louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02109172: A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Cross-Over Study of QD and BID Nebulized TD-4208 in Subjects With Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
Collaborators: name: Theravance Biopharma
First posted: 2014-04-09
Enrollment: 64
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluated the safety and efficacy of once and twice daily TD-4208 and placebo when administered using a jet nebulizer for 7 days in a cross-over design to patients with moderate to severe chronic obstructive pulmonary disease.


Eligibility criteria: Inclusion Criteria:

* Subject must have a negative pregnancy test, and must be prepared to use effective contraception if of child-bearing potential
* Subject is capable of performing reproducible spirometry maneuvers
* Subject has post-bronchodilator FEV1/FVC (forced expiratory volume in 1 second/forced vital capacity) ratio \<0.7
* Subject has moderate-to-severe stable COPD (Stage 2 or 3 according to the Global Initiative for the Treatment of Obstructive Lung Disease (GOLD) Guidelines)
* Subject has a post-bronchodilator FEV1 greater than or equal to 30% and less than 80% of predicted normal
* Subject demonstrates a post-ipratropium FEV1 response ≥ 12% and ≥ 200 mL of pre-ipratropium FEV1 response
* Subject has a current or past smoking history of at least 10 pack-years.

Exclusion Criteria:

* Subject has a significant respiratory disease or disorder other than COPD that would affect the interpretation of data from this study
* Subject has a history of reactions or hypersensitivity to inhaled anticholinergic or beta-agonist agents
* Subject suffers from any medical condition that would preclude the use of inhaled anticholinergic agents
* Subject has been hospitalized for COPD or pneumonia within 12 weeks.
* Subject requires long-term oxygen therapy (\>15 hours a day)

Primary outcomes:
measure: Weighted Mean (0-24hr) Change From Baseline FEV1 (Forced Expiratory Volume in 1 Second)
timeFrame: Following the Day 7 AM dose -12 hours post-dose and 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: American Health Research
state: North Carolina
Study officials:
affiliation: Theravance Biopharma, US, Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT03250572: Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among NAFLD Patients
Official title: Serum Ferritin as a Non-invasive Marker in Prediction of Hepatic Fibrosis Among Non-alcoholic Fatty Liver Disease Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Alcoholic Fatty Liver Disease
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 113
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Group I: included 30 healthy subjects as control. Group II: included 31 patients with NAFLD without liver fibrosis. Group III: included 52 patients with hepatic fibrosis on top of NAFLD.

Brief summary: This study was designed to assess the relation between serum ferritin and hepatic fibrosis in patients with NAFLD. It included 83 patients with NAFLD with or without hepatic fibrosis, in addition to 30 healthy subjects included as controls. Measurement of serum ferritin and its correlation with steatosis and fibrosis was done.

Detailed description: Background: many studies have found a relationship between hepatic iron, serum ferritin and NAFLD or its progress. Aim of the work: is to assess the value of serum ferritin as a non-invasive marker in prediction of hepatic fibrosis in NAFLD. Methods: This study included 113 subjects who were classified into 3 groups. Group I: included 30 healthy subjects as control with no evidence of NAFLD by liver biopsy. Group II: included 31 NAFLD patients without fibrosis proved by liver biopsy. Group III: included 52 patients with hepatic fibrosis on top of NAFLD proved by liver biopsy. Serum ferritin was determined using Ferritin ELISA kit. FIB4 was calculated and liver biopsy was done for all patients.

Eligibility criteria: Inclusion Criteria:

* adult patients with NAFLD with or without hepatic fibrosis

Exclusion Criteria:

* Significant alcohol consumption, other causes of liver disease such as viral hepatitis, schistosomiasis, autoimmune, hereditary, drug induced, or decompensated liver cirrhosis.

Primary outcomes:
measure: Serum ferritin in patients with hepatic fibrosis on top of NAFLD
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02430272: Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
Official title: Anticholinergic Premedication Induced Fever in Pediatric Ambulatory Anesthesia With Ketamine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fever
Keywords: Child
outpatient
premedication
Lead sponsor: Inje University
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 84
Sex: ALL
Minimum age (years): 12
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Anticholinergic drugs have traditionally been used for their antisialagogue properties. But use of anticholinergic drugs can interfere with thermoregulation via inhibition of the parasympathetically mediated sweat secretion. Sweating inhibition can reduce heat elimination, and children's thermoregulation depend more on sweating than adults and they can become hyperthermic when given these agents.

The investigators evaluated the fever-causing effects of adjunctive anticholinergics in children under general anesthesia using ketamine.


Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status classification I
* underwent surgery between 8 to 9 am
* undergoing ambulatory anesthesia with ketamine

Exclusion Criteria:

* who required endotracheal intubation
* who were administered with medications other than ketamine

Primary outcomes:
measure: Body temperature
timeFrame: every 30 minutes from base line ( up to 90min )
Secondary outcomes:
measure: Oral secretion (VAS)
timeFrame: up to operative end
Other outcomes:
Locations:
city: Goyang-si
country: Korea, Republic of
facility: Ilsan Paik hospital
state: Gyeonggi-do
Study officials:
affiliation: Inje Univ.
name: Won Joo Choe, M.D. Ph.D
role: STUDY_CHAIR
References:
citation: Kim KW, Choe WJ, Kim JH, Kim KT, Lee SI, Park JS, Kim JW, Heo MH. Anticholinergic premedication-induced fever in paediatric ambulatory ketamine anaesthesia. J Int Med Res. 2016 Aug;44(4):817-23. doi: 10.1177/0300060515595649. Epub 2016 May 25.
Clinical trial NCT04183972: Identification of Interscalene Brachial Plexus on Ultrasonography Using a Deep Neural Network
Official title: Identification of Interscalene Brachial Plexus Automatically on Ultrasonography Using a Deep Neural Network
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ultrasound Therapy; Complications
Keywords: peripheral nerve block
ultrasound image
deep neural network
brachial plexus
Lead sponsor: Huashan Hospital
Sponsor class: OTHER
First posted: 2019-12-03
Enrollment: 1126
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
Intervention model description: Patients who have been scheduled to surgery will be recruited for collecting ultrasound images.
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to develop and validate an algorithm based on deep neural networks (DNNs) to identify interscalene brachial plexus on ultrasonography automatically.

Detailed description: The investigators plan to develop a deep learning-based network to automatically identify interscalene brachial nerves on ultrasound images. The trained model will be validated on an independent dataset. The performance of the network will also be compared against practicing anesthesiologists.

Eligibility criteria: Inclusion Criteria:

* ASA physical status class I or II
* scheduled for elective surgery

Exclusion Criteria:

* skin lesion or infection of neck
* any known peripheral neuropathy
* brachial nerve plexus injury
* previous injury or operation on neck
* pregnancy
* allergic to ultrasound gel

Primary outcomes:
measure: The distance of the lateral midpoints of the nerve sheath contours
timeFrame: immediately after the procedure
Secondary outcomes:
measure: Accuracy, Sensitivity and specificity
timeFrame: immediately after the procedure
measure: The percentage of the intersection over union
timeFrame: immediately after the procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Huashan Hospital
state: Shanghai
Study officials:
affiliation: Huashan Hospital
name: Xiaoyu Yang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang XY, Wang LT, Li GD, Yu ZK, Li DL, Guan QL, Zhang QR, Guo T, Wang HL, Wang YW. Artificial intelligence using deep neural network learning for automatic location of the interscalene brachial plexus in ultrasound images. Eur J Anaesthesiol. 2022 Sep 1;39(9):758-765. doi: 10.1097/EJA.0000000000001720. Epub 2022 Jul 20.
Clinical trial NCT05262972: Percutaneous Needle Electrolysis on Metatarsalgia
Official title: APPLICATION OF ULTRASOUND-GUIDED PERCUTANEOUS ELECTROLYSIS IN THE PAIN OF THE SECOND METATARSOPHALANGEAL JOINT IN ADULT WOMEN
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metatarsalgia
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2022-03-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Percutaneous electrolysis is a minimally invasive method that involves the application of a galvanic current through an acupuncture needle. The needle is placed directly into the soft tissue structures, essential with ultrasound guidance. This technique involves the combination of mechanical stimulation produced by the needle and electrical/biochemical stimulation provided by the electrical current.

Endogenous pain modulation shows clinical relevance of this technique and plays an important role in the experience of pain.

Plantar plate injury is a pathology that frequently occurs in the forefoot, especially in middle-aged women, causing metatarsalgia that is sometimes very intense. In most cases it is secondary to a mechanical imbalance of the forefoot, related to an insufficiency of the first radius. For this reason, the researchers hypothesize that the application of ultrasound-guided percutaneous electrolysis on the plantar plate, combined with the conservative treatment consisting of the development of a personalized plantar orthosis, can cause positive effects in the patient's clinic as well as improve their quality of life.


Eligibility criteria: Inclusion Criteria:

* Adult female patients (40-65 years old)
* Having pain in the 2nd MTP joint of the foot due to pathology of the plantar plate, diagnosed by a specialized professional.

Exclusion Criteria:

* to have suffered an injury to their musculoskeletal system in the last 6 months.
* to have the present neuritic pathology,
* to have complete rupture of the plantar plate, 2nd finger supraadductus, flexor digitorum longus tenosynovitis,
* to have problems in the lumbar spine,
* to have undergone surgery in the lumbar spine or lower limbs.
* to use a plantar orthosis.
* to have the presence of associated pathologies in the foot,
* to be under the influence of any medication at the time of the study, fear of needles
* to be pregnant
* to be epileptic.

Primary outcomes:
measure: Quality of life
timeFrame: 1 month
measure: Subjetive level of pain
timeFrame: 1 month
measure: level of pain at palpation
timeFrame: 1 month
measure: Distribution of plantar pressures
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Blanca de la Cruz
Study officials:
References:
Clinical trial NCT04761172: NIR Fluorescence Imaging With ICG for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours
Official title: Near-infrared Fluorescence Imaging With IndoCyanine Green for the Intraoperative Identification of Gastrointestinal Stromal Cell Tumours: a Pilot Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: GIST
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label pilot study
Primary purpose: TREATMENT

Brief summary: This is an open-label pilot study including 10 GIST patients scheduled for an elective open or laparoscopic resection at Leiden University Medical Center (LUMC) and Erasmus Medical Center (EMC), Rotterdam. Patients will receive a single dose injection of 10mg ICG at a given moment during the 24 hours prior to surgery or during surgery. The timing of administration will be determined according to a step-up, step-down procedure. Standard of care surgery will be performed and a NIR fluorescence imaging system will be used to record the GIST under fluorescence.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with GIST by histology or cytology, localized or metastasized, scheduled to undergo an elective open or laparoscopic resection.
* 18 years

Exclusion Criteria:

* History of an allergy or hypersensitivity to sodium iodide, iodine or ICG
* Patients with hyperthyroidism and patients with an autonomous thyroid adenoma
* Patients pregnant or breastfeeding
* Patients with severe renal insufficiency (eGFR \<30)

Primary outcomes:
measure: Primary tumor detection
timeFrame: Intra-operative
Secondary outcomes:
measure: Detection of peritoneal tumor depositions
timeFrame: Intra-operative
measure: Tumor to background ratio
timeFrame: Through study completion, estimated to be 6 months
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Leiden University Medical Center
name: J. A. van der Hage
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00419172: Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers
Official title: A Phase I, Single Center, Open-label, One-sequence Cross-over Study to Investigate the Effect of a Potent Inducer Rifampicin on the Pharmacokinetics of Deferasirox in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Pharmacokinetics
Deferasirox
Exjade
ICL670
Rifampicin
Healthy, Volunteers
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-08
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The study will consist of two open-label periods, a Treatment Period I (deferasirox) and a Treatment Period II (rifampicin+deferasirox). At least 18 subjects are expected to complete both treatment periods as per protocol. For all subjects, in addition to the two treatment periods, there will be a 21 day screening period, one baseline evaluation (the day preceding deferasirox administration in Treatment Period I), and an end-of-study evaluation (EOS). Study subjects will be required to remain in the unit from Day -1 until Day 17. EOS evaluation (final safety assessment) will be performed 7-10 days after the last dose of rifampicin.


Eligibility criteria: Inclusion criteria

1. Able and willing to provide written informed consent prior to study participation
2. Male subjects from 18 - 45 years of age in good health and no evidence of iron deficiency. Subjects of reproductive potential must use barrier contraception throughout the trial.
3. Able to communicate well with the investigator and comply with the requirements of the study
4. Subjects must have a body mass index (BMI) between 18 and 33.
5. Serum ferritin value ≥20 ng/mL and transferrin saturation (Iron/TIBC) ≥15% at screening

Exclusion criteria

1. History or presence of impaired renal function
2. Abnormal serum electrolytes (e.g. sodium, potassium, chloride, or bicarbonate), magnesium and calcium
3. Evidence of urinary obstruction or difficulty in voiding at screening
4. Anemia (defined as hemoglobin \< 13 g/dL)
5. A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result at screening
6. Subjects with a known history of HIV seropositivity or history of immunocompromise
7. A past medical history of any ECG abnormalities or a family history of a prolonged QT-interval syndrome
8. Donation or loss of 400 mL blood or more within 12 weeks prior to dosing
9. Smokers (use of tobacco products in the previous 3 months). \* Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Evaluate the effect of rifampicin on pharmacokinetics after single dose administration of deferasirox
Secondary outcomes:
measure: Assess the safety and tolerability of concomitant administration of rifampicin and deferasirox
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT05825872: Ultrasound-Guided Internal Superior Laryngeal Nerve Block for Double-Lumen Bronchial Tube
Official title: Effect of Ultrasound-Guided Internal Superior Laryngeal Nerve Block on Sore Throat After Intubation by Double-Lumen Bronchial Tube for Thoracoscopic Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Postoperative Sore Throat
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: investigate the effectiveness and safety of ultrasound-guided bilateral internal branch of the SLN (iSLN) block for alleviating POST immediately after the operation.


Eligibility criteria: Inclusion Criteria:

* ASA 1 to 3

Exclusion Criteria:

* patients who did not provide consent
* with a pre-existing sore throat, hoarseness and upper respiratory tract infection
* tracheal pathology, tracheostomy
* a history of psychosis, diabetes and thyroid, oral cavity or pharynx surgery
* known or suspected allergy to ropivacaine
* chronic opioid use
* use of nonsteroidal anti-inflammatory drug medication within 24 hours
* known or suspected difficult airway
* patients who will be supported by tube ventilator after the operation.

Primary outcomes:
measure: the pain classification of postoperative sore throat
timeFrame: from immediate postoperative till 24 hours postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia University Hospitals
state: Menoufia
Study officials:
affiliation: Menoufia University
name: mostafa s mansour
role: STUDY_CHAIR
References:
Clinical trial NCT05340972: Evaluate the Predictive Impact of the MEESSI Score
Official title: Evaluate the Predictive Impact of the Meessi MEESSI Score for the Risk Stratification of Patients Admitted for Acute Heart Failure in Emergency Department
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergencies
Heart Diseases
Keywords: MEESSI score
ACUTE HEART FAILURE
Lead sponsor: University of Monastir
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient admitted to emergencies with a final diagnosis of AHF

Brief summary: Our primary purpose is to assess MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.

European Society of Cardiology recommend risk stratification for patients with AHF.

Detailed description: Improved risk stratification of acute heart failure (AHF) in the emergency department (ED) may help physicians' decisions regarding patient admission or early discharge disposition. The MEESSI-AHF (Multiple Estimation of risk based on the Emergency department Spanish Score In patients with AHF) score was developed to predict 30-day mortality in patients presenting with AHF EDs in Spain. Whether it performs well in other countries is unknown.

The MEESSI-AHF risk model includes 13 variables readily available on arrival to Emergency Department. The 40% of patients classified as LOW RISK (30-day mortality: \<2%) should be considered as potential candidates to be early discharged from Emergency Department without admission after adequate response to initial treatment. The 10% of patients classified as VERY HIGH RISK (30-day mortality: \>2%) may clearly benefit from hospital admission.

Objective: To externally validate the MEESSI-AHF score in another country.

Eligibility criteria: Inclusion Criteria:

* Major patient
* Patient admitted to emergencies with final diagnosis of AHF according to the opinion of two emergency experts after consulting the data from the clinical examination, cardiac echocardiography, and BNP level.
* Subject who accept to participate in the research

Exclusion Criteria:

* Patient who refuse to participate in the study
* Patient with coronary syndrome with ST segment elevation
* Other causes of dyspnea
* Impossibility of giving the patient informed information
* Pregnant woman

Primary outcomes:
measure: MEESSI score
timeFrame: 30 days
Secondary outcomes:
measure: Re-admission rate [ Time Frame: 30 days ]
timeFrame: 30 days
measure: Mortality rate [ Time Frame: 30 days ]
timeFrame: 30 days
measure: Sensitivity [ Time Frame: 30 days ]
timeFrame: 30 days
Other outcomes:
Locations:
city: Monastir
country: Tunisia
facility: Emergency department of University hospital Fattouma Bourguiba
Study officials:
affiliation: University of Monastir
name: Semir Nouira, Pr
role: PRINCIPAL_INVESTIGATOR
References: