louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02964806: Development and Clinical Validation of Ketogen-based Therapeutic Diet for Pancreaticobiliary Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ketogen-based Therapeutic Diet
Pancreaticobiliary Cancer
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2016-11-16
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: Decreased bowel function and loss of appetite in patients who underwent pancreaticobiliary surgery contribute impaired nutritional status in postoperative period. It can also affect perioperative and oncologic outcomes negatively. Therefore it is important to improve nutritional status in postoperative period by supply tailor-made optimal diets. The investigators have developed customized postoperative diets for pancreaticobiliary cancer patients. The investigators expect that customized diets for pancreaticobiliary patients will increase the food intake rate and contribute a improvement of perioperative outcomes and even oncologic outcomes.


Eligibility criteria: Inclusion Criteria:

* Adult (age more than 19)
* Pancreaticobiliary cancer patient who is scheduled pancreaticoduodenectomy or distal pancreatectomy
* Pancreatic cancer / Duodenal cancer / Distal bile duct cancer / Ampulla of Vater cancer

Exclusion Criteria:

* Patient who denied clinical trial
* Diabetes Mellitus(DM) patient with DM complication
* Hyperlipidemia patient with vascular co-morbidity
* Impaired renal function or renal failure (GFP\<90%)

Primary outcomes:
measure: Food Intake Rate(%) for postoperative diet
timeFrame: 3 days after the diet
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT05502406: Effectiveness of Manual Myofascial Release Versus Instrument Assisted Soft Tissue Mobilization (IASTM) in Patients With Chronic Neck Pain"
Official title: Effectiveness of Manual Myofascial Release Versus Instrument Assisted Soft Tissue Mobilization (IASTM) in Patients With Chronic Neck Pain"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Neck Pain
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2022-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: compare two treatment techniques the study type will be parallel experimental study.
Primary purpose: TREATMENT

Brief summary: Neck pain has a global prevalence of 30%, being the fourth leading cause of disability among general population and is more prevalent among females than males, as per concluded by evidence. It is undoubtedly the need of time, to address its proper treatment and to hinder its recurrence amongst the general population. The current physical therapy management of neck pain is more focused towards achieving the short term goals for the patient rather than addressing and amending the actual cause of its relapse. Manual Myofascial Release is one of the very effective treatment used to release soft tissue and fascial adhesions over the myofascia inorder to relieve chronic neck pain. The study aims to compare this manual treatment against Instrument Assisted soft tissue mobilization in order to determine which of the two provides improved outcome in terms of pain, neck disability and cervical Range of motion.


Eligibility criteria: Inclusion Criteria:

* Male and Female participants belonging to the age group of 18 to 40 years
* Participants suffering from neck pain for more than 3months.

Exclusion Criteria:

* Recent history of Whiplash Injury.
* Recent traumatic history of head, cervical spine, shoulder girdle or fractures of the cervical spine or shoulder complex.
* History of Cervical Radiculopathy, spondylosis, spondylolisthesis, disc prolapse, any other systemic disease or vascular syndrome such as vertebro-basilar Insufficiency.
* Diagnosed Fibromyalgia, myopathy or myelopathy
* Sensory/Motor dysfunction owing to any neurological pathology in the mid or upper back.

Primary outcomes:
measure: Pain intensity
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Rawalpindi
country: Pakistan
facility: Fauji Foundation Hospital
state: Punjab
Study officials:
References:
Clinical trial NCT04089306: Integration of Palliative Care in an Oncology and Hematology Unit
Official title: Integration of Palliative Care in an Oncology and Hematology Unit : a Retrospective Monocentric Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Advanced Cancer
Keywords: Advanced Cancer
End of Life
Agressiveness of Care
Palliative Care integration
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who has been followed in the oncohematology Unit of the University Hospital of Strasbourg for a solid tumor or haematological cancer

Brief summary: The main goal of this study is to assess retrospectively the integration of Palliative Care in an oncology and hematology unit. The investigators will study the last six month of life on advanced cancer patients and retrieve data from their medical file to obtain criterias of quality of care and integration of palliative care in this population.

Those criterias have been used before in other setting (Earle Criterias, ESMO Recommendations) and The investigators will compare our data to existing publications.

They also hope to see if it is retrospectively possible to assess the probability of death using the Pronopall score. This will help them asses if aggressive end of life care could have been avoided using the Pronopall Score


Eligibility criteria: Inclusion Criteria:

* Patient aged over 18 years old
* Patient who has been followed in the oncohematology Unit of the University Hospital of Strasbourg for a solid tumor or haematological cancer
* Died within the 1rst of January 2017 and the 31st of December 2018
* The patient has not expressed an opposition to the use of his medical data during his lifetime.

Exclusion Criteria:

* Patient receiving allogeneic stem cell transplant
* Patient expressed during his lifetime an opposition regarding the use of his medical data

Primary outcomes:
measure: Retrospective study of palliative care in oncohematology department
timeFrame: The period from January 1st, 2017 to December 31, 2018 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service D'Hematologie Et D'Oncologie
Study officials:
References:
Clinical trial NCT02520999: The Effect of Various External Pressure on Blood
Official title: Comparison of the Effect of Various External Pressure on Blood During Rapid Infusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhage
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Rapid infusion of blood is needed occasionally for control massive bleeding. For rapid infusion, external pressure can be used. The investigators will study correlation between external pressure and hemolysis and deformability of red blood cell.

Detailed description: Rapid infusion of blood is needed occasionally for control massive bleeding. For rapid infusion, external pressure can be used which cause hemolysis and alteration of red blood cell. The investigators will study correlation between variable external pressure and hemolysis and deformability of red blood cell. Differ from previous study, the investigator will use scanning electron microscope for observation red blood cell.

Eligibility criteria: Inclusion Criteria:

* healthy volunteers, without any underlying disease.

Exclusion Criteria:

* history of delivery, abortion in past 6 months.
* weight : male under 50kg, female under 45kg
* heart rate under 50 or over 100
* fever : over 37.5
* blood pressure : over 180/100

Primary outcomes:
measure: Hemolysis and alteration of deformability of red blood cell caused by external pressure
timeFrame: 1hour
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea university anam hospital
Study officials:
affiliation: Department of anesthesiology and pain medicine, Korea University Anam Hospital
name: Hyub Huh, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT03529799: Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)
Official title: Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Keywords: mTBI
TBI
brain injury
concussion
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Neurolign
First posted: 2018-05-18
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing.


Eligibility criteria: Inclusion Criteria:

* Age 18 to 65
* Both females and males

Exclusion Criteria:

* Central processing disorder
* Impaired vision without corrective lenses (max 20/60 uncorrected)
* Moderate to severe hearing loss (\>55 decibels (dB) pure tone audiometry (PTA), \<50% word identification)
* Vestibular disorder except for patients recruited for subjects recruited with a history of mild traumatic brain injury to compare to normal participants
* History of ear surgery other than myringotomy with or without tube placement
* Pregnant women
* Prisoners
* Adults unable to consent

Primary outcomes:
measure: Pseudorandom Ternary Sequence of Frequency
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Michael Hoffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04136899: Burn Out and Quality of Life at French General Practioners
Official title: Burn Out and Quality of Life at French General Practioners: is There a Link
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cross-Sectional Studies
Keywords: burn out
quality of life
general practioners
french
Lead sponsor: Centre Hospitalier St Esprit
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 1100
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All french general practitioner in activity

Brief summary: The suffering of caregivers is constantly increasing. General medicine, because of its primary role in primary care, is particularly exposed to the risk of burn-out and must protect itself. The aim of this study was to find an inverse relationship between health-related quality of life and being severely burned by French general practitioners.

Detailed description: descriptive quantitative cross-sectional study

Eligibility criteria: Inclusion Criteria:

* french general practitioner in liberal activity

Exclusion Criteria:

* retired doctor
* junior general practioner

Primary outcomes:
measure: Assesment of Burn-out
timeFrame: 30 days
measure: Assesment quality of life: Dukes Scale
timeFrame: 30 days
Secondary outcomes:
measure: Socio-demographic data
timeFrame: 30 days
measure: Mode of practice
timeFrame: 30 days
measure: Leisure time
timeFrame: 30 days
Other outcomes:
Locations:
city: Agen
country: France
facility: Centre Hospitalier St ESPRIT
Study officials:
affiliation: Centre Hospitalier St Esprit
name: Albert TRINH-DUC, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05319899: A Study of ALXN1840 (Non-coated) Administered With And Without Omeprazole In Healthy Adults
Official title: A Phase 1, Single-Center, Randomized, 3-Period Crossover Study to Evaluate the Relative Bioavailability of WTX101 in Healthy Subjects After Single Dose Administration of a Non-Coated Formulation With and Without a Proton Pump Inhibitor and With a Proton Pump Inhibitor With and Without Food
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ALXN1840
WTX101
Omeprazole
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2022-04-08
Enrollment: 18
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study.
Primary purpose: BASIC_SCIENCE

Brief summary: This was single-center, open-label, randomized, 3-period, 3-treatment, 6-sequence crossover study evaluating the PK of single doses of WTX101 in healthy participants based on the measurement of plasma total Molybdenum.


Eligibility criteria: Inclusion Criteria:

* Non-smoker
* Medically healthy with no clinically significant laboratory profiles, vital signs, or electrocardiograms.
* Body mass index ≥ 18 and ≤ 32.0 kilograms/meter squared.
* Willing and able to adhere to contraception requirements.

Exclusion Criteria:

* Participant was mentally or legally incapacitated
* History or presence of clinically significant medical or psychiatric condition or disease.
* History of any illness that might have interfered with drug absorption.
* History or presence of hypersensitivity or idiosyncratic reaction to the study medications, study medication excipients.
* History or presence of alcoholism or drug abuse.
* Female participants who were pregnant or lactating.
* Positive results at screening for human immunodeficiency virus, hepatitis B surface antigen, or hepatitis C virus.
* Serum ceruloplasmin and copper values outside of the normal range at screening.
* On a diet incompatible with the on-study diet within the 28 days prior to the first ALXN1840 dose and throughout the study; unable to consume the contents of a high-fat breakfast.
* Participation in a previous clinical trial with ALXN1840.

Primary outcomes:
measure: Area Under the Plasma Concentration Versus Time Curve, From Time 0 to the Last Measurable Concentration (AUC0-t) of Total Molybdenum (Mo)
timeFrame: Predose (0 hour) up to 192 hours postdose
measure: Maximum Measured Plasma Concentration (Cmax) of Total Mo
timeFrame: Predose (0 hour) up to 192 hours postdose
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 through 14 days following final dose (up to Day 43)
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Clinical Trial Site
state: Nebraska
Study officials:
References:
Clinical trial NCT03235999: The Experiences of Patients Living With Malignant Pleural Effusions
Official title: The Experiences of Patients Living With Malignant Pleural Effusions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Malignant Pleural Effusion
Lead sponsor: Gloucestershire Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2017-08-01
Enrollment: 20
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: Patients with malignant pleural effusions

Brief summary: Up to 20 patients with malignant pleural effusions will be interviewed about their experiences of having this condition and its management.


Eligibility criteria: Inclusion Criteria:

1. Adults diagnosed with a malignant pleural effusion
2. Has undergone either talc pleurodesis or IPC
3. Have signed a consent form prior to entering the study
4. Life expectancy \> 6 weeks based on LENT guidelines (Low/Moderate risk group) - The LENT score calculation assigns 0 (\<1500 IU/L) or 1 (\>1500 IU/L) for pleural fluid LDH level; 0 to 3 points for matching ECOG performance scores (3 and 4 are combined); 0 (\<9) or 1 (\>9) for neutrophil-to-lymphocyte ratio; and 0 (lowest risk), 1 (moderate risk), or 3 (highest risk) for tumor type.

Exclusion Criteria:

1. Any patient who is unable to understand sufficient English to take part in the semi-structured interviews
2. Weakness or fatigue sufficient so that the patient is unable to take part in the interviews

Primary outcomes:
measure: Patient Experiences of living with malignant pleural effusion and different pleural procedures
timeFrame: 4 weeks after IPC placement or talc pleurodesis
Secondary outcomes:
Other outcomes:
Locations:
city: Cheltenham
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
state: Gloucestershire
Study officials:
affiliation: Gloucestershire Hospitals NHS Foundation Trust
name: Paul Perkins, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04184999: Effect of Intraoperative Dexamethasone on Post-op Dry Eye
Official title: Evaluation of Intraoperative Use of Dexycu on the Signs and Symptoms of Dry Eye
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye Syndromes
Lead sponsor: SR Cornea Consultants
Sponsor class: OTHER
First posted: 2019-12-04
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, controlled prospective study.
Primary purpose: PREVENTION

Brief summary: To compare the signs and symptoms of dry eye after cataract surgery between subjects randomized to receive intraoperative dexamethasone in addition to the use of a standard topical post-op treatment regimen.

Detailed description: Forty patients requiring cataract surgery will be randomized to treatment of post-operative inflammation with a single intraoperative dexamethasone injection plus a standard course of topical ophthalmic corticosteroid drops or the standard treatment alone. Dry eye testing will be administered at baseline, 1 week and 3 weeks following surgery.

Eligibility criteria: Inclusion Criteria:

* undergoing bilateral cataract surgery

Exclusion Criteria:

* central corneal staining with fluorescein and/or a tear film osmolarity of greater than 340 in either eye

Primary outcomes:
measure: Evaluation of Intraoperative Use of Dexycu on Tear Film Osmolarity at 3 Weeks Postoperatively
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sycamore
country: United States
facility: Hauser Ross Surgical Center
state: Illinois
Study officials:
affiliation: SR Cornea Conslutants
name: Sanjay Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05105399: Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures
Official title: Evaluation of Serratus Plane Block on the Respiratory Pattern in Patients With Multiple Rib Fractures: a Perspective Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rib Fractures
Spirometry
Lead sponsor: Niguarda Hospital
Sponsor class: OTHER
First posted: 2021-11-03
Enrollment: 72
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In patients admitted following a trauma, the incidence of multiple rib fractures is reported to be 9,7%, and this can be even higher in high energy trauma like motor vehicle accidents (1). Pain deriving from rib fractures cause the patient to breath shallow in order to limit discomfort and this bring about negative consequences: shallow breathing and inability to clear secretions may cause pulmonary atelectasis eventually evolving to pneumonia. Given the aforementioned concerns, it is easy to understand why, in a context like this, control of chest pain become crucial. The best way to achieve adequate pain control have not yet been established: the aim of this study is to investigate on this clinical dilemma. In this study, 72 people with at least two monolateral rib fractures are going to be randomized into three groups: 1) standard treatment alone (intravenous analgesia: acetaminophen + morphine PCA); 2) continuous serratus plane block + standard treatment; 3) single-shot serratus plane block + standard treatment. The variables that are going to be recorded are the following: pain through the NRS scale, FEV1 and FVC through spirometry and finally an arterious gas analysis. Recording are going to be repeated at 72h after admission. The primary endpoint is to evaluate if the continuous serratus plane block is able to improve the FEV1/FVC compared to single shot or standard treatment alone. Secondary endpoints will be: the effect of continuous block on 1) resting and incident pain; 2) opioid consumption; 3) blood gas analysis parameters; 4) pulmonary complications at 1 month; 5) length of stay


Eligibility criteria: Inclusion Criteria:

1. Chest trauma with at least 2 monolateral rib fractures (monofocal or multifocal) with no flail chest
2. Age\>18 years
3. Hospital admission
4. Ability to provide written informed consensus
5. Awake patient, spontaneous ventilation

Primary outcomes:
measure: FEV1 (% of the predicted value)
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: ASST GOM Niguarda
Study officials:
References: