louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04415190: the Impact of Early Palliative Care on the Survival of Locally Advanced and / or Metastatic Cholangiocarcinoma Patients
Official title: Multicenter Retrospective Study Evaluating the Impact of Early Palliative Care on the Survival of Patients With Locally Advanced and / or Metastatic Cholangiocarcinoma (CCK)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cholangiocarcinoma
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cholangiocarcinoma metastatic or locally advanced

Brief summary: The prognosis for cholangiocarcinoma is bad. Potentially, early management by a palliative care team could increase overall survival. We will also assess whether early management by a palliative care team could impact progression-free survival, the place of death and the date of the last chemotherapy, in particular to avoid unnecessary chemotherapy cures in an imminent end of life


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years old
* intra- or extra-hepatic CCK or histologically proven vesicular adenocarcinoma
* Locally advanced and / or metastatic disease from the start or recurrent
* Initial diagnosis or recurrence between 1/01/2013 and 31/12/2019

Exclusion Criteria:

* \<18 years old
* death less than one week after the diagnostic

Primary outcomes:
measure: Global survival
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Vandœuvre-lès-Nancy
country: France
facility: Lopez
Study officials:
affiliation: CHRU Nancy
name: Anthony Lopez
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01994421: Effects of Kinesiotape on Quadriceps and Hamstring Muscle Strength
Official title: Effects of Kinesiotape on Quadriceps and Hamstring Muscle Strength
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Facilitating kinesiotape
Inhibiting kinesiotape
Classical tape
No tape
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2013-11-25
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Background: Kinesiotaping (KT) is an elastic therapeutic tape developed in the 70's by Dr Kenso Kase for prevention and treatment of sports injuries. Research shows that through activation of skin receptors KT improves blood and lymph flow, increases proprioception, helps relieve pain, facilitates joint and muscle alignment, and enhances muscle function. Despite the increasing popularity of KT, uncertainty remains regarding, in particular, its effectiveness in improving strength.

Purpose: The purpose of the current study was to investigate the short-term effects of KT on muscle strength when applied to the quadriceps muscles of healthy subjects.

Methods: A randomized controlled trial with 52 healthy subjects was conducted. Subjects were tested under four different conditions: a) facilitating Kinesiotape, b) inhibiting Kinesiotape, c) classical tape with no elastic properties, and d) no-taping across four different sessions. The parameters of interest were: quadriceps and hamstrings maximal strength and power using vertical jump tests (squat jump and countermovement jump), and peak concentric and eccentric knee torque (using isokinetic test protocol).


Eligibility criteria: Inclusion Criteria:

* at least 18 years of age
* allowed to perform jumps

Exclusion Criteria:

* pregnancy
* history of cardio-vascular disease
* antecedents of lower extremity injuries
* use of any doping substances listed by the World Anti-doping Agency
* any contraindication to exercise

Primary outcomes:
measure: Vertical jump height change with different tapes
timeFrame: Week 1, week 2, week 3, and week 4
Secondary outcomes:
measure: Isokinetic knee strength change with different tapes
timeFrame: Week 1, week 2, week 3, and week 4
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Unite d'orthopédie et traumatologie du sport
Study officials:
References:
Clinical trial NCT00723021: PF-04191834 Single Dose Bronchodilatory Study In Asthma.
Official title: A Phase 2a, Randomised, Double-Blind (3rd Party Open), Double-Dummy, Placebo And Active Controlled 5-Way Crossover Study To Assess The Bronchodilatory Action, Safety, Toleration And Pharmacokinetics Of Single Oral Doses Of PF-04191834 In Asthmatic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Bronchodilator
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-07-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to determine the bronchodilatory effects of PF-04191834 compared with zileuton in patients with asthma


Eligibility criteria: Inclusion Criteria:

* Persistent mild/moderate asthma for at least 6 months.
* Reduced lung function
* Reversible airway obstruction

Exclusion Criteria:

* Pregnant/nursing females.
* Liver function tests greater than upper limit of normal (ULN)

Primary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, 12 hours (hrs) post-dose
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, 24 hours (hrs) post-dose
Secondary outcomes:
measure: Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline, 12 hours (hrs) post-dose
measure: Change From Baseline in Forced Vital Capacity (FVC)
timeFrame: Baseline,24 hours (hrs) post-dose
measure: Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
timeFrame: Baseline, 12 hours (hrs) post-dose
measure: Change From Baseline in Forced Expiratory Flow Between 25 and 75% of Vital Capacity (FEF25-75)
timeFrame: Baseline, 24 hours (hrs) post-dose
Other outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
timeFrame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.
measure: Plasma Decay Half-Life (t1/2)
timeFrame: Pre-dose, 2, 4, 5, 6, 10, 14 and 24 hours following dosing in each period.
measure: Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
timeFrame: 14 and 24 hours following dosing in each period.
Locations:
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: North Dartmouth
country: United States
facility: Pfizer Investigational Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Omaha
country: United States
facility: Pfizer Investigational Site
state: Nebraska
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT06582121: Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
Official title: Controlled, Multicenter Study of Sleep Disorders in Prodromal and Definite Parkinsons Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
REM Sleep Behavior Disorder (iRBD)
Keywords: Parkinson disease
isolated RBD
Sleep
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 457
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participant will do polysomnographies during a 2-days stay in hospital with electroencephalogram, electromyogram and questionnaries. The urine will be also collected during 2 days.
Primary purpose: OTHER

Brief summary: Multicenter controlled study of sleep disorders in isolated REM Behavior Disorder and Parkinson\&#39;s disease (SOMPARK)

Detailed description: Sleep disturbances are common and understudied in established or prodromal Parkinson\&#39;s disease. The purpose of this study is to systematically and comprehensively determine the clinical characteristics and electrophysiologic patterns of the major sleep disorders in PD and isolated RBD.

Eligibility criteria: Inclusion Criteria:

Common to all groups:

* Age superior 18 years
* Patients who have received complete information about the study from an investigator and who fully consent to participate.

For Parkinson Disease (PD):

* Patients followed for PD diagnosed according to international criteria for the diagnosis of PD (MDS criteria),
* A MoCA score greater than 20/30
* No treatment with deep brain stimulation.

For REM Sleep Behavior Disorder (RBD):

* Diagnosis of RBD according to ICSD-3 criteria: presence on polysomnography of an abnormal elevation of muscle tone during REM sleep (more than 18% of REM sleep without chin atonia) and/or the presence of REM sleep behaviors on video-polysomnography,
* Absence of progressive neurodegenerative pathology: absence of diagnostic criteria for PD, multiple system atrophy, or Lewy body dementia.

For healthy controls:

- No neurological or psychiatric disease

Exclusion Criteria:

Common to all groups:

* Pregnant or breastfeeding women
* Subjects under guardianship/conservatorship
* Persons deprived of liberty.

Primary outcomes:
measure: Polysomnography to compare sleep efficiency
timeFrame: 25 months
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Lille
country: France
facility: CHU de Lille
city: Lyon
country: France
facility: CHU de Lyon
city: Nantes
country: France
facility: CHU de Nantes
city: Nîmes
country: France
facility: CHU de Nîmes
city: Paris
country: France
facility: CHU Pitié Salpêtrière
Study officials:
References:
Clinical trial NCT06418321: Early Identification of Age-related Hearing Impairment
Official title: Early Identification of Age-related Hearing Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss, Age-Related
Lead sponsor: Aalto University
Sponsor class: OTHER
Collaborators: name: Business Finland
name: Helsinki University Central Hospital
First posted: 2024-05-17
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: The need for future hearing rehabilitation is enormous. World Health Organization (WHO 2021) has estimated that by 2050, 2.5 billion people will have some degree of hearing loss, and 1/4 of them will require hearing rehabilitation. Currently, healthcare systems and processes are already overwhelmed and not adequately equipped to screen and diagnose this rapidly growing population suffering from hearing impairment. This study aims to investigate if the diagnostics of age-related hearing loss can be accelerated by involving patients in the hearing assessment process.

Detailed description: The investigational device used in the study is part of the Otoscreen hearing screening system that is developed by Aalto University.

The investigational device consists of the following parts:

* Digital otoscope
* User interface control unit.

The investigational device is designed to record high-quality images and videos of the eardrum and ear canal and guide users through a hearing screening test while collecting data from questionnaires, digital otoscopy, and audiometry.

The investigational device is used together with a CE-marked audiometer that is intended for hearing screening testing.

Eligibility criteria: Inclusion Criteria:

• Must be able to understand Finnish or Swedish

Exclusion Criteria:

• Clinical diagnosis of hearing loss

Primary outcomes:
measure: Comparison between investigational device and gold-standard device (otomicroscope) findings.
timeFrame: From digital otoscopy to the interpretation of pictures (up to six months).
measure: Comparison between the automated hearing screening self-test result and the gold-standard hearing test result performed with clinical Audiometer by an Audiologist.
timeFrame: From hearing tests to the comparison (up to six months).
Secondary outcomes:
measure: Participant group 2: The usability of the investigational device.
timeFrame: From study appointment to the analysis of the results (up to six months).
measure: Participant group 1: REM measurements.
timeFrame: From REM measurements to the analysis of the results (up to six months).
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Aalto University
city: Helsinki
country: Finland
facility: HUS Head and Neck Center
Study officials:
affiliation: Aalto University
name: Jouni Partanen, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05211921: Single Arm Study of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
Official title: A Single Arm Study to Confirm the Efficacy and Safety of Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacterial Vaginosis
Lead sponsor: Karo Pharma AB
Sponsor class: INDUSTRY
First posted: 2022-01-27
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Open, single arm trial that intends to confirm the safety and efficacy of Multi-Gyn ActiGel Plus for treatment of Bacterial Vaginosis. Adult women will be diagnosed by the gynaecologist based on the Amsel criteria at day 0. They will use the product for 7 days and will come to the practice at day 21. The primary endpoint is the clinical cure rate of Bacterial Vaginosis at 3 weeks after start of treatment.


Eligibility criteria: Inclusion Criteria:

* Women diagnosed with BV (3 out of 4 Amsel criteria positive, with at least presence of clue cells (\>20%)
* Women of childbearing potential
* Aged \>18 years
* Signed written informed consent form
* Willing to comply to the follow-up schedule

Exclusion Criteria:

* Current clinically manifest of sexually transmitted gynecologically infection, genital tract infection, vulvovaginal candidosis or aerobic vaginitis
* Presence of Trichomonas and/or Candida Albicans in vaginal smear during examination of the smears for Amsel criteria (clue cells detection)
* Current genital malignancies
* Chemotherapy for any reason in last 6 months
* Radiotherapy in the genitourinary system in the last 12 months
* Use of antibiotics for any reason in the last 14 days
* Pregnancy or currently attempting to conceive
* Lactation
* Use of other treatment for vaginal conditions during the course of the clinical investigation
* Known allergies to ingredients of the product
* Concomitant medication for treatment of vaginal infections, or other use of intravaginal medication during the course of the clinical investigation

Primary outcomes:
measure: The primary endpoint is clinical cure rate of BV at 3 weeks after start of treatment (Visit 2).
timeFrame: 3 weeks after start of treatment
Secondary outcomes:
measure: Relief of vaginal symptoms related to BV at Visit 2
timeFrame: 3 weeks after start of treatment
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Eurofins Dermascan Poland
Study officials:
References:
Clinical trial NCT00197821: Evaluation of the Immunogenicity and Reactogenicity of a Pneumococcal Conjugate Vaccine in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Streptococcus Pneumoniae
Lead sponsor: Public Health England
Sponsor class: OTHER_GOV
First posted: 2005-09-20
Enrollment: 611
Sex: ALL
Minimum age (years): 50
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: To compare the relative immunogenicity and reactogenicity of the existing 23 valent plain pneumococcal vaccine and a 7 valent pneumococcal conjugate vaccine in healthy UK adults aged 50-80 years, and subsequent antibody persistence and response to boosting.


Eligibility criteria: Inclusion Criteria:

* Written informed consent for participation in the study; ages between 50 and 80 years at recruitment

Exclusion Criteria:

* Lack of adequate comprehension of the information sheet, consent form and study nurse's explanation of the study in order to give informed consent.
* Current participation in any other clinical trial
* Any vaccination in the previous month (except influenza vaccination which can be given at any time during the study)
* Prior pneumococcal conjugate vaccine (PNC)
* 23 valent pneumococcal vaccine(PPV) in last 5 years
* Severe general or local reaction to a previous dose of PNC or PPV
* Patients currently immunocompromised as listed in UK Handbook "Immunisation Against Infectious Disease" ed 1996
* Patients who have received intravenous immunoglobulin in the previous month or who will require replacement intravenous immunoglobulin during the period of the study
* Patients in whom pneumococcal vaccination (PPV) is currently recommended as per the UK Handbook "Immunisation Against Infectious Disease"
* Deferral of vaccination if acute systemic illness or temperature \>38C on day of vaccination

Primary outcomes:
measure: Immunogenicity
timeFrame: Completed by dec 2008
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Heath Protection Agency
name: Elizabeth Miller, MBBS FRCPath
role: PRINCIPAL_INVESTIGATOR
References:
citation: Goldblatt D, Southern J, Andrews N, Ashton L, Burbidge P, Woodgate S, Pebody R, Miller E. The immunogenicity of 7-valent pneumococcal conjugate vaccine versus 23-valent polysaccharide vaccine in adults aged 50-80 years. Clin Infect Dis. 2009 Nov 1;49(9):1318-25. doi: 10.1086/606046.
Clinical trial NCT00377221: Anorectal Microbicide Project(AMP): Rectal Health, Behaviors and Microbicide Acceptability
Official title: Rectal Health, Behaviors and Microbicide Acceptability
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rectal Health
Rectal Behaviors
Anorectal Symptomatology
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: AIDS Research Alliance
name: Johns Hopkins Bloomberg School of Public Health
First posted: 2006-09-18
Enrollment: 896
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Time perspective: PROSPECTIVE

Brief summary: Observational, cross-sectional, single-visit study of 896 men and women in Los Angeles, CA and Baltimore, MD including a computer-assisted interview focusing on the behavioral repertoire surrounding RAI, symptoms, and health seeking behaviors and a multidimensional assessment of behaviors, anorectal examination, and testing for sexually transmitted infections (STIs).


Eligibility criteria: Inclusion Criteria:

Men and women are eligible who meet all of the following criteria:

1. At least 18 years of age
2. Willing to be tested for STIs including HIV
3. Willing to undergo an anal exam
4. Mentally competent to understand study procedures and give informed consent.
5. For the NO-RAI groups:

   No RAI in the past year for the non-RAI men and women
6. For the practicing RAI groups:

Males: report RAI in the past 30 days Females: report RAI in the past 12 months

Exclusion Criteria:

1. Less than 18 years of age
2. Unwilling to be tested for STIs (and HIV)
3. Unwilling to undergo an anal exam
4. Unwilling to complete study questionnaire
5. Not mentally competent to understand study procedures and give informed consent.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: AIDS Research Alliance
state: California
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: University of California, Los Angeles
name: Pamina Gorbach, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Peter A Anton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Los Angeles
name: Ross Cranston, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06392321: Dexmedetomidine vs Fentanyl in Controlling Labor Pain
Official title: Dexmedetomidine Versus Fentanyl as an Adjuvant to Single Low Dose Spinal Anesthesia in Controlling Labor Pain: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Labor Pain
Keywords: Dexmedetomidine
Fentanyl
intrathecal
labor pain
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: As most woman experience agonizing pain throughout vaginal labor. Adjuvants were added to intrathecal bupivacaine aiming to improve the quality of analgesia. This study aimed to assess the efficacy and outcome of intrathecal dexmedetomidine and fentanyl in controlling pain during delivery.

Detailed description: Throughout vaginal deliveries, many women suffered from pain. providing suitable analgesia is crucial (Lupu et al., 2023). Spinal anesthesia can provide pain management (Parikh et al., 2018).

Various types of analgesics can be combined to get the needed duration of perioperative analgesia. Dexmedetomidine has been used with effective pain management outcomes (Shrestha et al., 2023). Fentanyl can help pain relief in short duration procedures (Show et al., 2022).

Eligibility criteria: Inclusion Criteria:

* women planned for spontaneous vaginal delivery.

Exclusion Criteria:

* cardiac, liver or kidney disease, allergy to local anesthetics or the studied drugs, any contraindication of regional anesthesia and intrauterine growth retardation or fetal compromise.

Primary outcomes:
measure: efficacy of intrathecal dexmedetomidine
timeFrame: 120 minutes
Secondary outcomes:
measure: patient satisfaction
timeFrame: 2 hours
measure: mother's outocme
timeFrame: 1 and 5 minutes
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Al Azhar University
state: Naser City
Study officials:
References:
citation: Lupu VV, Miron IC, Raileanu AA, Starcea IM, Lupu A, Tarca E, Mocanu A, Buga AML, Lupu V, Fotea S. Difficulties in Adaptation of the Mother and Newborn via Cesarean Section versus Natural Birth-A Narrative Review. Life (Basel). 2023 Jan 21;13(2):300. doi: 10.3390/life13020300.
citation: Parikh KS, Seetharamaiah S. Approach to failed spinal anaesthesia for caesarean section. Indian J Anaesth. 2018 Sep;62(9):691-697. doi: 10.4103/ija.IJA_457_18.
citation: Shrestha IK, Chalise R, Poudel S, Regmi A, Ghimire A, Khadka B, Khanal K. Neostigmine and atropine as a treatment for postdural puncture headache after spinal anesthesia in cesarean section: A case report. Clin Case Rep. 2023 Nov 2;11(11):e8132. doi: 10.1002/ccr3.8132. eCollection 2023 Nov.
citation: Show KL, Ngamjarus C, Kongwattanakul K, Rattanakanokchai S, Duangkum C, Bohren MA, Betran AP, Somjit M, Win WYH, Lumbiganon P. Fentanyl for labour pain management: a scoping review. BMC Pregnancy Childbirth. 2022 Nov 17;22(1):846. doi: 10.1186/s12884-022-05169-x.