louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05098834: Electrical Impedence Tomography With ENLIGHT2100
Official title: Assessment of Lung Volumes During Liberation From Mechanical Ventilation Using Electrical Impedance Tomography in Children
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Extubation
Keywords: Acute respiratory failure
Breathing tube
Mechanical ventilator
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-10-28
Enrollment: 0
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Children with acute respiratory failure often need a breathing tube attached to a breathing machine, called a mechanical ventilator, to assist their breathing until they can recover. Once the cause of respiratory failure has resolved or improved enough, the breathing tube can be removed, and that is called extubation. The Extubation Readiness Test (ERT) is a simple evaluation commonly performed in the intensive care unit to determine if a child is ready to have the breathing tube removed.

The purpose of this study is to better understand how the ERT and the eventual removal of the breathing tube affect where the air is in the lungs, and whether this can help predict which children will succeed or fail having the breathing tube taken out. This can done be at the bedside with a device called electrical impedance tomograph. This novel device is painless and uses a belt fitted with sensors placed around the chest to show where the air is in the lungs.


Eligibility criteria: Inclusion Criteria:

* Patients less than 17 years of age admitted to the Duke Children's PICU or PCICU with acute respiratory failure due to a pulmonary illness will be considered eligible for the study

Exclusion Criteria:

* Patients with corrected gestational age less than 37 weeks
* Patients with contraindications to the ENLIGHT device (i.e. temporary or permanent pacemaker, vagal nerve stimulator, automatic implanted defibrillator, chest tubes that interfere with electrode belt placement, open chest wounds, unstable thorax, severe chest wall deformities)
* known pregnancy
* Patients previously enrolled in this study will be excluded from participation.

Primary outcomes:
measure: Change in expiratory lung volume as measured by global lung electrical impedance
timeFrame: Baseline, 60 mins, 75 mins, 90 mins
Secondary outcomes:
measure: Change in regional ventilation (Anterior/Posterior) distribution as measured by regional electrical impedance
timeFrame: Baseline, 60 mins, 75 mins, 90 mins
measure: Change in regional ventilation (Right/Left) distribution as measured by regional electrical impedance
timeFrame: Baseline, 60 mins, 75 mins, 90 mins
measure: Percent of failed extubation as measured by need for re-intubation
timeFrame: Within 24 hours
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Alexandre Rotta, MD, FCCM
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03793634: Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus
Official title: Evaluation of Topical Chamomile Versus Topical Triamcinolone Acetonide in Management of Oral Lichen Planus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Oral Lichen Planus
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 37
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Using of herbal medications as topical chamomile which has antioxidant, anti-inflammatory and anticarcinogenesis effect with little side effects is the aim for the future treatment of OLP.

Detailed description: Oral lichen planus (OLP) is a chronic inflammatory T cell mediated autoimmune disease that affects skin and any mucous membrane particularly oral mucosa.The patient complains of burning sensation, pain; interference with eating, swallowing and speech leading to worsening of quality of life.Oxidative stress plays a role in pathomechanism of OLP disease. Enzymatic and non- enzymatic anti-oxidants act as a physiological guard against reactive oxygen species (ROS) and cytokine-mediated toxicity.Herbal treatment is the aim of the future therapy.Chamomile has anti-oxidant , anti-inflammatory effect and accelerate healing.

Eligibility criteria: Inclusion Criteria:

* Symptomatic OLP.
* Patients with no history of taking corticosteroids for the last 6 months.
* Patients who agree to take medication.
* Medically free

Exclusion Criteria:

* Patients with oral lesions other than OLP.
* Lichenoid reaction .
* Pregnant females and lactation.
* Smokers

Primary outcomes:
measure: Pain using Numerical rating scale
timeFrame: 1 month
Secondary outcomes:
measure: clinical sign score
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01978717: General Anesthesia Combined With Epidural Anesthesia Mitigates the Surgical Stress-related Immunosuppression in Patients With Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: Anesthesia
T-helper
MDSCs
Colorectal cancer
Fast track
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 53
Sex: ALL
Minimum age (years): 51
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to prove whether general anesthesia combined with epidural anesthesia could better maintain body balance of Th1/Th2 and Treg/Th17 compared with general anesthesia, so as to reduce the surgical stress-related immunosuppression, and to improve the prognosis.


Eligibility criteria: Inclusion Criteria:

* patients with Colorectal Cancer(CRC);
* subjected to the Fast-Track processing of surgery;
* between 18 and 75 years old.

Exclusion Criteria:

* American Society of Anesthesiologists(ASA) grade \> III;
* BMI \> 30;
* a history of abdominal surgery, endocrine or immune system dysfunction;
* recent blood transfusions, hormone or non-steroidal anti-inflammatory therapy during the past month;
* previous contraindication to epidural anesthesia.

Primary outcomes:
measure: The changes of peripheral immune cells and cytokines
timeFrame: within the first 5 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhong Shan Hospital Fudan University
state: Shanghai
Study officials:
References:
citation: Chen WK, Miao CH. The effect of anesthetic technique on survival in human cancers: a meta-analysis of retrospective and prospective studies. PLoS One. 2013;8(2):e56540. doi: 10.1371/journal.pone.0056540. Epub 2013 Feb 20.
Clinical trial NCT01926717: A Comparative Clinical Research on Single Roux-en-Y and Traditional Roux-en-Y of Pancreaticojejunostomy-choledochojejunostomy For Treatment of Obstruction of Pancreatic Duct and Bile Duct
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pancreatic Cancer
Keywords: Single Roux-y of Pancreaticojejunostomy-choledochojejunostomy
Lead sponsor: The First Affiliated Hospital of Guangzhou Medical University
Sponsor class: OTHER
First posted: 2013-08-21
Enrollment: 100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with pancreatic cancer

Brief summary: This study is being done to learn more about how different surgery procedures bring back the quality of life.After removing the small intestine at least 20cm in patients with pancreatic cancer, Some patients develop problems because they are disorder their digestive system, such as cramping, heartburn,vomiting.


Eligibility criteria: Inclusion Criteria:

* Patient 30 years of age or older
* Pathologically confirmed pancreatic cancer (biopsy may be performed at our institution)
* No evidence of metastases(a)
* decide performe Roux-en-Y(b)
* single Roux-en-Y reconstruction is technically feasible(c)
* Patients will be registered and consent obtained, if the surgeon believes there is no evidence of metastases. If metastatic disease is identified at the time of operation, the patient will not be randomized.
* Patients will be conditionally enrolled, and consent obtained, if the surgeon believes the patient may need a sngle Roux-en-Y at the time of operation. If a sngle Roux-en-Y is not performed, the patient will not be randomized.
* the surgeon feels that the single Roux-en-Y is not technically feasible at the time of operation,the patients will be excluded. This may be due to prior abdominal surgery, anatomic variants, or anything else at the surgeon's discretion.

Exclusion Criteria:

* Not expected to be able to provide follow-up over 2 years (due to geographic or other limitations)

Primary outcomes:
measure: The secretion function of the pancreas
timeFrame: Participants will be followed for overall 3 year after surgery
Secondary outcomes:
measure: The function of biliary tract
timeFrame: Participants will be followed for overall 3 year after surgery
Other outcomes:
measure: The relief of abdominal pain symptom
timeFrame: Participants will be followed for overall 3 year after surgery
Locations:
city: Guiyang
country: China
facility: The Affiliated Hospital of Guiyang Medical College
state: Guizhou
Study officials:
References:
Clinical trial NCT01216917: The Influence of Ageing on Muscle Quality
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ageing Process
Muscle Quality
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2010-10-07
Enrollment: 45
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: elderly men (65+)

Brief summary: The purpose of the present study is to evaluate the influence of the ageing process on muscle quality. Therefore, muscle mass, muscle density and force-velocity characteristics are measured after a 5-yr interval in older adults (65+).


Eligibility criteria: Inclusion Criteria:

* male, +65 years
* participation in previous study "De effecten van oefenprogramma's op gezondheids- en fitheidsgerelateerde parameters in een groep van 60-plussers"
* able to perform a maximal strength test on a dynamometer

Exclusion Criteria:

* pathologies that prohibit a maximal strength test on a dynamometer

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Faculty of kinesiology and rehabilitation sciences
Study officials:
References:
Clinical trial NCT03802617: A Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Official title: A Phase II Clinical Study of MR13A9 in Hemodialysis Patients With Pruritus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Uremic Pruritus
Lead sponsor: Kissei Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Maruishi Pharmaceutical
First posted: 2019-01-14
Enrollment: 247
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Double-blind, Placebo-controlled study to evaluate the dose-response relationship of safety, efficacy and pharmacokinetics of MA13A9 in hemodialysis patients with pruritus.


Eligibility criteria: Inclusion Criteria:

* Japanese with male or female aged ≥ 20
* Patient with Chronic Kidney Disease (CKD) has been on hemodialysis 3 times per week
* Patient receiving treatment for itch
* Patient has a baseline NRS score \> 4

Exclusion Criteria:

* Patient has pruritus cause other than CKD or its complications
* Patients has hepatic cirrhosis
* Patient has a known history of allergic reaction to opiates

Primary outcomes:
measure: Change in Numerical Rating Scale (NRS) score of itch
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in itching scores of Shiratori severity criteria
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: Japan
facility: Research Site
Study officials:
affiliation: Clinical Development Div.
name: Naomi Koshihara
role: STUDY_DIRECTOR
References:
citation: Narita I, Tsubakihara Y, Uchiyama T, Okamura S, Oya N, Takahashi N, Gejyo F; MR13A9-4 Trial Investigators. Efficacy and Safety of Difelikefalin in Japanese Patients With Moderate to Severe Pruritus Receiving Hemodialysis: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2210339. doi: 10.1001/jamanetworkopen.2022.10339.
Clinical trial NCT03759717: Molecular and Cellular Characterization of Skull Base Tumors
Official title: Molecular and Cellular Characterization of Skull Base Tumors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Skull Base Neoplasm
Cellular Pathology
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2018-11-30
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with a skull base tumor

Brief summary: The purpose of the study is to analyze biological samples and genetic material for basic science research investigating the molecular and cellular characterization of skull base tumors.

Detailed description: The overall goal of this proposal is to determine new molecular and cellular features that define tumor subtypes that are clinically actionable, may drive important changes in patient management, and/or elucidate novel chemotherapeutic options. Skull base tumors are currently diagnosed based on histopathologic criteria, on which post-operative management is based. However, the investigators hypothesize that each tumor type (eg. chordoma or chondrosarcoma) will have molecular and/or cellular subcategories that will redefine how to categorize and diagnose patients, predict clinical outcome, and optimally design a patient-specific management strategy. In addition, we aim to catalogue changes that occur after treatment after surgical resection, chemotherapy, and/or radiation by comparing primary and recurrent tumors.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of a skull base tumor

Exclusion Criteria:

* Insufficient tumor sample at time of resection

Primary outcomes:
measure: Patient overall survival will be measured and reported.
timeFrame: Through study completion, an average of 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: Associate Professor
name: Paul Gardner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04310917: Clinico-biological Collection of Subjects With Hyper Lipoprotein a in Reunion Island
Official title: Clinico-biological Collection of Subjects With Hyper Lipoprotein a in Reunion Island
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Disease
Lead sponsor: Centre Hospitalier Universitaire de la Réunion
Sponsor class: OTHER
First posted: 2020-03-17
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Cardiovascular disease (CVD) is the second leading cause of death in France and the leading cause of death on Reunion Island. Some modifiable risk factors for cardiovascular diseases are well identified and can be easily modulated, in particular by hygiene and dietetic measures (tobacco, sedentary lifestyle). Other risk factors such as high blood pressure, diabetes or dyslipidemia can also be pharmacologically modulated. On the other hand, there is a cardiovascular risk factor that we do not know how to modulate: a high level of lipoprotein (a) (Lp (a)), whose regulation remains largely unknown.

High plasma levels of Lipoprotein (a) remain a major risk for the development of cardiovascular disease and its clinical complications, which no drug can currently reduce. Understanding the biological and genetic determinants modulating Lp (a) levels remains a major challenge for treating subjects with hyper Lp (a). Several individuals and possibly Reunion families have been detected as having abnormally high rates of apo (a)

Thanks to the link between cardiovascular clinical picture, Lp (a) concentration and other biological markers, the study should allow a better understanding of the mechanisms underlying the cardiovascular risk in order to offer advice. prevention and care of at-risk subjects screened; or even avenues for adapted genetic counseling (DNA sequencing).

At the genetic level, several hypotheses could be explored making it possible to link the expression of the apo (a) protein to the genotype, in particular the presence of mutations in the gene, in the promoter region, polymorphisms, or epistatic regulation.


Eligibility criteria: Inclusion Criteria:

* Patient with Lp (a)\> 200 nmol / L OR member of family of a patient with Lp (a)\> 200 nmol / L
* be affiliated or beneficiary of a social security scheme
* signed consent

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Carry out a family screening of the plasma Lp (a) level
timeFrame: at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Saint-Denis
country: France
facility: Centre Hospitalier Universitaire de la Réunion
Study officials:
affiliation: CHU de la Réunion
name: Ilya KHANTALIN, PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01879917: Liraglutide in Newly Onset Type 1 Diabetes.
Official title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multi-centre Trial of Liraglutide Treatment in Subjects With Newly Diagnosed Type 1 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 1
Keywords: c-peptide
insulin
hypoglycemia
Newly onset
Diabetes
Type 1
Beta cell
Autoimmune
Glucagon
Meal test
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
Collaborators: name: Steno Diabetes Center Copenhagen
name: Hillerod Hospital, Denmark
name: Bispebjerg Hospital
name: Odense University Hospital
name: Aarhus University Hospital
name: Aalborg University Hospital
name: Esbjerg Hospital - University Hospital of Southern Denmark
First posted: 2013-06-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effect and safety of liraglutide 1.8 mg once daily compared to placebo for 52 weeks on change in beta-cell function in patients with newly diagnosed type 1 diabetes as an adjunctive therapy to insulin treatment.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes according to WHO criteria diagnosed ≤ 6 weeks before visit 0
* Age 18 - 40 years - both inclusive
* Postprandial C-peptide \> 0.2 nmol/l following sustacal meal test
* Able to understand the written patient information and to give informed consent

Exclusion Criteria:

* Type 2 diabetes
* Body mass index \<20 kg/m2
* Pregnancy or unwillingness to use safe contraceptives
* Compromised kidney function (eGFR \< 60 ml/min/1,73m2), dialysis or kidney transplantation at visit 0
* Liver disease with elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal at visit 0

Primary outcomes:
measure: Beta-cell function
timeFrame: 52 weeks
Secondary outcomes:
measure: Postprandial glucagon
timeFrame: 52 weeks
Other outcomes:
measure: HbA1c
timeFrame: 52 weeks
measure: Insulin dose
timeFrame: 52 weeks
measure: Weight
timeFrame: 52 weeks
measure: Remission period
timeFrame: 52 weeks
measure: Hypoglycemia
timeFrame: 52 weeks
Locations:
city: Hvidovre
country: Denmark
facility: Dep. of Endocrinology, Hvidovre University Hospital
state: Capital
Study officials:
affiliation: Hvidovre University Hospital
name: Sten Madsbad, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT04420117: Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery
Official title: Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery- Atlas Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Disorders
Lead sponsor: Hospital Universitario La Fe
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 39
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: Patients undergoing laparoscopic colorectal surgery.

Brief summary: Evaluation of preoperative physical capacity and its evolution in the postoperative period in older patients after undergoing laparoscopic surgery for colorectal cancer, with the test:

- Short Physical Performance Battery (SPPB)

After the inclusion of the first 10 patients, a preliminary feasibility study will be carried out and thus we have coverage of this pilot study.


Eligibility criteria: Inclusion Criteria:

* Patients age ≥65 years.
* ASA I-III
* Patients with absence of cognitive deficit.
* Informed consent signed prior to surgery.

Exclusion Criteria:

* Refusal of the patient to participate in the study.
* Patients with disabilities to give their consent.
* ASA IV-V.
* Pregnancy or lactation.
* Health status that prevent physical exercise, such as unstable heart disease, severe systematic disease, or serious orthopedic conditions

Primary outcomes:
measure: Evaluation of the physical capacity
timeFrame: 21 days before surgery
measure: Evaluation of the physical capacity
timeFrame: 21 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: