louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02471261: Elastography as Gouty Arthropathy Outcome (EGO)
Official title: Elastography as Gouty Arthropathy Outcome (EGO), a Pilot Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gout
Lead sponsor: Arthritis & Rheumatism Associates, P.C.
Sponsor class: OTHER
First posted: 2015-06-15
Enrollment: 10
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: A pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.

Brief summary: Elastography as Gouty Arthropathy Outcome (EGO), a pilot study.

Detailed description: Pilot study to assess 10 subjects with tophaceous gout on urate lowering therapy or about to begin urate lowering therapy.

Eligibility criteria: Inclusion Criteria:

1. Subjects who are at least 18 years of age but younger than or equal to 99 years of age.
2. Subjects with gouty arthritis as determined by the ACR 1977 classification criteria for gouty arthritis.
3. Subjects with one palpable tophus detectable by one of the three clinical parameters described.

   -

Exclusion Criteria:

1. Subjects who are not eligible for urate lowering treatment or show a hypersensitivity to these drugs or class of compounds.
2. Subjects with significant cardiovascular, neuropsychiatric, hematologic, hepatic, renal or endocrine dysfunction who in the opinion of the principal investigator are unfit for participation in a clinical trial.
3. Subjects for which the clinical and laboratory assessment would provide undue discomfort and / or are contraindicated.

   -

Primary outcomes:
measure: Elastography as Gouty Arthropathy Outcome (EGO), a pilot study
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
Study officials:
References:
Clinical trial NCT00519961: A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery
Official title: A Prospective Study to Assess the Screening Value of N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) for the Identification of Patients That Benefit From Additional Cardiac Testing Prior to Vascular Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Peripheral Vascular Disease
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2007-08-23
Enrollment: 1800
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to validate the screening potential of NT-proBNP for the identification of patients scheduled for vascular surgery who would benefit from additional pre-operative cardiac testing. All patients will have NT-proBNP concentrations measured pre-operatively. For low-intermediate risk patients only those with abnormal values will receive further cardiac testing; all high risk patients will be referred for additional testing.


Eligibility criteria: Inclusion Criteria:

* Adult patients, \&#8805;18 years of age
* Patients with peripheral vascular atherosclerosis, scheduled for vascular surgery

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Collection of 30-day and 1-year postoperative cardiac events
timeFrame: 30-day and 1-year postoperation
Secondary outcomes:
Other outcomes:
Locations:
city: Dublin 4
country: Ireland
city: Rotterdam
country: Netherlands
Study officials:
affiliation: Roche Diagnostics GmbH
name: Wilma Verhagen-Kamerbeek
role: STUDY_DIRECTOR
References:
Clinical trial NCT02363361: Treatment of Cervical Spinal Cord Injury With Imatinib - a Safety and Feasibility Study
Official title: Treatment of Acute Cervical Spinal Cord Injury With Imatinib (Glivec®) - a Safety and Feasibility Study (EudraCT no 2014-002170-36)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cervical Spinal Cord Injury
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2015-02-16
Enrollment: 10
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: This is a phase II, single center, open-label, non randomized clinical study to assess the uptake, safety and tolerability of Imatinib in acute Cervical Spinal Cord Injury patients. The aim is to determine if Imatinib reaches sufficient blood levels when given to patients with cervical spinal cord injury, via a gastric feeding tube, and also evaluate the safety and tolerability of this drug treatment.


Eligibility criteria: Inclusion Criteria:

1. Men and women aged 18-80 years
2. Clinical signs of cervical spinal cord injury due to trauma.
3. In otherwise good health condition as determined by past medical history, physical examination, laboratory tests and vital signs
4. Patient that is conscious and oriented x 4 (regarding date/time, localisation, situation and personal details), with higher level of consciousness, i.e. Glasgow Coma Scale \> 14, and is assessed to be competent to give informed consent.

Exclusion Criteria:

1. Diabetes (type I and II)
2. Ongoing cancer treatment
3. Known allergy to study drug Imatinib or its excipients
4. On current therapy with drugs which may interfere with Imatinib, (e.g. paracetamol, ketoconazole, itraconazole, erythromycin, clarithromycin, dexamethasone, phenytoin, carbamazepine, rifampicin, phenobarbital, fosphenytoin, primidon, Hypericum perforatum).
5. Female subjects lactating or with positive pregnancy test
6. Known liver or kidney disease
7. Any relevant surgical or medical condition which in the opinion of the investigator may interfere with the conduct of the study or the scientific results. This includes hemorrhagic conditions.

