louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03066232: Delirium in Home-dwelling Old People Receiving Home Nursing Care
Official title: Delirium in Home-dwelling Old People Receiving Home Nursing Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium
Dementia
Physical function
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: Sandefjord kommune
name: Norwegian Centre for Ageing and Health
name: The Hospital of Vestfold
First posted: 2017-02-28
Enrollment: 211
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Persons older than 65 years living in their own home receiving home nursing care at least once a week.

Brief summary: Study the prevalence of delirium among old persons with home-nursing care living in the community. By recruiting the persons in a stable phase, the investigators wish to study the influence of an episode of delirium upon further cognitive and physical function.


Eligibility criteria: Inclusion Criteria:

* Home nursing service at least once a week.
* Home dwelling (not permanently institutionalised)
* Age 65 years or more
* Informed consent by the patient or a close relative (if the patient is unable to give a valid informed consent)

Exclusion Criteria:

* Patient or relative denies inclusion
* Terminal illness
* Patients diagnosed with dementia with Lewy bodies (its fluctuating course makes the diagnosis of delirium challenging)
* Patients with chronic diseases that have needed assistance from the home nursing service before the age of 65.
* Assistance from the home nursing service is due to addictive substances.
* Assistance from the home nursing service is due to psychiatric illnesses other than dementia.

Primary outcomes:
measure: Trajectory of cognitive function using the MoCa test
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sandefjord
country: Norway
facility: Sandefjord kommune
Study officials:
affiliation: Oslo University Hospital, University of Oslo
name: Torgeir Bruun Wyller, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05105932: The Study of Regional Lung Ventilation-perfusion by EIT
Official title: The Study of Regional Lung Ventilation-perfusion by EIT
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Ventilation
Pulmonary Perfusion
Keywords: EIT
pulmonary perfusion
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who need CTPA examination in the Department of nuclear medicine / radiology of Peking Union Medical College Hospital

Brief summary: This is a prospective observational trial. The purpose of this study is to explore the feasibility of EIT monitoring pulmonary blood flow and the consistency and difference between EIT monitoring pulmonary local ventilation blood flow and SPECT and CTPA monitoring methods


Eligibility criteria: Inclusion Criteria:

1. Admission to ICU was less than 72 hours;
2. Age ≥ 18 years old and ≤ 80 years old;
3. Volunteer to participate after communicating with patients' family members;

Exclusion Criteria:

1. The patients with heart implants could not be monitored by EIT;
2. Patients or their families refused to participate in the study;
3. Hypernatremia

Primary outcomes:
measure: Regional pulmonary perfusion by EIT
timeFrame: 1 Day
measure: Regional pulmonary perfusion by CTPA
timeFrame: 1 Day
Secondary outcomes:
measure: Regional pulmonary ventilation index by EIT
timeFrame: 1 Day
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Yun Long
role: STUDY_DIRECTOR
References:
Clinical trial NCT03025932: Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia
Official title: Clinical vs. Radiological Recurrence Rate After Laparoscopic Repair of Large Hiatal Hernia With Mesh and Anterior Fundoplication
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Hiatal Hernia Large
Lead sponsor: Spital Limmattal Schlieren
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Inclusion of all patients older than 18 years with initial large hiatal hernia (\>20% herniated into thoracic cavity) and laparoscopic hiatoplasty with mesh and anterior fundoplication

Brief summary: Patients who underwent laparoscopic repair of large hiatal hernias and anterior fundoplication with mesh are examined for their recurrence rate one year after surgery.


Eligibility criteria: Inclusion Criteria:

* Age older than 18 years
* Initially suffering from large hiatal hernia (\>20% of the stomach in the thoracic cavity)
* Performance of laparoscopic hiatal hernia repair with mesh and anterior fundoplication
* Informed Consent as documented by signature (Appendix: Informed Consent Form)

Exclusion Criteria:

* Performance of any other anti-reflux surgery such as Toupet- or Nissen-fundoplication
* Performance of anterior fundoplication without mesh
* Women who meet the inclusion criteria but are pregnant or breast feeding or have the intention to become pregnant during the course of the study

Primary outcomes:
measure: Radiological recurrence rate of hiatal hernia determined by computer tomography (CT) scan
timeFrame: minimum 1 year after surgery
Secondary outcomes:
measure: Quality of life by GIQLI
timeFrame: minimum 1 year after surgery
measure: Clinical outcome
timeFrame: minimum 1 year after surgery
measure: Peri- and postoperative morbidity / mortality
timeFrame: minimum 1 year after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Principal Investigator
name: Urs Zingg
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01320332: A Study of a Single Dose of ASP3291 in Subjects With Ulcerative Colitis
Official title: A Phase 1, Randomized, Double-Blind, Placebo Controlled Study to Assess the Pharmacokinetics, Safety, and Tolerability of ASP3291 Following a Single Oral Dose in Subjects With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
ASP3291
Lead sponsor: Telsar Pharma Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-22
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to determine the pharmacokinetics (PK) and to assess safety and tolerability of a single dose of ASP3291 in subjects with ulcerative colitis.

Detailed description: After an 11-day screening period, subjects check into a clinic, are dosed on Day 1 and stay in the clinic for 4 days to monitor pharmacokinetic and safety parameters.

Eligibility criteria: Inclusion Criteria:

* Subject has a previously documented diagnosis of ulcerative colitis (UC) with endoscopy and histology consistent with diagnosis
* If female, the subject is at least 2 years postmenopausal or is surgically sterile per documentation provided by a third party medical professional or the subject agrees to use 2 highly effective methods of birth control during the study and is not pregnant or lactating
* Subject is willing and able to comply with the study requirements
* Subject has a body mass index (BMI) of \<32 kg/m2
* Subject has ulcerative colitis requiring treatment with 5-aminosalicylic acid (5-ASA)

Exclusion Criteria:

* Subject has undergone previous resective colonic surgery
* Subject has previously diagnosed Crohn's Disease based on medical history
* Subject has an extension of disease limited to ulcerative proctitis
* Subject has active peptic ulcer disease based on medical history
* Subject is currently being treated with any prescription medication except the following: A stable dose of 5-aminosalicylic acid (5-ASA) for at least 2 weeks, oral contraceptives or hormone replacement therapy (HRT)
* Subject has a history of human immunodeficiency virus (HIV)
* Subject has a history of severe allergic or anaphylactic reactions
* Subject has a history of drug or alcohol abuse

Primary outcomes:
measure: Pharmacokinetic assessment through analysis of blood, fecal and urine samples
timeFrame: Up to Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Baltimore
country: United States
facility: SNBL Clinical Pharmacology Center
state: Maryland
city: San Antonio
country: United States
facility: Clinical Trials of Texas, Inc.
state: Texas
Study officials:
affiliation: Astellas Pharma Global Development
name: Senior Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02266732: Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?
Official title: Ultrasound Vs Nerve Stimulation - Why is a PNS so Effective?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Musculoskeletal Pain
Lead sponsor: The Leeds Teaching Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2014-10-17
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The traditional model of localizing a nerve for blockade is using a peripheral nerve stimulator, PNS. Recent advances in UltraSound technology has allowed UltraSound to guide nerve blockade. However despite excellent visualization nerve block success has not significantly improved. I aim to show that this is because the PNS stimulation of a nerve is more than a proximity response as thought but a correct fascial plane response and hence the high success rate of this blind approach.


Eligibility criteria: Inclusion Criteria:

* ASA 1 to 3 patients for any shoulder surgery or unilateral ACL knee surgery

Exclusion Criteria:

* Refusal to consent
* Allergy to Chirocaine local anaesthetic
* Pace maker in situ
* Sepsis at site of regional block

Primary outcomes:
measure: Nerve stimulation resulting in muscle contraction or not
timeFrame: Five minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04420832: Acute Achilles Tendon Rupture - Choice of Treatment Based on Ultrasound Findings
Official title: Diagnostic UltraSonography for the Choice of Treatment of Acute Achilles Tendon Rupture
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Achilles Tendon Rupture
Athletic Injuries
Ultrasonography
Rupture
Acute Disease
Lead sponsor: Sahlgrenska University Hospital
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 128
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with acute achilles tendon rupture will go through an acute ultrasound. Based on the distance between the ends of the tendon the investigators will decide if the patient is going to be treated with or without surgery.


Eligibility criteria: Inclusion Criteria:

* acute achilles tendon rupture diagnosed less than 48 hours from injury
* mid-substance rupture

Exclusion Criteria:

* previous achilles tendon rupture
* lower leg disability
* diabetes mellitus
* neurovascular disease
* immunosuppression
* non-Swedish speaker

Primary outcomes:
measure: Difference in functional outcome between patients treated surgically and non-surgically
timeFrame: 3 months
measure: Difference in functional outcome between patients treated surgically and non-surgically
timeFrame: 6 months
measure: Difference in functional outcome between patients treated surgically and non-surgically
timeFrame: 12 months
measure: Difference in functional outcome between patients treated surgically and non-surgically
timeFrame: 24 months
Secondary outcomes:
measure: Ultrasonography (US)
timeFrame: 6 months
measure: Ultrasonography (US)
timeFrame: 12 months
measure: Ultrasonography (US)
timeFrame: 24 months
measure: Achilles Tendon Rupture Score (ATRS)
timeFrame: 3 months
measure: Achilles Tendon Rupture Score (ATRS)
timeFrame: 6 months
measure: Achilles Tendon Rupture Score (ATRS)
timeFrame: 12 months
measure: Achilles Tendon Rupture Score (ATRS)
timeFrame: 24 months
measure: Physical Activity Scale (PAS)
timeFrame: 3 months
measure: Physical Activity Scale (PAS)
timeFrame: 6 months
measure: Physical Activity Scale (PAS)
timeFrame: 12 months
measure: Physical Activity Scale (PAS)
timeFrame: 24 months
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Department of Orthopedics
state: Västra Götalandsregionen
Study officials:
affiliation: Sahlgrenska University Hospital
name: Katarina Nilsson Helander, MD Ass Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00558532: Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment
Official title: Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Morbid Obesity
Cardiovascular Disease
Fatty Acid Levels
Keywords: Morbid obesity
Omega-3 fatty acid levels
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2007-11-15
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing an operation for morbid obesity will be candidates for inclusion in the study as will all candidates who are undergoing abdominoplasty or other abdominal operations post bariatric surgery.

Brief summary: The purpose of this study is to determine the concentration of omega-3 fatty acids in plasma, blood and abdominal fat before and after bariatric surgery to provide guidance for future studies.

Detailed description: The omega-3 fatty acids are essential for human growth, development and well-being. Numerous studies have shown that a relatively high intake of the omega-3 fatty acids are beneficial in brain and visual development, psychiatric disorders, rheumatic disorders, inflammatory responses and cardiovascular disease. As an example, low levels of tissue omega-3 fatty acids are associated with a markedly higher rate of death from cardiac causes compared to patients with relatively high concentrations of the omega-3 fatty acids. Obese patients often have an unhealthy dietary intake and evidence of increased inflammatory processes. After a gastric bypass patients will have decreased absorption of fats from the gastrointestinal tract and may become fatty acid deficient. While gastric bypass may decrease death from cardiovascular disease in morbidly obese patients, cardiovascular disease is still the most common cause of death after a gastric bypass. There are numerous nutritional deficiencies which occur after gastric bypass and many of these are well documented. However, there are no data concerning the plasma and tissue levels of omega-3 fatty acids in morbidly obese patients either before or after operation.

Eligibility criteria: Inclusion Criteria:

* Surgical group candidates must be undergoing surgery for morbid obesity, abdominoplasty or other abdominal operation.
* Must have adequate venous access.

Exclusion Criteria:

* Insufficient venous access

Primary outcomes:
measure: Omega-3 Fatty acid levels in whole blood, plasma and abdominal fat sample
timeFrame: Within 3 months of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
Study officials:
affiliation: UC Surgeons Center fo Surgical Weight Loss/ University of Cincinnati
name: J. W. Alexander, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05545332: Prospective Multidisciplinary Post-COVID-19 Registry Tyrol
Official title: Prospective Multidisciplinary Post-COVID-19 Registry Tyrol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post COVID-19 Condition
Keywords: post COVID-19 syndrom
long COVID
long term sequelae
Lead sponsor: Medical University Innsbruck
Sponsor class: OTHER
First posted: 2022-09-19
Enrollment: 600
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: Eligible patients will be screened by primary physicians in Tyrol (Wester Austria) using the post-COVID-19 functional status (PCFS) scale to assess the functional status, and a symptom checklist for the presence and severity of the 10 most common symptoms.

Brief summary: Longitudinal, prospective observational cohort study enrolling patients with persisting symptoms (\> 12 weeks) after COVID-19 in a multidisciplinary care model.

Detailed description: Post-COVID-19 syndrome comprises a set of persistent physical, cognitive and/or psychological symptoms that continue for more than 12 weeks after illness and are not attributable to alternative diagnoses. As these symptoms may manifest in all COVID-19 severity grades, even in patients with mild or moderate disease, there is an urgent need for resource allocation in the health care system and accompanied research proposals to understand disease phenotypes and clinical trajectories.

With this prospective multidisciplinary registry, the investigators aim to establish a clinical and researchbased system by providing optimized medical diagnostic and therapeutic approaches in a model region in Austria (Tyrol).

Eligibility criteria: Inclusion Criteria:

* Individuals with persistent post COVID symptoms ≥ 12 weeks
* post COVID functional status scale (PCFS) ≥ 2

Exclusion Criteria:

* observation time after infection \< 12 weeks
* PCFS \< 2

Primary outcomes:
measure: Prevalence rates of post-COVID patients requiring multidisciplinary care.
timeFrame: 2 years
measure: Characterisation of symptom patterns associated with impaired functional status.
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
Study officials:
References:
Clinical trial NCT01321632: Efficacy of Zingiber Officinalis (Homoeopathic Medicine) in Treatment of Acne Vulgaris
Official title: Efficacy of Lesser Known Homoeopathic Medicines in Acne Vulgaris - Zingiber Officinalis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris
Homoeopathy
Zingiber officinalis
Lead sponsor: Miglani, Anjali
Sponsor class: INDIV
Collaborators: name: Department of Indian Systems of Medicine and Homeopathy
First posted: 2011-03-23
Enrollment: 32
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acne is one of the most common skin problems in teenagers and adolescents. There are many lesser known homoeopathic medicines which have been mentioned in the literature for treatment of acne but their potential has not been properly assessed /documented and therefore these medicines don't form a part of many prescriptions. As a part of this study, efficacy of Zingiber officinalis will be studied in the treatment of Acne vulgaris


Eligibility criteria: Inclusion Criteria:

* Males and females between 12 to 25 years of age
* Presence of inflammatory and non-inflammatory lesions
* Able to follow-up according to protocol
* Patients not taking any medication for treatment of Acne in preceding one month.

Exclusion Criteria:

* Acne Conglobata
* Pregnant or Breast feeding females or females having intention of becoming pregnant
* Significant systemic disease
* Any drug/ alcohol addiction
* History of chronic diseases treated with medications in the preceding month which might affect acne condition and treatment outcome

Primary outcomes:
measure: percent change in acne lesion counts from the Baseline
timeFrame: 6 months
Secondary outcomes:
measure: change in quality of life of subjects from baseline
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Delhi Government Health Centre - Homoeopathic Dispensary - Sector 12, Dwarka
state: Delhi
Study officials:
affiliation: Department of Indian Systems of Medicine and Homeopathy
name: Anjali Miglani, BHMS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01764932: Accuracy of the Thoracic Epidural Catheter Insertion Confirmed by Fluoroscopic Imaging
Official title: Determining the Accuracy of Thoracic Epidural Continuous Catheter Insertion With Confirmatory Fluoroscopic Imaging
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patients Undergoing Thoracic Surgery
Patients Undergoing Upper Abdominal Surgery
Lead sponsor: Chicago Anesthesia Pain Specialists
Sponsor class: OTHER
First posted: 2013-01-10
Enrollment: 60
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
Primary purpose: TREATMENT

Brief summary: In patients scheduled for thoracic surgery or upper abdominal surgery, investigators will determine the accuracy of the epidural catheter placement by using fluoroscopic imaging.

Previous studies have drawn contradictory conclusions based the potential flaw assumption of 100% success rate for correct epidural catheter placement in the thoracic region.

Detailed description: Thoracic epidural analgesia (TEA) is a key tool in management of pain after thoracic or upper abdominal surgery. TEA optimizes pain relief while minimizing the use of systemic opioids, thus reducing the duration of postoperative ileus. TEA also attenuates surgical stress response and allows for early mobilization. Despite all the touted benefits of TEA, much controversy limits its use for post surgical pain due to fear of exceedingly rare, if not entirely theoretical complication of epidural hematoma.

Beneficial effects of TEA require that catheter placement and infusate be targeted at the thoracic segments innervating injured skin, muscle, and bone from which pain input originates. The purpose of this study is to determine the accuracy of thoracic epidural continuous catheter insertion by using fluoroscopic imaging.

Eligibility criteria: Inclusion Criteria:

* 18- 80 years old patients
* Patients undergoing thoracic surgery
* Patients undergoing upper abdominal surgery

Exclusion Criteria:

* Severe Aortic Valve stenosis
* Active Neurologic Disease
* Allergy to lidocaine or bupivacaine
* Allergy to iodine-based contrast
* Cutaneous Disorders at epidural insertion site
* Preoperative impaired coagulation status
* Pregnancy

Primary outcomes:
measure: Presumed intervertebral level of epidural catheter
timeFrame: During procedure
Secondary outcomes:
measure: Radiologic confirmation of epidural catheter placement
timeFrame: Post procedure within one week.
measure: Change in Numeric Rating Pain Score from baseline
timeFrame: 1, 24 and 48 hrs
Other outcomes:
measure: Patient satisfaction
timeFrame: Post procedure at 48 hours
Locations:
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
Study officials:
affiliation: Chicago Anesthesia Pain Specialists
name: Kenneth D Candido, M.D.
role: PRINCIPAL_INVESTIGATOR
References: