louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02958332: Effects of a Videogame-based Program on Women With Lymphedema Secondary to Breast Cancer
Official title: Effects of a Videogame-based Program on Women With Lymphedema Secondary to Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphedema
Breastcancer
Keywords: video games
Lead sponsor: Universidad de Burgos
Sponsor class: OTHER
First posted: 2016-11-08
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Aims: To demonstrate the effect of a program based on video games as a means to improve abilities and basic skills affected by lymphedema, and its impact on quality of life.

Design: longitudinal, pre-experimental, with pre / post-test and evaluation, assessor blinded study.

Method: Data on shoulder pain and disability, health-related quality of life, strength and articulate activated by the OSS (Oxford Shoulder Score), SPADI (Shoulder Pain and Disability Index), FACT-B + 4 (Functional Assesment of Cancer Therapy Questionnaire for Breast Cancer), respectively goniometry and dynamometry amplitude scales will be collected.

The intervention will be performed with the Wii ™ console and the Wii Balance BoardTM, during 5 individual weekly sessions of 30 minutes.


Eligibility criteria: Inclusion Criteria:

* Be over 18 years
* Have a diagnosis of lymphedema, secondary to breast cancer

Exclusion Criteria:

* Stage 0 or subclinical lymphedema
* Present other shoulder pathology apart from lymphedema

Primary outcomes:
measure: Change in Range motion
timeFrame: Pre intervention and one week after having finished the program
measure: Change in strength
timeFrame: Pre intervention and one week after having finished the program
measure: Change in Oxford Shoulder Scale
timeFrame: Pre intervention and one week after having finished the program
measure: Change in Shoulder Pain and Disability Index
timeFrame: Pre intervention and one week after having finished the program
Secondary outcomes:
measure: Change in quality of life (FUNCTIONAL ASSESMENT OF CANCER THERAPY QUESTIONNAIRE FOR BREAST CANCER (FACT-B+4)
timeFrame: Pre intervention and one week after having finished the program
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Universidad de Burgos. Facultad de Ciencias de la Salud.
Study officials:
affiliation: Universidad de Burgos
name: Montserrat Santamaría-Vázquez, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03207932: Ultrasound Guidance Versus Anatomical Landmarks for CVC Catheterisation:
Official title: Ultrasound Guidance Versus Anatomical Landmarks for Succlavic and Femoral Vein Catheterisation: an Observational Prospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Success Rate for Subclavian or Femoral Vein Catetherisation
Lead sponsor: University of Pisa
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: intensive care patients

Brief summary: anatomical landmarks on the body surface were used to insert central vein catheter. However, ultrasound technique is emerging as a new technique for vein catheterisation. For subclavian and femoral vein catheterisation, up to now, there is a lack of evidence of the superiority of one technique over the other.


Eligibility criteria: Inclusion Criteria:

* patients needing CVC

Exclusion Criteria:

* refusal of consent

Primary outcomes:
measure: The success rate for succlavic or femoral vein catetherisation using ultrasound versus landmark technique at the first attempt
timeFrame: during catheterization procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Pisa
country: Italy
facility: Francesco Forfori
Study officials:
References:
Clinical trial NCT05680532: The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori
Official title: The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
H Pylori Infection
Keywords: black raspberry
Alzheimer's patients
H pylori
Inflammatory cytokines
Antioxidant
Lead sponsor: Chung Shan Medical University
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 21
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori). Through checking various parameters including anthropometric, antioxidants, and CDR.

Detailed description: The current study was designed to check the impact of black raspberry (BR) on obese and mild Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori).

Preclinical studies (In vitro model) were conducted using 3T3-L1 adipocyte cells to check the anti-adhesion activity of BR.

For the clinical trial, a total of 21 obese mild AZ patients were recruited and separated into 2 groups: Experimental (BR group) and Placebo group.

Experimental group and Placebo group subjects were requested to take either 50 g of BR or 50 g of dextrin respectively for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* BMI ≧ 27, Waist circumference: men ≧ 90cm, women ≧ 80cm,
* Body fat: male ≧ 25%, female ≧ 30%,
* UBT 13C test value\> 10‰ (H. pylori (+)),
* CDR (clinical dementia rating) = 0.5

Exclusion Criteria:

* BMI\< 27
* Severe chronic diseases (liver disease, cardiovascular disease, kidney disease)
* Alcohol abuse
* Smoking habit
* Taking berry-related supplementation or any known allergies related to berries.
* Subjects with prior history of H. pylori infection were treated with triple therapy.

Primary outcomes:
measure: Glycemic indices
timeFrame: 8 weeks
measure: Anthropometric parameters
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung city
country: Taiwan
facility: Chung Shan Medical University
state: Taichung
Study officials:
affiliation: Chung Shan Medical University
name: Chin-Kun Wang, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02086032: The Effect of Different Types of Progestin on Sleeping of Menopausal Women
Official title: The Effect of Different Types of Progestin on Sleeping of Menopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menopausal and Postmenopausal Disorders
Keywords: Sleeping quality
menopause
climacteric
progestin
dydrogesterone
micronized progesterone
Lead sponsor: Chiang Mai University
Sponsor class: OTHER
First posted: 2014-03-13
Enrollment: 100
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators have found that sleeping disorder is an important problem in menopausal women.

There have been papers reporting the effect of hormonal therapy on sleeping, but fews have reported the effect of different progestogens on sleeping quality. There is a need for more in-depth study and more conclusive evidence about the progestins which have the most beneficial effects on sleeping disorders in menopausal women.

This study is going to collect the data from newly identified menopausal patients who are eligible for continuous estrogen-progestogen therapy for their climacteric treatment. The affects of the therapy will be monitored for 3 months.

Detailed description: New patients who are eligible for hormonal therapy will be selected.

They will be allocated randomly into 2 different groups, each group being prescribed 1 of 2 regimens of hormonal therapy:

* 17 beta estradiol 1mg/day plus oral micronized progesterone 100mg/day
* 17 beta estradiol 1mg/day plus dydrogesterone 10mg/day Patients will have their sleeping quality accessed using the Pittsburgh sleep quality index(PSQI) at their 1st visit and once a month for 3 months. The first and third PSQI score will be analysed.

Eligibility criteria: Inclusion Criteria:

* new menopausal patients at Maharaj Nakorn Chiang Mai Hospital
* suitable for estrogen plus progesterone treatment

Exclusion Criteria:

* contraindication for hormone replacement therapy
* recently used sleep enhancing medicine
* recently used psychotic medicine

Primary outcomes:
measure: Improving of sleeping quality (assessed by the PSQI score)
timeFrame: from March 2014 up to 15 months
Secondary outcomes:
measure: The side effects comparing the 2 arms.
timeFrame: from March 2014 up to 15 months
measure: The climacteric symptoms comparing the 2 arms.
timeFrame: from March 2014 up to 15 months
Other outcomes:
Locations:
city: Muang
country: Thailand
facility: Obstetrics and Gynecology department, Faculty of Medicine, Chiang Mai University
state: Chiang Mai
Study officials:
affiliation: Faculty of Medicine, Chiang Mai University, Thailand
name: Tawiwan Pantasri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leeangkoonsathian E, Pantasri T, Chaovisitseree S, Morakot N. The effect of different progestogens on sleep in postmenopausal women: a randomized trial. Gynecol Endocrinol. 2017 Dec;33(12):933-936. doi: 10.1080/09513590.2017.1333094. Epub 2017 Jun 13.
Clinical trial NCT01051232: A Study To Investigate Safety And Pharmacokinetics Of A Single Dose Of PF-00868554 (Filibuvir) In Japanese Healthy Adult Volunteers
Official title: A Double Blind, Placebo-Controlled, Randomized, Dose Escalation Study To Investigate Safety, Tolerability, And Pharmacokinetics Of PF-00868554 (Filibuvir) Following Single Oral Administrations Of PF-00868554 (Filibuvir) Under Fasting Conditions In Japanese Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: filibuvir
pharmacokinetics
Japanese
Asian
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-01-18
Enrollment: 24
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A single dose of PF-00868554 (filibuvir) will be safety and tolerable in Japanese healthy volunteers. The pharmacokinetics in Japanese will be consistent to that available in Western population.

Detailed description: Investigation of safety, tolerability and pharmacokinetics of single oral administration of PF-00868554 (filibuvir) in healthy adult Japanese volunteers.

Eligibility criteria: Inclusion Criteria:

* Healthy male and female subjects between the ages of 20 and 55 years.
* Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg.

Exclusion Criteria:

* A positive result for Hepatitis B surface antigen (HbsAg) or anti-hepatitis C virus serology, and HIV antigen/antibody.
* Male subjects with a history of subfertility/infertility and other conditions that in the opinion of the investigator may affect fertility.
* Pregnant or nursing females; females of childbearing potential.

Primary outcomes:
measure: Safety; ECGs/vital signs
timeFrame: Screening to Follow-up (Day 5)
measure: Safety; laboratory tests
timeFrame: Screening to Follow-up (Day 5)
measure: Safety; physical examination/adverse event monitoring
timeFrame: Screening to Follow-up (Day 5)
Secondary outcomes:
measure: Pharmacokinetics; Plasma PF-00868554 (filibuvir) concentrations
timeFrame: Day 1 to Day 3
measure: Pharmacokinetics; Urine PF-00868554 (filibuvir) concentrations
timeFrame: Day 1 to Day 3
Other outcomes:
Locations:
city: Shinjuku-ku
country: Japan
facility: Pfizer Investigational Site
state: Tokyo
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT02205632: Relationships Between Macular Pigment Optical Density and Lacquer Cracks in High Myopic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: High Myopia
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED

Brief summary: Lutein ans zeaxanthin, carotenoids provided by dietary intake are mainly located in the macular area.

Its absorption peak at 460 nm may reduce photic damages. The macular pigment density can be evaluated by its optical density.

Reduced macular pigment level is a significant risk factor for age-macular degeneration. The nutritional intake can minimise the risk of age-macular degeneration.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years-old
* High axial myopia \< -6 dioptries
* Presence or not of lacquer cracks in Bruch's membrane in one or both eyes
* Patients with social security coverage

Exclusion Criteria:

* Age \<18 years-old
* Amblyopia in the studied eye
* Prior ocular surgery
* Corneal disease or severe dry eye syndrome
* Other retinal disease: diabetic retinopathy, age-related macular degeneration, macular hole, epiretinal membrane central
* Extensive chorioretinal atrophy
* Allergy to tropicamide
* Pregnancy

Primary outcomes:
measure: Association between lacquer cracks related to high myopia and the macular pigment optical density
timeFrame: 1 day
Secondary outcomes:
measure: The macular pigment optical density among high myopic patients
timeFrame: 1 day
Other outcomes:
Locations:
city: Poitiers
country: France
facility: ophthalmology department, Poitiers University Hospital
state: Vienne
Study officials:
affiliation: Poitiers University Hospital
name: Nicolas LEVEZIEL, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06841432: Coblation Versus Suction Diathermy in Pediatric Adenoidectomy
Official title: Endoscopic Coblation Versus Suction Diathermy in Pediatric Adenoidectomy: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adenoid Hypertrophy
Adenoidectomy
Coblation Adenoidectomy
Suction Daithermy
Keywords: Endoscopic
Adenoidectomy
adenoid hypertrophy
Pediatric
Suction Diathermy
Coblation
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2025-02-24
Enrollment: 245
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare two surgical procedures in endoscopic adenoidectomy including Coblation and Suction diathermy

. The main questions it aims to answer are: Does the Coblation device have less time, less pain, less postoperative crustation and bad odor, less intraoperative bleeding, and less recurrence?

Participants will:

will undergo both procedures every day for 6 months Visit the clinic once every 2 weeks for checkups and tests Keep a diary of their symptoms


Eligibility criteria: Inclusion Criteria:

* all patients aged 2 to 18 years
* patients who had isolated adenoid hypertrophy
* patients' hemoglobin levels above 10 mg/dl

Exclusion Criteria:

* those with recent upper respiratory tract infections, evidence of bleeding disorders, serous otitis media, chronic tonsillitis
* those advised against undergoing adenoidectomy after consulting a phoniatrist
* patients with atrophic rhinitis those with nasal obstruction caused by other nasal or paranasal conditions such as inferior turbinate hypertrophy, Choanal atresia, deviated nasal septum, antrochoanal polyps, and other causes of nasal obstruction in children.

Primary outcomes:
measure: Operative duration
timeFrame: During the procedure
measure: Intraopertive blood loss
timeFrame: during the procedures
measure: Postopertaive Pain
timeFrame: Patients reported their pain levels every day before taking any pain medication during the 7 days after their surgery
Secondary outcomes:
measure: Development of bad breath
timeFrame: from the end of operation till 2 weeks post operation
measure: recovery time
timeFrame: three months post opertaive
measure: secondary bleeding
timeFrame: up to one month surgery
measure: Pre- and post-adenoid size grading
timeFrame: preintervention (one day before opertaion ) and postintervention (up to three months)
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Alazhar university Hopital in Assiut
Study officials:
References:
Clinical trial NCT04637932: Percutaneous Dilatation Tracheostomy, Broncoscopy, Pro-seal Laryngeal Mask
Official title: Use of Pro-seal LMA and Bronchoscopy During Percutaneous Dilatation Tracheostomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tracheostomy Complication
Keywords: percutan tracheostomy
bronchoscopy
pro-seal Laryngeal mask
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2020-11-20
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.
Primary purpose: OTHER

Brief summary: In this study, our primary goal is to compare whether there is any difference in the complication of using pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure. Our secondary goal is to compare in terms of processing time.

Detailed description: Following the approval of Muğla Sıtkı Koçman University Clinical Research Ethics Committee, 61 cases over the age of 18 who were scheduled for elective percutaneous dilatation tracheostomy in intensive care units were included in the study.

Elective percutaneous dilatation tracheostomy cases were randomly divided into two groups. Group 1 was determined as endotracheal tube and group 2 as pro-seal laryngeal mask group.

In the endotracheal tube group, which is a conventional method, after entering the trachea with percutaneous technique, the intubation tube was removed before dilatation and percutaneous dilatation tracheostomy was performed with the Seldinger method.

In the pro-seal laryngeal mask group, the fiberoptic bronchoscope was advanced with a pro-seal laryngeal mask, and after the correct position was achieved, percutaneous dilatation tracheostomy was performed using the Seldinger Method.

Arterial blood pressure, oxygen saturation, heart rate, arterial blood gas, mechanical ventilation mode, positive end expiratory pressure and mean airway pressure values were recorded before and 30 minutes after the procedure.

The time until the end of the procedure and complications were determined.

Eligibility criteria: Inclusion Criteria:hospitalized in intensive care units of our hospital and planned for elective percutaneous dilatation tracheostomy were included in the study.

-

Exclusion Criteria:

* history of cervical trauma,
* high-pressure mechanical ventilation (inspiratory pressure above 40 cmH2O),
* pulmonary edema,
* acute respiratory distress

Primary outcomes:
measure: complication of percutan dilatation tracheostomy procedure.
timeFrame: 7 days
Secondary outcomes:
measure: processing time.
timeFrame: minutes
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sitki Kocman University
Study officials:
affiliation: Mugla Sitki Kocman University Department of AnesthesiaDepartment of Anesthesia
name: semra Demirbilek
role: STUDY_DIRECTOR
References:
Clinical trial NCT03583632: Visual Acuity and Optical Coherence Tomography One Year After Peeling of Epiretinal Membranes
Official title: Visual Acuity and Optical Coherence Tomography One Year After Peeling of Epiretinal Membranes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epiretinal Membrane
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For this study only patients after vitrectomy with Membrane Peeling due to epiretinal membranes are selected

Brief summary: Improvement in visual acuity and retinal anatomy one year after surgery is assessed and compared to data preoperative and 3 months after surgery

Detailed description: Improvement in visual acuity and retinal anatomy (documented by optical coherence tomography) one year after surgery is assessed and compared to data preoperative and 3 months after surgery. Improvements in retinal morphology are analysed by remission of optical coherence biomarkers after surgery. Aim of the study is to examine possible improvements of surgical outcomes in the period up to the one year follow-up.

Eligibility criteria: Inclusion Criteria:

* vitrectomy with Membrane Peeling due to an epiretinal membrane

Exclusion Criteria:

* none

Primary outcomes:
measure: visual acuity
timeFrame: 3 minutes
Secondary outcomes:
measure: optical coherence tomography
timeFrame: 3 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery (VIROS), Hanusch Hospital Vienna
Study officials:
affiliation: VIROS at Hanuschkrankenhaus Vienna
name: Oliver Findl, MD, Prof
role: PRINCIPAL_INVESTIGATOR
References: