louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04067349: Physical Recovery After Laparoscopic vs. Open Liver Resection
Official title: Physical Recovery After Laparoscopic vs. Open Liver Resection - a Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Liver Diseases
Physical Stress
Surgery
Keywords: laparoscopic
minimal invasive
physical recovery
liver surgery
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2019-08-26
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: non-randomized cohort study, 2 parallel groups
Primary purpose: PREVENTION

Brief summary: The role of laparoscopic liver surgery with respect to clinical outcome remains unclear.

Detailed description: The role of laparoscopic liver surgery with respect to clinical outcome remains unclear. The investigators hypothesized that laparoscopic liver resection (LLR) is associated with better postoperative recovery than open liver resection (OLR).

Twenty-one patients who underwent LR were included in this study (11 OLR (52.4%) and 10 LLR (47.6%), respectively). Postoperative recovery was measured by bicycle stress testing at months 1 and 6 after surgery and compared to preoperative stress testing. Standardized performance for bicycle stress testing was calculated based on age, sex, height and weight. Postoperative recovery was compared between groups as change of performance (%).

Eligibility criteria: Inclusion Criteria:

* all patients undergoing liver resection (open vs. laparoscopic)
* all patients willing participate and gave written informed consent

Exclusion Criteria:

* pregnancy
* significant traumatic injury within 30 days prior to study enrolment
* inability or unwillingness to comply to the protocol or to perform bicycle ergometry

Primary outcomes:
measure: Overall change in performance
timeFrame: 1, 6 months
Secondary outcomes:
measure: Postoperative Complications
timeFrame: 1 months
measure: Liver resection and effect on postoperative fitness
timeFrame: 2 years
measure: length of stay
timeFrame: 1 month
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna, Department of Surgery
Study officials:
affiliation: Medical University of Vienna, Department of Surgery
name: Klaus Kaczirek, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00588549: Utility of PET In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases
Official title: Utility of Whole-Body 18-Fluorodeoxyglucose Positron Emission Tomography (PET) In the Pre-Operative Assessment of Patients With Hepatic Colorectal Metastases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Carcinoma
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2008-01-08
Enrollment: 204
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: Memorial Sloan-Kettering Cancer Center patients with colorectal cancer

Brief summary: This study aims to determine whether a test, called the PET scan, may be useful in determining if there are additional locations of cancer not otherwise detectable by other tests.

The PET scan is a nuclear medicine imaging study that measures how much radioactive sugar is used by your tumor. The study will compare pictures of the cancer from the PET scan to other x-ray exams, such as a CT scan, as well as to what your doctors find at the time of surgery. If the study results show that the PET scan gives us a good idea of what is happening to the tumor, then it may be useful in deciding which patients with colorectal metastases to the liver should be operated on and what operation should be performed.

Additionally, by comparing the results of PET scans with the other studies that will be performed as part of your care, we will try to determine which test best tells us which patient is most likely to benefit from surgery.


Eligibility criteria: Inclusion Criteria:

* initial diagnosis of colorectal carcinoma confirmed by the Pathology Department of Memorial Hospital or by diagnostic barium enema if the primary tumor is still in place.
* a candidate for liver resection for metastatic colorectal cancer as defined by members of the Department of Surgery of Memorial Hospital. Patients with metastatic colorectal cancer isolated to the colon, rectum, or liver are eligible. In addition, patients with limited, resectable pulmonary metastases are eligible.

Exclusion Criteria:

* Patients must not be pregnant; females of child bearing age must use an adequate form of contraception.

Primary outcomes:
measure: To assess if whole body 18F-FDG-PET enhances our ability to detect metastatic colorectal cancer restricted to liver and lung over conventional imaging such as CT and to determine the accuracy of PET in imaging extrahepatic tumors.
timeFrame: conclusion of the study
Secondary outcomes:
measure: To determine whether PET plays a role in altering clinical management of patients undergoing evaluation for liver resection for hepatic colorectal metastases.
timeFrame: conclusion of the study
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yuman Fong, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03456349: Multi-centre Study of HTL0018318 in Patients as an add-on to Standard-of-care
Official title: A Phase 1b Randomized, Double-blind, Placebo-controlled, Parallel Group, Multi-center Study to Determine the Safety and Tolerability of HTL0018318 in Subjects With Alzheimer's Disease Receiving Standard-of-care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
Lead sponsor: Nxera Pharma UK Limited
Sponsor class: INDUSTRY
Collaborators: name: Allergan
First posted: 2018-03-07
Enrollment: 60
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Multi-centre study of HTL0018318 in patients with Alzheimer's disease as an add-on to standard-of-care

Detailed description: This is a multi-centre study conducted in four countries. A total of 60 subjects with Alzheimer's disease who are on standard-of-care will be enrolled to receive one of 3 active HTL0018318 or placebo for a period of four weeks

Eligibility criteria: Inclusion Criteria:

1. Diagnostic evidence of Alzheimer's disease according to the 2011 National Institutes of Aging-Alzheimer's Association (NIA-AA) criteria
2. Participants with Alzheimer's disease on stable standard of care

Exclusion Criteria:

1. Presence of illness apart from Alzheimer's disease that could contribute to cognitive dysfunction
2. A current or history of clinically significant suicidal ideation within the past 6 months
3. Subjects who have been on anti-cholinergic and/or anti muscarinic treatment

Primary outcomes:
measure: Treatment emergent adverse events (TEAEs), Safety and Tolerability
timeFrame: Baseline to Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czechia
facility: Syneos
city: Warsaw
country: Poland
facility: Syneos
city: Bratislava
country: Slovakia
facility: Syneos
city: Barcelona
country: Spain
facility: Syneos
Study officials:
References:
Clinical trial NCT06534749: Ultrasound Screening of Congenital Anomalies of Kidney and Urinary Tract in Neonates
Official title: Ultrasound Screening of Congenital Anomalies of Kidney and Urinary Tract in Neonates
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Urinary Tract Anomalies
Kidney; Anomaly
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-08-02
Enrollment: 1000
Sex: ALL
Minimum age (years): 3
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neonates who will be born or admitted at Tanta University Hospital.

Brief summary: This cross sectional study will be conducted to investigate the incidence of the congenital anomalies of kidney and urinary tracts in neonates born or admitted at Tanta University Hospital.

Detailed description: This cross sectional study will be conducted for one year from October 2023 to October 2024 at Pediatric and Radiology Departments Tanta University Hospital (TUH).

This study will be conducted on neonates who will be born or admitted at Tanta University Hospital.

All patients included in the study will be subjected to: history taking, clinical examination and Ultrasound screening: by (SonoScape A6, Yizhe Building, Yuquan, Road Shenzhen, 518051, China). General-purpose diagnostic abdominal ultrasound equipment was used, with a 7.5-MHz linear-type probe. Screenings will be performed by radiologist with appropriate practice. The ultrasound examination will take 10 min for each patient. The recordings will consist of two bilateral renal images will be obtained and one transverse and longitudinal images. The urinary bladder will be observed with the patient in a supine position, and images will be recorded when abnormalities will be identified. The following will be investigated by ultrasound: number, size (including differences between sides), and location of the kidneys; pelvic dilatation; echogenicity, and other findings indicating cysts or tumours. Shape and wall thickening of the urinary bladder, as well as ureter dilatation, will be also examined.

Eligibility criteria: Inclusion Criteria:

* Neonates in the first month of life.

Exclusion Criteria:

* no exclusions

Primary outcomes:
measure: Incidence of CAKUT in neonates
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Sara Mabrouk Mohamed Elghoul
state: Tanta, Qism 1
Study officials:
affiliation: Tanta University
name: Sara Mabrouk Mohamed Elghoul, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01636349: Health Effects of Recreational Soccer in Type 2 Diabetic Men
Official title: Cardiovascular, Muscular Adaptations and Glycaemic Control to 6 Months of Recreational Soccer in Type 2 Diabetic Men
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Hypertension
Obesity
Metabolic Syndrome
Keywords: Type 2 diabetes
hypertension
obesity
metabolic syndrome
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2012-07-10
Enrollment: 22
Sex: MALE
Minimum age (years): 35
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The present study investigates the effects of recreational soccer in type 2 diabetic men in regard to muscular, cardiovascular adaptations and glycaemic control. 12 men participate in 6 month structured recreational soccer training and 10 men act as control with no change in lifestyle. Testing consisting of fasting blood samples, muscle biopsies, Dexa-scans, echocardiography, maximal oxygen consumption, Yo-Yo interval test, bloodpressure, Resting heart rate, and endothelial function (Itamar, Endopat)will be performed at baseline, after 12 and 24 weeks, respectively.

The study examines the hypothesis that the high-intensity aerobic work profile combined with a high anaerobic turnover from the nature of soccer (accelerations, decelerations, turns, sudden stops) will improve glycaemic control, muscle and cardiac function and taken together will improve the overall health profile in type 2 diabetic men


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes diagnosed
* 35-60 years old men

Exclusion Criteria:

* Smoker
* Ischaemic heart Disease
* Congestive heart failure
* Joint or limp pains to an extent where recreational soccer can not be performed.
* Apoplexia.
* Anticoagulant therapy (aspirin accepted)

Primary outcomes:
measure: Cardiac adaptations
timeFrame: Analysis of data at baseline, 12 and 24 weeks
measure: muscular adaptations
timeFrame: Data analysis after baseline, 12 and 24 weeks
Secondary outcomes:
measure: Vascular function
timeFrame: Data analysis after baseline, 12 and 24 weeks
measure: glycaemic control
timeFrame: Data analysis after baseline, 12 and 24 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: jakob friis schmidt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen TR, Schmidt JF, Thomassen M, Hornstrup T, Frandsen U, Randers MB, Hansen PR, Krustrup P, Bangsbo J. A preliminary study: effects of football training on glucose control, body composition, and performance in men with type 2 diabetes. Scand J Med Sci Sports. 2014 Aug;24 Suppl 1:43-56. doi: 10.1111/sms.12259. Epub 2014 Jun 5.
Clinical trial NCT05444049: NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest (ARISE)
Official title: A Feasibility Study of the NEURESCUE Device as an Adjunct to In-Hospital Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiac Arrest
Cardiopulmonary Arrest
Cardiovascular Diseases
Lead sponsor: neurescue
Sponsor class: INDUSTRY
First posted: 2022-07-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The NEURESCUE device is the first intelligent catheter for aortic balloon occlusion, an emergency technique that supercharges blood flow to the heart and brain within one minute from deployment.

The catheter-based device is delivered via the femoral artery, temporarily inflating a soft balloon in the descending aorta to redirect blood flow towards the upper body.

The objective of this study is to investigate the feasibility of the NEURESCUE device as an adjunct to Advanced Cardiac Life Support (ACLS) in adults with cardiac arrest.


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 and ≤80 years
2. CPR initiated within 7 min of presumed arrest
3. 8 min of continuous ACLS without ROSC

Exclusion Criteria:

1. Traumatic cardiac arrest
2. Intraoperative cardiac arrest
3. Known pregnancy
4. Known terminal disease
5. Known do-not-attempt-CPR order
6. Subjects whose femoral arterial access site cannot accommodate an 8 Fr introducer sheath
7. Subjects currently on mechanical circulatory support

Primary outcomes:
measure: Successful balloon inflation within 10 minutes from first vessel puncture
timeFrame: Assessed up to 10 min
Secondary outcomes:
measure: Change in central blood pressure
timeFrame: Assessed up to 1 hour
measure: Total ACLS time at initiation of the investigational procedure
timeFrame: Assessed up to 1 hour
measure: Time from first vessel puncture to successful sheath insertion
timeFrame: Assessed up to 1 hour
measure: Rate of occlusion success
timeFrame: Assessed up to 1 hour
measure: Return of spontaneous circulation (ROSC)
timeFrame: Assessed up to 1 hour
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Long Beach Medical Center
state: California
Study officials:
affiliation: Long Beach Medical Center
name: David Shavelle, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01176149: Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin
Official title: Role Of Self-monitoring of Blood Glucose and Intensive Education in Patients With Type 2 Diabetes Not Receiving Insulin: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: Diabetes
Self monitoring blood glucose
Lead sponsor: Consorzio Mario Negri Sud
Sponsor class: OTHER
Collaborators: name: LifeScan
First posted: 2010-08-05
Enrollment: 62
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this pilot study is to evaluate the validity and feasibility of an educational approach involving nurses, combined with SMBG, aimed at lifestyle modification and timely changes in therapy, when needed.


Eligibility criteria: Inclusion Criteria:

* Patients with Type 2 diabetes (known diabetes or new diagnosis) seen for the first time in the diabetes outpatient clinic;
* Patients on treatment with OHA monotherapy (i.e. metformin alone or sulphonylureas alone or TZDs alone);
* No need for insulin treatment;
* Male and female patients, aged between 45-75 years;
* Hba1c values between 7% and 9% included (considering a value of 6.0% as the upper limit of normal value)
* No experience of self monitoring of blood glucose in the previous 12 months (SMBG performed with a frequency of \< 1 times/week)
* Ability and willingness to comply with all study requirements
* Signature of consent form

Exclusion Criteria:

* Patients incapable to perform SMBG
* Patients needing insulin or multiple OHA association therapy
* Patients needing a regular use of SMBG (e.g. frequent hypoglycemic episodes)
* Diabetes care not exclusively managed by diabetic clinics
* Patients with serious underlying medical or psychiatric condition

Primary outcomes:
measure: Improvement of metabolic control
Secondary outcomes:
measure: Reduction in prandial Blood Glucose excursions
measure: Percentage of patients needing therapy modifications
measure: Percentage of patients reaching target HbA1c (i.e. <7.0%)
Other outcomes:
Locations:
city: Santa Maria Imbaro
country: Italy
facility: Consorzio Mario Negri Sud
state: Chieti
Study officials:
affiliation: Consorzio Mario Negri Sud
name: Antonio Nicolucci, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05139849: VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial
Official title: VAsopressin and STeroids in Addition to Adrenaline in Cardiac Arrest - a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Cardiac Arrest;In-hospital Cardiac Arrest; Methylprednisolone; Vasopressin; Adrenaline; Randomized Clinical Trial
Lead sponsor: Tiohundra AB
Sponsor class: INDUSTRY
Collaborators: name: Sahlgrenska University Hospital
name: Stockholm South General Hospital
First posted: 2021-12-01
Enrollment: 1276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an investigator initiated randomized, placebo controlled, double blind, superiority, multi-centre clinical trial. The estimated study project period runs over 3-4 years, including pilot phase. Based on preliminary assumptions, to confirm or reject an increase in survival from 9% to 14%, about1400 patients will be randomized in the study. In hospital cardiac arrest patients meeting criteria(s) for adrenaline administration according to current ERC guidelines are eligible for randomization in the study.

Informed consent for participating in the study cannot be obtained from the subject at the scene of the cardiac arrest since the victim is unconscious. Therefore, all hospitalized men \> 18 years and women \> 50 years, except those fulfilling the exclusion criterias; patients not capable to comprehend information to decide about participation in the study, women considered of childbearing potential (WOCBP)) and do not resuscitate (DNR) decision will be informed and asked about consent to participate in the study and in the case of cardiac arrest during the actual hospital stay randomized to either treatment. Only those patients experiencing an in hospital cardiac arrest meeting criteria(s) for adrenaline administration will be randomized.

Patients will be randomized to, in addition adrenaline, either treatment with vasopressin and steroids (intervention) or sodium chloride (placebo) (control).

Primary outcome is survival at 30 days.


Eligibility criteria: Inclusion Criteria:

* Hospitalized men \> 18 years and hospitalized women \> 50 years.

Exclusion Criteria:

* Patients not capable to comprehend information to decide about participation in the study
* Women considered of childbearing potential (WOCBP) i. e. premenopausal women
* Patients with do not resuscitate (DNR) descision
* Prior enrollment and randomization in the trial

Primary outcomes:
measure: Survival at 30 days
timeFrame: Survival at 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Norrtälje
country: Sweden
facility: Tiohundra
Study officials:
affiliation: Tiohundra AB
name: Sune Forsberg, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sahlgrenska University Hospital
name: Peter Lundgren, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04157049: Alpha-1 Research Registry
Official title: Alpha-1 Research Registry Protocol
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Alpha 1-Antitrypsin Deficiency
Keywords: AATD
ALPHA 1
COPD
AAT
ZZ
MZ
CARRIER
MM
MS
PiZZ
Lead sponsor: Alpha-1 Foundation
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 4000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The current protocol seeks to enroll 4,000 individuals of all age, race, and sex.

Brief summary: The Alpha-1 Research Registry is a confidential database made up of individuals diagnosed with Alpha-1 Antitrypsin Deficiency (Alpha-1) and individuals identified as Alpha-1 carriers. The Registry was established to facilitate research initiatives and promote the development of improved treatments and a cure for Alpha-1.

Detailed description: The purpose and goal of the Alpha-1 Research Registry (Registry, or group of patients) will be to obtain uniform, longitudinal (over the course of time), complete and accurate data that can be organized, and made available for the public to query. The collective number of Registry members enables investigators to enroll sufficient subjects to carry out their studies. The community benefits from having more research and potential therapies performed in their disease. Regular updates from patients will give objective data-points to measure the progression of disease.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with Alpha-1 Antitrypsin Deficiency (PiZZ, PiZNull, PiSZ etc.)
* Alpha-1 carriers (PiMZ, PiMS etc.)

Exclusion Criteria:

* Failure to provide informed consent
* Normal healthy individuals (MM)

Primary outcomes:
measure: Establish the Alpha-1 Research Registry using REDCap
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: Alpha-1 Foundation
state: Florida
Study officials:
References: