louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01416077: Decreasing Postoperative Complications by Goal-Directed Fluid Therapy During Esophageal Resection
Official title: Perioperative Goal Directed Fluid Therapy During Esophageal Resection A Prospective Randomized Controlled Open Multi-centre Trial to Study the Effect on Postoperative Complications
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Esophageal Cancer
Keywords: fluid
goal-directed
FloTrac
pulse contour analysis
postoperative complications
anesthesia
esophagus
Lead sponsor: University Hospital, Linkoeping
Sponsor class: OTHER
First posted: 2011-08-12
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Surgery for cancer of the esophagus is associated with a high risk of postoperative complications. It has been shown that the risk of postoperative complications can be decreased by optimising the amount and type of infusion fluids given during surgery, steered by measurement of cardiac stroke volume, mostly done with a device called esophageal Doppler. This device can however not be used during this type of surgery. This study wants to test the hypothesis that postoperative complications in patients operated for esophageal cancer can be partially prevented by using a goal directed strategy for the administration of fluids and drugs influencing the heart and vessels, based on measurement of stroke volume by pulse wave analysis (FloTrac).


Eligibility criteria: Inclusion Criteria:

* Patients scheduled for transthoracic esophageal resection because of malignancy, without colonic interposition who leave informed consent

Exclusion Criteria:

* ASA 4 or 5
* Atrial Fibrillation
* Significant Aortic or Mitral Valve Insufficiency
* Preoperative planned extensive monitoring beyond CVP, arterial blood pressure, diuresis, ECG and other standard monitors

Primary outcomes:
measure: Incidence of complications 5 and 30 days postoperatively
timeFrame: 5 and 30 days postoperatively
Secondary outcomes:
measure: length of stay ICU and total hospital
timeFrame: 30 days
measure: return of bowel function
timeFrame: 30 days
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: University Hospital Linkoeping
Study officials:
affiliation: University Hospital, Linkoeping
name: Lena Nilsson, MD PhD
role: STUDY_CHAIR
References:
citation: Bahlmann H, Halldestam I, Nilsson L. Goal-directed therapy during transthoracic oesophageal resection does not improve outcome: Randomised controlled trial. Eur J Anaesthesiol. 2019 Feb;36(2):153-161. doi: 10.1097/EJA.0000000000000908.
Clinical trial NCT05548777: Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed
Official title: Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anticoagulant-related Major Bleed
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Outcomes Insights
First posted: 2022-09-21
Enrollment: 5480
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed

Brief summary: This is an observational study based on data collected via an audit of electronic medical charts. The study population will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed, and their characteristics, treatments and outcomes will be described.

Detailed description: This observational study will include adult US patients treated with andexanet alfa or 4F-PCC during a hospitalization for an anticoagulation-related major bleed. Data will be collected via an audit of electronic medical charts. The primary objectives are to describe the patients' characteristics, treatments and outcomes, including length of stay and in-hospital mortality. Secondary objectives include subgroup analyses, including by bleed location. Potential differences between patients treated with andexanet alfa versus 4F-PCC, and potential differences in patient characteristics over time, will be assessed. If this assessment confirms that treatment groups can be adequately balanced and that patient characteristics have not substantially changed over time (i.e. no channeling bias is observed), the risk of in-hospital mortality with andexanet alfa versus 4F-PCC will be assessed in a comparative effectiveness analysis. If treatment groups cannot be balanced or clear signs of channelling bias are observed, the comparative analyses will be considered unfeasible and will not be performed.

Eligibility criteria: Inclusion Criteria:

* ICD-10-CM diagnosis code of D68.32 (Hemorrhagic disorder due to extrinsic circulating anticoagulants) as part of an inpatient admission
* Taking either an oral FXa inhibitor or enoxaparin at the time of hospitalization for their bleeding event
* Treated with either andexanet alfa or 4F-PCC during the hospitalization for their bleeding event
* Had documented discharge disposition

Exclusion Criteria:

* Less than 18 years old
* Treated with both andexanet alfa and 4F-PCC during the hospitalization for their bleeding event