Primary outcomes:
measure: Change in levels of Imatinib in plasma and cytokines in serum day 1-3, 7, 10, 14, 16, 19
timeFrame: Day 1-3, 7, 10, 14, 16, 19
Secondary outcomes:
measure: Adverse events
timeFrame: Day 1-19
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska University Hospital
name: Mikael Svensson, Prof.MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02852161: The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study
Official title: The Accuracy and Acceptability of Magnet Assisted Capsule Endoscopy in the Diagnosis of Esophageal Pathology: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Barrett's Oesophagus
Oesophageal Varices
Lead sponsor: University of Nottingham
Sponsor class: OTHER
First posted: 2016-08-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: A pilot study to assess the accuracy and acceptability of a magnet assisted capsule endoscopy in detecting esophageal pathology compared to standard endoscopy.

Detailed description: This will be a single centre feasibility study performed at Nottingham University Hospitals NHS Trusts.

We will assess the accuracy of MACE compared to gastroscopy in diagnosing Barretts oesophagus and esophageal varices. Patients will have both tests on the same ay, with the endoscopic findings compared.

Eligibility criteria: Inclusion Criteria:

Due to have a clinically indicated gastroscopy Barrett's oesophagus/ oesophageal varices or Controls Able to give informed consent

Exclusion Criteria:

Unable to give consent Pregnant Pacemaker swallowing difficulties

Primary outcomes:
measure: Diagnostic accuarcy
timeFrame: immediate
Secondary outcomes:
measure: comfort
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital
Study officials:
affiliation: Nottingham University
name: Krish Ragunath
role: STUDY_CHAIR
References:
citation: Beg S, Card T, Warburton S, Rahman I, Wilkes E, White J, Ragunath K. Diagnosis of Barrett's esophagus and esophageal varices using a magnetically assisted capsule endoscopy system. Gastrointest Endosc. 2020 Apr;91(4):773-781.e1. doi: 10.1016/j.gie.2019.10.031. Epub 2019 Oct 31.
Clinical trial NCT00630461: Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma
Official title: Safety Study of 20,000 EU of Clinical Center Reference Endotoxin in Allergic Adults With and Without Mild Asthma
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Mild Allergic Rhinitis
Mild Allergic Rhinitis With Mild Asthma
Keywords: mild asthma, mild allergies
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2008-03-07
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Endotoxin is a component of outdoor air pollution, an air contaminant found in a number of different workplaces, and is even found in homes. The endotoxin used for this study is obtained from the National Institutes of Health, and is called "Clinical Center Reference Endotoxin", or CCRE. The purpose of this Phase 1 research study is to identify a dose of inhaled endotoxin that is safe (does not cause prolonged cough, shortness of breath or other problems), but causes changes in your sputum cell samples that the scientists can measure. Phase 1 research studies like this one are not intended to be a treatment, but are a scientific investigation. Eventually, with these types of studies we will be able to examine why some people are more sensitive to endotoxin. Scientists at other universities have found that while most people do not have a considerable lung response to endotoxin at doses as high as 60,000 EU (endotoxin units), a few respond to as little as a total dose of 4500 EU. Our study is designed to identify if using a dose of 20,000 EU causes changes in the lung cells but does not cause symptoms in our study subjects. In our previous studies in our lab, using an endotoxin from another source, we have used higher doses (15,000 EUs) in subjects with asthma with no major problems, and we have used 10,000 EUs of CCRE in subjects with allergies and asthma without problems. We have used 20,000 EUs of CCRE in healthy individuals with no major problems.


Eligibility criteria: Inclusion Criteria:

* Mild allergic rhinitis
* Mild allergic asthma
* Normal lung function
* No other chronic illness

Exclusion Criteria:

* Use of inhaled or oral steroids
* Emergency treatment of asthma in last year
* Inhaled tobacco use

Primary outcomes:
measure: Increased sputum neutrophils with no adverse events
timeFrame: 6 hours post challenge
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Center for Environmental Medicine, Asthma and Lung Biology
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: David b Peden, MD, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03325361: The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage Anastomotic Leakage
Official title: The Role of Transanal Tube Drainage as A Mean of Prevention of Anastomotic Leakage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectal Cancer
Rectal Neoplasms
Anastomotic Leak
Lead sponsor: University of Rome Tor Vergata
Sponsor class: OTHER
First posted: 2017-10-30
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anastomotic leakage (AL) is considered the commonest major complication after surgery for rectal cancer. Transanal tube drainage role in the prevention of AL is still debatable.

Detailed description: Patients who underwent low or ultralow anterior resection for rectal cancer were enrolled between 01/2015 and 06/2017. A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.

Patients were followed-up on the ward and then in the outpatient's department at two weeks, and one month postoperative. Patients who were suspected to have AL underwent CT with rectal contrast to assess the integrity of the anastomosis. The primary outcome was the incidence of AL. We adopted the definition published by the International Study Group of Rectal Cancer.

Eligibility criteria: Inclusion Criteria:

* Low or ultralow anterior resection with primary anastomosis for biopsy-proven primary rectal cancer

Exclusion Criteria:

* No anastomosis

Primary outcomes:
measure: Anastomotic leakage
timeFrame: 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Policlinico Tor Vergata Hospital
state: RM
Study officials:
References:
Clinical trial NCT00746161: Evaluation of Double Tract Reconstruction After Total Gastrectomy in Patients With Gastric Cancer
Official title: A Prospective Randomized Controlled Trial Comparing Double Tract Method With Roux-en-Y Method After Total Gastrectomy in Patients With Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Gastric Cancer
Keywords: total gastrectomy
double tract reconstruction
gastric cancer
Total gastrectomy in patients with gastric cancer
Lead sponsor: Wakayama Medical University
Sponsor class: OTHER
First posted: 2008-09-03
Enrollment: 44
Sex: ALL
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the double tract reconstruction after total gastrectomy in patients with gastric cancer. A prospective randomized controlled trial was conducted to compare double tract method with Roux-en-Y method

Detailed description: Patients with gastric cancer were intraoperatively randomized for R-Y reconstruction or DT reconstruction after total gastrectomy.

Eligibility criteria: Inclusion Criteria:

* Histologically proven adenocarcinoma without esophageal invasion, tumor status T1-2
* Age 80 years or younger
* No distant metastasis

Exclusion Criteria:

* Carcinoma in the remnant stomach
* Stage intravenous (IV)
* History of laparotomy
* History of serious heart disease
* Liver cirrhosis or chronic liver disease with indocyanine green excretion test at 15 min of 15% or more
* Absence of informed consent

Primary outcomes:
measure: The %body weight ratio
timeFrame: 12 months after operation
Secondary outcomes:
measure: preoperative complication, PNI and QOL score
timeFrame: within one month, and 3 and 12months after operation
Other outcomes:
Locations:
city: Wakayama
country: Japan
facility: Second Department of Surgery, Wakayama Medical University
Study officials:
affiliation: Second Department of Surgery, Wakayama Medical University
name: Makoto Iwahashi
role: PRINCIPAL_INVESTIGATOR
References:
citation: Iwahashi M, Nakamori M, Nakamura M, Naka T, Ojima T, Iida T, Katsuda M, Ueda K, Yamaue H. Evaluation of double tract reconstruction after total gastrectomy in patients with gastric cancer: prospective randomized controlled trial. World J Surg. 2009 Sep;33(9):1882-8. doi: 10.1007/s00268-009-0109-0.
Clinical trial NCT00938483: Tolerability and Safety of An Infant Formula
Official title: A Multicenter, Single-blind, Randomized, Phase II Study of the Tolerability and Safety of NPS-202 in Infants With Clinically Diagnosed Cow's Milk Allergy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Milk Hypersensitivity
Keywords: infant formula
cow's milk allergy
Lead sponsor: Perrigo Nutritionals
Sponsor class: INDUSTRY
First posted: 2009-07-14
Enrollment: 108
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to evaluate an extensively hydrolyzed formula in infants with cow's milk allergy.


Eligibility criteria: Inclusion Criteria:

* clinically diagnosed CMA
* \</= 12 weeks at time of study entry
* full-term infant
* must be willing to use provided formula as sole source of nutrition
* other than CMA, infant must be otherwise healthy

Exclusion Criteria:

* underlying or confounding gastrointestinal abnormalities
* infants born from an addictive situation, HIV positive
* if parent/guardian is considered likely to be non-compliant with the protocol requirements

Primary outcomes:
measure: Infant reactivity to an extensively hydrolyzed infant formula
timeFrame: 29 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Perrigo Nutritionals
name: Cynthia M Barber, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01273961: Study of Radiofrequency Device for Use in Non-Invasive Cosmetic Procedures
Official title: Radiofrequency Magnetic Induction Device for Use in Non-Invasive Body Contouring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laxity of Skin
Lead sponsor: Rocky Mountain Biosystems, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-11
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot research study is to collect information on the safety and effectiveness of an experimental device used to treat and improve the appearance of the skin by reducing the visibility of wrinkles and by reducing the looseness of skin.


Eligibility criteria: Inclusion Criteria:

* Male or female 21 to 70 years old,
* For females, at least 9 months post-partum,
* Clinically appreciable skin laxity on the abdomen, thigh, upper arms or neck as determined by the study investigator,
* For females, post-menopausal, surgically sterilized, or using a medically accepted form of birth control for at least 3 months prior to the study,
* Apparently healthy,
* Informed consent signed by the subject.

Exclusion Criteria:

* History of skin hypersensitivity,
* Current skin disorder (e.g. keloid scarring) or infection (e.g., herpes simplex),
* Use of non-steroidal anti-inflammatory drugs within past 2 weeks,
* Suffering from hormonal imbalance which may affect weight or cellulite,
* Subjects with pacemakers, internal defibrillators or electronically, magnetically, and mechanically activated implants,
* Subjects with implanted medical prostheses (such as clips, pins or plates) proximal to the treatment site,
* The current or recent use (within the past 12 months) of isotretinoin,
* Pregnancy or breast feeding,
* Infectious diseases (such as HIV) present,
* Are a tobacco smoker,
* Insulin dependent diabetic subjects,
* Oxygen dependent subjects,
* Subjects with severe chronic illness, scleroderma, or lupus,
* Subjects with open sores or scars in the treatment region, or
* Subjects with ischemia in the treatment region.

Primary outcomes:
measure: Improvement in cosmesis
timeFrame: 1 and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Golden
country: United States
facility: Center for Cosmetic Surgery
state: Colorado
Study officials:
affiliation: Center for Cosmetic Surgery
name: Andrew Wolfe, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rocky Mountain Biosystems, Inc.
name: Stephen Flock, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00582283: NM404 as an Imaging Agent in Patients With NSCLC
Official title: NM404 as an Imaging Agent in Patients With Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Non Small Cell Lung Cancer
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Cellectar Biosciences, Inc.
First posted: 2007-12-28
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study seeks to determine imaging characteristics of radiolabelled 131-I-NM404 in ten patients with cancer, including calculations of PKs, radiation dosimetry, biodistribution, and optimal imaging times (part 1 - complete).

In addition, specific tumor accumulation and metabolic fate of 131-I-NM404 will be determined in NSCLC tumors collected in 5 patients (part 2 - complete). Lastly, the study will collect preliminary data on imaging NSCLC tumors in up to 12 patients with evaluable disease (part 3 - ongoing).


Eligibility criteria: Inclusion Criteria: Part 3

* Histologically or cytologically documented NSCLC with measurable of disease
* Disease is evaluable by CT scan
* At least 18 years old. Women cannot be pregnant or breastfeeding
* Karnofsky score \>/= to 60
* Adequate renal/hepatic function
* Adequate blood cell count levels

Exclusion Criteria:

* Concomitant infection
* Other active cancers

Primary outcomes:
measure: Qualitative Image Analysis of NSCLC tumors with 124I-NM404 imaging agent
timeFrame: 5 days
Secondary outcomes:
measure: Semi-quantitative lesion scoring to evaluate Tumor biodistribution
timeFrame: up to 7 days
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Comprehensive Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Anne M Traynor, MD
role: PRINCIPAL_INVESTIGATOR
References: