louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03004235: Suspected Cases of Carbon Monoxide Poisoning in the ED
Official title: ED Data Collection of Suspected Carbon Monoxide Poisoning
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carbon Monoxide Poisoning
Lead sponsor: Nonin Medical, Inc
Sponsor class: INDUSTRY
First posted: 2016-12-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The participants will be selected based on symptoms in the Emergency Department.

Brief summary: The purpose of this study is to collect non-invasive observational data in suspected or known carbon monoxide poisoning.


Eligibility criteria: Inclusion Criteria:

* Known or suspected carbon monoxide poisoning

Exclusion Criteria:

* Less than 18 years of age

Primary outcomes:
measure: Values from the test device will be compared to the values from co-oximetry to determine the accuracy of the test device
timeFrame: Through study completion, an average of 2 years.
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
Study officials:
affiliation: Hennepin County Medical Center, Minneapolis
name: James Miner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00669435: Losartan and Simvastatin in Hypertensive Obeses With Liver Steatosis
Official title: Ultrasonographic Modification of Liver Steatosis and Visceral Fat Induced by Treatment With Losartan and Simvastatin in Hypertensive Normocholesterolemic Obese Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypertension
Keywords: Essential hypertension
Liver steatosis
Lead sponsor: University of Pavia
Sponsor class: OTHER
First posted: 2008-04-30
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Angiotensin II has been proposed as a lipid metabolism regulator. It is known that adipocytes secrete a variety of protein, such as TNFα, plasminogen activator inhibitor (PAI)-1, leptin, resistin and adiponectin; these proteins have a wide range of biological effects and are associated with insulin resistance. Adipocytes also produce angiotensinogen and angiotensin II and a local renin-angiotensin system (RAS) is present in adipose tissue. In overweight or obese hypertensive normocholesterolemic patients the treatment with AT1-receptor blocker (Losartan) may have a better effect on hepatic steatosis and visceral fat deposition than the antihypertensive treatment with calcium channel blocker (amlodipine). Simvastatin will be added to both groups. The aim of this study is to evaluate the effect of losartan and simvastatin on ultrasonographic qualitative and quantitative parameters in overweight or obese hypertensive normocholesterolemic patients with hepatic steatosis.


Eligibility criteria: Inclusion Criteria:

* Gender: 50% Male and 50% female
* Age: 40-80 years
* Race: Caucasian
* Overweight or obese: respectively BMI25-30 kg/m2 or BMI \> 30 kg m2
* Hypertensive: PA \> 140/90 mmHg
* Normocholesterolemic (LDL\< 160 mg/dl HDL \> 35 mg/dl)
* Liver steatosis

Exclusion Criteria:

* other antihypertensive treatment after wash out period of 2 weeks
* abnormal heart rest function (EF \< 55%).
* valvular heart disease
* congenital heart disease
* heart failure or prior myocardial infarction
* diabetes
* renal disease
* liver disease
* connective tissue disease
* pregnancy or lactation
* serious adverse experience
* sensitivity to the study drugs or its components
* contraindication from an approved label

Primary outcomes:
measure: All patients will undergo anthropometric evaluation and abdominal ultrasonography (performed by the same examiner); will be taken routine liver US and US measurement of visceral and subcutaneous fat.
timeFrame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
Secondary outcomes:
measure: Determination of insulin sensitivity, leptin, adiponectin, TNFα, IL6, hsPCR
timeFrame: Between 08.00 and 10.00 at baseline, and after 1, 6, and 12 months
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: University of Pavia
Study officials:
References:
Clinical trial NCT03686735: Patient Satisfaction Scales
Official title: How to Measure Patient Satisfaction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: All Orthopedic Disorders
New or Follow-up Patients
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2018-09-27
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All new and follow-up patients seeing an upper- or lower-extremity surgeon will be invited to enroll at the end of their visit.

Brief summary: This study aims to assess differences between 4 types of single satisfaction measures. Secondly, if there is a difference in satisfaction between English speaking and Spanish speaking patients.


Eligibility criteria: Inclusion criteria:

* All new or return patients seeing a UE / LE surgeon
* Age 18-89
* Able to provide informed consent
* English speaking
* UT Health Austin Musculoskeletal Institute, Austin Regional Clinic, Seton Institute for Plastic and Reconstructive Surgery, Orthopaedic Specialists of Austin, Texas Orthopedics, and ATX Ortho.