Primary outcomes:
measure: Mortality
timeFrame: During hospitalisation, approximately 6 days
Secondary outcomes:
Other outcomes:
Locations:
city: Agoura Hills
country: United States
facility: Research Site
state: California
Study officials:
References:
Clinical trial NCT01955577: Vitamin D Supplement for Patients With Tibial Fracture
Official title: Vitamin D Supplement for Patients With Tibial Fracture Treated With an External Ring Fixator. A Prospective Randomized Double-blind Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Tibial Fracture
Keywords: Vitamin D deficiency
Ring fixator
Tibial fracture
Lead sponsor: Northern Orthopaedic Division, Denmark
Sponsor class: OTHER
First posted: 2013-10-07
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose is to study:

1. the frequency of vitamin D deficiency at patients with tibial fracture treated with an external ring fixator
2. if vitamin D supplement facilitates fracture healing
3. a possible relation between vitamin D deficiency and the risk of complications and the time of fracture healing

Detailed description: External ring fixator is a widespread and well-known method to treate complex tibial fractures. The effect of treating proximal and distal intra-articulatio tibial fractures has been positive until now.

Complications such as malunions, nonunions, re-fractures and extended time of ring fixation will occur in 5-10% of all tibial fractures in patients treated with ring fixator. Factors like trauma of soft tissue, smoking and compromised afflux of blood are associated with a higher frequency of nonunion.

It has been documented that elderly people with hypovitaminosis D have a higher risk of being affected by osteoporosis and fractures. Furthermore, there is a possible association between the severity of fracture and hypovitaminosis. The time of fracture healing is also extended compared to fractures in patients who are not affected by osteoporosis.

Until now research has not shown whether the fracture healing process is influenzed by vitamin D.

Eligibility criteria: Inclusion Criteria:

* Patients with tibial fracture
* A written signed statement of consent
* All potential patients primary with osteosynthesis Iliazov

Exclusion Criteria:

* Tumours in bone
* Metastases to bone marrow
* Chronic renal disease
* Drug abuse
* Abuse of alcohol (\>21 drinks a week for men and \> 14 drinks a week for women)
* Morbus Cushing disease
* Glandulae thyroid disease
* Pregnancy
* Chronic steroid therapy
* Hepatic insufficiency
* Sarcoidosis, tuberculosis or silocosis
* Patients under 18 years
* Inability to take medicine
* Adverse effects of vitamin D or allergic to vitamin D

Primary outcomes:
measure: Time of fracture healing
timeFrame: 20 weeks
Secondary outcomes:
measure: Vitamin D receptor DNA
timeFrame: 20 weeks
measure: Complications
timeFrame: 20 weeks
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
state: Region Northern Jutland
Study officials:
affiliation: Aalborg University Hospital, Denmark
name: Tine L. Bennedsen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02869477: Institut Paoli Calmettes Cardia Cancer Database
Official title: Institut Paoli Calmettes Cardia Cancer Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stomach Neoplasms
Cardia
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2016-08-17
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with a diagnosis of Cardia Cancer

Brief summary: Database of Institut Paoli-Calmettes patients diagnosed with cardia cancer


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cardia cancer

Exclusion Criteria:

-

Primary outcomes:
measure: Survival of patients
timeFrame: 10 years
Secondary outcomes:
measure: Collection of patients characteristics
timeFrame: 10 years
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli-Calmettes
state: Bouches-du Rhône
Study officials:
References:
Clinical trial NCT01530477: DXA Precision and Accuracy Comparison Study
Official title: DXA Precision and Accuracy Comparison Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Osteopenia
Keywords: Bone mineral density
weight
body composition
DEXA
DXA
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2012-02-10
Enrollment: 82
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study is being conducted to examine the performance of three common DXA machines (1) Lunar iDXA, (2) Lunar Prodigy and (3) Hologic Discovery A in measuring bone density and body fat.

Detailed description: For this study, two specific groups of volunteers will be recruited. In one group, the scan will measure bone density and in the other group the scan will measure fat. The groups will be broken into weight groups to determine which of the scanners the subject will be scanned on. Subjects will have the option to participate in either one or both groups.

Eligibility criteria: Inclusion Criteria:

1. Men and women \> 20 years old
2. Willing to provide consent
3. Falls into one of three weight categories, with minimum 30 subjects per category.

   * Less than 200 lbs.
   * 200 (inclusive) to less than 350 lbs.
   * 350 (inclusive) to less than 450 lbs.
4. Participate in only one weight category in either skeletal or body composition cohort, or both.

Exclusion Criteria:

1. Inability to remain still for the duration of the DXA scans as judged by study Investigator.
2. Un-removable internal / external scan artifacts e.g. plaster casts, metal rodding naso-gastric tubes, etc.
3. Females of childbearing potential\* with actual (confirmed by positive urine pregnancy test) or suspected (based on study Investigator evaluation despite a negative urine test) pregnancy.
4. Subject had already given consent to participate in any aspect of this study.

Primary outcomes:
measure: Short Term Precision Comparison Across Three DXA Devices
timeFrame: Less than 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lakewood
country: United States
facility: Colorado Center for Bone Research
state: Colorado
Study officials:
affiliation: Study site
name: Paul Miller, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05990777: Assessment of Knowledge and Attitude Toward Obstructive Sleep Apnea in Medical Teams
Official title: Assessment of Knowledge and Attitude Toward Obstructive Sleep Apnea in Medical Teams: Multicenter Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: OSA
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 377
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Medical teams including:

All responders to the questionnaires will be included regarding that they belong to these groups- within the study period

* Students of medical schools and dentistry
* General practitioners
* Dentists
* Medical specialists
* Highly trained nurses (HIN)

Brief summary: Obstructive sleep apnea (OSA) is a serious and often underreported condition, despite its highly prevalent distribution. Medical teams play an integral role in screening and managing patients with a high risk of developing OSA.


Eligibility criteria: Inclusion Criteria:

Medical teams including:

* Students of medical schools and dentistry
* General practitioners
* Dentists
* Medical specialists
* Highly trained nurses (HIN)

Exclusion Criteria:

* Non- medical personnel's

Primary outcomes:
measure: explores the knowledge and attitude towards OSA among medical teams
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Aliae AR Mohamed-Hussein
city: Assiut
country: Egypt
facility: Aliae Mohamed-Hussein
Study officials:
References:
Clinical trial NCT05498077: Immediate Effects of a 10-minute Body Scan Meditation on People Who Has Central Sensitization
Official title: Immediate Effects of a 10-minute Body Scan Meditation on People Who Has Central Sensitization
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Pain
Keywords: Central Sensitization
Meditation
Lead sponsor: Therapeutic Neuroscience Research Group
Sponsor class: NETWORK
Collaborators: name: Rockhurst University
name: Evidence In Motion
First posted: 2022-08-11
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case series
Primary purpose: TREATMENT

Brief summary: For patients with chronic pain, how does a 10 minute guided body scan meditation affect pressure pain threshold and extent of pain on a body diagram?

Detailed description: Patients who present with central sensitization in physical therapy will go through a 10 minute body scan meditation. If patient meets criteria then they will fill out pre-intervention measures including hand dominance, gender identity, duration of pain, work status, pain body diagram, current pain level, previous medication and a neck disability index or an oswestry disability index.

Subject will then be asked what position they feel most comfortable to be led through this body scan meditation.

After the meditation, the participant will fill out another pain body diagram, current pain level, global rating of change and pain pressure threshold.

At this point the study is over and the subject will return to their physical therapy treatment.

Eligibility criteria: Inclusion Criteria:

* Subjects are from a convenience sample of patients seeking physical therapy care from a physician referral or direct-access to a privately owned physical therapy clinic English speaking
* Central Sensitization Inventory \> 40
* Subject complains of disproportionate non mechanical unpredictable pattern of pain provocation in response to multiple non-specific aggravating/easing factors
* Pain disproportionate to the nature and extent of injury or pathology
* Strong association with maladaptive beliefs and pain behaviors
* Diffuse, nonanatomic areas of pain and tenderness on palpation

Exclusion Criteria:

* Does not meet the criteria above

Primary outcomes:
measure: Global Rating of Change
timeFrame: Immediately After intervention
measure: Pain pressure Threshold
timeFrame: Immediately Before and immediately after intervention
measure: Neck Disability Index
timeFrame: Immediately Before the intervention
measure: Oswestry Disability Index
timeFrame: Immediately Before the intervention
measure: Pain Body Diagram
timeFrame: Immediately Before the intervention and immediately after intervention
measure: Numeric Pain Rating Scale
timeFrame: Immediately Before the intervention and immediately after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Whole Body Health Physical Therapy
state: Oregon
Study officials:
References:
Clinical trial NCT02891577: Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock
Official title: Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hemodynamic Instability
Keywords: intra abdominal hypertension
shock
critically ill
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-09-07
Enrollment: 100
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: Critically ill patients receiving catecholamine for shock state at the time of ICU admission.

Brief summary: This study aims to describe the ratio of the diameter of inferior vena cava to the common femoral vein measured by ultrasonography in critically ill patients with shock, and to evaluate the potential link between this ratio and the existence of intra-abdominal disease.

Detailed description: Among patients presenting with severe abdominal disease and shock, observations shown that the diameter of the common femoral vein was larger than the inferior vena cava. The hypothesis is that this observation could be secondary to a compression of the inferior vena cava related to an increased intra abdominal pressure.

Eligibility criteria: Inclusion Criteria:

* Adult
* Need for ICU admission
* Need for vasopressor (epinephrine or norepinephrine) to obtain a mean arterial pressure at least of 65 mmHg

Exclusion Criteria:

* Deep venous thrombosis related to inferior vena cava or common femoral veins
* Inability to measure inferior vena cava and common femoral vein diameters using ultrasonography

Primary outcomes:
measure: Ratio of the diameter of the inferior vena cava related to the common femoral vein
timeFrame: Up to 28 days after ICU admission
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
affiliation: CHU Besançon
name: Gaël PITON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02098577: Crossover Versus Stabilometric Platform in Parkinson's Disease
Official title: Effect of Two Different Rehabilitation Programs on Balance in Parkinsonian Patients: Crossover Versus Stabilometric Platform
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson's Disease
Keywords: Balance
Lead sponsor: Ospedale Generale Di Zona Moriggia-Pelascini
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 60 patients with PD in stage III Hoen\&Yahr according to Gelb et la. with the ability to walk without any assistance and with Mini Mental State Examination (MMSE) score \> 26.

Brief summary: The aims of this study is to assess the efficacy of the crossover on balance in Parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform.

Detailed description: Parkinson's disease (PD) is a neurodegenerative disorder characterized by different motor symptoms (rigidity, akinesia, tremor and impairment of balance and gait). Even though pharmacological treatment has changed the natural course of the disease, balance worsens over time and leads to falls. The aims of this study is to assess the efficacy of the crossover (group 1) on balance in Parkinsonian patients and compare this results with the results of a control group of patients treated with a stabilometric platform (group 2). The group 1 executed 6 days/week for a 4-weeks cycle a crossover protocol based on the first 4 level of resistance and a training which lasts at most 5 minutes. The group 2 executed 6 days/week for a 4-weeks cycle different exercises with the stabilometric platform in monopodalic and in bipodalic standing.

Eligibility criteria: Inclusion Criteria:

* PD in stage III Hoen\&Yahr according to Gelb et la. with the ability to walk without any assistance and with Mini Mental State Examination (MMSE) score \> 26

Exclusion Criteria:

* MMSE \< 26
* Coexistence of other neurological diseases
* PD patients with relevant orthopedic, rheumatic and muscular conditions

Primary outcomes:
measure: BBS
timeFrame: One month
Secondary outcomes:
measure: 6MWT
timeFrame: One month
measure: TUG
timeFrame: One month
measure: UPDRS II
timeFrame: One month
measure: UPDRS III
timeFrame: One month
Other outcomes:
Locations:
city: Gravedona
country: Italy
facility: Ospedale generale di zona "Moriggia-Pelascini"
state: Como
Study officials:
affiliation: Ospedale generale di Zona "Moriggia-Pelascini", Gravedona ed Uniti 22015 - CO, Italy
name: Giuseppe Frazzitta, MD
role: PRINCIPAL_INVESTIGATOR
References: