louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01524328: Complementary and Alternative Medicine in Patients With Inflammatory Bowel Disease. A Cross Sectional Study in Norway.
Official title: Complementary and Alternative Medicine in Patients With Inflammatory Bowel Disease. A Cross Sectional Study in Norway.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Diseases
Keywords: Complementary and alternative medicine
HRQoL, Inflammatory bowel disease
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2012-02-01
Enrollment: 460
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with (\>18 years) a verified diagnosis of Crohn's disease or ulcerative colitis attending an outpatient clinic in a Norwegian hospital.

Brief summary: The purpose of this study is to investigate the proportion of use of complementary and alternative medicine (CAM) in patients with inflammatory bowel disease (IBD). In addition, the reason for, and satisfaction with use of CAM.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years and with verified diagnosis of Crohn's disease or ulcerative colitis attending an outpatient clinic in a Norwegian hospital.

Exclusion Criteria:

* Patients \<18 years.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo university hospital
Study officials:
affiliation: Oslo University Hospital
name: Bjorn Moum, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00476528: Early Rehabilitation of Patients With Posttraumatic Amnesia
Official title: Early Rehabilitation of Patients With Posttraumatic Amnesia. A Clinical Controlled Investigation of the Effect of a Nursing Programme in Patients With Traumatic Brain Injury in the Acute Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Amnesia
Keywords: Posttraumatic amnesia
Early intervention
A systematic nursing programme in the ICU
Early identification of patients with posttraumatic amnesia
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2007-05-22
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to investigate if a systematic intervention with early identifying of patients with posttraumatic amnesia using a reality orientation therapy can reduce the period with posttraumatic amnesia in order to get a better outcome for patients with traumatic brain injury

Detailed description: 1. A systematic review with the latest investigation and treatment of patients with posttraumatic amnesia
2. Investigate the effect of a systematic nursing programme on the length of posttraumatic amnesia
3. Investigate the effect of a systematic nursing programme after 12 month
4. Describe perspectives for the future within the early rehabilitation of patients with posttraumatic amnesia

Eligibility criteria: Inclusion Criteria:

* Patients should be able to speak and understand danish
* Patients with traumatic brain injury
* A verified brain injury at the CT scanning

Exclusion Criteria:

* Patients with medical illness
* Patients with other neurological illness
* Patients with neuroinfections meningitic, encephalitic
* Patients who does not understand and speaks danish

Primary outcomes:
measure: Duration of posttraumatic amnesia Results of score with RLAS, GOAT, GOSE and LOS
timeFrame: 12month
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: University Hospital
state: Region Midtjylland
Study officials:
affiliation: Department of Neurosurgery NK
name: Jens Christian Soerensen
role: STUDY_DIRECTOR
References:
Clinical trial NCT05893628: Effect of Pectoralis Minor on Endurance
Official title: Effect of Pectoralis Minor Length on Scapular Endurance and Core Endurance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pectoralis Minor Length
Keywords: pectoralis minor length
scapular muscle endurance
core muscle endurance
dominant arm
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 93
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy adult women

Brief summary: The aim of this study evaluate the effects of dominant and non-dominant pectoralis minor (PM) length on scapular and core muscle endurance in the absence of scapular dyskinesia.


Eligibility criteria: Inclusion Criteria:

* volunteered to participate in the study
* and did not have scapular dyskinesia according to the evaluations made

Exclusion Criteria:

* did not want to participate in the study
* and those with previous neurological or orthopedic upper extremity disorders,
* pain problems in any part of their body,
* previous abdominal surgery,
* and had communication problems

Primary outcomes:
measure: Pectoralis Minor Length and Index
timeFrame: 10 minutes
measure: Scapular Dyskinesia
timeFrame: 15 minutes
measure: Scapular Muscle Endurance
timeFrame: 10 minutes
measure: Core Muscle Endurance
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
References:
Clinical trial NCT05065528: Mag Con: Efficacy of Oral Mag. in Acute Concussion in Adolescents
Official title: A Randomized Trial Evaluating the Efficacy of Oral Magnesium in Symptomatic Reduction of Acute Concussion in Adolescents
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Concussion, Mild
Traumatic Brain Injury, Mild
Lead sponsor: Spectrum Health - Lakeland
Sponsor class: OTHER
First posted: 2021-10-04
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized trial will compare the clinical efficacy of adding oral magnesium oxide to acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury using the Post-Concussion Symptom Severity Score Index.

Detailed description: This randomized trial will compare the clinical efficacy of oral magnesium oxide, acetaminophen and ondansetron, to that of PO acetaminophen and ondansetron in the treatment of adolescents presenting within 48 hours of a mild traumatic brain injury. Our primary endpoint will be to evaluate if magnesium has an impact on patient's Post-Concussion Symptom Severity Score Index. This will be evaluated both at the initial presentation in-person and then at 24, 48, and 72 hours via phone

Eligibility criteria: Inclusion Criteria:

* age 12 to 18 years;
* presenting chief complaint of headache, head injury, or concussion within the first 48 hours of injury;
* GCS \> 13 on arrival

Exclusion Criteria:

* age \< 12 years or \> 18 years;
* inability to provide informed consent;
* vomiting \> 2 episodes following injury;
* physical or mental disability hindering adequate response to assessment of symptoms;
* hemodynamic instability/medical condition requiring further acute life-saving medical intervention;
* known brain mass, intracranial hemorrhage, skull fracture;
* known contraindications/allergy to magnesium, ondansetron, or acetaminophen
* pregnant patients

Primary outcomes:
measure: Post-Concussion Symptom Severity Score
timeFrame: 48, 72 hours
Secondary outcomes:
measure: adverse effect related to medication administration
timeFrame: 48, 72 hours
measure: return to baseline
timeFrame: 48, 72 hours
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Spectrum Health Lakeland
state: Michigan
Study officials:
affiliation: Spectrum Health - Lakeland
name: Chris Trigger, DO
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00843128: The Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Multiple Sclerosis Patients
Official title: Phase II Study of the Effectiveness of Locomotor Therapy Using Robot-Driven Gait Orthosis System in Acute Stroke Patients: A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2009-02-13
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Objective: To evaluate the efficacy of robot-assisted gait training (RAGT) in MS patients with severe walking disabilities (Expanded Disability Status Scale \[EDSS\] 5.5-7) as compared to regular physiotherapy.

Methods: Prospective, randomized, controlled clinical trial comparing RAGT with conventional walking training (CWT) in a group of stable MS patients (n=40) during an outpatient rehabilitation program. Inclusion criteria are chronic or secondary progressive MS patients with EDSS between 5.5-7, stable treatment 3 months before study entry, without generalized diseases. All patients will sign an informed consent. Following randomization, 20 patients will be treated with RAGT, 12 sessions over three weeks. The control group will be treated by CWT, 12 sessions in three weeks. The primary outcome measures will be the Functional Ambulatory Capacity (FAC) scale and the 6-minutes walking distance. The secondary outcome measures will be the Time up \& Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS score, FIM score and RAND questioner for quality of life. All tests will be performed by an external blinded assessor at baseline, after three weeks, and at follow-up after 3 months and six months.

Importance: We anticipated that Robot-assisted gait training will be found as feasible and may be an effective therapeutic option in MS patients with severe walking disabilities.


Eligibility criteria: Inclusion Criteria:

1. chronic or secondary progressive MS patients with EDSS between 5.5-7,
2. stable treatment 3 months before study entry.

Exclusion Criteria:

1. Other generalized diseases.
2. Pregnancy.

Primary outcomes:
measure: Functional Ambulatory Capacity (FAC) scale and the 6-minutes walking distance
timeFrame: At baseline, after three weeks, and at follow-up after 3 months and six months.
Secondary outcomes:
measure: Time up & Go (TUG) test, 10 Meter Walking test, Berg balance test, EDSS score, FIM score and SF36 questioner for quality of life.
timeFrame: At baseline, after three weeks, and at follow-up after 3 months and six months.
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah University Hospital
Study officials:
affiliation: Hadassah Medical Organization
name: Zeev Meiner, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04635228: Biodesign® Otologic Repair Graft
Official title: Post-market Real-world Collection Data for the Biodesign® Otologic Repair Graft
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Tympanic Membrane Perforation
Eardrum Perforation
Keywords: tympanoplasty
myringoplasty
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2020-11-19
Enrollment: 151
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any eligible patient

Brief summary: The post-market follow-up clinical trial of the Cook® Biodesign® Otologic Repair Graft will follow patients up to 3 months post-implantation to determine the percent of patients with complete closure of the tympanic membrane.


Eligibility criteria: Inclusion Criteria:

* Patient requires tympanic membrane closure.

Exclusion Criteria:

* Life expectancy \< 12 months
* Known sensitivity to porcine material

Primary outcomes:
measure: Percent of closure
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals-Cleveland
state: Ohio
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
References:
Clinical trial NCT05629728: Tai Chi for Improving Functions of Frail Older Adults
Official title: Effect of Tai Chi on Physical and Cognitive Function Among Frail Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Frailty
Keywords: Tai Chi
frail
older adults
Lead sponsor: Chungnam National University
Sponsor class: OTHER
Collaborators: name: National Research Foundation of Korea
First posted: 2022-11-29
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: the frail older adults recruited from the community, randomly assigned to either the experimental group or the wait-list control group.
Primary purpose: PREVENTION

Brief summary: The goals of this study are to examine the physical function, cognitive function, and quality of life among frail elderly residing in the community

Detailed description: This randomized clinical trial recruited 100 frail older adults, assigned to either the Tai Chi group or the wait-list control group. Tai Chi intervention will be provided to the Tai Chi group for 12 weeks with 12-week follow-up and pretest and posttest measures will be conducted.

The primary outcome is the function variables (physical function of balance, flexibility, mobility; cognitive function of MOCA-K) The secondary outcome is quality of life measured by SF12.

Eligibility criteria: Inclusion Criteria:

* being frail (3 out of the following 5 criteria): feeling fatigued, difficulty climbing 10 stairs without help, difficulty walking 300m without help, more than 5 chronic illness, weight loss 5 % or more past 1-5 years
* living in the community
* able to participate in Tai Chi program twice a week

Exclusion Criteria:

* participated in any formal exercise program past 6 months
* not have transportation to come to the class

Primary outcomes:
measure: physical function - balance
timeFrame: changes from pretest to 12 week posttest scores
measure: physical function - flexibility
timeFrame: changes from pretest to 12 week posttest scores
measure: physical function - mobility
timeFrame: changes from pretest to 12 week posttest scores
measure: cognitive function
timeFrame: changes from pretest to 12 week posttest scores
Secondary outcomes:
measure: Short Form health survey 12 (SF12)
timeFrame: changes from pretest to 12 week posttest scores
Other outcomes:
Locations:
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University
Study officials:
affiliation: Chungnam National University
name: Rhayun Song, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06356428: Psychometric Properties and Cross-cultural Adaptation of the Turkish Version of Physcian Attitudes Toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R)
Official title: Psychometric Properties and Cross-cultural Adaptation of the Turkish Version of Physcian Attitudes Toward Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Physician's Role
Lead sponsor: Karamanoğlu Mehmetbey University
Sponsor class: OTHER
First posted: 2024-04-10
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population of the study is physicians. The sample was physicians who volunteered to participate in the study, to whom the study could be announced/notified, and who provided active service in patient diagnosis and treatment. In the literature, it is stated that the number of individuals to be included in the study in order to achieve meaningful and valid results in the scale development process is at least 5 times the number of items in the scale and ideally 10 times. In our study, the number of individuals to be included in the study to test the validity of the scale was planned to be at least 100 individuals (PACRR-R consists of 20 items). In order to examine the test-retest reliability of the scale, it was planned to reapply the scale to at least 25% of the individuals in the sample.

Brief summary: Research has reported that the reasons for low implementation of CR are multifactorial at the health system, physician and patient levels. It has also been found that patients are more likely to initiate CR if physicians strongly and positively promote the importance of CR participation. Unfortunately, there are insufficient and ineffective data on CR, referral to CR and both clinical and cost-effectiveness outcomes of CR in Turkey. In this context, it is important to examine more objectively from the perspective of physicians who play a key role in referring patients to CR. However, in our country, there is no relatively objective measurement tool to evaluate physicians' attitudes towards CR. Therefore, this study aims to adapt the original "Physician Attitudes towards Cardiac Rehabilitation and Referral Scale-Revised (PACRR-R)" into Turkish and to examine its psychometric properties.


Eligibility criteria: Inclusion Criteria:

* To be a physician,
* Providing active service in patient diagnosis and treatment

Exclusion Criteria:

* Not providing active service in patient diagnosis and treatment despite being a physician (administrative position, etc.).

Primary outcomes:
measure: Physician Attitudes toward Cardiac Rehabilitation and Referral (PACRR)-Revised Scale Score
timeFrame: 10-15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Karaman
country: Turkey
facility: Karamanoglu Mehmetbey University
Study officials:
References:
Clinical trial NCT06546228: Long Term Predictors of Acute Myocardial Infarction in Patients With Coronary Revascularization
Official title: Long Term Predictors of Acute Myocardial Infarction in Patients With Coronary Revascularization: a Machine Learning Analysis After a 7 Years Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Infarction
Revascularization
Lead sponsor: Azienda Ospedaliera Universitaria Policlinico "G. Martino"
Sponsor class: OTHER
First posted: 2024-08-09
Enrollment: 652
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized for acute coronary syndrome (ACS)

Brief summary: Worldwide, Ischemic heart disease is the single most common fatal disease. One of the most common causes of acute myocardial infarction is represented by obesity. Numerous cardio metabolic variables play a key role in incidence of adverse cardiovascular outcomes. The purpose of this research was to investigate the factors allowing to acute coronary syndrome, related to the metabolic status, to help guide each patient toward early preventing behaviors.


Eligibility criteria: Inclusion Criteria:

* Patients met the criteria for Acute Coronary Syndrome (ACS) as defined by the Joint European Society of Cardiology/American College of Cardiology Committee.
* Patients underwent immediate coronary revascularization (primary PCI) for ST-Elevation Myocardial Infarction (STEMI).
* Patients underwent coronary revascularization (early PCI) within 24 hours for Non-ST-Elevation Myocardial Infarction (NSTEMI).
* Patients underwent diagnostic coronary angiography following coronary artery bypass graft surgery (CABG).

Exclusion Criteria:

* Known coronary artery disease or previous ACS.
* PCI following CABG.
* Cardiogenic shock.
* Atrial fibrillation.
* Peripheral artery disease.
* Severe cardiac valve disease.
* Prosthetic aorta.

Primary outcomes:
measure: Incidence of Acute Myocardial Infarction (AMI)
timeFrame: 7 years
Secondary outcomes:
measure: Change in Left Ventricular Ejection Fraction (LVEF)
timeFrame: 7 years
measure: Incidence of Cardiovascular Death
timeFrame: 7 years
Other outcomes:
Locations:
city: Messina
country: Italy
facility: Azienda Ospedaliera Universitaria G. Martino
Study officials:
References:
Clinical trial NCT01793428: Capillary Lactate and Transfusion Needs
Official title: Predictive Abilities for Transfusion Needs of Capillary Lactate Measure in Emergency for Injured Normotensive Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: adults admitted in vital emergency unit
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2013-02-15
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults admitted in vital emergency unit due to severe trauma based on a local severity score.

Patients are normotensive

Brief summary: 13% of injured normotensive patients arriving in emergency unit need mass blood-transfusion of six or more units of packed Red Blood Cells. It is currently difficult to predict the need for such a mass blood-transfusion. Indeed hemoglobin point of care testing (hemocue) and blood pressure can be normal during the first hours despite intensive bleeding.

It's well known that blood or arterial lactate measures correlate with trauma severity but these measures are not available in a pre-hospital setting. The investigators want to test whether capillary lactate measures also correlate with trauma severity and can therefore predicts earlier transfusion needs.


Eligibility criteria: Inclusion Criteria:

* Adult admitted in vital emergency unit
* Severe trauma
* normotensive (Systolic Blood Pressure \>90mmHg)
* patient subjected to capillary haemoglobin and glucose measurements
* patient beneficiary of social security

Exclusion Criteria:

* pregnant woman
* liver deficiency
* pre-hospital transfusion
* hypothermia below 35°C
* protected persons according to the law
* Nor epinephrine \> 0.1gamma/kg/min

Primary outcomes:
measure: Transfusion of 6 or more units of packed Red Blood Cells (RBC)
timeFrame: 48 hours
Secondary outcomes:
measure: arterial lactate measures
timeFrame: upon arrival at the vital emergency unit
measure: injury scores (ISS,SOFA)
timeFrame: 24h
measure: transfusion of 4 units of packed RBC
timeFrame: 48 hours
measure: blood lactate measure
timeFrame: upon arrival at vital emergency unit
measure: Intensity of medical care
timeFrame: upon arrival at vital emergency unit
measure: Bleeding Predictive Score
timeFrame: upon arrival at vital emergency unit
measure: Mortality
timeFrame: 28 days
Other outcomes:
Locations:
city: La Tronche
country: France
facility: Grenoble University Hospital
state: Isere
Study officials:
affiliation: University Hospital, Grenoble
name: Marc Vinclair, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bouzat P, Schilte C, Vinclair M, Manhes P, Brun J, Bosson JL, Payen JF. Capillary lactate concentration on admission of normotensive trauma patients: a prospective study. Scand J Trauma Resusc Emerg Med. 2016 Jun 7;24:82. doi: 10.1186/s13049-016-0272-x.