Exclusion criteria:

* Not fluent in English

Primary outcomes:
measure: Patient satisfaction scale 1
timeFrame: Immediately after the visit. Through study completion, approximately 6 months.
measure: Patient satisfaction scale 2
timeFrame: Immediately after the visit. Through study completion, approximately 6 months.
measure: Patient satisfaction scale 3
timeFrame: Immediately after the visit. Through study completion, approximately 6 months.
measure: Patient satisfaction scale 4
timeFrame: Immediately after the visit. Through study completion, approximately 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Regional Clinic
state: Texas
city: Austin
country: United States
facility: Texas Orthopedics
state: Texas
city: Austin
country: United States
facility: HTB Musculoskeletal Institute
state: Texas
city: Austin
country: United States
facility: Seton Institute for Plastic and Reconstructive Surgery
state: Texas
city: Austin
country: United States
facility: Orthopedic Specialists of Austin
state: Texas
city: Austin
country: United States
facility: ATX Ortho
state: Texas
Study officials:
References:
Clinical trial NCT04807335: Study of CT001 in Healthy Volunteers
Official title: Bioavailability Study of Intranasal CT001 in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Bioavailability
Lead sponsor: Cessatech A/S
Sponsor class: INDUSTRY
Collaborators: name: Dantrials Aps
name: Smerud Medical Research International AS
First posted: 2021-03-19
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: A phase 1, three arms, cross over comparison study to evaluate bioavailability, pharmacokinetics and safety of intra nasal CT001 in healthy volunteers.

Detailed description: A single site phase 1 study including a randomised, open label, three periods, single dose, cross over design in 12 healthy male volunteers.

Eligibility criteria: Inclusion Criteria:

* Age from 18 up to 55 years
* Non-smokers
* Body mass index (BMI) from 18.5 kg/m2 up to 30 kg/m2 v) Categorized as American Society of Anesthesiologists (ASA)
* Physical Status Class 1 or 2
* Clinically normal medical history, physical findings, vital signs, ECG and laboratory values.

Exclusion Criteria:

* Mental illness
* Opioid Risk Tool score of \>3
* Pain Catastrophizing Scale score, total points \>30
* Hospital Anxiety and Depression Scale (HADS), points ≥11 for anxiety or ≥11 points for depression
* Daily intake of analgesics
* History of alcohol or drug abuse or use of illicit drugs.
* Use of prescription drugs within 14 days or over-the-counter drugs 24 hours (intranasal medication 48 hours) prior to the first dose of study medication.
* Participant showing abnormal nasal cavity/airway
* History or presence of allergy to the study drug or drugs of this class, or a history of drug or other allergy.
* Positive tests for HIV, hepatitis B and hepatitis C
* Positive COVID-19 test or clinical symptoms of COVID-19
* Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 30 days of signing the informed consent for this trial
* Blood donation within 4 weeks prior to the first dosing visit

Primary outcomes:
measure: concentration of CT001 in the blood
timeFrame: baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose
measure: Total amount of CT001 in the blood over time
timeFrame: baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose
Secondary outcomes:
measure: distribution and elimination of CT001
timeFrame: baseline, 3, 5, 10, 15, 30, 60, 90, 180, 240 minutes and 6, 9, 24, 32, 48 hours after dose
measure: number of study participants with adverse events
timeFrame: from baseline to 48 hours post dose
measure: elimination of CT001
timeFrame: from baseline to 48 hours
measure: vital signs
timeFrame: from baseline to 48 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Dantrials
state: DK
Study officials:
affiliation: Rigshospitalet, Denmark
name: Mads Werner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03907735: Oxytocin Receptor Expression in Pregnancy
Official title: Oxytocin Receptor Expression in Pregnancy: When Does it Turn on
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Post-Abortion
Hemorrhage, Obstetric
Keywords: Post-abortion hemorrhage
Obstetric hemorrhage
Preterm labor
Abnormal labor
Oxytocin
Oxytocin receptor
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a study of reproductive age women over 18 years of age being performed at Oregon Health \& Science University (OHSU) in Portland, OR. It will include subjects who present for pre-operative appointments in our outpatient Center for Women's Health Family Planning Clinic and OHSU Labor and Delivery.

Brief summary: This study aims to determine when during gestation oxytocin receptor (OXTR) expression increases in the myometrium, which will contribute new insight to the management of obstetric hemorrhage and our understanding of normal and abnormal labor.

Detailed description: In this descriptive study, we will obtain myometrial tissue samples by core needle biopsy under ultrasound guidance in anesthetized women immediately following surgical abortion and from controls, all of whom are undergoing a separate planned obstetric/gynecologic surgery. Tissue studies will be performed on these biopsy samples to examine oxytocin receptor expression and function.

Eligibility criteria: Inclusion Criteria:

* Women age 18-50
* Gestational age 14-26 weeks; or 6-13 weeks, 37-42 weeks, or non-pregnant (controls)
* Undergoing another planned surgical procedure with anesthesia (suction D\&C, D\&E, gravid hysterectomy, cesarean section, or laparoscopic tubal ligation)
* Able to give informed consent in English or Spanish

Exclusion Criteria:

To optimize biopsy safety, we will exclude patients with anticipated difficult cases, that have additional risks of hemorrhage, or those with features that limit ultrasound visualization.

Increased risk of hemorrhage:

* Anemia (Hgb \< 9)
* Anticoagulation, bleeding disorder, or coagulopathy
* Multiple gestation
* Infection or sepsis

For ultrasound-guided procedures:

* Obese, BMI ≥ 40
* History of ≥2 cesarean sections
* Large fibroids or uterine anomalies obstructing view
* Other poor visualization
* Thin myometrium \< 1cm

Primary outcomes:
measure: Oxytocin receptor expression
timeFrame: 30 minutes
Secondary outcomes:
measure: Function of myometrial oxytocin receptor
timeFrame: 30 minutes
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Jessica Reid, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02246335: Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly
Official title: Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Femoral Neck Fractures
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 120
Sex: ALL
Minimum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly

Detailed description: Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).

Eligibility criteria: Inclusion Criteria:

* Acute displaced femoral neck fracture of hip (Garden classification 3-4)
* Independent walker with or without walking aides
* Patient willing to participate in the study and give written consent.

Exclusion Criteria:

* Fracture older than 36 hours before admission
* Osteoarthritis in the fractured hip
* Rheumatoid arthritis in the fractured hip
* Pathological fractures
* Contraindication for hip arthroplasty surgery
* Not suitable for inclusion for other reasons e.g. substance abuse

Primary outcomes:
measure: Harris hip score
timeFrame: 2 years
Secondary outcomes:
measure: EQ-5D
timeFrame: 2 years
measure: EQ-5D
timeFrame: 4 years
measure: EQ-5D
timeFrame: 6 years
measure: EQ-5D
timeFrame: 10 years
measure: Adverse events
timeFrame: 2 years
measure: Adverse events
timeFrame: 4 years
measure: Adverse events
timeFrame: 6 years
measure: Adverse events
timeFrame: 10 years
measure: Harris hip score
timeFrame: 4 years
measure: Harris hip score
timeFrame: 6 years
measure: Harris hip score
timeFrame: 10 years
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Orthopaedic department, Danderyd Hospital
Study officials:
References:
citation: Skoldenberg O, Chammout G, Mukka S, Muren O, Nasell H, Hedbeck CJ, Salemyr M. HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial. BMC Musculoskelet Disord. 2015 Oct 19;16:307. doi: 10.1186/s12891-015-0763-3.
Clinical trial NCT02887235: Food as Medicine: An RCT to Study the Effect of Home Delivered, Medically Tailored Meals on Patients With Metastatic Cancer
Official title: Food as Medicine: A Phase III Randomized Controlled Trial of Home Delivered, Medically Tailored Meals (HDMTM) on Quality of Life in Metastatic Lung and Non-colorectal GI Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-09-02
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to determine whether medically tailored meals (HDTM) can improve quality of life for patients with metastatic cancer.

Detailed description: The current standard of care at the cancer center is for all patients receiving cytotoxic therapy to undergo a nutritional consultation and evaluation with a registered oncology dietitian. The goal of this consultation is to prevent nutritional deficiencies, promote optimal nutritional intake, hydration, and weight maintenance, as well as maintain lean body mass.

All patients on this study will receive standard of care nutritional services including nutrition consult, evaluation, and as needed follow-ups. However, patients randomized to arm 2 will receive home delivered, medically tailored meals in addition to the standard nutritional care.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of pathologically confirmed metastatic pancreatic, hepatobiliary, esophageal, or lung cancer, either newly metastatic or metastatic at presentation (M1+) and enrollment within 6 weeks of diagnosis; measurable disease need not be present.
* Pain Score (PS) 0-3
* Age\>18
* Both male and female subjects eligible
* All ethnicities eligible
* Access to refrigerator or freezer

Exclusion Criteria:

* Diagnosis of metastatic cancer no greater than 6 weeks prior to expected study enrollment
* Currently receiving home delivered meals from other sources
* Evidence of any alimentary tract obstruction or other condition preventing oral alimentation
* Requirement for enteral or parenteral nutrition at time of diagnosis
* Incarcerated individuals

Primary outcomes:
measure: Quality of life measurement
timeFrame: At 12 weeks follow up
Secondary outcomes:
measure: Change in mood assessment
timeFrame: From baseline to 12 weeks
measure: Patient weight assessment
timeFrame: From baseline to 12 weeks
measure: Nutritional status assessment
timeFrame: From baseline to 12 weeks
measure: Financial toxicity assessment
timeFrame: From baseline to 12 weeks
measure: Food security assessment plus HDMTM from baseline to 12 weeks
timeFrame: From baseline to 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Perlmutter Cancer Center
state: New York
Study officials:
affiliation: NYU Perlmutter Cancer Center
name: Peter Schiff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02514135: Intra-abdominal Hypertension in Critically Ill Patients
Official title: Intra-abdominal Hypertension in Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intra-Abdominal Hypertension
Abdominal Compartment Syndrome
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2015-08-03
Enrollment: 286
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adults (\>18 years of age) admitted to the intensive care unit at Victoria Hospital, London, Ontario who have a Foley catheter in-situ

Brief summary: The aim of the proposed study is to determine the incidence and prevalence of intra-abdominal hypertension and abdominal compartment syndrome in consecutive intensive care admissions using broad inclusion criteria.

Detailed description: Increased pressure within the abdominal cavity is particularly common in intensive care patients and has been shown to be an independent risk-factor for mortality in this patient population. The quoted rates of intra-abdominal hypertension of range anywhere from 20-60% are dependent on the population of patient studied. The prospective observational studies performed to date have been underpowered, used strict inclusion/exclusion criteria or were performed prior to consensus guidelines on the definition and measurement of intra-abdominal pressure and hypertension.

Eligibility criteria: Inclusion Criteria:

* Foley catheter in-situ on admission

Exclusion Criteria:

* Contra-indication to bladder pressure measurement
* Home service asked that patient is not included
* Death within 24 priors of admission before bladder pressure measured
* No bladder pressure performed within 24 hours of admission
* Consent refused or unable to be obtained (lack of SDM, patient unable to provide)

Primary outcomes:
measure: Mortality
timeFrame: While patient in-hospital, expected stay one week on average
Secondary outcomes:
measure: Length of stay
timeFrame: While patient in-hospital, expected stay one week on average
measure: Abdominal decompression
timeFrame: While patient in-hospital, expected stay one week on average
Other outcomes:
Locations:
city: London
country: Canada
facility: Victoria Hospital
state: Ontario
Study officials:
affiliation: Western University
name: Kelly N Vogt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kirkpatrick AW, Roberts DJ, De Waele J, Jaeschke R, Malbrain ML, De Keulenaer B, Duchesne J, Bjorck M, Leppaniemi A, Ejike JC, Sugrue M, Cheatham M, Ivatury R, Ball CG, Reintam Blaser A, Regli A, Balogh ZJ, D'Amours S, Debergh D, Kaplan M, Kimball E, Olvera C; Pediatric Guidelines Sub-Committee for the World Society of the Abdominal Compartment Syndrome. Intra-abdominal hypertension and the abdominal compartment syndrome: updated consensus definitions and clinical practice guidelines from the World Society of the Abdominal Compartment Syndrome. Intensive Care Med. 2013 Jul;39(7):1190-206. doi: 10.1007/s00134-013-2906-z. Epub 2013 May 15.