2003-2018

Exclusion Criteria:

* Fistula due to gender reconstructive surgery

Primary outcomes:
measure: Surgical repair
timeFrame: Assessed on average 3 months postoperatively
Secondary outcomes:
measure: Health-related Quality-of-life
timeFrame: Through study completion, on average 10 years
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset (Uppsala University hospital)
Study officials:
References:
citation: Soderqvist EV, Cashin PH, Graf W. Surgical treatment of rectovaginal fistula-predictors of outcome and effects on quality of life. Int J Colorectal Dis. 2022 Jul;37(7):1699-1707. doi: 10.1007/s00384-022-04206-7. Epub 2022 Jul 2.
Clinical trial NCT01980186: Transcranial Ultrasonography Using Linear 2D Imaging of the Brain
Official title: Transcranial Ultrasonography Using Linear 2D Imaging of the Brain and Surrounding Tissues
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Autism
Extra-axial Fluid
Keywords: transcranial ultrasound
autism
cortical dysplasia
extra-axial fluid
Lead sponsor: Brain Treatment Center
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with autism of any age and their neurotypical otherwise healthy siblings of any included age (6 months to 21 years).

Brief summary: This study will use linear 2D ultrasound imaging to look at the brain of individuals diagnosed with autism and their siblings. This is called transcranial ultrasound (TUS). It is hypothesized that TUS will allow real-time imaging of the fluid spaces outside the brain and will further allow the imagining of brain areas important to language and social function.

Detailed description: TUS will be evaluated as a simple and low cost screening technique to evaluate the presence of increased extra-axial fluid (EAF)or(subarachnoid cerebral spinal fluid). A recent study (Shen et al. 2013) demonstrated increased EAF was predictive of risk of autism. We believe TUS is capable or rapid, safe, low cost, non-invasive measurement of EAF spaces. Where prior imaging, ie., MRI or CT exist they will be used as comparisons. Both individuals with autism and their siblings will be screened to create a database and standard for TUS measurements. It is further believed that TUS may be able to detect areas of cortical abnormalities called dysplasias. The procedure requires no sedation and only takes a few minutes to perform. If validated, this would make TUS an ideal screening test for autism risk and allow for early referral and more definitive imaging with MRI where necessary.

Eligibility criteria: Inclusion Criteria: Confirmed diagnosis of autism or the sibling thereof and willingness of a parent to consent and where applicable for the individual to assent or consent depending on age.

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Exclusion Criteria: Siblings must have no obvious health issues or developmental abnormalities.

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Primary outcomes:
measure: Extra-axial fluid as measured at the gyral summit.
timeFrame: This study will collect data for up to 3 years to determine the accuracy of the predictive assessments for autism risk
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Brain Treatment Center
state: California
city: Buford
country: United States
facility: Brain Treatment Center
state: Georgia
Study officials:
affiliation: Brain Treatment Center
name: James J Bradstreet, MD
role: PRINCIPAL_INVESTIGATOR
References: