louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03412214: Validity of Perfusion Index to Evaluate the Level of General Anaesthesia in Children.
Official title: Validity of Perfusion Index to Evaluate the Level of General Anaesthesia in Children.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Awareness, Anesthesia
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-01-26
Enrollment: 41
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: ASA physical status I-II patients aged 4-12 years and scheduled for elective tonsillectomy due to recurrent or chronic tonsillitis will be included in the study. Excluded from the study will be patients with significant cardiac, renal, pulmonary or hepatic disease.

Brief summary: The aim of this study is to evaluate the validity of perfusion index to determine the level of anesthesia in comparison with auditory evoked potential in children undergoing tonsillectomy.

Detailed description: The use of the perfusion index as an added monitoring tool during anesthesia provides the anesthetist with a number of benefits. It is a useful tool to forewarn the clinician of possible light planes of anesthesia, allowing for agent dose adjustment. It is a preexisting technology that is already widely available and used in most urban, regional,and rural centers, in both developed and developing countries, is noninvasive, continuous, and inexpensive.

The AEP Monitor/2 (Danmeter A/S, Odense, Denmark), a commercialized system for depth of anesthesia monitoring, extracts the middle latency auditory evoked potentials (MLAEP) from the EEG-signal by using an autoregressive model with an exogenous input adaptive method

Eligibility criteria: Inclusion Criteria:

* Patients aged 3-12 years
* Elective tonsillectomy due to recurrent or chronic tonsillitis

Exclusion Criteria:

* Cerebral disease
* Cardiac disease,
* Renal disease,
* Pulmonary disease
* Hepatic disease.

Primary outcomes:
measure: PI
timeFrame: Introperative
measure: AAI index
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university main hospital
state: Assiut Governorate
Study officials:
affiliation: Professor in anesthesia and intensive care
name: Hala S Abdelghaffar, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abdel-Ghaffar HS, Abdel-Wahab AH, Roushdy MM. Using the Perfusion Index to predict changes in the depth of anesthesia in children compared with the A-line Autoregression Index: an observational study. Braz J Anesthesiol. 2024 Sep-Oct;74(5):744169. doi: 10.1016/j.bjane.2021.04.030. Epub 2021 May 12.
Clinical trial NCT05778214: A Clinical Trial for the Interventional Robotic System
Official title: A Multi-Center, Randomized, Non-Inferiority, Prospective and Parallel-Group Trial to Evaluate the Safety and Efficacy of the Interventional Robotic System for Cerebral Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Angiography
Keywords: Cerebral Angiography
Interventional Surgical Robot
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-03-21
Enrollment: 142
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this multi-center clinical trial is to evaluate the efficacy and safety of the interventional robotic system for cerebral angiography, researchers will compare the ordinary angiography to assess the clinical success rate, operation time, radiation absorption, etc.


Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 and ≤ 85 years;
2. Plan to undergo cerebral angiography;
3. Voluntarily participated in this trial and signed the informed consent form.

Exclusion Criteria:

1. Preoperative mRS score \>2;
2. Allergy or intolerance to iodine contrast media;
3. Allergy to interventional devices;
4. Severe cardiac, hepatic and renal insufficiency;
5. Active systemic infection;
6. Severe stenosis, occlusion or skin infection at the puncture site;
7. Subjects who are to undergo surgery at the same time as cerebral angiography;
8. Subjects with severe coagulation disorders, bleeding tendencies, or contraindications to anticoagulant drugs (e.g., heparin);
9. Subjects who are enrolled in clinical studies with other devices or drugs 3 months prior to screening;
10. Female subjects of childbearing age who are pregnant or breastfeeding;
11. Other subjects who, in the judgment of the investigator, are not suitable for participation in this trial.

Primary outcomes:
measure: Clinical Success Rate
timeFrame: at the end of surgery
Secondary outcomes:
measure: Super-selective Technique Success Rate
timeFrame: at the end of surgery
measure: Super-selective Catheterization Time for Target Vessels
timeFrame: at the end of surgery
measure: DSA Fluoroscopy Time
timeFrame: at the end of surgery
measure: Surgical Time
timeFrame: at the end of surgery
measure: Primary Operator Radiation Absorbed Dose
timeFrame: at the end of surgery
measure: Instrument Performance Evaluation
timeFrame: at the end of surgery
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai City
Study officials:
References:
Clinical trial NCT03985514: Acute Appendicitis: Active Observation With and Without Antibiotics
Official title: Optimized Treatment for Uncomplicated Acute Appendicitis; Active Observation With or Without Antibiotic Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Appendicitis
Lead sponsor: Göteborg University
Sponsor class: OTHER
Collaborators: name: Vastra Gotaland Region
First posted: 2019-06-13
Enrollment: 126
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: Selected patients with assumed uncomplicated acute appendicitis are allocated to groups "Active observation" or "Antibiotic treatment" in a 1:1 ratio.
Primary purpose: TREATMENT

Brief summary: This study evaluates if early provision of antibiotics is a superior treatment compared to "traditional wait and see" with regard to symptom relief for suspected acute uncomplicated appendicitis.

Detailed description: Recent long-term follow up results of antibiotic treatment of acute appendicitis in unselected populations indicate that approximately 70-80 % of patients respond to antibiotics, while the remaining 20-25% need an operation. Antibiotic treatment was associated with significantly fewer severe and non-severe complications compared to surgery. Therefore, antibiotic treatment can be regarded as safe and effective initial treatment of acute appendicitis based on evidence.

However, it remains to be evaluated to what extent antibiotic treatment is more effective compared to the most conservative application of procedures in the care of patients with acute appendicitis. A well- recognized approach in Sweden is watchful waiting at in-hospital conditions. A certain number of patients with suspected uncomplicated appendicitis will likely recover without any active treatment, but controlled evidence are lacking to what extent such recoveries may occur in the short- and long-term perspective.

The hypothesis is that antibiotic treatment is superior to active observation with regard to symptom relief at suspected acute appendicitis in selected patient groups.

Eligibility criteria: Inclusion Criteria:

* Subjects with suspected appendicitis.
* Age\<60 years.
* C-reactive protein \< 60 mg/L.
* White blod cell Count (leucocytes) \< 13 e9 /L.

Exclusion criteria:

* Pregnant

Primary outcomes:
measure: Number of participants with no symptom relief
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Göteborg
country: Sweden
facility: Department of surgery, Sahlgrenska University Hospital
Study officials:
affiliation: Göteborg University
name: Kent Lundholm, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04010214: A Registered Cohort Study on Cerebellar Ataxia in the Organization in South-East China for Cerebellar Ataxia Research (OSCCAR)
Official title: A Registered Cohort Study on Cerebellar Ataxia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebellar Ataxia
Lead sponsor: First Affiliated Hospital of Fujian Medical University
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 1500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cerebellar ataxia who are diagnosed by tow neurologists in the Organization in South-East China for Cerebellar Ataxia Research (OSCCAR) from the First Affiliated Hospital of Fujian Medical University.

Brief summary: Cerebellar ataxia is a form of ataxia originating in the cerebellum. Cerebellar ataxia can occur as a result of many diseases and may present with symptoms of an inability to coordinate balance, gait, extremity and eye movements. To understand the clinical and genetic characteristics of cerebellar ataxia, we establish a registered cohort to follow up Chinese patients with cerebellar ataxia.


Eligibility criteria: Inclusion Criteria:

* Patients with cerebellar ataxia based on the diagnoses of tow neurologists
* Relatives of patients with cerebellar ataxia
* Unrelated healthy controls
* Participants or legal guardian(s) willing and able to complete the informed consent process

Exclusion Criteria:

* Participants are unable to comply with trial procedures and visit schedule

Primary outcomes:
measure: The incidence of hereditary cerebellar ataxia
timeFrame: Up to 20years
Secondary outcomes:
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Neurology ,First Affiliated Hospital Fujian Medical University
state: Fujian
Study officials:
References:
Clinical trial NCT05112614: Role of Gut Microbiome in Cancer Therapy
Official title: Role of Gut Microbiome in Cancer Therapy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-09
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing cancer therapy for any underlying cancer diagnosis and patients undergoing stem cell transplant for any hematological condition

Brief summary: This study examines how gut microbiome can affect cancer therapy in cancer patients undergoing cancer therapy or stem cell transplant. The human microbiome affects the way some cancer drugs are metabolized in the human body. Information from this study may help doctors improve the way cancer treatment is delivered, and increase its effectiveness and success.

Detailed description: PRIMARY OBJECTIVE:

I. To correlate gut microbiome with specific cancer diagnoses and the clinical response (efficacy), and adverse effects of cancer therapy (single or multiple) and stem cell transplant.

OUTLINE:

Patients undergo collection of blood and stool samples and have their medical records reviewed.

Eligibility criteria: Inclusion Criteria:

* Age 18-99
* Diagnosis of cancer and undergoing cancer therapy or scheduled to start cancer therapy or undergoing stem cell transplant for any hematological condition

Exclusion Criteria:

* Unable to provide informed consent
* Vulnerable adults

Primary outcomes:
measure: Gut microbiome associations with cancer diagnoses
timeFrame: Through study completion, average of 1 year
measure: Associations between microbial community abundances and clinical outcomes
timeFrame: Through study completion, average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Purna C. Kashyap, MBBS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06714214: PREdiction of succeSSful weanING From Continuous Renal Replacement Theraphy: the Possible Role of Delta C-cistatin
Official title: PREdiction of succeSSful weanING From Continuous Renal Replacement Theraphy: the Possible Role of Delta C-cistatin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Acute Kidney Injury
Keywords: C cistatin
acute kidney injury
CRRT
weaning
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2024-12-03
Enrollment: 152
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: The study will include all adult patients suffering from acute renal injury needing to CRRT, admitted to the enrolling centers starting from the approval of the Ethics Committee

Brief summary: The goal of this observational study is to know if, in patients with acute kidney injury, naive for renal injurie, admitted to different ICUs, the change in plasma concentration of c-cistatin, between initiation and discontinuation of CRRT, is a predictive finding to optimize the withdrawal time of renal support


Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years;
* diagnosis of acute kidney injury (defined according to KDIGO 2012 criteria)
* need for support with CRRT according to the indications of the nephrologist consultants and Clinical Practice
* Obtaining informed consent

Exclusion Criteria:

* CRRT already ongoing (in another department not participating in the study) at the time of transfer/admission to intensive care;
* need for RRT (any type and modality) in the 14 days prior to enrolment;
* diagnosis of AKD/CKD/ESRF on admission;
* Discontinuation of CRRT under conditions that do not comply with the criteria established by the study;
* Need for CRRT not associated with AKI condition (e.g. elimination of toxicants);
* pregnant women;
* presence of known thyreopathy
* Continuous use of corticosteroids
* patient with known neoplastic disease.

Primary outcomes:
measure: the change in plasma concentration of c-cistatin between initiation and discontinuation of CRRT is a predictive finding in patients with acute kidney injury admitted to the ICU
timeFrame: From enrlollment to the weaning from CRRT and 14 days after
Secondary outcomes:
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna - Anestesia e Terapia Intensiva nelle emergenze locali, regionali e nazionale e nella chirurgia addominale maggiore
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna -Anestesiologia e terapia intensiva polivalente
Study officials:
affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
name: Francesco Marino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00155714: Efficacy of Type-5 Phosphodiesterase Inhibitors in Primary and Secondary Pulmonary Hypertension
Official title: Clinical Efficacy of Type-5 Phosphodiesterase Inhibitors (Sildenafil and Vadenafil) in Primary and Secondary Pulmonary Hypertension
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Primary and Secondary Pulmonary Hypertension
Keywords: pulmonary arterial hypertension
type-5 phosphodiesterase Inhibitors
Sildenafil
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-12
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this trial is to evaluate the efficacy of type-5 phosphodiesterase inhibitors (sildenafil) in primary and secondary pulmonary hypertension

Detailed description: Patients with primary and secondary pulmonary hypertension will be recruited and admitted to the ICUs of the National Taiwan University Hospital. Each patient will undergo Swan-Ganz catheterization and hemodynamic monitoring during administration of sildenafil. Efficacy of inhaled NO and Iloprost will also be compared.

Eligibility criteria: Inclusion Criteria:Patients with primary and secondary pulmonary arterial hypertension

-

Exclusion Criteria:Unstable patients or patients with allergy to sildenafil

Primary outcomes:
measure: mean pulmonary artery pressure
measure: 6 min walking distance
measure: WHO functional status
measure: PaO2
Secondary outcomes:
measure: cardiac output
measure: VO2max
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Ping-Hung Kuo
Study officials:
affiliation: National Taiwan University Hospital
name: Ping-Hung Kuo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05380414: Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
Official title: A Single-center, Prospective Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Metastatic Pancreatic Cancer
Advanced Pancreatic Cancer
Keywords: Molecular screening
Genomic profiles
Transcriptomic profiles
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
First posted: 2022-05-18
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone.


Eligibility criteria: Inclusion Criteria:

* Male or female patient \> 18 years
* metastatic or advanced PDAC
* Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy).
* Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block.
* Life expectancy \> 3 months
* PS score 0 or 1.

Exclusion Criteria:

* Curative therapy available
* Any condition contraindicated with blood sampling procedures required by the protocol.
* Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer.
* Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.

Primary outcomes:
measure: Number of patients with at least one actionable alteration defined as an alteration shown to predict for sensitivity to a drug FDA/EMA approved for use in another cancer type, or a relevant alteration for inclusion in a clinical trial.
timeFrame: At the end of study (5 years)
Secondary outcomes:
measure: Time from ICF signature to day 1 of next line of therapy
timeFrame: At day 1
measure: Number of patients initiating a targeted therapy according to this molecular screening program with type of therapy initiated
timeFrame: At the end of study (5 years)
measure: Progression-Free Survival (PFS)
timeFrame: Up to 12 months
measure: Best overall response (BoR)
timeFrame: Up to 12 months
measure: Overall survival (OS)
timeFrame: Up to 12 months
measure: Duration of response (DoR)
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Centre Léon Bérard
Study officials:
affiliation: Centre Leon Berard
name: Philippe CASSIER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03813914: A New Supplement for the "Metabolic Syndrome"
Official title: Corosolic Acid and Cinnamon for the Treatment of the "Metabolic Syndrome" in Menopausal Transition Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolic Syndrome
Keywords: insulin resistance, blood pressure,
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2019-01-23
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid for the treatment of metabolic syndrome. Participants receive the supplement or a placebo.

Detailed description: The supplement is composed by of a combination of glycirrhizic acid, Cinnamomun Zeylanicum and corosolic acid. They act in different way reducing insulin resistance, which is the main cause of metabolic syndrome. It was a randomized, controlled study involving 60 women with the metabolic syndrome following the criteria proposed by ATP III in 2015. Main outcomes were the improvement of the parameters that characterizes the metabolic syndrome, such as glucose and insulin levels, triglycerides, HDL-cholesterol and blood pressure.

Eligibility criteria: Inclusion Criteria: Postmenopausal women affected by Metabolic Syndrome, diagnosed by ATP 2015 criteria.

-

Exclusion Criteria: treatment with steroids or with hypoglycemic or anti-cholesterol drugs

-

Primary outcomes:
measure: Changes in glycemia
timeFrame: 3 months
measure: Changes in HDL-cholesterol
timeFrame: 3 months
Secondary outcomes:
measure: changes in HOMA-IR
timeFrame: 3 months
measure: changes in total-cholesterol
timeFrame: 3 months
measure: changes in triglycerides
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References: