louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03909503: A Case Series Evaluating a Collagen Wound Dressing to Treat Wounds
Official title: A Case Series Evaluating a Porcine-derived Collagen Wound Dressing to Treat Chronic Lower Extremity Wounds
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Wound
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2019-04-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic wounds are a source of significant morbidity and escalated healthcare costs. The wound care professional has a myriad of modern wound dressings to choose from, each of which has benefits and drawbacks. An understanding of how a given dressing performs in healing a particular wound is crucial in order to determine a clinical mapping of wound dressings to wound types; such a categorization would lead to more efficient clinical decision making and better patient outcomes. This case series will evaluate the ability of a porcine-derived collagen dressing to improve healing of chronic lower-extremity wounds.


Eligibility criteria: Inclusion Criteria:

* Has at least one of the following types of wounds below the knee: diabetic ulcer, pressure ulcer, venous ulcer, ulcer of mixed-vascular origin, traumatic wound, post-surgical wound
* Wound has been present for at least four weeks
* Wound is free of necrotic tissue or it is possible for necrotic tissue to be removed by typical debridement practices prior to or during treatment phase
* Wound has not healed after using at least one other type of advanced wound care treatment
* Wound size is between 1 and 100 cm2
* Patient has adequate circulation, as demonstrated by biphasic or triphasic Doppler waveform, measured within three months prior to study enrollment. If monophasic on exam, then non-invasive tests must display Ankle Brachial Index greater than 0.8 and no worse than mild disease on segmental pressures.
* Wound is free of infection and absence of osteomyelitis.

Exclusion Criteria:

* Pregnant, planning to become pregnant during the study timeframe, or breast feeding
* Has a known allergy to porcine products
* Has an allergy or sensitivity to any type of collagen
* Unable or unwilling to receive porcine collagen
* Wound is infected or there is presence of osteomyelitis
* Inability, in the opinion of the Investigator to follow protocol requirements, attend follow up visits in a timely manner, or otherwise comply with the requirements of the protocol

Primary outcomes:
measure: Change in wound size over a twelve week period
timeFrame: Baseline to 84 days
Secondary outcomes:
measure: Bates-Jensen Wound Assessment Tool score
timeFrame: Baseline to 84 days
measure: Change in reported pain level: verbal numeric pain rating scale
timeFrame: Baseline to 84 days
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00568503: Safety, Tolerability and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide and Placebo in Mild-to-moderate Chronic Obstructive Pulmonary Disease (COPD) Patients.
Official title: A Partially Blinded, Single-dose, Cross-over Proof of Concept Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAX028 Compared to Open-label Tiotropium Bromide (Positive Control) and Placebo in Mild-to-moderate COPD Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Keywords: COPD/TIOTROPIUM/QAX028
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-12-06
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This will be a single dose Proof-of-Concept study in mild-to-moderate COPD patients. The study will investigate the safety and tolerability of QAX028 as well as the bronchodilatory effects of QAX028 compared to tiotropium and placebo in mild-to-moderate COPD patients.


Eligibility criteria: Inclusion Criteria:

* Male or female patients aged 40-75 years with diagnosis of mild or moderate COPD
* Current or X-smokers with a smoking history of \>10 pack-years.
* Screening ipratropium post-bronchodilation FEV1 at 1 h post-dose will be greater than 50% of the normal predicted FEV1 value.

Exclusion Criteria:

* Patients who can not comply with the following washout periods for standard

COPD treatments as follows should be excluded:

* Short-acting bronchodilators
* Long-acting bronchodilators
* Inhaled steroids

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Safety, tolerability and pharmacodynamics of a single dose of QAX028 compared to tiotropium bromide 18μg and to placebo.
timeFrame: throughout the study
Secondary outcomes:
measure: The forced expiratory volume in 1 second (FEV1)and time profile using a kinetic pharmacodynamic (KPD) model on single doses of QAX028. Pharmacokinetics of inhaled doses of QAX028.
timeFrame: throughout the study
Other outcomes:
Locations:
city: Birkeroed
country: Denmark
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigative site
name: NOVARTIS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00503503: Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan
Official title: Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2007-07-18
Sex: ALL
Minimum age (years): 11
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: The objective of this surveillance is to determine the following items in all patients receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset (frequency, severity and other details) of adverse events, 3) factors considered to affect the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other details) of the followings will be key issues of this surveillance:Infection (tuberculosis, opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor, interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and application site reactions.


Eligibility criteria: Inclusion Criteria

· Patients with rheumatoid arthritis \[only those refractory to the previous treatment\]

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, Takeuchi T, Tanaka Y, Yamanaka H, Fujii K, Freundlich B, Suzukawa M. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009 May;36(5):898-906. doi: 10.3899/jrheum.080791. Epub 2009 Mar 30.
Clinical trial NCT05158803: Lung Ultrasound in Comparison With C.T in Covid-19
Official title: Can Lung Ultrasound Play a Competitive Role With Computed Tomography in Diagnosis and Follow up of Covid-19 Patients?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2021-12-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: covid 19 patients in acute phase and follow up after 1 and 2 months

Brief summary: investigate the diagnostic ability of thoracic ultrasound in suspicious COVID-19 infection and/or COVID-19 pneumonia. Also, to compare its findings to CT and follow up these findings.

Detailed description: ultrasound and C.T will be assessed in acute presentation of Covid 19 patients and then those patients will be reassessed again after 1 month by lung ultrasound and C.T and if ultrasound will show the same efficacy of diagnosis or not

Eligibility criteria: Inclusion Criteria:

* all cases of covid 19 patients

Exclusion Criteria:

* all other causes of consolidation ,ground glass fibrosis or collapse findings of C.T and ultrasound

Primary outcomes:
measure: diagnostic ability of thoracic ultrasound for diagnosis and follow up of covid19 patients
timeFrame: after 1 month of acute presentation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04537403: PET Detection of CCR2 in Human Atherosclerosis
Official title: PET Detection of CCR2 in Human Atherosclerosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Carotid Atherosclerosis
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-09-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: : Use of novel radio-pharmaceutical 64CUDOTA-ECL1i to evaluate arterial atherosclrosis

Detailed description: Using 64CUDOTA-ECL1i to evaluate arterial atherosclrosis in normal volunteers and patients with carotid or femoral arterial atherosclerosis..

Eligibility criteria: Inclusion Criteria: Normal Volunteers: 18-40 years of age, non smoker, no history of diabetes, hypertension, or hyperlipidemia. Patients: 50-89 years of age, adequate nutritional status, with or without smoking history, diabetes, hypertension, and hyperlipidema. Both asymptomatic and symptomatic patients with known carotid artery atherosclrosis \>70% and scheduled to undergo surgery. Advanced peripheral artery disease.

-

Exclusion Criteria:Inability to receive and sign informed consent. Currently enrolled in another study. Patients who have type 1 diabetes or are in septic shock, receiving steroid therapy, recent history of heavy alcohol consumption, (male \>2 drinks per day, and female \> 1 drink per day. following extreme diets like Atkins or South Beach diet or with Stage 4 chronic renal failure. Patients with unstable clinical condition that in the opinion of the PI precludes participation in the study. Inability to tolerate 60 minutes in a supine position with arms down at sides. Contraindications to MR imaging, (pacemaker, brain aneurysm clips, shrapnel, etc. Positive pregnancy test or lactating. Have another conditions such as cancer or autoimmune/inflammatory diseases, e.g. rheumatoid arthritis or multiple sclerosis that are known to have increased expression of CCR2.

-

Primary outcomes:
measure: Evaluation of 64CU-ECL1i , imaging characteristics
timeFrame: 1 or 2 days
Secondary outcomes:
measure: PET/MR camera, imaging performance
timeFrame: 1-2 days
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University CCIR
state: Missouri
Study officials:
References:
Clinical trial NCT04096703: Idiopathic Esophagogastric Junction Outflow Obstruction
Official title: Characterization of Lower Esophageal Sphincter Function in Idiopathic Esophagogastric Junction Outflow Obstruction and Clinical Response to Pneumatic Dilation
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Esophagogastric Junction Disorder
Keywords: Idiopathic Esophagogastric Junction Outflow Obstruction
Esophageal Sphincter Function
Esophagogastric Junction
Pneumatic Dilation
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-09-20
Enrollment: 0
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: BASIC_SCIENCE

Brief summary: This study compares two treatments for Idiopathic Esophagogastric Junction Outflow Obstruction: pneumatic dilation compared with expectant management, on symptoms and liquid barium emptying exams.

Detailed description: The objectives of this study are to address these gaps in knowledge by:

Performing a randomized controlled trial in patients with idiopathic EGJOO that compares treatment outcomes after pneumatic dilation versus expectant management (disease controls) (expectant management). And, determining rational physiological and objective measures of treatment response.

Eligibility criteria: Inclusion Criteria:

* Initial HRIM consistent with the diagnosis of EGJOO and mechanical esophageal obstruction has been excluded by prior upper endoscopy.
* EGJOO patients with a retained liquid barium column on TBE ≥5cm in height at 1 minute
* Patients must have symptomatic dysphagia

Exclusion Criteria:

* Diseases that potentially could cause mechanical obstruction such as gastroesophageal reflux disease with erosive esophagitis, peptic stricture, cancer, eosinophilic esophagitis, prior fundoplication, adjustable gastric band surgery and hiatal hernias. Patients with any identifiable anatomic esophageal or gastric obstruction will be excluded from the study
* Patients with previous surgery on the esophagus or stomach
* Previous history of per oral endoscopic myotomy or prior pneumatic dilation
* History of gastroparesis

Primary outcomes:
measure: Brief esophageal dysphagia questionnaire (BEDQ)
timeFrame: Week 0
measure: Brief esophageal dysphagia questionnaire (BEDQ)
timeFrame: 6 months
measure: Eckardt Score
timeFrame: Week 0
measure: Eckardt Score
timeFrame: Week 4
measure: Eckardt Score
timeFrame: Week 6
measure: Number of participants with retained barium column ≥5cm
timeFrame: Week 6
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Medical Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Steven Clayton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01495403: Treatment of Muscle Cramps in Patients With Liver Cirrhosis
Official title: A Pilot Study of Hydroxychloroquine for the Treatment of Muscle Cramps in Patients With Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Liver Cirrhosis
Muscle Cramps
Keywords: liver cirrhosis
muscle cramps
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-12-20
Enrollment: 3
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a pilot study to see if hydroxychloroquine (HCQ) if safe and effective to use with patients having cramps due to their cirrhotic liver disease.

Detailed description: This project is proposed as a pilot study to gather preliminary data for a full-scale randomized trial to assess the efficacy and safety of hydroxychloroquine (HCQ) in the treatment of muscle cramps in patients with cirrhosis.

Eligibility criteria: Inclusion Criteria:

* previous diagnosis of cirrhosis
* adult (\>21 years)
* able to complete a written questionnaire in English
* stable and ambulatory
* MELD score \< 25, Platelet count \>25,000

Exclusion Criteria:

* people allergic to hydroxychloroquine, 4-aminoquinolone derivatives or any component of the formulation
* previous diagnosis of retinal or visual field changes attributable to 4-aminoquinolone
* previous diagnosis of porphyria
* previous diagnosis of psoriasis
* fulminant hepatic failure
* pregnant women

Primary outcomes:
measure: frequency and severity of muscle cramps in cirrhotic patients reporting the symptom, based on the modified muscle cramps questionnaire (mMCQ)
timeFrame: 1 month after completion of questionnaire
Secondary outcomes:
measure: safety and efficacy of HCQ for severe cramping using mMCQ, SF-12, and AE inventory.
timeFrame: 28 days after first dose
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Patrick Kamath, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03502603: Pilot Study of New Computer-based Neuropsychological Tool: Visual Tests, Touch Responses
Official title: Pilot Study of New Computer-based Neuropsychological Tool: Visual Tests, Touch Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cerebral Neurological Illness
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-04-18
Enrollment: 137
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is aimed at investigating three new tests that will form part of a computerized tool designed to test brain/cognitive functioning. The system will be evaluated along with the tests' usability on samples of healthy controls and neurologically impaired patient participants. These new tests will be assessed with regard to reliability and validity. Reliability will be addressed through investigation of internal consistency of the test items. Validity will be evaluated relative to traditional paper-and-pencil tests and differentiation between patient and healthy participants.Each participant will complete both the computerized and paper and pencil-based tests. The results will be analyzed to see how performances on the two test types compare. The overall aim of this project is to determine if these new computerized tasks are an improvement over standard paper and pencil-based neuropsychological measures.


Eligibility criteria: Inclusion Criteria:

Individuals without positive cerebral findings on neuroimaging (Non-PCF)

* Participants can be male or female and between the ages of 21 and 65 years old.
* Participants will have adequate perceptual and motor capabilities to participate in testing.

Neuroimaging-positive cerebral findings (PCF)

* Patients at NYULMC identified to have significant cerebral findings on neuroimaging.
* Participants will be male or female and between the ages of 21 and 65 years old.
* Participants will have adequate perceptual and motor capabilities to participate in testing.

Exclusion Criteria:

* Participants without adequate perceptual and motor capacities preventing them from participation in the testing.
* Participants with severe dysfunction at the level of dementia that can interfere with informed consent.

Primary outcomes:
measure: Score on Railroad Test
timeFrame: 1 Day
measure: Score on Swamp Test
timeFrame: 1 Day
measure: Score on President Recognition Test
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Alexander Chervinsky, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06729203: Effect of Ultrasound Cavitation on Insulin Resistance in Patients with Central Obesity in Female
Official title: Effect of Ultrasound Cavitation on Insulin Resistance in Patients with Central Obesity in Female
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Central Obesity
Keywords: central obesity
ultrasound cavitation
insulin resistance
HOMA ir
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2024-12-11
Enrollment: 52
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effect of ultrasound cavitation on insulin resistance, HbA1c and skin fold in patients with abdominal central obesity.

Detailed description: Few researchers have detected the effects of ultrasonic cavitation on insulin resistance in subjects with central obesity. However, there were many conflicts and no clear evidence in the literature concerning the superiority of cavitation on body contour adjustment. Consequently, this study aimed to investigate the effects of ultrasound cavitation, aerobic exercise and a low-calorie dietary program on insulin resistance and total plasma HOMA ir and body contouring in female with abdominal obesity.

Eligibility criteria: Inclusion Criteria:

* Female subjects with central obesity.
* Female participants aged between 25 to 40 years.
* Body Mass Index (BMI) ranged from 30 to 35 kg/m2 as high BMI indicates more obesity and central obesity.
* Waist circumference greater than 88 cm, indicative of abdominal obesity.
* Diagnosed with insulin resistance (HOMA-IR \> 2.9).
* Sedentary lifestyle, defined as engaging in less than 150 minutes of moderate-intensity physical activity per week.
* Willingness to provide informed consent and comply with study procedures.

Exclusion Criteria:

* • Subjects diagnosed with DM (HbA1c more than 6.5%).

  * History of metabolic disorders such as type 1 diabetes or thyroid disorders.
  * Subjects with BMI less than 30 kg/m2.
  * Subjects diagnosed with heart disease, liver as well as kidney diseases.
  * Subjects who take oral contraceptives.
  * Subjects with gestational Diabetes.
  * Pregnant or breastfeeding women were excluded from the study.
  * Use of weight-loss medications or supplements within the past six months.
  * Previous surgical procedures for weight loss or body contouring.
  * Contraindications to ultrasound therapy (e.g., metal implants in the abdomen, active skin infections).
  * Participation in another clinical trial within the last three months.

Primary outcomes:
measure: HOMA ir
timeFrame: "From enrollment to the end of treatment at 8 weeks"
Secondary outcomes:
measure: Skin fold by caliper
timeFrame: "From enrollment to the end of treatment at 8 weeks"
measure: Waist circumference (WC) by tape measurement
timeFrame: "From enrollment to the end of treatment at 8 weeks"
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
References: