louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01683305: Biomarker Breast Pap Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Tumors
Keywords: biomarker,
NAF
Subjects
Lead sponsor: Silbiotech
Sponsor class: INDUSTRY
First posted: 2012-09-11
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any woman age 18 or older

Brief summary: This will be a Phase I study. During the Phase I study, our goals are: 1) screen a number of cancer biomarkers in Nipple Aspirate Fluid (NAF) from women who have no mammographically detectable tumors, and those who have detectable tumors, 2) identify all the detectable markers and 3) establish that biomarkers detected in NAF could also be detected in the biopsied tumor tissue that was removed for diagnostic purpose in subjects who have detectable tumors.


Eligibility criteria: Inclusion Criteria:

* Any female subject aged 18 years or older

Exclusion Criteria:

* none

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05683405: Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis.
Official title: Management of Peri-implantitis: Non-surgical Treatment of Peri-implantitis: Mechanical Debridement vs. Air-polishing
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Peri-Implantitis
Keywords: Peri-implantitis
Non-surgical treatment
Air-polishing
Mechanical debridement
Bleeding on probing
periodontal pocket depth
Lead sponsor: Tannhelsetjenestens Kompetansesenter for Nord-Norge
Sponsor class: OTHER
Collaborators: name: Malmö University
First posted: 2023-01-13
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each participant will be randomized to non-surgical treatment of peri-implantitits with either mechanical debridement or with air-polishing.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare non-surgical treatment by mechanical debridement with air-polishing in peri-implantitis. The main question it aims to answer is:

• Does non-surgical treatment of peri-implantitis with an air-polishing devise (Perioflow® EMS, Nyon Switzerlad) provide a better treatment result than conventional cleaning with mechanical instruments?

Participants will receive non-surgical treatment of peri-implantitis either with mechanical debridement and with an air-polishing devise.

Researchers will compare pocket depth and bleeding/suppuration on probing in implants treated with the two methods to see if either of them is more efficient in treatment of peri-implantitis.


Eligibility criteria: Inclusion Criteria:

* Referred to TkNN (Tannhelsetjenestens kompetansesenter for Nord-Norge) for treatment of peri-implantitis
* Participants should have at least one implants with peri-implantitis according to the diagnostic criteria from the 2017 Chicago Consensus Meeting.

Exclusion Criteria:

* Cemented prosthetic reconstructions, individuals smoking more than 10 cigarettes per day, individuals with diabetes and poor control of blood glucose levels, antibiotic treatment during the past threee months, and implants that are preferably to be extracted due to prognosis or function, are excluded.

Primary outcomes:
measure: Probing depth
timeFrame: 26 weeks
measure: Bleeding on probing
timeFrame: 26 weeks
measure: Suppuration on probing
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tromsø
country: Norway
facility: Tannhelsetjenestens kompetansesenter for Nord-Norge
state: Troms
Study officials:
References:
Clinical trial NCT03821805: Acute Effect of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform
Official title: Effects of Foot Reflexology Massage on Heart Rate Variability and Arterial Pulse Waveform After Yo Yo Intermittent Recovery Test and Repeated Sprint Test
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Massage
Anaerobic Exercise
Aerobic Exercise
Keywords: Heart rate variability
Arterial pulse waveform
Lead sponsor: University of Taipei
Sponsor class: OTHER
First posted: 2019-01-30
Enrollment: 28
Sex: MALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Foot reflexology treatment provides acute and chronic effects on cardiovascular and hemodynamic functions. However, no information is available to us in regarding the treatment effect of foot reflexology after exercise. This study investigated the acute effect of foot reflexology treatment on heart rate variability after anaerobic-based and aerobic-based intermittent exercises.

Detailed description: The sympathetic activation and sympathy-vagal balance after repeat sprint performance can be immediately modulated by foot reflexology massage. The acute benefits of foot reflexology intervention on cardiac sympathovagal balance can be considered as exercise recovery strategies in sports.

Eligibility criteria: Inclusion Criteria:

* Undertake football/futsal training at least 3 times a week
* Age between 18 and 30 years old

Exclusion Criteria:

* History of severe neuromuscular injury
* Current lower extremity injury
* Current neurological diseases

Primary outcomes:
measure: Heart rate variability
timeFrame: immediately following intervention phase
Secondary outcomes:
measure: Arterial pulse waveform
timeFrame: immediately following intervention phase
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01189305: Behavioral Couples Therapy for Female Drug-Abusing Patients
Official title: Behavioral Couples Therapy for Female Drug-Abusing Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Drug Abuse
Keywords: Drug Abuse
Female Patients
Lead sponsor: Harvard University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2010-08-26
Enrollment: 185
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In treating drug addiction, many studies of male patients show Behavioral Couples Therapy (BCT) helps the whole family (the drug abuser, the relationship partner, and their children) and is more effective than typical individual and group counseling. Only one study of BCT has been done with female drug-abusing patients, and results were promising but not definitive. The proposed study will test with married or cohabiting female drug-abusing patients whether BCT will produce more positive outcomes for the women, their male partners, and their children than standard individual counseling for the patient alone.


Eligibility criteria: Inclusion Criteria:

* female patients with primary drug abuse diagnosis \& their relationship partners
* patient married or cohabiting with relationship partner
* partner without current alcohol or drug problem

Exclusion Criteria:

* both patient and partner without severe mental health disorders

Primary outcomes:
measure: percent days abstinent from illicit drugs
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Worcester
country: United States
facility: AdCare Hospital of Worcester Inc.
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Timothy J O'Farrell, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03169205: Diabetes Mellitus With Pregnancy in Benisuef Localities
Official title: Diabetes Mellitus With Pregnancy in Benisuef Localities
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pregnancy in Diabetics
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2017-05-30
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All pregnant ladies with impaired glucose intolerance either known before or fisrt diagnosed during current pregnancy

Brief summary: The aim of this work is to demonstrate the variation of Diabetes mellitus either preexisting or gestational Diabetes mellitus among pregnant ladies in our localities, detect maternal \& fetal complications and to predict the risk factors for poor maternal, fetal \& neonatal outcomes


Eligibility criteria: Inclusion Criteria:

* all pregnant ladies with Diabetes mellitus either type 1 or type 2
* all pregnant ladies with glucose intolerance which is first diagnosed during current pregnancy

Exclusion Criteria:

* ladies age less than 18 year or above 45

Primary outcomes:
measure: Maternal outcome
timeFrame: 2 years
Secondary outcomes:
measure: fetal outcome
timeFrame: 2 years
Other outcomes:
Locations:
city: Beni-suef
country: Egypt
facility: Faculty of Medicine
city: Beni-suef
country: Egypt
Study officials:
References:
Clinical trial NCT04843605: Systematic Screening for COPD in Tabacology Consultation
Official title: Impact of Systematic Screening for COPD in Tabacology Consultation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking Cessation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2021-04-13
Enrollment: 112
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients followed in tabacology unit

Brief summary: COPD is a very common disease, an estimated 3 million people are affected in France. Unfortunately, this pathology is under-diagnosed. Several reasons can be mentioned: the banality of the symptoms or the several comorbidities.

Screening faces a major difficulty: the realization of a spirometry. Various studies have shown the complexity of the implementation of mass screening in cities by mini-spirometry.

The COPD World Health Days allow this mass screening but without visibility on the actual entry into a care pathway.

The objective of this study is to assess the impact of systematic screening for COPD during a tabacology consultation


Eligibility criteria: Inclusion Criteria:

* Subjects over 45 years old, followed in Tabacology unit at CHRU of BREST - No COPD patient or COPD patients not followed for more than 3 years (considered out of care)
* No opposition filed

Exclusion Criteria:

* Patients already followed for COPD
* Contraindication to spirometry
* Refusal to participate

Primary outcomes:
measure: COPD DIAGNOSIS
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Chu Brest
Study officials:
affiliation: CH des pays de Morlaix
name: Marc Beaumont, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chapman KR, Mannino DM, Soriano JB, Vermeire PA, Buist AS, Thun MJ, Connell C, Jemal A, Lee TA, Miravitlles M, Aldington S, Beasley R. Epidemiology and costs of chronic obstructive pulmonary disease. Eur Respir J. 2006 Jan;27(1):188-207. doi: 10.1183/09031936.06.00024505. No abstract available.
citation: Fuhrman C, Delmas MC; pour le groupe epidemiologie et recherche clinique de la SPLF. [Epidemiology of chronic obstructive pulmonary disease in France]. Rev Mal Respir. 2010 Feb;27(2):160-8. doi: 10.1016/j.rmr.2009.08.003. Epub 2010 Jan 19. French.
Clinical trial NCT04789005: Comparison of Phenylephrine and Norepinephrine for Spinal-induced Hypotension
Official title: Comparison of Intravenous Phenylephrine and Norepinephrine for Treatment of Spinal-induced Hypotension in Caesarian Deliveries
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Induced-hypotension
Lead sponsor: Tribhuvan University Teaching Hospital, Institute Of Medicine.
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypotension after spinal anaesthesia for cesarean deliveries is frequently encountered. Phenylephrine an α-agonist is commonly used for the prevention and treatment of spinal-induced hypotension. Phenylephrine causes baroreceptor-mediated bradycardia leading to subsequent reduction in cardiac output. Preservation of heart rate and cardiac output is important in high-risk conditions such as placental insufficiency, fetal distress and maternal cardiac disease. Recently, norepinephrine has been found as effective as phenylephrine in treatment of spinal induced hypotension. When norepinephrine is used as a bolus, it is effective at maintaining blood pressure while also conferring a greater heart rate and cardiac output compared to phenylephrine.


Eligibility criteria: Inclusion Criteria:

Elective cesarean delivery under spinal anaesthesia ASA PS II Age ≥18 years Singleton pregnancy beyond 37 weeks' gestation Weight between 50 and 100 kg Height between 150 and 180 cm

Exclusion Criteria:

Patient refusal to participate Allergy or hypersensitivity to Norepinephrine or Phenylephrine Preexisting or pregnancy-induced hypertension Cardiovascular or cerebrovascular disease Fetal abnormalities Use of monoamine oxidase inhibitors or tricyclic antidepressants

Primary outcomes:
measure: To compare blood pressure between two groups.
timeFrame: 6 months
measure: To compare percentage of incidence of hypotension between two groups.
timeFrame: 6 months
measure: compare percentage of incidence of bradycardia between the two groups
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kathmandu
country: Nepal
facility: Tribhuvan university teaching hospital
state: Bagmati
Study officials:
References:
Clinical trial NCT01723605: Insitu Repair Versus Uterine Exeriorization During Cesarean Section
Official title: Insitu Repair Versus Uterine Exeriorization During Cesarean Section: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complications; Cesarean Section
Keywords: insitu repair
intestinal motility
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2012-11-08
Enrollment: 1000
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Two types of uterine repair described during cesarean section, the investigators will try to compare between the two techniques.

Detailed description: Insitu repair of the uterus during cesarean section in Comparison to exteriorisation of the uterus during uterine closure

Eligibility criteria: Inclusion Criteria:

* pregnant women

Exclusion Criteria:

* liver disease
* kidney disease
* bleeding tendency
* abnormal placentation
* preeclampsia

Primary outcomes:
measure: Bowel movement
timeFrame: 12 hours
Secondary outcomes:
measure: Surgery duration
timeFrame: 2 hours
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of medicine
Study officials:
affiliation: Cairo University
name: Waleed El-khayat
role: STUDY_CHAIR
References:
citation: El-Khayat W, Elsharkawi M, Hassan A. A randomized controlled trial of uterine exteriorization versus in situ repair of the uterine incision during cesarean delivery. Int J Gynaecol Obstet. 2014 Nov;127(2):163-6. doi: 10.1016/j.ijgo.2014.05.004. Epub 2014 Jun 19.
Clinical trial NCT04288505: Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO
Official title: Evaluation of a Virtual Reality Tool for Identifying the Cognitive Functions of the Right Hemisphere in Patients With Glioma -TANGO
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Brain Tumor
Virtual Reality
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2020-02-28
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Evaluate the diagnostic performance of a virtual reality application to detect the presence of cognitive impairment of the non-dominant hemisphere in patients with glioma


Eligibility criteria: Inclusion Criteria:

* Indication for glioma surgery
* Karnofsky \> 70

Exclusion Criteria:

-

Primary outcomes:
measure: PERFORMANCE OF the VR APPLICATION compared to classic cognitive tests batery for the detection of cognitive deficit
timeFrame: from surgery to 3 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: University hospital
Study officials:
References:
Clinical trial NCT00981305: Impact of Lactate-Containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors
Official title: Impact of Lactate-containing Vaginal Lubricant on Sexual Dysfunction in Young Breast Cancer Survivors: Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Sexual Dysfunction
Breast Cancer Survivors
Keywords: dyspareunia
breast cancer
sexual dysfunction
vaginal lubricant
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Medical Research Collaborating Center, Seoul, Korea
First posted: 2009-09-22
Enrollment: 136
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether lactate-containing vaginal lubricant is effective in the treatment of young breast cancer survivors with sexual dysfunction.

Detailed description: Study scheme

* study arm: apply lactate-containing lubricants at the time of sexual intercourse and before sleep at least 3 times per a week for 8 weeks
* control arm: placebo apply

Outcome measures

* Female Sexual function Index (FSFI-20): at 0 wk and at 8 wk
* vaginal maturation index: at 0 wk and 8 wk
* vaginal pH: at 0 wk and 8 wk

Eligibility criteria: Inclusion Criteria:

* breast cancer survivors over 20 years-old
* premenopausal at the time of diagnosis
* treated with operation and chemotherapy
* newly developed dyspareunia after cancer treatment

Exclusion Criteria:

* recent (\< 2 months) start or cessation of hormonal treatment (tamoxifen etc.)
* depression or other psychological problems
* active vaginal infection
* evidence of cancer recurrence
* previously use of lactate-containing lubricants
* other chronic diseases which severely disturb the sexual life

Primary outcomes:
measure: Change of Pain Score of Female Sexual Function Index
timeFrame: Baseline and 8 weeks
Secondary outcomes:
measure: Change of a Total and Other Five Domains of Female Sexual Function Index Score
timeFrame: Baseline and 8 weeks
measure: Change of Vaginal pH
timeFrame: Baseline and 8 weeks
measure: Change of Vaginal Maturation Index
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Myung Jae, Jeon
Study officials:
affiliation: Seoul National University Hospital
name: Myung Jae Jeon, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim YH, Park S, Lee M, Hahn S, Jeon MJ. Effect of a pH-Balanced Vaginal Gel on Dyspareunia and Sexual Function in Breast Cancer Survivors Who Were Premenopausal at Diagnosis: A Randomized Controlled Trial. Obstet Gynecol. 2017 May;129(5):870-876. doi: 10.1097/AOG.0000000000001988.
Clinical trial NCT03390205: OCT Angiography in Vitreo and Chorioretinal Pathologies
Official title: Optical Coherence Tomography Angiography in Vitreo and Chorioretinal Pathologies Under the Influence of Dark and Light Adaptation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Optical Coherence Tomography
Lead sponsor: CRG UZ Brussel
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pathology in vitreo and chorioretinal complex and age matched controls

Brief summary: In many diseases of the vitreo and chorioretinal complex, perfusion changes have a diagnostic, prognostic or causative role. The visualisation of perfusion was limited to invasive techniques, which were only to depict vasculature in one plane. Optical coherence tomography is able to visualise and quantify eye perfusion layer-specific and non-invasive.


Eligibility criteria: Inclusion Criteria:

* Patient with vitreo and chorioretinal pathology, aged-adapted controls

Exclusion Criteria:

* Minors, concomitant ocular pathologies, pregnancy, contra-indication for tropicamide

Primary outcomes:
measure: Vessel density
timeFrame: 5 minutes after intervention ends
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06365905: Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia with an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients with Post-Menopausal Bleeding
Official title: Non-Invasive Identification of Endometrial Cancer/Endometrial Atypical Hyperplasia with an AI-Based Classifier Applied to Transvaginal Ultrasound in Patients with Post-Menopausal Bleeding
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Endometrial Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 300
Sex: FEMALE
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with at least one episode of postmenopausal bleeding.

Brief summary: This study evaluates if AI can be used with transvaginal ultrasound images for early detection of endometrial cancer or premalignant lesions.

Detailed description: PRIMARY OBJECTIVE:

I. Prospective validation of an artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS) to identify patients with premalignant/malignant in a population of women with postmenopausal bleeding (PMB).

OUTLINE: This is an observational study.

Patients undergo a transvaginal ultrasound examination and endometrial sampling per standard of care and have their medical records reviewed on study.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 55 years
* At least one episode of postmenopausal bleeding (PMB)
* Endometrial biopsy available from at Mayo Clinic (MN, AZ, FL), Mayo Clinic Health System (MCHS), or an external institution
* Acceptance to participate in the study

Exclusion Criteria:

* Diagnostic tests performed more than 90 days apart
* Physical impediment/refusal to undergo transvaginal ultrasound (TVUS)

Primary outcomes:
measure: Accuracy of artificial intelligence (AI) algorithm applied to transvaginal ultrasound (TVUS)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Gretchen E Glaser, MD
role: PRINCIPAL_INVESTIGATOR
References: