louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00693602: Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma
Official title: Compassionate Use of Erwinase For Pediatric Patients With Acute Lymphoblastic Leukemia Or Non Hodgkins Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acute Lymphoblastic Leukemia
Non Hodgkins Lymphoma
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
Collaborators: name: Jazz Pharmaceuticals
name: Parexel
First posted: 2008-06-09
Enrollment: 87
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: This is a compassionate use protocol for patients with acute lymphoblastic leukemia (ALL) who have developed hypersensitivity or intolerance to E. coli L-asparaginase and/or PEG-L-asparaginase.

Detailed description: Primary Objective

To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase and/or PEG-asparaginase.

TREATMENT PLAN

Erwinia L-asparaginase administration will be given according to the protocol or non-protocol treatment plan under which the patient is currently being treated.

Erwinase will be discontinued in any patient experiencing an allergic reaction or any Grade 3 or higher adverse event believed to be attributable to this agent.

Eligibility criteria: Inclusion Criteria:

* Patients on treatment for acute lymphoblastic leukemia or non-Hodgkins lymphoma receiving ALL-type therapy who have developed hypersensitivity or intolerance to E. coli L-asparaginase or PEG-L-asparaginase or both.
* Informed consent explained to and signed by parent/legal guardian, with emphasis that although approved for use in Europe and Canada, Erwinase is NOT approved by the United States Food and Drug Administration

Exclusion Criteria:

* Documented history of severe hypersensitivity or intolerance to Erwinase

Primary outcomes:
measure: To provide Erwinase to patients with acute lymphoblastic leukemia (ALL) or non-Hodgkins lymphoma who are intolerant or have developed hypersensitivity to E. coli asparaginase and/or PEG-asparaginase
timeFrame: June 2009
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Sima Jeha, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06589102: Prevalence and Consequences of Hyperlactemia Following Pancreatic Surgery
Official title: Prevalence and Consequences of Hyperlactemia Following Pancreatic Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Cancer
Pancreatic Cyst
Chronic Pancreatitis
Keywords: Pancreatic surgery
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 491
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients scheduled to undergo major pancreatic surgery in a tertiary university hospital during 2016-18

Brief summary: The goal of this observational study is to investigate the role of lactate elevation.

The main aims are:

* Determine the frequency of lactate elevation following pancreatic surgery and its relationship to postoperative complications
* Investigate what patient and surgical related factors that are associated with postoperative lactate elevation This is a retrospective study based on existing medical data and will not affect the medical care of the studied patients.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing pancreatic surgery 2016-2018

Exclusion Criteria:

* Patients unable to undergo scheduled surgery
* Missing data in the postoperative period

Primary outcomes:
measure: Length of hospital stay
timeFrame: All patients are followed until they leave the hospital, but a maximum of six months
Secondary outcomes:
measure: General postoperative complications
timeFrame: All patients are followed until they leave the hospital, but a maximum of six months
measure: ICU care
timeFrame: All patients are followed until they leave the hospital, but a maximum of six months
measure: Surgery specific complications
timeFrame: 90 days
Other outcomes:
Locations:
city: Huddinge
country: Sweden
facility: Karolinska University Hospital
state: Stockholm
Study officials:
References:
Clinical trial NCT01945502: Nasopharyngeal Packing and Rhinologic Surgery.
Official title: The Effectiveness of Three Different Nasopharyngeal Packing on the Prevention of Postoperative Nausea- Vomiting and Postoperative Throat Pain in Rhinologic Surgery.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Nasal Surgery
Tampons
PONV
Lead sponsor: Ankara University
Sponsor class: OTHER
First posted: 2013-09-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients (18-60 years) scheduled for routine nasal and/or paranasal sinus surgeries in Ankara Univerity Faculty of Medicine, ETN operating rooms were recruited into this study.

Brief summary: The purpose of this study is to assess the efficacy of three different pharyngeal packing during routine rhinologic surgery in the prevention of postoperative nausea and vomiting, and to evaluate the influence of pharyngeal packing on postoperative throat pain.


Eligibility criteria: Inclusion Criteria:

* 18-60 years old adult patient
* nasal and/or paranasal sinus surgeries
* general anesthesia

Exclusion Criteria:

* patients submitted to another intervention at the same time (adenoidectomy, tonsillectomy)
* patients with a serious systemic disease (acquired immunodeficiency syndrome,leukemia, lymphoma, or other neoplasias under chemotherapy treatment)
* patients presenting contraindications for using nonsteroid anti-inflammatory drugs

Primary outcomes:
measure: Postoperative nausea vomiting
timeFrame: 3 months
measure: sore throat
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ankara University Faculty of Medicine ENT operating rooms
Study officials:
References:
Clinical trial NCT02256202: Quality Assurance of Electronic Data Capturing (EDC) in Pain Treatment
Official title: Pilot Study of Quality Assurance in Interventional Pain Therapy in the Lumbal Spinal Column. Non-randomised, Evaluative, Multicentral Study Concerning the Applicability of a Tablet-PC.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain
Lead sponsor: Qualitouch-HC Foundation
Sponsor class: OTHER
Collaborators: name: Mundipharma Pte Ltd.
First posted: 2014-10-03
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Back pain patients

Brief summary: There are actually no standardized quality assurance procedures included in pain treatment processes.

In this observational, feasibility study the use of tablet-Personal Computer (PC) is tested in pain therapy centres using the validated questionnaire "Activity Index". The acceptance of electronic data capturing is tested in patients and therapy teams (doctors and nurses).

Detailed description: Regarding the demand for a duly documented efficacy of the therapy applied, a standardized procedure is imperative to show the medical and economic advantages of a given therapy. To obtain valid results, it is necessary to use a standardized process, monitored with a validated questionnaire.

In this multi-center study the Activity Index Questionnaire will be tested regarding its outcome quality regarding usability and patient acceptance. Each center collects data of 10 patients with injection pain therapy. Each patient is interviewed twice and after the 2nd interview each patient will fill out a feasibility questionnaire. During the whole study, the use and consumption of oral analgetic drugs are monitored in a diary. The statistical Analysis is done descriptive. Before entering the study, each patient has to give informed consent to participate. National Registration Guidelines for post market surveillance will be obtained.

Eligibility criteria: Inclusion Criteria:

* Willingness for therapeutic pain injection in lumbar spine

Exclusion Criteria:

* Cognitive impairment, technical Problems in interviewing patients

Primary outcomes:
measure: Feasibility of Tablet-PC in interviewing pain patients
timeFrame: 6-12 months
Secondary outcomes:
measure: Problems in application of EDC in Tablet-PC
timeFrame: 12 months
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Stadtspital Triemli
state: ZH
Study officials:
affiliation: Stadtspital Triemli Zurich, Department of Rheumatology
name: Robert Theiler
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01881802: Study of Opioid Immunosuppressive Effects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Opioid Abuse or Dependence
Keywords: Opioid drug Abuse
Morphine
Immune Function
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2013-06-20
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Guangzhou Psychiatric Hospital

Brief summary: This trial aims to investigate the effects of opioid-inducing immune suppression on opioid drug abused patients. The methods of the investigators research mainly includes the expression of morphine-related miRNAs in peripheral blood mononuclear cells and cytokine in plasma.


Eligibility criteria: Inclusion Criteria:

* subjects were excluded if they had a chronic systemic illness (cardiac, renal, pulmonary, hepatic, endocrine, metabolic, or autoimmune disorders) or
* a major psychiatric disorder or
* if they were abusing substances other than heroin (as determined by urine drug test result). For women, pregnancy was also a reason for exclusion.

Exclusion Criteria:

* Control subjects with no history of drug or alcohol abuse were also excluded if they had
* major medical or psychiatric disorders

Primary outcomes:
measure: real-time quantitative polymerase chain reaction
timeFrame: up to 2 months
Secondary outcomes:
measure: enzyme-linked immuno sorbent assay
timeFrame: up to 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04552002: The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients
Official title: The Effect of Synbiotic Consumption on Glycemic, Inflammatory Markers and Body Composition on Prediabetic and Diabetic Patients: A Double Blinded Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Dietary Supplements
Lead sponsor: Imam Abdulrahman Bin Faisal University
Sponsor class: OTHER
First posted: 2020-09-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled trial that will be conducted on Saudi prediabetic and diabetic adults aged 18 to 70 years. The aim of the study is to investigate the effect of synbiotic consumption on gut microbiome, glycemic control, and other diabetes-related outcomes in patients with prediabetes and diabetes. A total of 160 participants will be recruited from King Fahd Hospital of the University, Eastern Province, Saudi Arabia and randomly assigned to synbiotic group (prediabetic and diabetic, n=40 each group) or control group (prediabetic and diabetic, n=40 each group) for a 6-month trial. A structured questionnaire will be used for data collection from subjects. The questionnaire will include data related to socioeconomic status, health and diet related history. Primary outcomes including gut microbiome sequencing, glycemic control related parameters and secondary outcomes including inflammatory markers, food intolerance and anthropometric measurements will be measured before the study, after 3 months and after 6 months. The findings of the current study will shed light on the significance of synbiotic consumption on glycemic control and other diabetes-related outcomes and their relation to food allergy and autoimmunity.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with type 1 diabetes
* Patients on insulin therapy
* Patients on antibiotics
* Pregnant and lactating women
* Smoking individuals
* Patients with comorbidities (except for hyperlipidemia and blood pressure)
* Patients taking immunosuppressants
* Patients taking probiotics, prebiotics or synbiotics

Exclusion Criteria:

* Patients with prediabetes (HbA1c of 5.7- 6.4% or a fasting plasma glucose of 100 -125 mg/dl)
* Patients with type 2 diabetes (HbA1c of ≥ 6.5% or a fasting plasma glucose of ≥ 126 mg/dl
* Male and female patients aged (18-70) years
* Patients with HbA1c of ≥ 5.7 or a fasting plasma glucose of ≥100 mg/dl
* BMI ≥ 25

Primary outcomes:
measure: Glycemic markers
timeFrame: 6 months
measure: Inflammatory markers
timeFrame: 6 months
measure: Body Composition parameters
timeFrame: 6 months
measure: BMI
timeFrame: 6 months
measure: Waist circumference
timeFrame: 6 months
Secondary outcomes:
measure: Microbiome sequencing
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05211102: Venous Sinus Thrombosis : Clinical Picture and Outcome
Official title: Venous Sinus Thrombosis : Clinical Picture and Outcome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cerebral Vein Thrombosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2022-01-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients of both sex above 18years and below 70years presenting to Assiut University Hospital with cerebral venous sinus thrombosis

Brief summary: Cerebral venous sinus thrombosis (cvst) is an underdiagnosed neurological condition with variable clinical presentations and variable risk factors CVST is often an underdiagnosed cause of acute or slowly progressive neurological deficit.

With increasing awareness of the entity and easy accessibility to the non-invasive test like CT and MRI scans,CVST cases are now being diagnosed more frequently and it is now thought to occur more commonly than previously assumed.it is also probably true that this condition is more frequent in underdeveloped countries


Eligibility criteria: Inclusion Criteria:

1. All patients admitted to the neurology department and ER of an assuit university hospital with the diagnosis of venous sinus thrombosis
2. accepting to participate in the study
3. of both sex above 18 years and below 70 years

Exclusion Criteria:

* 1. any case evident to have neurological deficit due to cause other than venous sinus thrombosis 2. patients refused to participate in this study 3-patients with uncertainty about her imaging study

Primary outcomes:
measure: cerebral venous sinus thrombosis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06716502: A New Portable Device for Non-invasive Ventilatory Support
Official title: A New Portable Device for PRE-hospital Non-invasive VENTilatory Support in Acute Respiratory Failure
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Healthy
Respiratory Disease
Keywords: CPAP
NIV
Respiratory failure
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
Collaborators: name: Azienda Ospedaliera Universitaria Integrata Verona
name: Città di Lecce Hospital
First posted: 2024-12-04
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Acute respiratory failure is a medical emergency rapidly leading to death, if not timely treated. Prompt Continuous Positive Airway Pressure (CPAP) improves patient outcomes. However, pre-hospital CPAP is currently limited to healthcare providers due to the absence of easy-to-use and immediate devices specifically designed for the non-medical population.

The efficacy and usability of a new portable CPAP device will be assessed. This device is specifically designed for potential use in out-of-hospital scenarios involving acute respiratory failure. The evaluation will focus not only on the performance of the device but also on its easiness of use.

Detailed description: The efficacy and usability of a new portable CPAP device will be assessed in different clinical settings. The study will take place in three hospitals in Italy, with the objective of collecting data to support the future implementation of the device as a first-aid support tool for patients with respiratory failure in real-world scenarios.

Eligibility criteria: Arm 1

Inclusion Criteria:

1. Age ≥65 years
2. Clinically stable: non-hospitalized and not in acute illness
3. no professional medical knowledge: no experience as a health care provider
4. Ability to express informed consent as requested by the ethical committee

Arm 1 Exclusion Criteria: none

Arm 2

Inclusion Criteria:

1. Hospitalized adult patient
2. SpO2 of 90-93% in room air

Arm 2

Exclusion Criteria:

1. Facial burns/trauma/recent facial or upper airway surgery
2. Vomiting
3. Fixed upper airway obstruction
4. Undrained pneumothorax
5. Recent upper gastrointestinal surgery
6. Inability to protect the airway
7. Bowel obstruction
8. Patient refusal

Primary outcomes:
measure: Device easiness-to-use
timeFrame: Up to 2 hours
measure: Duration of proper pressure delivery
timeFrame: Up to 2 hours
measure: Battery power consumption and duration
timeFrame: Up to 2 hours
measure: Change in SpO2 level
timeFrame: Up to 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Lecce
country: Italy
facility: Città di Lecce Hospital
state: Puglia
city: Milan
country: Italy
facility: IRCCS San Raffaele
city: Verona
country: Italy
facility: Università degli studi di Verona
Study officials:
affiliation: IRCCS San Raffaele
name: Giovanni Landoni, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04104802: Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors
Official title: Study of the Facial Nerve in MRI 3T in the Preoperative Assessment of Parotid Tumors
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Parotid Tumor
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-09-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patient candidate for first-line surgery for a parotid tumor

Brief summary: Preoperative evaluation of the precise localization of the intrapartotic facial nerve is essential for the ENT surgeon to assess the risk of nerve damage during parotid tumor excision, and inform the patient of the risk of post-paralyzed facial nerve palsy. procedure

Detailed description: 1. st visit: Inclusion, parotid MRI 3Tesla high resolution with specific sequences and gadolinium injection performed at the A. de Rothschild Foundation. Evaluation by two radiologists of the exact position of the parotid tumor with respect to the trunk of the facial nerve and its first branches, classified into two categories: contact (≤ 5 mm) or distance (\> 5 mm).
2. nd visit: Surgical intervention of the parotid tumor. The surgeon will specify the same data as those collected by the radiologists after the MRI. The surgeon will not be aware of the data concerning the ratios of parotid tumor to facial nerve collected on MRI sequences for research purposes.

Eligibility criteria: Inclusion Criteria:

* Patient over 18 years old
* Patient seeking first-line surgery for a parotid tumor (single or multiple, benign or malignant)
* Parotidian tumor located near the trunk of the facial nerve and / or its first division branches (temporofacial and cervicofacial), during a clinical evaluation performed by the surgeon in preoperative consultation
* Patient affiliated or beneficiary of a social security scheme
* Written consent to participate in the study

Exclusion Criteria:

* Personal history of ipsilateral parotid surgery
* Contraindication to MRI (electronic device, metallic foreign body, claustrophobia)
* Known hypersensitivity to gadolinium contrast agents
* Renal impairment known: glomerular filtration rate \<30 mL / min
* Pre or post-operative period of liver transplantation
* Patient benefiting from a legal protection measure
* Pregnant or lactating woman

Primary outcomes:
measure: To determine the sensitivity of a high-resolution 3 Tesla MRI with gadolinium injection with specific sequences versus intraoperative findings of the surgeon (gold standard), to evaluate the anatomic relationships between parotid tumor and facial nerve.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Adolphe De Rothschild
city: Paris
country: France
facility: Hôpital Saint Joseph
city: Paris
country: France
facility: Institut Arthur Vernes
city: Suresnes
country: France
facility: Hôpital FOCH
Study officials:
References: