louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00516308: A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
Official title: A Non-Randomized Study of the NightHawk Peripheral Plaque Excision System During Plaque Excision of Peripheral Arterial Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Peripheral Vascular Diseases
Keywords: CLI
Critical Limb Ischemia
PAD
Paripheral Arterial Disease
Artherosclerosis
Leg pain
Cardiovascular
Atherectomy
NightHawk
Lead sponsor: FoxHollow Technologies
Sponsor class: INDUSTRY
First posted: 2007-08-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the proximity of the catheter to the vessel wall and to correlate excised tissue with images collected by the integrated Optical coherence Tomography (OCT) imaging system. The primary endpoints are correlation between OCT images and histological characterization of excised tissue.


Eligibility criteria: Inclusion Criteria:

1. Patient requires treatment for peripheral arterial disease (PAD).
2. Patient is willing and able to provide Informed Consent.
3. Patient has at least one focal, de novo infrainguinal lesion in a native vessel.
4. The minimum reference vessel diameter is 2.0 - 4.5 mm, dependent on the NightHawk device used.
5. The lesion is ≥ 50% stenosed by quantitative vascular angiography.
6. The lesion is ≤ 7 cm in length.
7. The patient must be able to take at least one form of anti-platelet or anti-thrombotic therapy.

Exclusion Criteria:

1. Patient presents with degree of limb disease or a co-existing medical condition that makes revascularization inappropriate.
2. The patient has diffuse peripheral arterial disease and/or the disease is heavily calcified.
3. Patient presents with concomitant disease contraindicating an endovascular intervention.
4. Patient is pregnant.
5. The patient has a hypersensitivity to contrast materials that cannot be adequately pretreated.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: Austin Heart
state: Texas
Study officials:
References:
Clinical trial NCT02939508: Should Colon or Non-colon Originated Lesions be Distinguished?
Official title: Acute Lower Gastrointestinal Dysfunction in Critical Care Patients: Should Colon or Non-colon Originated Lesions be Distinguished?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Acute Lower Gastrointestinal Dysfunction
Keywords: Acute lower gastrointestinal dysfunction
Colon-originated lesions
Critical patient
Colonoscopic decompression
Anticholinergic drugs
Lead sponsor: Chinese Medical Association
Sponsor class: NETWORK
First posted: 2016-10-20
Enrollment: 158
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This prospective study was designed to compare the difference of effects of conventional treatment, medicine intervention, endoscopic therapy, and surgery between colon originated and non-colon originated ALGID in critical patients, in order to alert doctors to differ the treatment of the two ALGID and provide basis for treatment.


Eligibility criteria: Inclusion Criteria:

1. Patients in our ICU aged 18-75 years.
2. Patients with a confirmed diagnosis of ALGID.

Exclusion Criteria:

1. mechanical intestinal obstruction (including tumor, stercoral obstruction etc.)
2. gastrointestinal hemorrhage within 72 hours.
3. history of inflammatory bowel disease (ulcerative colitis or Crohn's disease) or radiation enteritis.
4. pregnancy.
5. contraindications of neostigmine administration.

Primary outcomes:
measure: 28-day mortality after admission
timeFrame: 1-28 day after admission
measure: ICU mortality, n (%)
timeFrame: 1-28 day after ICU admission
Secondary outcomes:
measure: ICU stage, (day)
timeFrame: 1-60 day after ICU admission
measure: Hospitalization, (day)
timeFrame: 1-60 day after admission
measure: intra-abdominal pressure
timeFrame: 1-28 day after admission
measure: Abdominal compartment syndrome
timeFrame: 1-28 day after admission
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Jinling Hospital
state: Jiangsu
Study officials:
References:
Clinical trial NCT05556408: High-Resolution Solid-State Manometry of the Effect of Succinylcholine on Barrier Pressure
Official title: High-Resolution Solid-State Manometry of the Effect of Succinylcholine on Barrier Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: the Effect of Succinylcholine on Barrier Pressure
Keywords: lower esophageal sphincter
intragastric pressure
succinylcholine
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2022-09-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The lower esophageal sphincter（LES）plays a key role in preventing regurgitation and aspiration. The pressure of LES partly comes from striated muscles derived from the crural portion of the diaphragm. The effect of succinylcholine on esophagogastric junction during anesthesia induction is not clear. We conducted a prospective interventional study on the effect of succinylcholine on the barrier pressure (BrP) of the esophagogastric junction.

Detailed description: 14 patients participated in the study. Propofol and succinylcholine were used for anesthesia induction. High-resolution solid-state manometry (HRM) was used to monitor the changes of the LES pressure and the intragastric pressure (IGP).The administration of propofol could significantly increase the LES pressure during end expiration and during inspiration. The application of succinylcholine had no effect on the LES pressure during end expiration, but significantly reduced the LES pressure during inspiration. Propofol had no effect on BrP. After the application of succinylcholine, BrP decreased significantly during inspiration.

Propofol significantly increased the LES pressure. Succinylcholine significantly reduced the pressure of LES and BrP during inspiration.

Eligibility criteria: Exclusion criteria：patients who classified as American Society of Anesthesiologists classification system (ASA) II were included. Patients were included in the study if they had on history of diabetes, pharynx and digestive diseases.

Exclusion criteria：currently pregnant or breastfeeding, a body mass index (BMI) over 30 kg/m2. All patients underwent preoperative preparation according to clinical routine and did not give preoperative drugs.

Primary outcomes:
measure: pressure of lower esophageal sphincter
timeFrame: 15 minutes
measure: pressure of intragastric
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03385408: Effectiveness of HILT in Shoulder Osteoarthritis
Official title: Effectiveness of High-intensity Laser Therapy in Shoulder Osteoarthritis; a Prospective, Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of the Shoulder
Lead sponsor: University of Rzeszow
Sponsor class: OTHER
First posted: 2017-12-28
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will determine the efficacy of High Intensity Laser Therapy (HILT) for the treatment of shoulder osteoarthritis.

Detailed description: Shoulder osteoarthritis (SO) is a musculoskeletal joint disease that affects the elderly. SO is characterized by degeneration of the articular cartilage in the involved joints and its underlying bone within a joint as well as bony overgrowth. It is one of the major causes of physical disability that has a social and public health impact due to pain, stiffness, joint instability, and muscle weakness.

The diagnosed patients with SO will be treated with HILT for a total of ten sessions during the entire duration of the treatment protocol. Parameters to be evaluated are: range of motion, pressure pain (algometer), pain perception (Visual Analog Scale (VAS), Modified Laitinen Pain Questionnaire), quality of life (WHOQoL-BREF) These parameters will be recorded before the first treatment (baseline), after completion of treatment, three and 12 months after completion treatment. A change in above parameters will be evaluated.

Eligibility criteria: Inclusion Criteria:

1. painful osteoarthritis of the shoulder for at least 6 months
2. not engage in any other treatment during treatment period
3. pain ≥4 on the visual analog scale (VAS) in the previous 3 months

Exclusion Criteria:

1. presence of any other musculoskeletal problems associated with the shoulder joint, such as fracture, tendon or ligament tears, meniscus injury, rheumatoid arthritis, or shoulder surgery
2. receiving physical therapy and/or intra-articular corticosteroid or hyaluronic acid injections during the last 6 months
3. absolute and relative contraindications of Laser Therapy

Primary outcomes:
measure: Change in the pain perception
timeFrame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Secondary outcomes:
measure: Change in the quality of life
timeFrame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
measure: Change in the range of motion
timeFrame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
measure: Change in the pressure pain
timeFrame: at baseline, immediately after treatment completion, 3 and 12 months after treatment completion
Other outcomes:
Locations:
city: Rzeszów
country: Poland
facility: University of Rzeszów
Study officials:
affiliation: University of Rzeszow
name: Justyna Wyszyńska, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05501808: Color Stability of Two Different Resin Matrix Ceramics
Official title: Color Stability of Two Different Resin Matrix Ceramics: Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Restoration
Keywords: ceramics
color
stability
resin Matrix
Lead sponsor: Fayoum University
Sponsor class: OTHER
First posted: 2022-08-15
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: patient with endo treated first molar
Primary purpose: TREATMENT

Brief summary: This is in vivo study aimed to evaluate the color stability of the newly introduced resin ceramic matrix (cerasmart )\& (vita-enamic ) after a one year

Detailed description: This is in vivo randomized clinical trial aimed to evaluate the color stability and patient satisfaction of the newly introduced resin ceramic matrix (cerasmart )\& (vita-enamic ) in posterior endodontically treated teeth through one year follow-up

Eligibility criteria: Inclusion Criteria:

* diagnose need for restoration in endo treated posterior teeth
* good general health and oral health
* occlusal stability

Exclusion Criteria:

* smoking
* pregnancy
* use drugs that affect oral health
* Para functional habits

Primary outcomes:
measure: color change
timeFrame: 12 months
Secondary outcomes:
measure: patient satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: Fayoum
country: Egypt
facility: Faculty of Dentistry- Fayoum University
Study officials:
References:
citation: Kanat-Erturk B. Color Stability of CAD/CAM Ceramics Prepared with Different Surface Finishing Procedures. J Prosthodont. 2020 Feb;29(2):166-172. doi: 10.1111/jopr.13019. Epub 2019 Jan 24.
citation: Jorquera GJ, Atria PJ, Galan M, Feureisen J, Imbarak M, Kernitsky J, Cacciuttolo F, Hirata R, Sampaio CS. A comparison of ceramic crown color difference between different shade selection methods: Visual, digital camera, and smartphone. J Prosthet Dent. 2022 Oct;128(4):784-792. doi: 10.1016/j.prosdent.2020.07.029. Epub 2021 Mar 17.
Clinical trial NCT02140008: A Comparison of the I-gel and the Self-pressurised Air-Q Intubating Laryngeal Airway in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: General Anesthesia
Supraglottic Airway Devices
Keywords: supraglottic airway devices
the i-gel
the self-pressurised air-Q intubating laryngeal airway,
children
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-05-16
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 108
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Supraglottic airway devices (SADs) are well established in pediatric anesthetic practice. The pediatric i-gel and the self-pressurised air-Q (air-Q) are new supraglottic airway devices for children. The i-gel is made of a soft, gel-like elastomer with a noninflatable cuff. The air-Q is a new single-use device that may optimise the airway seal while reducing the potential for postoperative complications such as sore throat. The overall structure of the air-Q SP is identical to the original air-Q, except with regard to the inflatable cuff. The aim of this randomized trial was to compare the clinical performance of the i-gel and the air-Q SP.


Eligibility criteria: Inclusion Criteria:

* Children (1-108 month of age and 7-30kg) scheduled for elective surgery of short duration (less than 2 hr) undergoing general anesthesia using supraglottic airway

Exclusion Criteria:

* Patients with a potentially difficult airway, risk of aspiration such as gastroesophageal reflux disease, or active upper respiratory tract infection

Primary outcomes:
measure: airway leak pressure
timeFrame: within 5 min after insertion of each device
Secondary outcomes:
measure: Insertion time (insertion parameter)
timeFrame: During and 1 min after insertion of each device
Other outcomes:
measure: Ease of insertion (insertion parameter)
timeFrame: During and 1 min after insertion of each device
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT06092008: Performance of New Diagnostic Methods in Older Adults With Pneumonia
Official title: Establishing and Implementing Pneumonia Diagnosis in ED Older Adults: A Mixed Methods Approach
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2023-10-23
Enrollment: 250
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: Adults aged 65 and older presenting to the Emergency Department

Brief summary: Create a clinical diagnostic pathway for older ED adults with pneumonia and its subgroups (bacterial, viral, and co-infection) and determine whether novel biomarkers improve diagnostic accuracy. The investigators will conduct a prospective observational trial of 250 ED patients ≥65 years old with suspected pneumonia. The investigators will perform analyses overall and by subgroups, seeking common models to ease adoption.


Eligibility criteria: Inclusion Criteria:

- Adults aged 65 and older presenting to the ED with suspected pneumonia defined as (1) either a physician order for CXR OR CT OR a chief complaint consistent with dyspnea; AND (2) physician suspicion of pneumonia prior to ED testing (score of 2-5 on Likert scale)

Exclusion Criteria:

* inability to obtain consent from the patient or an LAR
* active cancer
* organ transplant
* immunosuppression
* trauma activation
* suicidal ideation
* incarceration
* antibiotics in the last 14 days
* a separate episode of lower respiratory illness in the last 30 days

Primary outcomes:
measure: Pneumonia
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University
state: Ohio
Study officials:
References:
Clinical trial NCT04071808: Painless Myocardial Ischemia in Diabetic Patients.
Official title: Changes of Plasma Orphanin and Norepinephrine Levels in Patients With Painless Myocardial Ischemia and Diabetes Mellitus.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Painless Myocardial Ischemia
Lead sponsor: Second Hospital of Shanxi Medical University
Sponsor class: OTHER
First posted: 2019-08-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: This study aims to investigate the relationship between the concentrations of blood orphanin, norepinephrine and the morbidity of painless myocardial ischemia in patients with diabetes mellitus. Hopefully, the biomarker(s) in the blood of diabetic patients can be found for screening high risk patients in the diabetes sufferers to prevent the painless myocardial ischemia.


Eligibility criteria: Inclusion Criteria:

* Subject has diabetes

Exclusion Criteria:

* History of myocardial ischemia
* Symptoms of myocardial ischemia（ECG changes except）

Primary outcomes:
measure: Blood orphanin content
timeFrame: 24 hours
measure: Blood norepinephrine content
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Taiyuan
country: China
facility: Second of Shanxi Medical University
state: Shanxi
Study officials:
References:
Clinical trial NCT03735108: Neutrophil Extracellular Traps Mediate Antiphospholipid Antibody-induced Pregnancy Loss
Official title: Neutrophil Extracellular Traps Mediate Antiphospholipid Antibody-induced Pregnancy Loss
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Neutrophil Extracellular Traps; Antiphospholipid Antibody-induced Pregnancy Loss
Lead sponsor: Shanghai First Maternity and Infant Hospital
Sponsor class: OTHER
First posted: 2018-11-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: City

Brief summary: 1. Establish a multi-platform detection system for neutrophil extracellular traps in blood and tissues, and evaluate the detection performance;
2. Comparing the expression levels of neutrophil extracellular traps in peripheral blood and decidua of patients with antiphospholipid antibody-induced pregnancy loss and normal control group;
3. Comparing the expression levels of neutrophil extracellular traps in peripheral blood and decidua of mice with antiphospholipid antibody-induced pregnancy loss and normal control group;
4. After treatment of antiphospholipid antibody-induced mouse abortion model with metformin,the effect of metformin on embryo loss rate and viable embryo body weight was observed.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Recurrent spontaneous abortion
* Clinical diagnosis of Antiphospholipid syndrome

Exclusion Criteria:

* Other autoimmune diseases
* Hematopoietic system diseases
* Cardiovascular system diseases
* Gastrointestinal system diseases
* Urinary system diseases
* Nervous system or mental diseases
* Have taken other drugs recently

Primary outcomes:
measure: NETs level
timeFrame: through study completion, an average of 8 months
Secondary outcomes:
measure: complete blood count (CBC)
timeFrame: through study completion, an average of 8 months
Other outcomes:
measure: C3 level
timeFrame: through study completion, an average of 8 months
Locations:
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
Study officials:
References:
Clinical trial NCT01334008: Study of Circulating Tumoral DNA in Metastatic Choroidal Melanoma
Official title: Development and Validation of a Circulating Tumor DNA Detection Technique in Patients With Metastatic Choroidal Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choroidal Melanoma, Diffuse
Keywords: Circulating tumor DNA
Choroidal Melanoma
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2011-04-12
Enrollment: 40
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: Circulating tumor DNA detection and quantification in patients with metastatic choroidal melanoma.

Detailed description: Technique development: In first step, the different available techniques will be evaluated for specificity and sensibility using serial dilutions of cell lines with or without GNAQ mutation.

Validation: The tumor DNA detection rate will be estimated from metastatic uveal patient's blood. The investigators will study 40 patients to obtain at least 15 patients bearing a GNAQ mutation in the primitive tumor or in metastasis. With those 15 patients, the investigators will determinate the most sensitive technique and the best cost/efficiency ratio.

Eligibility criteria: Inclusion Criteria:

* Age \> or = 18 years.
* Patient with a metastatic choroidal melanoma.
* Patient with tumor or metastasis available for GNAQ (Guanine nucleotide blinding protein) status characterization.
* Patient able to stand a blood collection.
* Signed written informed consent approved by competent authority and ethic committee.

Exclusion Criteria:

* Patient without social protection/insurance.
* Current pregnancy and lactation.
* All social, medical, psychological, situations making the study impossible.
* Person deprived of liberty.

Primary outcomes:
measure: Assessment and development of circulating tumor DNA detection techniques
timeFrame: 2 years
Secondary outcomes:
measure: Detection technique comparison (PAP (pyrophosphorolysis activated polymerisation), BEAMing, NGS(next sequencing generation)) in terms of feasibility, robustness, sensitivity and cost.
timeFrame: 2 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
affiliation: Institut Curie
name: Sophie PIPERNO-NEUMANN, MD
role: PRINCIPAL_INVESTIGATOR
References: