louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03592758: Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes
Official title: Ultrasound in Evaluation of Difficult Airway Management Predictive Indexes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Airway Complication of Anesthesia
Lead sponsor: University of Roma La Sapienza
Sponsor class: OTHER
First posted: 2018-07-19
Enrollment: 200
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 patient \> 18 ys undergoing general anesthesia for elective surgery

Brief summary: evaluate the efficacy of the ultrasound approach in predicting difficult mask ventilation in a heterogeneous population of patients undergoing general anesthesia.

Detailed description: Preoperative ultrasound of the upper airway and detection of 5 ultrasound measurements:

Trachea-skin distance at the level of the thyroid isthmus; Trachea-skin distance at the jugular level Front commissure-skin distance; Distance from skin to the thyroid membrane Distance between hyoid bone and skin. Comparison of this measurement with HAN-scale for prediction of difficult mask ventilation during general anesthesia

Eligibility criteria: Inclusion Criteria:

- all patient \> 18years old undergoing general anesthesia for elective surgery

Exclusion Criteria:

* Patients with fractures of the bones of the facial mass;
* Patients with laryngeal tumors
* Patients previously undergoing demolition of the larynx or neck;
* Tracheostomized patients;
* Pregnancy;
* Inter-incisive distance \<3 cm;
* severely limited cervical mobility;
* Patients who are not given muscle relaxants
* Patient rejection.

Primary outcomes:
measure: ultrasound assessment
timeFrame: Ultrasound assessment will be performed 30 minutes before induction of general anaesthesia and the mask ventilation evaluation will be performed 3 minutes after induction with ''Han scale".
Secondary outcomes:
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Policlinico Umberto I - UNiversità Sapienzadi Roma
Study officials:
References:
citation: Alessandri F, Antenucci G, Piervincenzi E, Buonopane C, Bellucci R, Andreoli C, Alunni Fegatelli D, Ranieri MV, Bilotta F. Ultrasound as a new tool in the assessment of airway difficulties: An observational study. Eur J Anaesthesiol. 2019 Jul;36(7):509-515. doi: 10.1097/EJA.0000000000000989.
Clinical trial NCT01373658: Safety and Efficacy Registry of Yinyi Stent (SERY-II)
Official title: Safety and Efficacy Registry of Yinyi Polymer-free Paclitaxel-eluting Stent
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Coronary Artery Disease
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2011-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Drug-eluting stents effectively reduce restenosis but may increase late thrombosis and delayed restenosis. Persistent polymer could be responsible. Local delivery of paclitxel from a polymer-free Yinyi stent (Dalian Yinyi biomaterial research and development co.ltd) may prevent these complications.


Eligibility criteria: Inclusion Criteria:

* age 18-80 years old
* both gender
* native coronary lesion
* narrowing \> 70%
* vessel size 2.5-4.0 in diameter

Exclusion Criteria:

* without informed consent,
* ST elevation myocardial infarction within 7 days,
* patient with ≤ 70% coronary narrowing at target lesion,
* left main lesion,
* multivessel narrowing need more than 3 stent implantations,
* by-pass graft,
* abnormal liver function before randomization,
* active hepatitis or muscular disease,
* impaired renal function with serum creatinine level \> 3mg/dl,
* impaired left ventricular function with LVEF \< 30%,
* participate in other studies.

Primary outcomes:
measure: late lumen loss
timeFrame: 12 months
Secondary outcomes:
measure: major adverse cardiac events
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: ruijin hospital, Shanghai Jiao Tong University, School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Ruiyan Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01807858: The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
Official title: The Effects of Synbiotics on Morbidity and Mortality in Preterm Infants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Necrotizing Enterocolitis
Sepsis
Keywords: Necrotizing enterocolitis
Sepsis
Length of hospital stay
Mortality
Lead sponsor: Dr. Sami Ulus Children's Hospital
Sponsor class: OTHER
First posted: 2013-03-08
Enrollment: 400
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Study, the inclusion of very low birth weight premature infants followed in Dr.Sami Ulus Maternity and Children Training and Research Hospital, Department of Neonatology; be randomized to very low birth weight premature infants began eating until you are discharged from the hospital once a day to feed a group+ 900 mg of 5 billion active Bifidobacterium lactis, the addition of chicory inulin, in the other group given placebo; Patients taking weekly blood cultures, the presence of residues in both groups during feeding, to evaluate the incidence of NEC and sepsis are planned. Randomization and the number of patients planned to separate into groups.

Detailed description: Patients separated into four groups using the sealed envelope method.

Eligibility criteria: Inclusion Criteria:

* VLBW infants admitted to NICU at the first 7 days of life

Exclusion Criteria:

* expected life lower than 7 days,
* babies who could not be fed (any metabolic disorders, gastrointestinal system surgical disorders etc.),
* severe asphyxia,
* severe congenital anomaly

Primary outcomes:
measure: Necrotizing enterocolitis
timeFrame: 8 weeks
Secondary outcomes:
measure: length of hospital stay
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Şevket Yılmaz Research Hospital
city: Diyarbakır
country: Turkey
facility: Diyarbakır Research Hospital
city: İstanbul
country: Turkey
facility: Okmeydani Research Hospital
city: İstanbul
country: Turkey
facility: Umraniye Research Hospital
Study officials:
affiliation: Assoc Prof
name: Dilek Dilli, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fouhy F, Ross RP, Fitzgerald GF, Stanton C, Cotter PD. Composition of the early intestinal microbiota: knowledge, knowledge gaps and the use of high-throughput sequencing to address these gaps. Gut Microbes. 2012 May-Jun;3(3):203-20. doi: 10.4161/gmic.20169. Epub 2012 May 1.
citation: Dilli D, Aydin B, Fettah ND, Ozyazici E, Beken S, Zenciroglu A, Okumus N, Ozyurt BM, Ipek MS, Akdag A, Turan O, Bozdag S. The propre-save study: effects of probiotics and prebiotics alone or combined on necrotizing enterocolitis in very low birth weight infants. J Pediatr. 2015 Mar;166(3):545-51.e1. doi: 10.1016/j.jpeds.2014.12.004. Epub 2015 Jan 13.
Clinical trial NCT03562858: Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations
Official title: Post-operative Hyper-sensitivity Assessment After Immediate Versus Delayed Dentine Sealing in Teeth for Indirect Tooth Colored Restorations: Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypersensitivity Dentin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: PICOT elements:P: Teeth restored with indirect tooth colored restoration I: Immediate dentin sealing using universal adhesive C: Delayed dentin sealing O: Post-operative Hypersensitivity T: -Hypersensitivity assessment one week during provisionalization period and post-cementation S: Randomized Controlled Clinical Trial


Eligibility criteria: Inclusion Criteria:

* Extensive carious lesions indicated for indirect restorations
* Lower first molars
* Age of patients range is 18 -50 years
* Patients have not received antibiotic therapy for 1 month before sampling
* Males or Females (Both genders)
* Patients with Good oral hygiene
* Co-operative patients approving the trial

Exclusion Criteria:

* Pregnancy
* Systemic disease or severe medical
* Patients having complications as:

Periodontal problems Mobile teeth, arrest caries and non-vital teeth

* Heavy smoking patients
* Xerostomia
* Lack of compliance

Primary outcomes:
measure: Post-operative hypersensitivity at baseline
timeFrame: 10 minutes
measure: Post-operative hypersensitivity one week after temporization
timeFrame: 1 week
measure: Post-operative hypersensitivity after cementation of the indirect tooth coloured restoration
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry cairo university
Study officials:
References:
Clinical trial NCT03856658: Hepatic Artery Infusional Floxuridine to Treat Pancreatic Cancer Liver Metastases
Official title: A Phase II Trial of Hepatic Artery Infusional Floxuridine With Systemic Chemotherapy in the Treatment of Pancreatic Cancer Liver Metastases
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Pancreatic Adenocarcinoma
Liver Metastases
Keywords: pancreatic cancer, pancreatic ductal carcinoma, liver metastases, HAI, hepatic artery infusion pump, FUDR, Floxuridine
Lead sponsor: Spectrum Health Hospitals
Sponsor class: OTHER
First posted: 2019-02-27
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm study without blinding
Primary purpose: TREATMENT

Brief summary: This is a single arm, phase II study without blinding. The purpose is to determine the impact of hepatic artery infusion Floxuridine (FUDR) on liver metastases from pancreatic adenocarcinoma. Patients at Spectrum Health will receive standard of care chemotherapy. They will also receive chemotherapy via surgically placed hepatic artery infusion (HAI) pump.

Detailed description: This study hypothesizes that the combination of Floxuridine (FUDR), a type of chemotherapy, delivered via a hepatic artery infusion (HAI) pump, with standard of care systemic chemotherapy will lead to improved survival in the treatment of pancreatic cancer liver metastases. Patients will receive 6 cycles of FUDR and will be followed for two years.

Eligibility criteria: Inclusion Criteria:

* Biopsy-proved pancreatic adenocarcinoma with synchronous liver metastases
* Elevated Cancer Antigen 19-9 (CA19-9) at diagnosis (\>37 U/mL)
* Ages 18-75 years
* Karnofsky performance status ≥70
* Ability to undergo general anesthesia and HAI pump placement procedure
* CT or MRI scan imaging of the abdomen demonstrating accessibility of the gastroduodenal artery within 2 months of enrollment
* Received a minimum of 2 months of systemic chemotherapy with stable tumor markers and imaging.

Exclusion Criteria:

* Primary tumor resected
* Model for End Stage Liver Disease (MELD) score \>20, using the variables of: Bilirubin, serum Sodium, International Normalized Ratio (INR), serum Creatinine, and Dialysis twice in the past week.
* Greater than 60% liver parenchymal involvement by tumor
* Evidence of peritoneal metastases
* Current alcohol abuse
* Pregnant or lactating women

Primary outcomes:
measure: Hepatic progression-free survival
timeFrame: 1 year
Secondary outcomes:
measure: Overall survival
timeFrame: 2 years
measure: Progression-free survival at any site
timeFrame: 2 years
measure: Rate of tumor response in the liver
timeFrame: 2 years
measure: EORTC Quality of Life Questionnaire
timeFrame: 2 years
Other outcomes:
Locations:
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
Study officials:
affiliation: Corewell Health
name: G. Paul Wright, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04736758: A Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Clinical Study on the Safety and Efficacy of GP681 Tablets in the Treatment of Uncomplicated Acute Influenza
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.
Sponsor class: INDUSTRY
First posted: 2021-02-03
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Analyse the time of flu symptom relief in adults with uncomplicated acute influenza,to evaluate the antiviral effects of high and low doses of GP681 tablets, and explore the optimal dose for phase III clinical trials.


Eligibility criteria: Inclusion Criteria:

* Positive Influenza rapid antigen test;
* Fever (axillary temperature ≥37.3℃) or the axillary temperature ≥37.3℃ after taking the medicine for more than 4 hours;
* At least one systemic symptom and respiratory symptom related to a moderate or above influenza virus infection:

  1. Systemic symptoms: headache, fever or chills, muscle or joint aches, fatigue;
  2. Respiratory system symptoms: cough, sore throat, nasal congestion.
* Time of disease symptoms ≤48h

Exclusion Criteria:

* Diagnosed as severe influenza patient ;
* Known history of dysphagia or any gastrointestinal disease that affects drug absorption (including but not limited to reflux esophagitis, chronic diarrhea, inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, stomach After subtotal resection, etc.);
* Have used anti-influenza virus drugs (oseltamivir, zanamivir, peramivir, favipiravir, abidol, baloxavir dipivoxil, amantadine, or diamond) within 2 weeks before screening Ethylamine, etc.);
* Acute respiratory infections, otitis media, sinusitis or other infectious diseases such as bronchitis, pneumonia, tuberculosis, etc. occurred within 2 weeks before screening, and are in the acute stage;
* Patients who also suffer from bacterial or viral infections and need systemic antibacterial or antiviral therapy

Primary outcomes:
measure: time to alleviation of influenza symptoms
timeFrame: Day 15
Secondary outcomes:
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
Study officials:
affiliation: China-Japan Friendship Hospital
name: Bin Cao, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05206058: To Exam the Effects of Phyllanthus Niruri Extracts on Human Neutrophils
Official title: To Exam the Effects of Phyllanthus Niruri Extracts (Corilagin, Phyllanthin and Brevifolin) on Human Neutrophils
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neutrophil
Phyllanthus Abnormis Poisoning
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2022-01-25
Enrollment: 240
Sex: ALL
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Voluntary healthy donor (20-35 years old) do not have coagulopathy, systemic infective disease and severe liver and renal function impairment.

Brief summary: To exam the effects of Phyllanthus niruri extracts(corilagin, phyllanthin and brevifolin) on human neutrophils

Detailed description: Phyllanthus niruri extracts have anti-inflammatory effects in various cellular systems (monocytes, neutrophil). However, the underlying effects and mechanisms of Phyllanthus niruri extracts on neutrophils have not yet been investigated in detail.

In this study, first we would like to systemic exam the effects of corilagin, phyllanthin and brevifolin, three major active components, on human neutrophils.

Further to clarify whether Phyllanthus niruri extracts have any effect on neutrophils that may provide some insights on the ability of these compounds to modulate the innate immune response in acute organ injury.

Eligibility criteria: Inclusion Criteria:

* Healthy volunteers who aged 20-35 years.
* Do not have coagulopathy, systemic infection disease and severe liver and renal function impairment
* Accept venipuncture

Exclusion Criteria:

* Healthy volunteers who aged over 35 years.
* Have coagulopathy, systemic infection disease and severe liver and renal function impairment

Primary outcomes:
measure: Measurement of superoxide anion release
timeFrame: After neutrophil isolation, an average of 3 months
measure: Measurement of intracellular ROS formation
timeFrame: After neutrophil isolation, an average of 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References:
Clinical trial NCT06771258: Red Light Childhood Myopia Proof-of-concept
Official title: What Effect Does Looking At Red Light Have on the Eye in Children and Young People? - a Proof-of-concept Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Myopia
Lead sponsor: University College, London
Sponsor class: OTHER
First posted: 2025-01-13
Enrollment: 24
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: BASIC_SCIENCE

Brief summary: In this project the research team will begin to find out whether shining a red LED light at the eyes can slow down the worsening of short-sightedness in children.

This is important, because short-sightedness now starts at a younger age and worsens faster than in the past. Many people are at risk of permanently losing their eyesight in middle-age because of short-sightedness.

The researchers plan to use red LED light, which is safe to use. Red-light treatment improves the blood flow at the back of the eye, in a layer called "choroid", which can be measured on eye-scans. The team have done a study with healthy adults, which showed that red-light is safe and gently improves the blood flow at the back of the eye. In adults, this has no effect on myopia, because their eyes are fully grown. In children, red-light may slow down myopia, and in this project, the researchers want to find out which level of red-light is needed to have this effect. The researchers will ask 24 children age 5-12 years to use red-light for three minutes twice a day for three months. Three will be 4 groups of children, and each group will use a different level of brightness. The researchers will measure the eye length and the thickness of the choroid at the start and 1 and 3 months later and compare the change in eye length between the different groups.

In practice, children will need to use the treatment for several years. The researchers will use the results of this study to prepare a longer study with more children.


Eligibility criteria: Inclusion Criteria:

* short-sightedness between -1.00D and -6.00 diopters in both eyes
* best-corrected visual acuity 0.1 logMAR or better in both eyes

Exclusion Criteria:

* underlying condition/syndrome causing myopia
* previous or current myopia-modifying treatment
* abnormal ocular refractive anatomy or previous intraocular or ocular surgery

Primary outcomes:
measure: Axial length
timeFrame: 3 months
Secondary outcomes:
measure: Spherical equivalent
timeFrame: 3 months
measure: Subfoveal choroidal thickness
timeFrame: 3 months
measure: Colour contrast sensitivity
timeFrame: 3 months
measure: Visual acuity
timeFrame: 3 months
measure: Tolerability/usability
timeFrame: 3 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: UCL
name: Annegret Dahlmann-Noor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02420158: Trans-cutaneous Vagal Nerve Electrical Stimulation and Irritable Bowel Syndrome
Official title: Sympatho-vagal Balance in Patients With Irritable Bowel Syndrome, and Evaluation of a Transcutaneous Vagal Nerve Electrical Stimulation on Symptoms and Quality of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable Bowel Syndrome
Vagal nerve stimulation
Quality of life
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-04-17
Enrollment: 18
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This pilot study plan to investigate the sympathovagal balance in women affected by Irritable Bowel Syndrome (IBS), and to evaluate the effect of 6 months of trans-cutaneous vagal nerve electrical stimulation on digestive physiology (intestinal transit time, intestinal mucosal permeability, systemic and local inflammation), symptoms and quality of life.

The safety of the electrical stimulation of the left vagal nerve will also be evaluated.

Ten women, age between 18 and 60, will be included.


Eligibility criteria: Inclusion Criteria:

* women aged 18-60,
* clinical Rome III criteria for IBS

Exclusion Criteria:

* pregnancy,
* low intensity symptoms (Francis score between 75-150)
* IBD, coeliac disease
* past history of abdominal surgery (appendectomy and cholecystectomy allowed)
* chronic use of analgesics, anti-depressants

Primary outcomes:
measure: Improvement of clinical symptoms of IBS, based on the evolution of symptom score (Francis) and symptom scale (UCLA-SSS)
timeFrame: 3 and 6 months after the beginning of electrical stimulation
Secondary outcomes:
measure: Safety and tolerance of trans-cutaneous nerve stimulation as measured by any symptom occurring in relation with electrical stimulation, number of hours per day of system use
timeFrame: 6 months
measure: Evolution of digestive physiology during vagal nerve stimulation
timeFrame: 3 and 6 months
measure: Effect of vagal nerve stimulation on quality of life
timeFrame: 3 and 6 months
measure: Evaluation of sympatho-vagal balance
timeFrame: 0, 3 and 6 months
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Clinique Universitaire d'Hépato-Gastroentérologie - CHU de Grenoble
city: LYON Cedex 03
country: France
facility: Service d'Exploration Fonctionnelle Digestive - Hôpital Edouard Herriot - Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: François MION, MD
role: PRINCIPAL_INVESTIGATOR
References: