louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04171154: Effects of Micro-Interventions on Stress Reactivity
Official title: The Effects of Brief, Psychological Interventions (Micro-Interventions) on the Individual Stress Reactivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Psychological Stress
Physiological Stress
Lead sponsor: Philipps University Marburg
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study aims to investigate the effects of short, psychological interventions on bio-psychological stress responses after an acute stressor. The efficacy of two different approaches (expectation-bases vs. acceptance-based) will be compared to a control-group.


Eligibility criteria: Inclusion Criteria:

* fluent in German language

Exclusion Criteria:

* chronic disease
* mental disease
* the evening before the day of the experiment until end of the experiment (the next day):
* caffeine, alcohol, intensive physical exercise, chewing gum
* acute hay fever
* current intake of psychotropic medication
* current intake of orale contraceptives
* visual impairments
* heart conditions (self and close relatives)

Primary outcomes:
measure: Change in Subjective Stress Ratings
timeFrame: at baseline, before the intervention, after the intervention; during the stressor, after the stressor; in total 45 minutes
measure: Change in Cortisol Levels
timeFrame: at baseline (min. -37), after the intervention (min. -19), after the stressor (min. 0), recovery 1 (min. +15), recovery 2 (min. +30); in total 67 minutes
measure: Changes in Heart-Rate-Variability (HRV)
timeFrame: during baseline (duration 10 minutes), during the stressor (duration 20 minutes), during recovery (duration 10 minutes); in total 40 minutes
measure: Changes in Affect
timeFrame: at baseline, after the stressor; in total 45 minutes
Secondary outcomes:
measure: Self-Efficacy
timeFrame: at baseline, after the recovery-phase; in total 55 minutes
measure: Positivity
timeFrame: at baseline, after the recovery-phase; in total 55 minutes
Other outcomes:
Locations:
city: Marburg
country: Germany
facility: Philipps University Marburg Medical Center
Study officials:
affiliation: Philipps University Marburg
name: Frank Euteneuer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00906854: Urinary Incontinence and Practice of Physical Exercises
Official title: Urinary Incontinence and Practice of Physical Exercises Among Nulliparous and Nulligest Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Urinary Incontinence
Keywords: urinary incontinence
physical exercise
Lead sponsor: Universidade de Franca
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 108
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 108 women, nulliparous and nulligest, average age 23.9 years old (from 18 to 30 years old) who exercise regularly. They were divided into 3 groups according to the regular practice of exercise forms, they are (G1) weight training, (G2) aerobic exercises, included jump, step and dancing classes, and (G3) swimming. All participants were questioned about the perception of leakage of urine during the practice of exercises.

Brief summary: Introduction: Urinary incontinence is often seen as a problem that affects multipara and old-aged women, however, there is evidence that during high impact physical activity, mainly, or those ones which promote a sudden increase of intra-abdominal pressure, this symptom is common, even among young women, physically active, and without known risk factors.

Objective: Evaluate the prevalence of urinary incontinence in nulliparous and nulligest women who regularly practice physical activities.

Method: 108 women, nulliparous and nulligest, average age 23.9 years old (from 18 to 30 years old) who exercise regularly. They were divided into 3 groups according to the regular practice of exercise forms, they are (G1) weight training, (G2) aerobic exercises, included jump, step and dancing classes, and (G3) swimming (crawl mode). All participants were questioned about the perception of leakage of urine during the practice of exercises. The established exclusion criterion included: surgeries of urinary tract, urinary infections, gestations, child-birth, advanced aged, obesity, sedentariness and practice of only one form of physical activity.

Detailed description: The assessment was carried out in academies of the city of Franca. All participants were questioned about the perception of loss of urine during the practice of exercises.

Eligibility criteria: Inclusion Criteria:

* practice of exercises

Exclusion Criteria:

* surgeries of urinary tract
* urinary infections
* gestations
* child-birth
* advanced aged
* obesity
* sedentary and practice of only one form of physical activity

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Universidade de Franca
name: Lislei Patrizzi
role: STUDY_DIRECTOR
References:
Clinical trial NCT01411254: Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema (TSUBASA)
Official title: A Randomized, Multicenter, Sham Controlled, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetic Macular Edema
Keywords: DME
Lead sponsor: Santen Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2011-08-08
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* Provided signed, written informed consent
* 20 years of age or older with diabetic macular edema

Exclusion Criteria:

* Active proliferative diabetic retinopathies (PDR) in the study eye
* Uncontrolled diabetes mellitus and hypertension
* Known steroid-responder

Primary outcomes:
measure: Best Corrected Visual Acuity(BCVA)
Secondary outcomes:
measure: retinal thickness
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Santen study sites
Study officials:
References:
Clinical trial NCT04788654: Multimodal Analgesia for Cholecystectomy
Official title: The Comparison of Multimodal Analgesic Protocols for Laparoscopic Cholecystectomy: Pharmacologic Interventions and Combination of Pharmacologic and Operative Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Laparoscopic Cholecystectomy
Keywords: postoperative pain
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: It is important to decrease the postoperative pain in patients undergoing laparoscopic cholecystectomy. We will compare the pharmacologic analgesia with the parmacologic and surgical analgesia in patients undergoing laparoscopic cholecystectomy.


Eligibility criteria: Inclusion Criteria:

* Patients aged 19 years old or older, with American Society of Anesthesiologists Physical Status 1-3, and scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria:

1. Recent gastric ulcer disease
2. Hepatic or renal insufficiency
3. Opioid dependency
4. Coagulopathy
5. Pre-existing neurologic or anatomic deficits in the lower extremities
6. Severe psychiatric illness
7. pregnancy

Primary outcomes:
measure: Area under curve of postoperative pain for 24 hour
timeFrame: At postoperative 24 hour
Secondary outcomes:
measure: Postoperative pain score,
timeFrame: At postoperative 0, 2, 6, and 24 hour
measure: Analgesic requirements,
timeFrame: At postoperative 24 hour
measure: Sleep quality
timeFrame: At postoperative 24 hour
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Do-Hyeong Kim
Study officials:
References:
Clinical trial NCT02782754: Chemotherapy Plus Reduced Radiotherapy in Intracranial Germinoma
Official title: Treatment of Intracranial Germinoma With Chemotherapy Prior to Reduced Dose and Volume of Radiotherapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Intracranial Germinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-05-25
Enrollment: 40
Sex: ALL
Minimum age (years): 3
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the outcome of intracranial germinoma treated with chemotherapy plus reduced radiotherapy.

Detailed description: Treatment outcome of intracranial germinoma is excellent with radiotherapy/chemotherapy. However, late sequelae are unavoidable especially with craniospinal irradiation, and various efforts have been done to reduce the dose and extent of radiotherapy. In this study, chemotherapy and further reduced dose of radiotherapy will be used to minimize the late sequelae in the patients with intracranial germinoma.

Eligibility criteria: Inclusion Criteria:

* Patients with pathologically proven intracranial germinoma

Exclusion Criteria:

* Elevated serum/cerebrospinal fluid alpha-feto protein
* Patients with organ dysfunction as follows (creatinine elevation, ejection fraction, liver function test \> CTCAE grade 2)

Primary outcomes:
measure: Rate of late sequelae
timeFrame: Up to 5 years
Secondary outcomes:
measure: Rate of event free survival
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
References:
citation: Lee JW, Lim DH, Sung KW, Cho HW, Ju HY, Yoo KH, Koo HH, Kim JH, Suh YL, Shin HJ. Induction Chemotherapy Reduces Radiation Therapy Dose and Volume in the Treatment of Intracranial Germinoma: Results of the SMC-G13 Trial. Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):649-656. doi: 10.1016/j.ijrobp.2020.05.051. Epub 2020 Jun 2.
Clinical trial NCT05027854: Brain Network Mechanisms Causally Underlying Human Decisions Revealed by Brain Stimulation and Functional MRI
Official title: Brain Network Mechanisms Causally Underlying Human Decisions Revealed by Brain Stimulation and Functional MRI
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Behavior and Behavior Mechanisms
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2021-08-30
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: We will examine how stimulation of specific brain areas with transcranial magnetic stimulation (TMS) or transcranial electric stimulation (tES) changes specific aspects of behavior and brain activity, in order to test hypotheses about brain behavior relationships (basic research).


Eligibility criteria: Inclusion Criteria:

* between 18 and 80 years of age (whereby for most studies the majority of recruited participants will be between 18 and 40 years of age)
* right-handedness and/or one specific gender (male or female) can be inclusion criteria to reduce variation in the data.

Exclusion Criteria:

* inability to understand the instructions and insufficient knowledge of the project language
* Internal electronic and/or metallic objects in the head, neck, or shoulders (e.g. artificial cochleae, deep brain stimulators, medical pumps, shrapnel, metallic splinters due to accidents during metal welding)
* One or more epileptic fits in the participant or a first-degree relative
* Vascular, traumatic, tumoral, infectious, or metabolic brain damage
* Use of medication that significantly alters cortical excitability
* Acute sleep deprivation or withdrawal from alcohol
* pregnancy
* to reduce bias, students of psychology or economics can be excluded if there is a possibility that they are familiar with the relevant paradigm.

Primary outcomes:
measure: Speed of Behaviour
timeFrame: 0-60 minutes after stimulation
measure: Accuracy of Behaviour
timeFrame: 0-60 minutes after stimulation
measure: Cognitive Function driving Behaviour
timeFrame: 0-60 minutes after stimulation
measure: Brain activity
timeFrame: 0-60 minutes after stimulation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Zurich
name: Christian Ruff, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06882954: The Management of Asymptomatic Carotid Stenosis
Official title: The Management of Asymptomatic Carotid Stenosis: Monocentric Experience
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Carotid Artery Diseases
Carotid Stenosis
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 500
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: All the patients with significant internal carotid artery stenosis referred to the Unit of Vascular Surgery of Fondazione Policlinico Gemelli IRCCS Rome for carotid artery endoarterectomy and stenting

Brief summary: Carotid stenosis are asymptomatic if no hemispheric or retinal symptoms have appeared in the 6 months preceding the discovery of the stenosis. Asymptomatic carotid stenosis (ACS) accounts for about ¾ of all carotid lesions. The goal of treating carotid stenosis is to prevent a stroke. While carotid surgery is recommended in the elderly patients in cases of symptomatic carotid stenosis, that of ACS in patients over 75 years old, even when tight, remains subject to many controversies. Indeed, the debate, concerning the benefit to be expected from a surgical procedure or a possible angioplasty procedure, is not yet closed. The aim of our study, through a retrospective evaluation of the results of all consecutive carotid endarterectomy (CEA) and stenting in the participating center.


Eligibility criteria: Inclusion Criteria:

* Asymptomatic carotid stenosis
* Patient with degree of carotid stenosis greater than 80% measured by the maximum systolic velocity at the site of the stenosis which must have been greater than 250 cm/s
* Ultrasound characteristics of a possibly unstable plaque

Exclusion Criteria:

* Symptomatic carotid artery stenosis

Primary outcomes:
measure: Stroke rate
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References:
Clinical trial NCT02169154: A Safety Study to Investigate the Skin Irritancy Potential of Diclofenac-Menthol Gel
Official title: A Cumulative Skin Irritation Study Investigating the Skin Irritancy Potential of MFC51123 Diclofenac-Menthol Gel
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2014-06-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This research study is being conducted to investigate the skin irritancy potential of a new medication which contains two active ingredients (diclofenac and menthol) together in a gel formulation and is being developed to treat mild to moderate pain and inflammation, such as acute sport injuries, sprains and strains.

Detailed description: Approximately 36 healthy subject volunteers will be exposed to seven test products (study treatment gel and six control products) simultaneously for 21 consecutive days. The seven test products will be applied using a 7-channel patch assembly that will be affixed to the infrascapular areas of the back of each subject for approximately 24 hours daily.

The subject will return to the clinic to undergo a skin irritation assessment at approximately 24 hours after the time the patch assembly was initially affixed.

During the visits, doctors or trained staff members will examine the signs of irritation (if any) of the skin where the test products are applied. The skin irritation assessment will primarily characterize the test products individually in terms of symptomatology using a 7-point categorical scale ranging from 1 (glazing and/or wrinkling) to 7 (erosion and/or vesiculation).

Eligibility criteria: Inclusion Criteria:

* Male/female volunteer ≥18 years
* No systemic/dermatologic disorder

Exclusion Criteria:

* Visible skin disease at the site of application that might interfere with skin assessments
* Allergy or hypersensitivity to NSAIDs or menthol or any of the excipients in the test product
* History of physical or psychiatric illness, or medical disorder
* Recent history of alcohol or drug abuse
* Pregnant or lactating females

Primary outcomes:
measure: Treatment mean cumulative irritation score
timeFrame: Day 21
measure: Adverse event assessment
timeFrame: 21 days + 5 days follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Paramus
country: United States
facility: TKL Research Inc
state: New Jersey
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02517554: A Study Of TeleGenetics Versus Usual Care To Increase Access To Cancer Genetic Services
Official title: A Randomized Study Of TeleGenetics Versus Usual Care To Increase Access To Cancer Genetic Services
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Ovarian Cancer
Colorectal Cancer
Keywords: meet National Comprehensive Cancer Network® criteria for cancer genetic testing for breast, ovarian and colorectal cancers
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-08-07
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Candidate for genetic testing for BRCA or colon cancer related genes

Brief summary: The goal of this research is to evaluate the relative advantage of remote counseling over usual care in community health practices without access to genetic services. We will evaluate ability of remote telemedicine, referred to going forward as TeleGenetic services (phone or videoconferencing), to increase uptake of genetic testing and identification of genetic carriers compared to usual care. Secondly, we will evaluate the advantages of videoconferencing over telephone for delivery of remote genetic services and the short-term and longitudinal outcomes of TeleGenetic services in socio-demographically diverse patients in community practices.


Eligibility criteria: Inclusion Criteria:

1. Eligible participants will include adult men and women (aged 18 and older) who can understand and communicate in English
2. meet National Comprehensive Cancer Network® criteria for cancer genetic testing for breast, ovarian or colorectal cancers
3. have insurance coverage for genetic testing.

Exclusion Criteria:

1. Under 18 years old - professional guidelines do not recommend genetic testing for cancer risk in minors.
2. Does not speak English.
3. Does not have insurance.

Primary outcomes:
measure: Completion of Surveys
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Elkton
country: United States
facility: Union Hospital
state: Maryland
city: Cape May Court House
country: United States
facility: Cape Regional Medical Center
state: New Jersey
city: Sewell
country: United States
facility: Kennedy Health
state: New Jersey
city: Somers Point
country: United States
facility: Shore Cancer Center
state: New Jersey
city: Gettysburg
country: United States
facility: Gettysburg Cancer Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Drexel Cancer Care at Hahnemann
state: Pennsylvania
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Angela Bradbury, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02170454: Effect of Pharyngeal Inhibition by rTMS on Swallowing Function
Official title: Effect of Pharyngeal Cortical Area Inhibition Induced by rTMS on Swallowing Function in Healthy Subject: Video Fluoroscopic Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oropharyngeal Dysphagia
Keywords: neuromodulation
swallowing
magnetic stimulation
healthy subjects
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2014-06-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to test the hypothesis that rTMS on the dominant swallowing hemisphere is able to modify swallowing coordination.

Detailed description: The aim of the study is to demonstrate that rTMS (on the dominant hemisphere, on the nondominant hemisphere and placebo rTMS) are able to modify swallowing coordination on healthy subjects. Swallowing function will be studied before and after rTMS with videomanometry.

Eligibility criteria: Inclusion Criteria:

* 18-50 years old
* healthy subjects

Exclusion Criteria:

* epilepsia
* brain injury
* stroke
* pregnancy

Primary outcomes:
measure: pharyngeal pressure
timeFrame: Day 1
Secondary outcomes:
measure: swallowing time
timeFrame: Day 1
Other outcomes:
Locations:
city: Rouen
country: France
facility: VERIN
Study officials:
affiliation: Rouen University
name: Eric VERIN, MDPhD
role: PRINCIPAL_INVESTIGATOR
References: