louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04953702: Study of the Associations Between Subchondral Insufficiency Fractures of the Knee and Pre-existing Health, Lifestyle, and/or Musculoskeletal Conditions
Official title: Insufficiency Fractures of the Knee: Insufficient of Nutrients or Cartilage?
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Subchondral Insufficiency Fracture
Keywords: Exercise
Musculoskeletal diseases
Nutrition disorders
Pain
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with SIFK from ages ≥18 years old who seek treatment at the University of Massachusetts for their musculoskeletal care and are not a member of a special population.

Brief summary: This prospective cohort study is designed to investigate possible association(s) between subchondral insufficiency fractures (SIFKs) of the knee and pre-existing health, lifestyle, and/or musculoskeletal conditions. In doing so, this research may shed light on the underlying cause(s) of SIFKs. It is hypothesized that SIFKs of the knee are related to osteoarthritis, weak bone, and/or metabolic issues, rather than trauma.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with SIFK from ages ≥18 years old who seek treatment at the University of Massachusetts for their musculoskeletal care.

Exclusion Criteria:

* Patients with a history of associated conditions such as cancer, inflammatory arthritis, or chronic alcohol or tobacco dependence will be excluded.

The following special populations will be excluded:

* Adults unable to consent and/or unable to follow two-step commands
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Non-English-speaking patients

Primary outcomes:
measure: Correlation between subchondral insufficiency fractures (SIFKs) and coexisting conditions
timeFrame: 12 months
Secondary outcomes:
measure: Correlation between type of treatment for subchondral insufficiency fractures (SIFKs) and treatment outcome (pain level)
timeFrame: 12 months
measure: Correlation between activity level and treatment outcome (pain level)
timeFrame: 12 months
measure: Correlation between coexisting conditions and treatment outcome (pain level)
timeFrame: 12 months
Other outcomes:
Locations:
city: Worcester
country: United States
facility: University of Massachusetts Memorial Health
state: Massachusetts
Study officials:
affiliation: University of Massachusetts, Worcester
name: Lauren Scarpetti
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02977702: Sarcopenia is an Independent Prognostic Factor for Overall Survival in Patients With Pancreatic Adenocarcinoma
Official title: Sarcopenia is an Independent Prognostic Factor for Overall Survival in Patients With Pancreatic Adenocarcinoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Lead sponsor: Institut de Cancérologie de Lorraine
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients records would be extracted from the electronic health record system of Institut de Cancérologie de Lorraine

Brief summary: The primary objective of this study was to validate Total Psoas Area (TPA) measurement as an independent prognostic factor of overall survival in patients with pancreatic adenocarcinoma. Secondary objective was to describe the evolution of the TPA during the follow-up.


Eligibility criteria: Inclusion Criteria:

* All patients consecutive enrolled from January 2009 to December 2015 who underwent at least one chemotherapy for pancreatic adenocarcinoma, whatever the stage

Exclusion Criteria:

* A patient record captured outside the time frame from January 2009 to December 2015

Primary outcomes:
measure: overall survival
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03664102: Automated Fastener Device Versus Manually Tied Knot in MiAVR
Official title: Comparison of Automated Fastener Device Versus Manually Tied Knot in Minimally-invasive Isolated Aortic Valve Replacement Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Valve Diseases
Lead sponsor: Centre Hospitalier La Chartreuse
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 221
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient operated on an Isolated aortic valve replacement with stented prosthesis by Minimally-invasive approach (right anterior minithoracotomy)

Brief summary: The aim of the investigator's study was to evaluate the efficacy and the safety of the Cor-Knot device in isolated aortic valve replacement (AVR) by right anterior minithoracotomy (RAMT).

Four hundred and forty patients were operated for AVR by RAMT. Of these patients, 221 underwent isolated AVR surgery with stented prosthesis. Sutures were secured using the Cor-Knot titanium fastener in 63 patients and knots were hand-tied in 158.

The aortic cross-clamping and cardiopulmonary bypass times were significantly decreased in the AT group compared with the MT group. Clinical outcomes were similar in the two groups, whether in the analysis of non-matched or matched groups. There was no difference in 30 day-mortality and the stroke and TIA rates were comparable The automated Cor-Knot fastener is an easy-to-use, time-saving device which does not increase perioperative morbi-mortality in patients undergoing AVR by right anterior minithoracotomy.


Eligibility criteria: Inclusion Criteria:

* age \> 18 years
* Elective patient
* Isolated aortic valve replacement with stented prosthesis
* Minimally-invasive approach (right anterior minithoracotomy)

Exclusion Criteria:

* Associated procedure
* Aortic valve replacement with sutureless or rapid valve deployment prosthesis
* Active endocarditis
* Prior cardiac surgery

Primary outcomes:
measure: Cardiac surgery times
timeFrame: peroperative data
Secondary outcomes:
measure: Morbimortality
timeFrame: Perioperative (30 days) and 24 months follow up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02076802: Regular Physical Exercise and Salt Diet on Coronary Artery Disease in Patients With Prehypertension(RESTRAIN Pre-HT)
Official title: Regular Physical Exercise and Salt Diet Effect on Progression of Coronary Disease in Patients With Prehypertension
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Atherosclerosis
Cardiovascular Disease
Keywords: prehypertension
coronary atherosclerosis
cardiovascular disease
Lead sponsor: General Hospital of Shenyang Military Region
Sponsor class: OTHER
First posted: 2014-03-04
Enrollment: 120
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Coronary atherosclerosis patients with prehypertension

Brief summary: The epidemic data shows that prehypertension is associated with cardiovascular disease, and heavy dietary salt intake could improve the developing of hypertension. We detected the risk factors of coronary atherosclerosis of prehypertensive patients with different levels of salt intake.

The aim of this multicenter prospective, randomized controlled study is to evaluate regular physical exercise and salt diet effects on progression of coronary artery disease in patients with prehypertension.


Eligibility criteria: Inclusion Criteria:

aged 45-75 Admission systolic BP between 120 and 139mmHg or diastolic BP between 80 and 89mmHg coronary artery stenosis was 30%-70% -

Exclusion Criteria:

with a history of myocardial infarction, coronary revascularization, congenital heart disease and cerebrovascular diseases

-

Primary outcomes:
measure: fatal and nonfatal myocardial infarction, or coronary revascularization
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shenyang
country: China
facility: General Hospital of Shenyang Militaly Region
state: Liaoning
Study officials:
References:
Clinical trial NCT00397202: FLOW-Finding Lasting Options for Women
Official title: FLOW-Finding Lasting Options for Women: A Prospective, Randomized, Multicenter Trial Comparing Tampons to a Menstrual Cup
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Menstruation
Keywords: Menstruation
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: National Research System-College of Family Physicians of Canada
First posted: 2006-11-08
Enrollment: 110
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: 1. Purpose: To compare the use of the menstrual cup "The DivaCupTM " to a menstrual strategy using tampons as the primary method of menstrual flow management using indicators of user-satisfaction, urinary tract infection, vaginal irritation, cost and waste.
2. Hypothesis: The "The DivaCupTM" will have similar rates of user-satisfaction, urinary tract infection, and vaginal irritation as a menstrual strategy using tampons as the primary method of menstrual flow management but will likely be more reasonable in terms of cost and will generate less waste.

Detailed description: Method:

Prospective study of 100 women from family practice offices in Vancouver, Victoria and Prince George who currently use tampons to manage menstrual flow. After an information session and consent, subjects will be randomized to tampon use or Diva Cup use and record their experience on a diary for 3 months. Women who attend the information session and who do not enrol, or those who drop out will be asked their reasons for discontinuing, and their pre-study questionnaire will be used for analysis.

Eligibility criteria: Inclusion Criteria:

* Women between the ages of 19 and 40 who have menstrual flow most months and who currently self-identify as using tampons as their primary method of menstrual management

Exclusion Criteria:

* Have a sensitivity or allergy to silicone
* Have an active vaginal or urogenital infection
* Are pregnant, or who have plans to become pregnant before spring 2007 (end of study data collection)
* Have used systemic antimicrobials within the previous 14 days
* Are unable to understand the nature and purpose of the study
* Are unable to understand and express themselves in written and spoken English

Primary outcomes:
measure: Overall satisfaction with menstrual strategy.
Secondary outcomes:
measure: Diagnosed UTI
measure: Diagnosed vaginitis
measure: Vaginal irritation
measure: Waste
measure: Cost
Other outcomes:
Locations:
city: Victoria, Vancouver, Prince George
country: Canada
facility: Private family physician offices
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Konia Trouton, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Howard C, Rose CL, Trouton K, Stamm H, Marentette D, Kirkpatrick N, Karalic S, Fernandez R, Paget J. FLOW (finding lasting options for women): multicentre randomized controlled trial comparing tampons with menstrual cups. Can Fam Physician. 2011 Jun;57(6):e208-15.
Clinical trial NCT00177502: Effect of Exercise on Prevention of Weight Gain
Official title: Effect of Exercise on Prevention of Weight Gain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Weight Loss
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2005-09-15
Enrollment: 294
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the dose-response of exercise on prevention of weight gain in overweight adults.


Eligibility criteria: Inclusion Criteria:

1. Female or Male
2. 18-55 years of age
3. BMI = 25-29.9 kg/m2
4. Ability to provide informed consent.
5. Ability to provide consent from their personal physician to participate in this study.

Exclusion Criteria:

1. Reporting regular exercise participation of at least 20 minutes per day on at least 3 days per week during the previous six months. (This study is designed to recruit relatively sedentary adults.)
2. Diabetes, hypothyroidism, or other medical conditions which would affect energy metabolism.
3. Women who are currently pregnant, pregnant within the previous six months, or planning on becoming pregnant within the next 12 months. (Pregnancy during initial screening will be based on self-report and will be included on the detailed medical history that is completed by subjects. However, this will be confirmed with the urine pregnancy test that will be conducted prior to the baseline DEXA.)
4. Non-medicated resting systolic blood pressure \>160 mmHg or non-medicated resting diastolic blood pressure \>100 mmHg, or taking medication that would affect blood pressure.
5. Taking medication that would affect resting heart rate or the heart rate response during exercise (e.g., beta blockade).
6. Arrhythmia on resting or exercise electrocardiogram that would indicate that vigorous exercise was contraindicated.
7. History of myocardial infarction or valvular disease.
8. History of orthopedic complications that would prevent optimal participation in the exercise component (e.g., heel spurs, severe arthritis).

Primary outcomes:
measure: body weight
Secondary outcomes:
measure: fitness
measure: physical activity
measure: dietary intake
measure: mediators
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: John M Jakicic, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Janney CA, Jakicic JM. The influence of exercise and BMI on injuries and illnesses in overweight and obese individuals: a randomized control trial. Int J Behav Nutr Phys Act. 2010 Jan 6;7:1. doi: 10.1186/1479-5868-7-1.
Clinical trial NCT00988702: Shaolin Dan Tian Breathing Fosters Relaxed and Attentive Mind
Official title: Shaolin Dan Tian Breathing Fosters Relaxed and Attentive Mind: A Randomized Controlled Neuroelectrophysiological Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Attention
Electroencephalography
Keywords: Dan Tian Breathing
Physiological measurement
progressive muscle relaxation
Monitoring, Physiologic
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Chinese University of Hong Kong
First posted: 2009-10-02
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The present study aimed to utilize these well-known neuroelectrophysiological techniques to investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique.

Detailed description: Neuroelectrophysiological studies on various types of meditative breathing revealed its association with either a relaxing (i.e., enhanced alpha asymmetry) or an attentive state (i.e., enhanced intra- and inter-hemispheric theta coherence). The present study aimed to utilize these well-known neuroelectrophysiological techniques to investigate the relatively less studied Shaolin Dan Tian Breathing (DTB) technique. This technique consists of two components -- Passive DTB and Active DTB, and is considered not only as a relaxation exercise but also a form of Qigong. Based upon some pilot neuroimaging data and clinical observation, it was hypothesized that after familiarizing with the method, practicing DTB can induce both relaxing and attentive states. Twenty-two adults received training on the DTB (experimental group) for one month. They were instructed to practice the technique daily, and at each practice, until they felt warm and/or relaxed. Twenty age-, gender- and education-matched adults receiving conventional progressive muscle relaxation training were recruited as control. All participation was voluntary. Quantitative EEG and bio-physiological data were collected at baseline and post training. Eyes-closed resting EEG data before and immediately after each type of breathing were obtained individually at two time points.

Eligibility criteria: Inclusion Criteria:

* healthy controls
* age 20 to 60 years

Exclusion Criteria:

* history of head injury,
* seizure,
* stroke,
* other CNS diseases or psychiatric illnesses of psychosis or mania.

Primary outcomes:
measure: Quantitative electroencephalography
timeFrame: Before and after one month's training
Secondary outcomes:
measure: Bio-physiological measures
timeFrame: Before and after one month's training
Other outcomes:
Locations:
Study officials:
affiliation: The ChineseUniversity of Hong Kong
name: Agnes S Chan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03938402: Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different PEEP Levels
Official title: Intraocular Pressure and Optic Nerve Sheath Diameter Changes at Different Positive End-expiratory Pressure Applications in Laparotomic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Intraocular Pressure
Intracranial Pressure
Positive End-expiratory Pressure
Keywords: Intraocular pressure
Optic nerve sheath diameter
Positive end-expiratory pressure
Lead sponsor: Marmara University
Sponsor class: OTHER
First posted: 2019-05-06
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Positive end-expiratory pressure (PEEP) is sometimes used during perioperative period, as it has favourable effects on lung mechanics. Unfortunately, it has some negative effects on the patients, like increased intraabdominal, intrathoracic, intracranial and intraocular pressures. In this study the investigators aimed to investigate the effects of different PEEP levels on the patients' intraocular and intracranial pressures. Intraocular pressure will be measured by ocular tonometry, and intracranial pressure will be estimated by optic nerve sheath diameter measurement. The measurements will be performed in the operating room in the patients undergoing laparotomic surgery.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing laparotomy for gastrointestinal surgery
* American Society of Anesthesiologists (ASA) 1 or 2 physical status
* Elective surgery

Exclusion Criteria:

* Patients with glaucoma
* ASA 3 or over physical status
* Emergency surgery

Primary outcomes:
measure: Changes in intraocular pressure
timeFrame: Throughout the operation (usually about 1.5 hours).
measure: Changes in optic nerve sheath diameter
timeFrame: Throughout the operation (usually about 1.5 hours).
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Marmara University School of Medicine
state: Pendik
Study officials:
affiliation: Marmara University School of Medicine, Dep of Anesthesiology and Reanimation
name: Ruslan Abdullayev
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04578002: Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine
Official title: Telestroke 2: Prehospital Triage of Patients With Suspected Stroke Using Onsite Mobile Telemedicine- Efficacy Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Acute
Keywords: pre-hospital triage
Stroke, suspected
Telemedicine
telemedical triage
Door-to-treatment-time
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: propatient Forschungsstiftung
First posted: 2020-10-08
Enrollment: 94
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Any patient aged ≥ 18 years with suspected acute stroke as per the first judgement of the paramedics on-site at the University hospital of Basel.

Brief summary: This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.

Detailed description: One of today's main challenges in stroke medicine is to further decrease event-to-treatment-time. On-site, pre-hospital, clinical assessment of patients with suspected acute stroke can optimize further diagnostic and treatment pathways after patient arrival at the dedicated stroke center. A telemedical approach (interactive video and audio streaming) allows time efficient pre-hospital triage, via patient evaluation by simple, pre-defined assessment measures and a standardized questionnaire. This study is to investigate clinical efficacy of the pre-hospital triage of patients with suspected acute stroke by using advanced telecommunication tools with digital audio and video real-time streaming.

Eligibility criteria: Inclusion Criteria:

* suspected acute stroke as per the first judgement of the paramedics on-site

Exclusion Criteria:

* Patients with a known history of epilepsia or non-epileptic seizures
* Patients after/while displaying an epileptic seizure
* Recent head trauma
* Patient with a reduced Glasgow Coma Scale or other condition not allowing Rapid Arterial oCclusion Evaluation (RACE) examination

Primary outcomes:
measure: Door-to-treatment-time (minutes)
timeFrame: one point assessment at baseline
Secondary outcomes:
measure: National Institutes of Health Stroke Scale (NIHSS) at 24hours
timeFrame: one point assessment at 24hours after hospital admission
measure: National Institutes of Health Stroke Scale (NIHSS) at 90 days
timeFrame: one point assessment at 90 days after hospital admission
measure: modified Rankin Scale (mRS) at 90 days
timeFrame: one point assessment at 90 days after hospital admission
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Stroke Center, Neurology, University Hospital Basel
Study officials:
affiliation: Stroke Center, Neurology, University Hospital Basel
name: Philippe Lyrer, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: