louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04078256: The Importance of Exercise to Prevent Injuries in Athletes
Official title: EFFECTIVENESS OF A PROPRIOCEPTIVE EXERCISE PROGRAM IN THE PREVENTION OF INJURIES IN RECREATIONAL RUNNERS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Injury;Sports
Keywords: proprioception
running
prevention
injuries
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Introduction: running is one of the most accessible and practiced sports in the world since the 21st century. Unfortunately, the incidence of injuries in the population that practices it is high regardless of experience, although the risk of injury increases in amateur runners. One of the main keys to reduce the incidence of running related injuries may be to improve the ability to reduce the load or impact. For this, there are different strategies such as a gradual increase in the load to run, and exercise within which is muscle strengthening and balance training or proprioception.

Objective: to verify the effectiveness of a program of proprioceptive exercises based on the static and dynamic balance for the reduction of lower limb injuries in amateur runners during the competition season.

Detailed description: Methodology: 66 amateur runners, after simple size calculation, will be randomized into two groups. Experimental group will carry out the proprioceptive exercise program during 8 weeks at the begining of the season and control group will continue with their usual training routine. The main variable running related injury will be collected weekly during the follow-up.

Results: When all the data needed for the study has been collected, researchers gathers results and exports them for statistical interpretation.

Eligibility criteria: Inclusion Criteria:

* Weekly training of at least 15 kilometers.
* At least practice running 6 months for 1-3 times a week.

Exclusion Criteria:

* To have some type of lower limb or lower back injury at present or in the last 6 months.
* Having undergone surgery for any back or lower limb injury.
* Pregnant.
* Neural dysfunction / disability.

Primary outcomes:
measure: Knee Joint Position Sense (JPS)
timeFrame: Change from Baseline Joint Position Sense Pressure at 8 weeks
Secondary outcomes:
measure: The Y Balance Test (YBT)
timeFrame: Change from Baseline dynamic balance at 8 weeks
measure: The countermovement jump (CMJ)
timeFrame: Change from Baseline jump height at 8 weeks
Other outcomes:
Locations:
city: Alcala de Henares
country: Spain
facility: Grupo Fisioterapia y Dolor
state: Madrid
Study officials:
affiliation: Alcala University
name: Tomas Gallego-Izquierdo, Dr.
role: STUDY_CHAIR
References:
Clinical trial NCT04325256: Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor
Official title: Accuracy of Different Scoring Systems for Predicting Successful Induction of Labor: a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Induction of Labor Affected Fetus / Newborn
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-03-27
Enrollment: 400
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: pregnant women who will attend the labor unit for induction

Brief summary: Induction of labour (IOL) nowadays is a common procedure in obstetric practice. Presently, IOL is done for 20% of pregnancies for various maternal and fetal indications and nearly 20% of labour inductions end up in caesarean deliveries. The success of IOL mainly depends upon "favourability" of the cervix which is usually assessed by manual examination and Scored as Bishop Score. However, this method is limited by subjectivity and reproducibility and though done in all the patients prior to IOL, several studies have demonstrated poor correlation between Bishop Score and outcome of IOL


Eligibility criteria: Inclusion Criteria:

1. Singleton pregnancy.
2. Pregnant ≥ 37 weeks gestation.
3. Fetus with longitudinal lie and vertex presentation.
4. Intact membranes.
5. No vaginal bleeding.

Exclusion Criteria:

1. Patients with previous cesarean delivery.
2. Previous uterine surgery.
3. Antepartum hemorrhage.
4. Cephalopelvic disproportion.
5. Category II or III non-stress test.
6. Malpresentation.
7. Intrauterine fetal death.
8. Fetal growth restriction.
9. Fetuses with major congenital malformations

Primary outcomes:
measure: The rate of successful induction of labor
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Ahmed Abbas
state: Cairo
Study officials:
References:
Clinical trial NCT00591656: Systemic Consolidation Therapy After Primary Chemoradiation Therapy for Locally Advanced Cervical Cancer
Official title: A Phase II Study of Systemic Consolidation Therapy With Paclitaxel Plus Carboplatin Following Primary Chemoradiation for Locally Advanced Cervical Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cervical Cancer
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2008-01-11
Enrollment: 69
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Care clinic

Brief summary: The purpose of this study is to determine the therapeutic efficacy and complications of systemic consolidation therapy with paclitaxel plus carboplatin following primary chemoradiation for locally advanced cervical cancer.

Detailed description: Systemic consolidation therapy with paclitaxel plus carboplatin (3 cycles per 3 weeks) following primary chemoradiation (3 cycles per 3 weeks) for locally advanced cervical cancer will elevate the therapeutic efficacy by removing the microscopic metastatic lesions which could not be identified by naked eye and diagnostic imaging tests.

Eligibility criteria: Inclusion Criteria:

* patients who underwent three cycles of concurrent chemoradiation therapy with paclitaxel and carboplatin for non-small cell type cervical cancer stage IB2, bulky size (\>4cm) IIA,IIB-IVA
* above 20 years
* GOG performance status 0-2
* Informed consent
* Platelet\>100K, Hb\> 10.0 g/dl, ANC\>1500/mm3, Cr \<1.25\*upper normal limit, bilirubin\<1.5mg/dl, AST \& ALT\<\*3 upper normal limit
* Expected life \> 6 months

Exclusion Criteria:

* Peripheral neurotoxicity \> NCI CTCAE grade 2
* Sever infection
* Previous history with chemotherapy or radiation therapy
* Pleural effusion, pericardial effusion, and ascites which could cause dyspnea \> NCI grade 2
* Paraaortic lymph node metastasis
* Allergy with platinum
* Previous history of atrial or ventricular arrhythmia or congestive heart failure
* Uncontrolled infection, diabetes mellitus, hypertension, ischemic heart disease, myocardiac infarct within 6 months
* Severe disease such as acute or chronic renal failure and acute cerebral infarct, cerebral hemorrhage, recurrent hepatitis, liver cirrhosis, unknown fever above 39 degrees centigrade

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jae Weon Kim, Professor
role: STUDY_DIRECTOR
affiliation: Seoul National University Hospital
name: Seung Su Han, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01063556: Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
Official title: Pharmacokinetics Study of Donepezil HCl in Subjects Receiving Haemodialysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: End-Stage Renal Disease
Keywords: end-stage renal disease hemodialysis donepezil hydrochloride pharmacokinetics Cross-Over Study
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2010-02-05
Enrollment: 6
Sex: ALL
Minimum age (years): 20
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the pharmacokinetics of donepezil HCl 3 mg in subjects with end-state renal disease who were receiving haemodialysis.

Detailed description: This is a randomised, single-center, open-label, single-dose, two-period crossover pharmacokinetics study of donepezil HCl tablets 3 mg in subjects receiving haemodialysis. Subjects will be or will not be receiving haemodialysis. After intervals of over 15 days, the subjects will be receiving the other treatment.

Eligibility criteria: Inclusion criteria:

Subjects with end-stage renal disease who were receiving haemodialysis. Subject who are able and willing to give written informed consent.

Exclusion criteria:

Subjects with known hypersensitivity to drugs or foods. Subjects with a corrected QT interval greater than 450 msec at Screening period.

Primary outcomes:
measure: Pharmacokinetics parameter: maximum drug concentration in plasma
timeFrame: 0-48 hours
measure: Pharmacokinetics parameter: maximum drug concentration time in plasma
timeFrame: 0-48 hours
measure: Pharmacokinetics parameter: area under the plasma concentration time curve from Time 0 to 48.
timeFrame: 0-48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Moriya
country: Japan
state: Ibaraki
Study officials:
affiliation: Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
name: Hirotake Ishigami
role: STUDY_DIRECTOR
References:
Clinical trial NCT01180556: Effect of Probiotics in Childhood Abdominal Pain
Official title: The Effect of Probiotics in Childhood Abdominal Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Keywords: childhood
abdominal pain
probiotics
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2010-08-12
Enrollment: 101
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effect of probiotics in childhood recurrent abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4 weeks with a follow up phase of additional 4 weeks.

Detailed description: Prospective randomized double-blind placebo-controlled trial.

Eligibility criteria: Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* Any chronic or organic illness

Primary outcomes:
measure: Frequency and intensity of abdominal pain
timeFrame: Eight weeks
Secondary outcomes:
measure: School absenteeism
timeFrame: Eight weeks
measure: Other gastrointestinal symptoms
timeFrame: Eight weeks
measure: Adverse effects related to treatment
timeFrame: Eight weeks
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
Study officials:
affiliation: Soroka University Medical Center
name: Zvi Weizman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Weizman Z, Abu-Abed J, Binsztok M. Lactobacillus reuteri DSM 17938 for the Management of Functional Abdominal Pain in Childhood: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr. 2016 Jul;174:160-164.e1. doi: 10.1016/j.jpeds.2016.04.003. Epub 2016 May 4.
Clinical trial NCT04963556: Effects of Red Bull® on the Effects of Training and Haemodynamic Parameters
Official title: Effects of Red Bull® on the Effects of Moderate Endurance Training Measured by Haemodynamic Parameters
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Effects of; Food, Allergic
Lead sponsor: University of Basel
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Background:

The consumption of Energy Drinks (EDs) can acutely lead to negative side effects, such as raised blood pressure and impaired endothelial function. Nevertheless, they are sold worldwide and are often consumed before physical activity (PA). In contrast to the blood pressure elevating effect of EDs, PA leads to a reduction of blood pressure. The effect of ED consumption on blood pressure response during and after endurance training is currently unresolved.

Methods:

A total of 23 participants (eleven men, twelve women) were evaluated in the intervention study with a blinded Cross-Over Design. They consumed on two different days either 355 ml Red Bull (RB) or 355 ml Placebo (Pla) in randomised order. The peripheral (PBP) and central blood pressure (CBP) were measured before, during and after a 30-minute aerobic endurance training, by the Schiller BR-102 plus PWA device.

Detailed description: Background:

The consumption of Energy Drinks (EDs) can acutely lead to negative side effects, such as raised blood pressure and impaired endothelial function. Nevertheless, they are sold worldwide and are often consumed before physical activity (PA). In contrast to the blood pressure elevating effect of EDs, PA leads to a reduction of blood pressure. The effect of ED consumption on blood pressure response during and after endurance training is currently unresolved.

Methods:

A total of 23 participants (eleven men, twelve women) were evaluated in the intervention study with a blinded Cross-Over Design. They consumed on two different days either 355 ml Red Bull (RB) or 355 ml Placebo (Pla) in randomised order. The peripheral (PBP) and central blood pressure (CBP) were measured before, during and after a 30-minute aerobic endurance training, by the Schiller BR-102 plus PWA device.

Eligibility criteria: Inclusion Criteria:

* No known cardiovascular diseases such as arterial hypertension and diabetes mellitus.
* No ophthalmological diseases such as glaucoma or macular degeneration.
* No regular medication
* No vasodilator abuse for 24 h before the respective intervention (e.g. smoking, use of stimulants, β-blockers).
* No pregnancy (anamnestic)

Primary outcomes:
measure: Effect on blood pressure
timeFrame: 24 hours
Secondary outcomes:
measure: Pulse wave velocity
timeFrame: 24 hours
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University of Basel
Study officials:
affiliation: University of Basel
name: Arno Schmidt-Trucksäss, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06052709: Investigation of Occupational Balance in Individuals With and Without Bruxism
Official title: Investigation of Occupational Balance in Individuals With and Without Bruxism
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bruxism
Occupational Problems
Keywords: Bruxism
Occupational Balance
Stress
Lead sponsor: Tokat Gaziosmanpasa University
Sponsor class: OTHER
First posted: 2023-09-25
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Considering that occupational balance and bruxism are negatively affected by stress, this study aims to determine whether there is a difference in terms of occupational balance between individuals with and without bruxism.

Detailed description: Occupation refers to daily life activities and task groups that are named, organized, given value and meaning by individuals and a culture. Occupation is everything people do to keep themselves busy, including taking care of themselves, enjoying life, and contributing to the social and economic fabric of their communities.

Bruxism is a parafunctional habit among temporomandibular disorders that occurs as a result of clenching and grinding teeth and overloading the stomatognathic structures. At the same time, bruxism is the chewing movement of the mandible, characterized by involuntary, rhythmic and non-functional teeth clenching and grinding, usually seen during sleep, and manifested by severe head and neck pain, limitation in jaw movements, pain and spasm in the chewing muscles. Although its etiology cannot be fully explained, it is thought that factors such as stress, occlusal disorders, allergies and sleep quality may be the source.

The deterioration or decrease in occupational balance may also be associated with people's quality of life. Occupational imbalance is reported to affect both physical and psychological state, creating significant stress on the body and mind, causing mental health problems and burnout.

Considering that occupational balance and bruxism are negatively affected by stress, this study aims to determine whether there is a difference in terms of occupational balance between individuals with and without bruxism.

Eligibility criteria: Inclusion Criteria:

* To be volunteer

Exclusion Criteria:

* Psychological disorders,
* Neurological disorders,
* Orthopedic disorders,
* Cognitive impairment.

Primary outcomes:
measure: Fonseca Anamnestic Index
timeFrame: up to 3 months
measure: Occupational Balance Questionnaire
timeFrame: up to 3 months
measure: Perceived Stress Scale
timeFrame: up to 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tokat
country: Turkey
facility: Tokat Gaziosmanpasa University
Study officials:
References:
Clinical trial NCT04899609: The Effects of Anger and Joy Expressions on Approach and Avoidance Behaviors in Healthy Volunteers
Official title: Behavioral Adaptation to Negative and Positive Social Signals in Healthy Volunteers
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Major Depressive Episode
Keywords: Emotion
Motivation
Decision making
Goal-director behavior
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2021-05-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy volunteers

Brief summary: Social interactions are part of our daily lives. Communicating with others is a recurring choice which is based on emotional cues, such as facial expression. Our action must be adapted to the emotional state of our interlocutor, otherwise the investigators will have poor quality interactions An emotional stimulus would cause a conditioned response (innate reaction). Thus, the presence of an angry person would automatically trigger flight behavior. More recently, however, it has been envisioned that this same avoidance behavior could be the result of a goal-directed behvior. In this case, the avoidance behavior would be the result of an evaluation of the consequences of the selected action. These goal-directed behaviors are guided by a mental representation of consequences The project aims to study behavioral choices (approach and avoidance) in response to negative and positive social cues (anger and joy) in 40 healthy volunteers using a computerized neuropsychological task, and to determine wheter these choices are the result of goal-directed behavior.

The study also aims to assess the modulation of behavioral adaptation by the level of impulsivity, lonilness, empathy, and by the capcity to understand others' intenstions.


Eligibility criteria: Inclusion criteria:

* Being between 18 and 65 years old
* Absence of psychiatric pathology over the entire life
* Being able to understand the nature, purpose and methodology of the study

Exclusion criteria:

* Mental retardation or sever medical co-morbidity
* Sensory or cognitive disability
* Pregnant or breastfeeding woman
* Protection by law (guardianship or curatorship)
* Deprivation of liberty (by judicial or administrative decision)
* Exclusion period in relation to another protocol
* Inability to understand, speak and write French

Primary outcomes:
measure: Percentage of approach and avoidance behavior in response to positive (joy) and negative (anger) social signals
timeFrame: 1 day
Secondary outcomes:
measure: Response time
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: University hospital
Study officials:
affiliation: University Hospital, Montpellier
name: Emilie Olie, MD PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05943509: Hearing Program in Primary Care
Official title: Feasibility of a Hearing Program in Primary Care for Underserved Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Deafness
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: During a primary care visit, investigators will screen and identify participants with hearing loss and then randomize to a) counseling on accessible assistive listening devices or b) referral to traditional audiology care pathway alone.


Eligibility criteria: Inclusion Criteria:

* speaks English or Spanish;
* capacity to consent to research

Exclusion Criteria:

• has or uses hearing aids or cochlear implants

Primary outcomes:
measure: Number of Potential Participants Approached
timeFrame: Up to Month 3
measure: Number of Potential Participants Screened
timeFrame: Up to Month 3
measure: Percentage of Screened Participants with Hearing Loss
timeFrame: Up to Month 3
Secondary outcomes:
measure: Percentage of Intervention Arm Participants who Complete Counseling Session
timeFrame: Up to Month 3
measure: Percentage of Participants who Respond to Outreach to Confirm Recommendations within 72 Hours
timeFrame: Up to Month 3
measure: Percentage of Participants who Respond to 3-Month Follow-Up
timeFrame: Month 3
Other outcomes:
Locations:
city: New York
country: United States
facility: NYC H+H/Bellevue
state: New York
Study officials:
affiliation: NYU Langone Health
name: David Friedmann
role: PRINCIPAL_INVESTIGATOR
References: