louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05038540: The Effect of Virtual Reality Glasses on Dental Anxiety Control
Official title: Evaluation of the Effect of Virtual Reality Glasses Used During Scaling and Root Planing on Dental Anxiety Control
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontitis
Dental Anxiety
Dental Fear
Gingivitis
Calculus, Dental
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2021-09-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this clinical study, it was aimed to evaluate whether there is a decrease in patient anxiety by applying virtual reality glasses, which are the product of new technology, during scaling and root planing treatment.

Patients who required scaling and root planing treatment and also scored 9 or above according to the Dental Anxiety Scale were included in our study. Scaling and root planing was performed in a randomly selected intraoral quadrant of the patients, in the same way, with or without the use of virtual reality glasses. In the virtual reality glasses application, a video consisting of images of nature landscapes developed for patient rehabilitation was projected onto the screen in front of the patient's eyes. The Dental Anxiety Scale was reapplied after the completion of the treatment.

In the intraoral quadrant where virtual reality glasses were used, it is expected that lower Corah Dental Anxiety Scale scores may be obtained after the treatment is completed, compared to the intraoral quadrant where the treatment is performed without glasses, thus reducing anxiety.


Eligibility criteria: Inclusion Criteria:

* Being over 18 years old
* Being systemically healthy
* Needing treatment in at least two quadrants of the mouth
* At least five teeth in each quadrant and at least one region with a terminal pocket depth ≥4 mm
* Having a score of 9 or higher on the dental anxiety scale

Exclusion Criteria:

* Having a history of seizures or a convulsive disorder
* Balance disorders such as nystagmus, vertigo
* Use of psychotropic drugs
* Getting treatment for anxiety
* Presence of dermatological lesions on the face and especially around the eyes
* The presence of a lesion in the eye that will prevent the use of virtual reality glasses

Primary outcomes:
measure: Lower Corah Dental Anxiety Scale scores in virtual reality application group
timeFrame: Baseline
measure: Lower blood pressure and heart rate values in virtual reality application group
timeFrame: Baseline
Secondary outcomes:
measure: Patients' feedback
timeFrame: Baseline, 1st month
measure: Dentist's feedback
timeFrame: Baseline
Other outcomes:
Locations:
city: Kütahya
country: Turkey
facility: Kutahya Health Sciences University
Study officials:
References:
Clinical trial NCT06514040: Nebulized Dexmedetomidine Versus Oral Sumatriptan in Treatment of Post Dural Puncture Headache in Cesarean Section
Official title: Nebulized Dexmedetomidine Versus Oral Sumatriptan for Treatment of Post-Dural Puncture Headache Following Caesarian Section (Randomized Comparative Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Dural Puncture Headache
Lead sponsor: Fayoum University Hospital
Sponsor class: OTHER
First posted: 2024-07-23
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: comparison between oral sumatriptan and Nebulized Dexmedetomidine in Post Dural Puncture Headache in Cesarean Section

Detailed description: A total of 48 patients will be randomly chosen to receive either inhaled dexmedetomidine (Group D, n= 24) or oral sumatriptan (Group S, n= 24) by a random sequence number generated by the computer kept in sealed envelopes. Those envelopes will be opened once the patient is recruited and participants will receive either inhaled dexmedetomidine or oral sumatriptan as per the envelope. Data collectors will be blinded to the type of used medication (Dexmedetomidine or Sumatriptan).

Eligibility criteria: Inclusion criteria:

1. Pregnant female aged between 18 and 40 years old.
2. ASA II and III undergoing elective caesarean section.
3. Diagnosed with Postdural puncture headache with visual analogue score (VAS) ≥ 4 and Lybecker classification score ≥ 2.

Exclusion criteria:

1. Patient refusal.
2. History of primary headaches such as migraine, cluster and tension headaches.
3. Hypersensitivity of dexmedetomidine or sumatriptan.
4. Hypertensive disorders of the pregnancy.
5. Contraindication to spinal anesthesia as coagulopathy or infection at site of injection.
6. Symptoms of ischemic heart disease (IHD) e.g. angina.
7. Cerebrovascular disease e.g. stroke or transient ischemic attacks (TIAs).
8. Using of Monoamine oxidase inhibitors (MAOIs) in the last 24h.

Primary outcomes:
measure: visual analogue scale
timeFrame: First 48 hours
Secondary outcomes:
measure: visual analogue scale
timeFrame: 6 hours.
measure: visual analogue scale
timeFrame: 12 hours.
measure: visual analogue scale
timeFrame: 18 hours.
measure: visual analogue scale
timeFrame: 24 hours.
measure: visual analogue scale
timeFrame: 30 hours.
measure: visual analogue scale
timeFrame: 36 hours.
measure: visual analogue scale
timeFrame: 42 hours.
measure: Lybecker score
timeFrame: 6 hours
measure: Lybecker score
timeFrame: 12 hours
measure: Lybecker score
timeFrame: 18 hours
measure: Lybecker score
timeFrame: 24 hours
measure: Lybecker score
timeFrame: 30 hours
measure: Lybecker score
timeFrame: 36 hours
Other outcomes:
Locations:
city: Madīnat Al Fayyūm
country: Egypt
facility: Fayoum University hospital
state: Faiyum Governorate
Study officials:
affiliation: Faculty of medicine,Fayoum University
name: Mohamed A Hamed, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05012540: SII And PALBI is Associated With the Prognosis of Pancreatic Cancer Surgery(SII,PALBI)
Official title: Systemic Immune-inflammation Index (SII) And Platelet-albumin-bilirubin (PALBI) is Associated With the Prognosis of Pancreatic Cancer Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Keywords: pancreatic cancer
Systemic immune inflammation index
Platelet-albumin-bilirubin grade
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 214
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: age≥18 years old

Brief summary: Chronic inflammation and immune dysfunction play a key role in the development of tumors. The aim of the study is to investigate the predictive value of SII and PALBI grade for the patients with pancreatic cancer surgery.

Detailed description: The systemic immune-inflammation index(SII), based on the counts of platelets, neutrophils, and lymphocytes,was first found to be related to the prognosis of patients in melanoma12, and was subsequently confirmed in malignant tumors such as hepatocellular carcinoma13,and lung cancer12. A retrospective multicenter cohort study showed that bilirubin levels can interfere some inflammation index'prognosis of PDAC7.The platelet-albumin-bilirubin (platelet-albumin-bilirubin, PALBI) grade as a prognostic indicator of inflammation has been found in recent years, and its role has been confirmed in patients with liver cirrhosis14,15 and hepatocellular carcinoma 16, but there is no research to verify its role in patients with pancreatic cancer. This study aims to verify the predictive value of systemic immune inflammation index (SII) and platelet-albumin-bilirubin grade (PALBI) for the prognosis of patients with pancreatic cancer surgery, and to explore the significance of other inflammatory indicators in the overall survival(OS) and disease-free survival (DFS).

Eligibility criteria: Inclusion Criteria:

Age ≥ 18 years old; It was diagnosed as pancreatic cancer by clinical manifestations, laboratory examination indexes, and pathology, and then surgically removed; Agree to participate in this study and sign an informed consent form;

Exclusion Criteria:

All kinds of acute or chronic inflammation, infectious diseases and blood system diseases; Metastasis of tumors in other parts; Benign pancreatic diseases such as chronic pancreatitis and autoimmune pancreatitis; Periampullary tumors without pancreatic cancer; Suspicious pancreatic cancer patients who cannot be diagnosed; Refuse to follow up.

Primary outcomes:
measure: The overall survival
timeFrame: 2013.8-2019.12
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05657340: Video Head Impulse Test and Seasickness Susceptibility
Official title: Video Head Impulse Test and Seasickness Susceptibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sea Sickness
Keywords: motion sickness
video head impulse test
vestibular testing
seasickness susceptibility
Lead sponsor: Medical Corps, Israel Defense Force
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This a case control study on seasickness susceptibility. 86 healthy maritime personal were divided to seasickness susceptible and non susceptible groups based on a seasickness questionnaire (Golding) and motion sickness score.

All subjects from both groups underwent video head impulse testing (vHIT). VHIT parameters - gain, asymmetry ect were compared between both groups.


Eligibility criteria: Inclusion Criteria:

* 18-40 healthy military naval subjects
* At least six month of active sailing.

Exclusion Criteria:

* A history of hearing loss
* Ear pathology observed at otoscopic examination
* A neck injury precluding head movement.
* Abnormal otoneurological examination findings
* Subject's withdrawal of informed consent.
* Failure to complete the video head impulse test.

Primary outcomes:
measure: vHIT gain
timeFrame: Immediate
measure: paired semi-circular canal asymmetry
timeFrame: Immediate
Secondary outcomes:
measure: anterior semicircular canal gain o ipsilateral horizontal canal gain
timeFrame: Immediate
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Israeli Naval Medical Institute
Study officials:
References:
Clinical trial NCT00326040: A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects
Official title: A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Open-Angle Glaucoma
Keywords: Open angle
Glaucoma
Refractory
Surgery
Lead sponsor: Glaukos Corporation
Sponsor class: INDUSTRY
First posted: 2006-05-16
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in refractory open-angle glaucoma subjects.

Detailed description: Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on maximally tolerated medical therapy or where noncompliance with medication has been document
* Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant)

Exclusion Criteria:

* Angle closure glaucoma
* Fellow eye already enrolled

Primary outcomes:
measure: Efficacy
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne
city: Neubradenbrug
country: Germany
facility: Klinik für Augenheilkunde
city: Genova
country: Italy
facility: University Eye Clinic
city: Parma
country: Italy
facility: Instituto di Oftalmologia
city: Rotterdam
country: Netherlands
facility: Ophthalmic Clinic
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Zaragoza
country: Spain
facility: Instituo Oftalmologico de Aragon
Study officials:
affiliation: Glaukos Corporation
name: Head of Clinical Affairs
role: STUDY_DIRECTOR
References:
Clinical trial NCT02149940: Feasibility of Pharmaceutical Interventions in Elderly Heart Failure Patients.
Official title: Feasibility of Pharmaceutical Interventions in Elderly Heart Failure Patients: a Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Elderly
Frailty
Polypharmacy
Medication review
Clinical pharmacy services
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 29
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Heart failure therapies (e.g. beta blockers) have been successful in decreasing mortality rates, as well as diminishing hospitalizations. Also, pharmacist collaboration has been shown to have a beneficial impact on heart failure related outcomes. Regardless, a high residual event rate is to be noted.

In our pilot study, we wished to document whether a clinical pharmacist could still play a role in the heart failure management of an elderly inpatient heart failure population.


Eligibility criteria: Inclusion Criteria:

* 75 years or older
* diagnosis of previous or new heart failure based on signs and symptoms as defined by the 'European Society of Cardiology guidelines on acute and chronic heart failure'
* diagnosis had to be confirmed by a recent echocardiogram

Exclusion Criteria:

* not Dutch speaking
* treatment restrictions had been applied on admission

Primary outcomes:
measure: the number of heart-failure related pharmaceutical interventions
timeFrame: during hospital stay (average of 14 days)
Secondary outcomes:
measure: acceptance rate of the pharmaceutical interventions
timeFrame: during hospital stay (average of 14 days)
measure: clinical feasibility of the accepted interventions
timeFrame: during hospital stay (average of 14 days)
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospitals Leuven
state: Flemish Brabant
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Karolien Walgraeve, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Lorenz R Van der Linden, PharmD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jos Tournoy, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Walgraeve K, Van der Linden L, Flamaing J, Fagard K, Spriet I, Tournoy J. Feasibility of optimizing pharmacotherapy in heart failure patients admitted to an acute geriatric ward: role of the clinical pharmacist. Eur Geriatr Med. 2018 Feb;9(1):103-111. doi: 10.1007/s41999-017-0019-x. Epub 2018 Jan 4.
Clinical trial NCT00853840: Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc
Official title: A Randomized, Single-Blinded, Placebo-Controlled Two-Way Crossover Study To Investigate The Hemodynamic Effects Of Single Dose Vardenafil In Subjects Receiving Maraviroc
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: AIDS
Keywords: pharmacodynamics. maraviroc, vardenafil, blood pressure
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2009-03-02
Enrollment: 18
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to estimate the effects of a single dose of vardenafil on the blood pressure (BP) in subjects receiving maraviroc (MVC) (dosed to steady-state) and to assess the safety and tolerability of MVC in subjects receiving a single dose of vardenafil.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects. no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead electrocardiogram and clinical laboratory tests.
* Body mass index (BMI) of approximately 18 to 30 kg/m2; and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
* Subjects with a supine systolic BP of greater than 140 mm Hg, or a supine diastolic BP of greater than 90 mm Hg, either at Screening or at the predose measurements.

Primary outcomes:
measure: Standing and Supine Systolic and Diastolic Blood Pressure (BP)
timeFrame: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose
Secondary outcomes:
measure: Standing and Supine Pulse Rate
timeFrame: 1.5, 2, 2.5, 3, 4, 6, 8, 12 hours post Vardenafil or Placebo dose
measure: Postural Changes in Systolic and Diastolic Blood Pressure
timeFrame: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg
measure: Postural Changes in Pulse Rate
timeFrame: Baseline, 6 and 12 hours post dose on Day 1 from the First Day of each Treatment Leg
measure: Number of Subjects With Postural Hypotension
timeFrame: Period 1 and Period 2 (up to 8 days)
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05484440: Intervention Program With Perpetrators of Intimate Partner Violence
Official title: Intervention Program With Perpetrators of Intimate Partner Violence
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intimate Partner Violence
Keywords: Intimate partner violence
Perpetrator
Intervention program
Lead sponsor: University of Minho
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 50
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current project aims to develop, implement and assess the effectiveness of an intervention program for perpetrators of intimate partner violence (both volunteers and court-mandated) that incorporates Motivational Interviewing techniques (MIT) as well as cognitive-behavioral and psychoeducational strategies implemented in a community setting. The intervention focuses on ending violence against the intimate partner and promoting the batterer's personal and social skills. The study uses pre- and post-treatment measures, with an experimental group (intervention) and two control groups (a group without intervention and a group without MIT). Data were collected at pre-test, post-test, and follow-up.


Eligibility criteria: Inclusion Criteria:

* being an adult male;
* having perpetrated physical, psychological, and/or sexual violence against a female intimate partner or ex-partner;
* be able to read and write.

Exclusion Criteria:

* psychotic disorders;
* cognitive impairment;
* psychological and/or personality disorders;
* substance abuse.

Primary outcomes:
measure: Perpetration of abuse against intimate partner
timeFrame: 18 weeks
measure: Attitudes towards intimate partner violence
timeFrame: 18 weeks
measure: Psychopathological symptoms
timeFrame: 18 weeks
measure: Coping skills
timeFrame: 18 weeks
measure: Risk of intimate partner violence
timeFrame: 18 weeks
measure: Motivation to change
timeFrame: 18 weeks
Secondary outcomes:
measure: Self-esteem
timeFrame: 18 weeks
measure: Self-concept
timeFrame: 18 weeks
measure: Aggression
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Braga
country: Portugal
facility: Associação de Psicologia da Universidade do Minho
state: None Selected
city: Póvoa De Varzim
country: Portugal
facility: Junta de Freguesia Aver-o-Mar
Study officials:
References:
Clinical trial NCT00242840: Observational Study Of A Protease Inhibitor (PI) Containing Regimen In Subjects With PI Mutations Selected During Prior Treatment With GW433908 (Fosamprenavir)
Official title: A 24 Week Phase IIIb/IV Single Arm Open Label Observational Study to Explore the Efficacy of Protease Inhibitors Given in Combination With Reverse Transcriptase Inhibitors to HIV-1 Infected Subjects With Protease Mutations Selected During Therapy With GW433908 Containing Antiretroviral Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection, Human Immunodeficiency Virus I
HIV Infection
Keywords: protease inhibitor
ritonavir
GW433908
HIV-1
fosamprenavir
Lead sponsor: ViiV Healthcare
Sponsor class: INDUSTRY
First posted: 2005-10-21
Enrollment: 20
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study will assess the efficacy of subsequent protease inhibitor (PI)-containing therapy in subjects who have acquired HIV-1 protease mutations whilst receiving a GW433908 (fosamprenavir)-containing regimen.


Eligibility criteria: Inclusion criteria:

* Prior participation in study APV30005 AND one of the following studies: APV30001, APV30002, AZL30006, APV30003.
* Must be failing virologically (\>1000 copies at two consecutive time-points) and have a screening genotype with evidence of at least one new APV-associated protease mutation: V32I (+/- I47V), I50V, I54L/M, I84V acquired since commencing treatment with GW433908.

Exclusion criteria:

* Have 2 or more of the primary resistance mutations D30N, G48V, V82A/F/T/S and L90M.
* Have a medical need for use of an non-nucleoside reductase transferase inhibitor (NNRTI).
* Have an acute CDC Class C event requiring therapeutic intervention.
* Are pregnant or lactating.
* Have any other condition which in the opinion of the investigator would preclude their participation.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Lauderdale
country: United States
facility: GSK Investigational Site
state: Florida
city: Orlando
country: United States
facility: GSK Investigational Site
state: Florida
city: Tampa
country: United States
facility: GSK Investigational Site
state: Florida
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Atlanta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Augusta
country: United States
facility: GSK Investigational Site
state: Georgia
city: Brescia
country: Italy
facility: GSK Investigational Site
state: Lombardia
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials, MD
role: STUDY_DIRECTOR
References: