louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03968575: Sub-threshold Micro-Pulse Laser Therapy for Drusen of Dry AMD
Official title: The Affiliated Eye Hospital of Wenzhou Medical University
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drusen
Lead sponsor: The Eye Hospital of Wenzhou Medical University
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To investigate the efficacy and safety of sub-threshold micro-pulse laser therapy for drusen of dry age-related macular degeneration (AMD) .


Eligibility criteria: Inclusion Criteria:

1. Older than 50 years of age.
2. Male or female patients with nonexudative AMD with a drusen diameter of at least 125um in the central 3mm circle
3. clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
4. Able to give an informed consent.

Exclusion Criteria:

1. Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
2. unclear media that no clear colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT can performed.
3. Ocular or periocular infections.

Primary outcomes:
measure: Change in macular drusen volume
timeFrame: 6 and 12 months
measure: Change in macular drusen area
timeFrame: 6 and 12 months
Secondary outcomes:
measure: Change in visual acuity
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: The eye of Wenzhou Medical University
state: Zhejiang
Study officials:
References:
Clinical trial NCT01754675: Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease
Official title: Cardiovascular Effects of a Soccer Match in Viewers With With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Lead sponsor: Instituto de Cardiologia de Santa Catarina
Sponsor class: OTHER
First posted: 2012-12-21
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: Watching football matches could cause increased blood pressure and heart rate induced by catecholamines and thus increase the incidence of cardiovascular events. However, no studies have evaluated the responses of blood pressure and heart rate in soccer spectators.

This study evaluates the hemodynamic response in Brazilian soccer fans suffering from coronary artery disease during a dispute over a game of your favorite team.


Eligibility criteria: Inclusion Criteria:

* Coronary artery disease;
* Avai or Figueirense (brazilian soccer teams) fans

Exclusion Criteria:

* Acute coronary syndrome in less than 7 days

Primary outcomes:
measure: Average mean arterial pressure
timeFrame: 90 minutes
Secondary outcomes:
measure: Mean heart rate
timeFrame: 90 minutes
measure: Systolic blood pressure
timeFrame: 90 minutes
measure: Diastolic blood pressure
timeFrame: 90 minutes
measure: Double product
timeFrame: 90 minutes
measure: Angina
timeFrame: 90 minutes
Other outcomes:
Locations:
city: São José
country: Brazil
facility: Instituto de Cardiologia de Santa Catarina
state: Santa Catarina
Study officials:
affiliation: Instituto de Cardiologia de Santa Catarina
name: Daniel M Moreira, MD. MSc.
role: STUDY_CHAIR
References:
Clinical trial NCT00364975: Development of Gourmet Healthy Cooking Workshop for Cancer Patients
Official title: Development of Gourmet Healthy Cooking Workshop for Cancer Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: gourmet healthy cooking
quality of life
adjuvant chemotherapy
weight
breast cancer
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2006-08-16
Enrollment: 0
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Subjects that participate in the practical workshop will improve their metabolic indexes, control their weight and improve their quality of life, in contrast to the participants that will take part in the nutritional consulting sessions

Detailed description: Participants will be randomly assigned to a dietary consultation-only control group or to a gourmet medical cooking workshop. The workshop will consist of 6 lessons with the following lessons: introduction, caloric density of food, fats, vegetable and fruits, Whole grains and legumes, Healthy desserts . All the lessons will start with half an hour theoretical introduction, followed by a 2.5 hours "hands on" session under supervision of a medical chef. The study population will include women receiving adjuvant chemotherapy for breast cancer. 72 patients will be recruited and will be randomly divided into two groups: an intervention group of 36 will commence the workshop during 2007 and a control group of 36 who will take part in dietitian consulting sessions only.

Eligibility criteria: Inclusion Criteria:

* Adjuvant chemotherapy

Primary outcomes:
measure: Primary: We expect to see change in the following outcomes: the patient's metabolic state, the patient's weight, body composite, patient's quality of life.
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: hadassah univercity hospital
name: berry elliot, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03667859: Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation
Official title: Vaginal Elasticity Assessment Before and After Brachytherapy/Pelvic Radiation as Measured by Vaginal Tactile Imaging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radiation Injuries
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2018-09-12
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.

Brief summary: Female patients with either uterine/cervical malignancies will be evaluated for vaginal elasticity using vaginal tactile imaging both before and after radiation treatment.

Detailed description: Patients will be recruited and sign a consent form. The patients included are patients with either uterine/cervical malignancies. Each participant undergoes radiation treatment either as primary or complementary treatment.

Assessment of vaginal elasticity via vaginal tactile imaging will be performed at 3 different points:

* Before the first treatment session (baseline).
* After the last session of laser treatment.
* 3 months post final treatment. Every patient will serve as her own control. Demographic, gynecologic and obstetric history will be obtained from patients' electronic files.

Eligibility criteria: Inclusion Criteria:

* Any woman undergoing either brachytherapy or pelvic radiation treatment as primary or complementary treatment for a cervical/uterine malignancy.

Exclusion Criteria:

* Women that are not in the age range.
* Women with massive vaginal bleeding.
* Women after pelvic exenteration.

Primary outcomes:
measure: Vaginal elasticity assessment
timeFrame: up to 6 months from enrollment
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam health care campus
Study officials:
affiliation: Rambam Health Care Campus
name: Roy Lauterbach, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03891459: Neural Account of Social Placebo Effect
Official title: Neural Account of Social Placebo Effect
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spray+ Group
Control Group
Keywords: social placebo effect
fMRI
neural account
Lead sponsor: Beijing Normal University
Sponsor class: OTHER
First posted: 2019-03-27
Enrollment: 68
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The current study aimed to reveal the neural mechanism of social placebo belief formation and belief representation, and also investigated how the brain pattern predict the social behavior performance under placebo manipulation.

Detailed description: Participants were randomly assigned to spray+ group (sprayed with saline but told as "oxytocin") and control group (sprayed with saline but told as "saline"). After 10 min, participants were invited to the resting-state, text viewing task in fMRI scanner.

In resting state session, participants with their eyes open and were instructed to attend to a black fixation cross centrally presented on a grey projection screen for 8 min (240TR).

The Text viewing task employed a mixed block and even-related fMRI design. Participants were asked to judge whether they could understand the stimuli or not by a button press (1=understand; 2=not understand). Three kinds of stimuli were presented in separate block including "oxytocin-function", "oxytocin-knowledge", "robot" related stimuli, each category contained 20 sentences. In each block, the sentence (within one category) was presented pseudo-randomized from 5s to 9s (with mean duration of 7s), then followed by a jittered time interval (interval time = sentence duration - response time; if participants made response within 5s, the sentence would not disappear until its duration reached 5s). There were two sessions with six blocks per session, and there were 5 sentences (trials) per block. The order of blocks and sentences were designed to present in pseudo-random order and were applied to all participants.

Eligibility criteria: Inclusion Criteria:

* All participants had normal or corrected-to-normal vision, and mental healthy.

Exclusion Criteria:

* Participants who reported no history of neurological, endocrine or psychiatric disorders, who majored in psychology in college or recently participated in any other drug study were not recruited.

Primary outcomes:
measure: The brain functional connectivity
timeFrame: 8 mins, 240 TR in scanner
measure: Social brain network properties in resting-state
timeFrame: 8 mins, 240 TR in scanner
measure: The brain response pattern for the key concepts about oxytocin
timeFrame: 5.33mins, 160TR in scanner
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Normal University
state: Beijing
Study officials:
References:
Clinical trial NCT03236259: The Effect of Berry Extract Administration on Cognitive Health
Official title: The Effect of Berry Extract Administration on Cognitive Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Overweight and Obesity
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
Collaborators: name: BioActor B.V.
First posted: 2017-08-01
Enrollment: 102
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to investigate the effects of daily supplementation of Brainport for a period of 6 months on cognitive health.


Eligibility criteria: Inclusion Criteria:

* healthy individuals
* Age between 40 and 60 years
* BMI 25 - 35 kg/m2

Exclusion Criteria:

* History of severe cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat). Dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and /or laboratory assessments that might limit participation in or completion of the study protocol.
* Diabetes
* Use of medication that might have influence on endpoints (hypertension medication)
* Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study in the 180 days prior to the study
* Use of antibiotics in the 30 days prior to the start of the study
* Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
* Pregnancy, lactation
* Abuse of products (\> 20 alcoholic consumptions per week and drugs)
* Smoking
* Weight gain or loss (\> 3 kg in previous 3 months)
* High physical activity (\>4.5 hours of running/week)
* History of any side effects towards intake of berries

Primary outcomes:
measure: Cognition
timeFrame: 6 months
measure: Cognition
timeFrame: 6 months
measure: Cognition
timeFrame: 6 months
Secondary outcomes:
measure: vascular structure
timeFrame: 6 months
measure: Mood
timeFrame: 6 months
measure: Blood pressure
timeFrame: 6 months
measure: Liver function
timeFrame: 6 months
measure: flavo-enzyme
timeFrame: 6 months
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
Study officials:
References:
Clinical trial NCT04741659: Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure
Official title: Tidal Volume in Patients With "de Novo" Acute Hypoxemic Respiratory Failure Receiving Non-invasive Respiratory Supports: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Hypoxemic Respiratory Failure
Keywords: De novo
ARF
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Protective ventilation can be difficult to achieve during noninvasive ventilation for "de novo"acute hypoxemic respiratory failure (i.e., not due to exacerbation of chronic lung disease or cardiac failure).Recent data suggest patient self-inflicted lung injury (P-SILI) as a possible mechanism aggravating lung damage in these patients.

The aim of this study is evaluate the tidal volume, measured by respiratory inductance plethysmography, in patients receiving different non invasive respiratory support.


Eligibility criteria: Inclusion Criteria:

* Acute Respiratory Failure (ARF) ( 100 \<PaO2/FiO2 \<300) due to Covid-19 infection
* Informed consent
* Enrollment within the first 24 hours after ARF

Exclusion Criteria:

* Clinical, radiological or istological evidence of chronic pulmonary disease.
* Body Mass Index (BMI) \> 30 kg/m2;
* Previous diagnosis of Obstructive sleep apnea syndrome (OSAS)
* Chest wall disease
* Heart failure
* Severe hemodynamic instability ( need for amine support)
* Acute coronary syndrome (ACS)
* Severe arrhythmia
* Patients unable to protect respiratory airways
* Respiratory arrest and need for endotracheal intubation
* Pregnancy
* Need for sedation
* Home long-term oxygen therapy

Primary outcomes:
measure: respiratory pattern
timeFrame: 30 minutes
measure: respiratory mechanics
timeFrame: 30 minutes
Secondary outcomes:
measure: changes in Arterial Blood Gases (ABGs)
timeFrame: immediately after intervention
measure: Dyspnea score
timeFrame: immediately after intervention
measure: Comfort score
timeFrame: immediately after intervention
measure: Blood pressure (BP) and Heart rate (HR) measurements
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Policlinico di Sant'Orsola
Study officials:
affiliation: Alma Mater Studiorum University of Bologna (IT)- Director of Respiratory and Critical Care Unit/ IRCSS S.Orsola-Malpighi University Hospital, Bologna (IT)
name: Stefano Nava, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05343559: First Impressions and Attractiveness Levels of Smiling Individuals With and Without a Mask
Official title: The Influence of a Mask on the First Impressions Projected and Attractiveness Levels of Smiling Individuals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: First Impressions
Attractiveness
Keywords: attractiveness
first impressions
smiling
mask
masking
rating
Lead sponsor: DeNova Research
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 808
Sex: ALL
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

1. Models who are males and females of ages 21-39.
2. Live and random raters who are males and females of ages 18-39.
3. Models and raters that understand the purpose and aspects of the study, freely sign the consent and complete the required visit.
4. Models and raters must all be able to understand English fluently.

Exclusion Criteria:

1. Model participants younger than 21 or older than 40 will not be included.
2. Live and random rater participants younger than 18 and older than 40 will not be included.
3. Models with unusual hair styles or colors
4. Facial piercing other than ears
5. Facial and/or neck scaring or tattooing
6. Models and raters that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required visit will also be excluded.

Brief summary: Evaluation on the effects of smiling on first impressions and attractiveness with and without wearing a facial surgical mask.


Eligibility criteria: Inclusion Criteria:

1. Models who are males and females of ages 21-39.
2. Live and random raters who are males and females of ages 18-39.
3. Models and raters that understand the purpose and aspects of the study, freely sign the consent and complete the required visit.
4. Models and raters must all be able to understand English fluently.

Exclusion Criteria:

1. Model participants younger than 21 or older than 40 will not be included.
2. Live and random rater participants younger than 18 and older than 40 will not be included.
3. Models with unusual hair styles or colors
4. Facial piercing other than ears
5. Facial and/or neck scaring or tattooing
6. Models and raters that do not understand the purpose and aspects of the study, do not sign the consent and do not complete the required visit will also be excluded.

Primary outcomes:
measure: To evaluate the effects of smiling on first impressions with and without wearing a mask
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: DeNova Research
state: Illinois
Study officials:
References:
Clinical trial NCT02590159: Clinical Study for the BONGO NASAL Expiratory Positive Airway Pressure (EPAP) Device in the Treatment of Obstructive Sleep Apnea (OSA)
Official title: Clinical Study for the BONGO NASAL EPAP Device in the Treatment of Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: InnoMed Healthscience Inc.
Sponsor class: INDUSTRY
Collaborators: name: RVW Clinical Consulting
First posted: 2015-10-28
Enrollment: 9
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single center clinical study for the BONGO NASAL EPAP device in the treatment of obstructive sleep apnea for the purpose of obtaining safety and efficacy data


Eligibility criteria: Inclusion Criteria:

* Capacity and willingness to sign informed consent
* ≥ 21 years of age
* Diagnosis of mild to moderate OSA (AHI ≥ 5 and AHI \< 30) within 12 months of the screening visit.
* Able to tolerate using the device during a day time trial/acclimation
* Are currently using CPAP or have been prescribed CPAP and are considered CPAP non-adherent (as per either their CPAP data card and/or verbal confirmation of a diagnosis and unwillingness to use CPAP)

Exclusion Criteria:

* Nasal deformities
* Severe nasal allergies
* Rhinitis or moderate nasal congestion, acute upper respiratory (including nasal, sinus or middle ear) inflammation or infection, or perforation of the ear drum
* Co-morbid sleep disorders
* Currently on a hypnotic for insomnia (who have had insomnia for more than a month and take a hypnotic on a daily basis and/or transient insomnia being treated)
* Uncontrolled or serious illness, including but not limited to: severe breathing disorders including hypercapnic respiratory failure, respiratory muscle weakness, bullous lung disease (as seen in some types of emphysema), bypassed upper airway, pneumothorax, pneumomediastinum, etc.; severe heart disease (including heart failure); or pathologically low blood pressure.
* Full Face Mask user
* Mouth breather
* Pregnant (Female subjects of child bearing age will be asked if they are and/or planning on becoming pregnant during the study; acceptable methods of birth control include birth control pills and barrier method)

Primary outcomes:
measure: Apnea Hypopnea Index
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Sleep Therapy and Research Center
state: Texas
Study officials:
affiliation: Sleep Therapy and Research Center
name: Nagwa Lamaie, MD
role: PRINCIPAL_INVESTIGATOR
References: