louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03154424: Dynamic External Fixation in Treatment Distal Radius Fractures - Elderly Patients
Official title: Bridging Versus Non-bridging Dynamic External Fixation in Early Total Care Treatment Unstable Distal Radius Fractures in Elderly Polytrauma Patients: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Distal Radius Fracture
Multiple Trauma
Elderly Person Maltreatment
Lead sponsor: Faculdade de Medicina do ABC
Sponsor class: OTHER
First posted: 2017-05-16
Enrollment: 150
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A single center, parallel group, prospective, randomized clinical trial was conducted at the department of Hand Surgery, ABC (Andre, Bernardo, Caetano) Foundation University Hospital, Santo Andre, Brazil. Two implants used for fixation in closed reduction of distal radius fractures were compared: the bridging dynamic Galaxy Wrist external fixator (Orthofix®, Verona) and the non-bridging Galaxy wrist external fixator system (Orthofix®, Verona).

Detailed description: Dynamic external fixator in the ETC (Early Total Care) of unstable DRFs (distal radius fractures) may be a good choice of treatment. Because it's fast, safe, minimally invasive and easily performed method, it could help in the inflammatory systemic response to trauma, unable earlier functional recovery and shorten the hospitalization time of these patients (elderly and polytrauma). From this, in this study to obtain relevant information about each type of treatment, avoid possible selection bias, information and confusion. Choose a reproducible and effective method (external fixator), which presents a cost / benefit compatible with our reality, but that generates doubt the best way to apply this "bridging" which is already used and that will be our control group and "non-bridging", which will be the group to be tested.

Rather than establishing the actual value of each of these procedures, is necessary to optimize and improve the quality of life of these patients in order to return to your personal and professional activities as soon as possible.

Eligibility criteria: Inclusion Criteria:

* skeletally mature patients, elderly (60 y.o. or more)
* all with a diagnosis of unstable distal radius fractures (AO type A or C)
* associated a multiple injured ( polytrauma ).

Exclusion Criteria:

* ongoing chemo or radiotherapy,
* mental illness,
* alcohol abuse.

Primary outcomes:
measure: Grip strenght
timeFrame: 12 months
Secondary outcomes:
measure: range of wrist motion
timeFrame: 12 months
measure: Radiograph assesment
timeFrame: 12 months
measure: DASH Questionnaire
timeFrame: 12 months
measure: VAS (visual analog scale)
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00573924: Trial of Oral Versus Intravenous Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers
Official title: Prospective Randomized Comparison of the Effect of Frequent Oral Dosing Versus Constant IV Infusion of Proton Pump Inhibitor on Intragastric pH in Patients With Bleeding Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peptic Ulcer Hemorrhage
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 66
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: Patients with bleeding ulcers identified by endoscopy will be randomly assigned to receive an acid-blocking drug (called a proton pump inhibitor \[PPI\]) either by mouth every 3 hours for 24 hours or intravenously (IV) by constant infusion for 24 hours. A pH probe in the stomach will be used to determine intragastric pH (a measure of the acid production in the stomach) at baseline and during the 24 hours of therapy. The purpose of the study is to determine if the continuous intravenous administration of the drug provides better reduction of acid in the stomach than the oral administration.


Eligibility criteria: Inclusion Criteria:

* Patients presenting to hospital with overt upper GI bleeding and found to have an ulcer as the cause on endoscopy

Exclusion Criteria:

* Previous gastric surgery
* Active bleeding at end of endoscopy (despite hemostatic therapy)
* Recent PPI or H2RA use

Primary outcomes:
measure: Intragastric pH > 6
timeFrame: 24 hours
Secondary outcomes:
measure: Mean intragastric pH
timeFrame: 24 hrs
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: L.A. County + U.S.C. Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Loren Laine, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Laine L, Shah A, Bemanian S. Intragastric pH with oral vs intravenous bolus plus infusion proton-pump inhibitor therapy in patients with bleeding ulcers. Gastroenterology. 2008 Jun;134(7):1836-41. doi: 10.1053/j.gastro.2008.03.006. Epub 2008 Mar 10.
Clinical trial NCT00794924: Probiotics and Hospital Outcome in the Elderly
Official title: Effects of Commercially Available Probiotics on Hospital Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhea
Constipation
Keywords: probiotics
elderly
motility
diarrhea
Lead sponsor: Kaplan-Harzfeld Medical Center
Sponsor class: OTHER
First posted: 2008-11-20
Enrollment: 345
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Probiotics have been shown to reduce the rate of diarrhea and constipation. The purpose of this study was to investigate if probiotics could improve outcome of hospitalized orthopedic elderly patients.

Detailed description: The patients were divided into two groups. One received probiotics for 45 days and the second received placebo. The patients had a clinical and epidemiological as well as nutritional assessment. They were followed-up as for their bowel movements, abdominal pain and nosocomial infections and for the incidence of helicobacter pylori and clostridiume difficille diarrhea.

Eligibility criteria: Inclusion Criteria:

* Patients who were hospitalized in the Department of Geriatric Orthopedic Rehabilitation a week before their enrollment in the study and signed an informed consent.

Exclusion Criteria:

* Known or suspected allergy to any probiotics
* Neutropenia
* Inability to sign an informed consent

Primary outcomes:
measure: Reduction in Number of Days of Either Constipation or Diarrhea in Comparison to the Control Group
timeFrame: 45 days of measuring the outcome
Secondary outcomes:
measure: Improvement in Nutritional and Immunological Measurements
timeFrame: 45 days
Other outcomes:
Locations:
Study officials:
affiliation: Chief dietician
name: Hilla Zahroni, MA
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zaharoni H, Rimon E, Vardi H, Friger M, Bolotin A, Shahar DR. Probiotics improve bowel movements in hospitalized elderly patients--the PROAGE study. J Nutr Health Aging. 2011 Mar;15(3):215-20. doi: 10.1007/s12603-010-0323-3.
Clinical trial NCT01145924: Transbronchial Needle Forceps for Endobronchial Ultrasound
Official title: Transbronchial Needle Forceps for EBUS
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Lung Cancer
Lymph Nodes
Keywords: bronchoscopy
endobronchial ultrasound
transbronchial needle aspiration
lung cancer
staging
Lead sponsor: Heidelberg University
Sponsor class: OTHER
First posted: 2010-06-17
Enrollment: 50
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: DIAGNOSTIC

Brief summary: Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes

Detailed description: Patients with enlarged mediastinal lymph nodes must be staged. The EBUS TBNA technique is an established technique. Unfortunately the size of the needle is limited to 21 gauge. With tne new designed needle forceps it should be possible to obtain more material and establish the diagnosis more often

Eligibility criteria: Inclusion Criteria:

* enlarged mediastinal lymph nodes

Exclusion Criteria:

* comorbidities

Primary outcomes:
measure: Number of Participants with a positive biopsy result
timeFrame: 2 days after intervention
Secondary outcomes:
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: 3 weeks after
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik
Study officials:
affiliation: Heidelberg University
name: Hendrik Dienemann, PhD, MD
role: STUDY_DIRECTOR
References:
citation: Herth FJ, Schuler H, Gompelmann D, Kahn N, Gasparini S, Ernst A, Schuhmann M, Eberhardt R. Endobronchial ultrasound-guided lymph node biopsy with transbronchial needle forceps: a pilot study. Eur Respir J. 2012 Feb;39(2):373-7. doi: 10.1183/09031936.00033311. Epub 2011 Jun 23.
Clinical trial NCT04678024: Sensitivity Evaluation of Serological Tests for Covid-19
Official title: Multicentric Sensitivity Assessment of Antibody Diagnostic Tests Developed for Diagnosis of SARS-CoV2 Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Keywords: test sierologici
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2020-12-21
Enrollment: 410
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients or individuals exposed to Sars-Cov2 Infection.

Brief summary: The primary objective of this study is to test the diagnostic sensitivity of antibody tests for the diagnosis of SARS-CoV2 infection, available to clinical laboratories, within a national network of hospitals carrying out research activities. Test the diagnostic specificity of antibody tests for the diagnosis of SARS-CoV2 infection. Complete a systematic evaluation of the different approaches. Perform Health technology Assessment (HITA) of the methodologies under study, in order to verify their reliability to the immunoglobulin levels produced by each individual exposed patient.


Eligibility criteria: Inclusion Criteria:

All patients or individuals exposed to Sars-Cov2 Infection.

Exclusion Criteria:

There are no criteria for excluding patients or individuals, if not the refusal to participate to project

Primary outcomes:
measure: Sensitivity
timeFrame: Up to 22 weeks
Secondary outcomes:
measure: Specificity
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: HTA
timeFrame: Up to 20 weeks
Locations:
city: Milan
country: Italy
facility: Istituto Ortopedico Galeazzi
Study officials:
affiliation: IRCCS Orthopedic Institute Galeazzi
name: Giuseppe Banfi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01360424: Teriparatide Treatment in Patients With Inherited Osteoporosis
Official title: Efficacy of Teriparatide Treatment in Patients With New Forms of Inherited Low-Turnover Osteoporosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoporosis
Keywords: osteoporosis
teriparatide
bone turnover
New forms of inherited low-turnover osteoporosis
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2011-05-25
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to analyse efficacy of teriparatide treatment in patients with new forms of inherited low-turnover osteoporosis.


Eligibility criteria: Inclusion Criteria:

* inherited low-turnover osteoporosis
* lumbar spine or hip BMD T-score ≤ -2.5
* a written informed consent.

Exclusion Criteria:

* age less than 18 years
* generally accepted contraindications for the treatment

Primary outcomes:
measure: Change from baseline in lumbar bone mineral density (BMD)
timeFrame: 0, 12 and 24 months
Secondary outcomes:
measure: Change from baseline in whole body bone mineral density (DXA)
timeFrame: 0,12 and 24 months
measure: Change from baseline in hip bone mineral density (DXA)
timeFrame: 0,12 and 24 months
measure: Change from baseline in histomorphometry of bone biopsy samples
timeFrame: 0 and 24 months
measure: Change from baseline in bone microarchitecture assessed by micro computed tomography of bone biopsy samples
timeFrame: 0 and 24 months
measure: Change from baseline in peripheral quantitative computed tomography (pQCT) measured cortical and trabecular volumetric bone mineral density of tibia and radius
timeFrame: 0,12 and 24 months
measure: Number of vertebral fractures (spine X-ray)
timeFrame: 24 months
measure: Change from baseline in serum procollagen type I N-terminal propeptide (PINP)
timeFrame: 0,3,6,12 and 24 months
measure: Change from baseline in serum type I collagen C-telopeptides (CTX)
timeFrame: 0,3,6,12 and 24 months
measure: Change from baseline in serum osteocalcin
timeFrame: 0,3,6,12 and 24 months
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Department of Orthopaedics and Traumatology and Division of Endocrinology, Department of Medicine and Pediatric Endocrinology, Hospital for Children and Adolescents, Helsinki University Central Hospital
Study officials:
affiliation: Division of Endocrinology, Department of Medicine, Helsinki University Central Hospital
name: Matti Välimäki, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06739824: Comparison of Spencer Technique and Conventional Treatment in Adjuncts to Corticosteroid Injection in Frozen Shoulder
Official title: Comparison of Spencer Technique and Conventional Treatment in Adjuncts to Corticosteroid Injection in Frozen Shoulder
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Frozen Shoulder
Lead sponsor: Superior University
Sponsor class: OTHER
First posted: 2024-12-18
Enrollment: 2
Sex: ALL
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study will compare the effectiveness of the Spencer Technique combined with intra-articular injection versus conventional therapy combined with intra-articular injection in managing frozen shoulder. The research problem addresses the need for optimal therapeutic approaches to improve pain relief, range of motion, and functional recovery in patients with frozen shoulder.

Detailed description: Utilizing a randomized controlled trial, the study will recruit 100 participants, divided into two groups: Group A receiving the Spencer Technique with intra-articular injection and Group B receiving conventional therapy with intra-articular injection. Outcome measures will include pain levels, range of motion, shoulder functional status and patient satisfaction, assessed through validated tools. The significance of this study lies in its potential to provide robust comparative data to guide clinical decisions and enhance patient outcomes, particularly in populations with a high prevalence of diabetes

Eligibility criteria: Inclusion Criteria:

* 30 years 60 years old.
* Diagnosed with unilateral adhesive capsulitis presenting symptoms of pain.
* restricted range of motion of frozen shoulder Stage 2 and 3

Exclusion Criteria:

* Rotator cuff injury
* Long-term Systemic Corticosteroid use
* Previous Ipsilateral shoulder CSI within 12 months.

Primary outcomes:
measure: Functional Shoulder Scale
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Sheikhupura
country: Pakistan
facility: New Haider Hospital/THQ Muridke
state: Punjab
Study officials:
References:
Clinical trial NCT02686424: Tumor Markers Study in Gastric Cancer for Cancer Immunotherapy (ONCO-RD 010 CRT)
Official title: Tumor Markers Study in Gastric Cancer for Cancer Immunotherapy
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Stomach Neoplasms
Keywords: MAGE-A3 protein
NY-ESO-1 protein
WT1 Proteins
PRAME protein
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2016-02-19
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gastric carcinoma patients who received ghastrectomy

Brief summary: Gastric cancer is one of the leading causes of cancer-related deaths worldwide. Despite advances in therapeutic intervention, the mortality from this disease remains high. As a result, most patients are now offered varying combinations of surgery, chemotherapy, and radiation therapy in order to derive benefits from a multidisciplinary approach. Unfortunately, therapies are often toxic or debilitating and therapeutic responses can vary. Thus new therapeutic strategy is required for the treatment of gastric cancer.

In the early 1980s, the discovery of cytolytic T cells (cytolytic T lymphocytes, CTLs) directed against an antigen presented on tumor cells was published. They can kill many invasive cells by recognizing the tumor specific antigens on the major histocompatibility complex (MHC) molecules. It is now generally agreed that although tumors express tumor antigens, they usually lack immunogenicity because of their inability to activate the immune response. The current view is that tumor cells are antigenic, but not immunogenic. If we can artificially activate the immune system against the tumor, it may be possible to eradicate the tumor. This approach is the basis of cancer immunotherapy.

Many tumor antigens have been defined in terms of multiple solid tumors: MART-1/Melan-A, gp100, carcinoembryonic antigen (CEA), HER-2, mucins (i.e., MUC-1), prostate-specific antigen (PSA), and prostatic acid phosphatase (PAP) are just a short list. Some immune-based therapies targeting these tumor antigens are in phase III trials assessing whether immunizing against these antigens affects overall survival. In gastric cancer, some tumor antigens such as MAGE-A3, NY-ESO-1, and WT-1 have been reported to be expressed in substantial proportion of cases. They have the potential to be the targeting molecules for immunotherapy in the future. In this study, we aim to explore the expression levels of the four tumor markers (MAGE-A3, NY-ESO-1, WT-1 and PRAME) in gastric cancers of Korean patients and to examine the correlations of the expression levels of the four markers to clinic-patholoical factors.


Eligibility criteria: Inclusion Criteria:

* gastric carcinoma
* received gastrectomy

Exclusion Criteria:

* neoadjuvant therapy

Primary outcomes:
measure: overall survival
timeFrame: five years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04717024: The Nanowear Wearable Covid-19 Observational and Analysis Trend
Official title: The Nanowear Wearable Covid-19 Observational and Analysis Trend
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Covid19
Lead sponsor: Nanowear Inc.
Sponsor class: INDUSTRY
First posted: 2021-01-20
Enrollment: 100
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: Subjects of legal age to give informed consent who are currently or recently hospitalized with a primary diagnosis of Covid-19

Brief summary: The NanoCOAT study is a multi-center, prospective, non-randomized, feasibility, observational, non-significant risk study. The NanoCOAT study will enroll a minimum of 10 and a maximum of 100 subjects in a potential for a multi-site in order to collect data and analyze physiological and biometric trends due to Covid-19.


Eligibility criteria: Inclusion Criteria:

* Subject has provided informed consent
* Male or female over the age of 18 years
* The patient is currently hospitalized with a primary diagnosis of Covid-19

Exclusion Criteria:

* Subject is unwilling or unable to wear the vest during hospitalization.
* Subjects who are pregnant.
* Subject is intubated or admitted to ICU
* Subject has an implantable cardiac device (i.e pacemaker or internal cardioverter defibrillator)

Primary outcomes:
measure: Hosptialized patient data
timeFrame: up to 30 days of monitoring leading to discharge or admission to ICU
Secondary outcomes:
measure: Trends in COVID 19 exacerbation
timeFrame: up to 30 days of monitoring leading to discharge or admission to ICU
Other outcomes:
Locations:
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
Study officials:
References:
Clinical trial NCT01857024: Post Authorisation Safety Study of Renvela® in Chronic Kidney Disease Patients Not on Dialysis With Hyperphosphataemia
Official title: Renvela® Post-Marketing Observational Study to Monitor the Clinical Use in Adult Hyperphosphataemic Chronic Kidney Disease Patients Not On Dialysis With Serum Phosphorus ≥1.78 mmol/L
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyperphosphataemia
Chronic Kidney Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2013-05-20
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult Chronic Kidney Disease (CKD) patients not on dialysis with serum phosphorus ≥ 1.78 mmol/L.

Brief summary: The primary objective of this study is to assess in a post-approval clinical setting the safety profile of sevelamer carbonate (Renvela®) tablets and powder in adult hyperphosphataemic chronic kidney disease (CKD) patients not on dialysis with serum phosphorus ≥1.78 mmol/L. Patients will be treated in accordance with the Renvela® Summary of Product Characteristics (SmPC) and followed according to the investigator's standard clinical practice management. Each patient will be followed up for 12 months or up to the time they start dialysis, whichever occurs first.


Eligibility criteria: Inclusion Criteria:

* Adult Chronic Kidney Disease (CKD) patients not on dialysis with serum phosphorus ≥ 1.78 mmol/L.
* Prescribed Renvela (800 mg tablets or 2.4 g powder for oral suspension) in accordance with the Renvela SmPC.
* Provide signed informed consent (patient or their legally authorised representative)

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Frequency of non-serious and Serious Adverse Drug Reaction (ADRs)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
city: Linz
country: Austria
city: Aalborg
country: Denmark
city: Cabestany
country: France
city: Dijon
country: France
city: Lille
country: France
city: St. Laurent du Var
country: France
city: Toulouse
country: France
city: Berlin
country: Germany
city: Dortmund
country: Germany
city: Hannover
country: Germany
city: Mettman
country: Germany
city: Wiesbaden
country: Germany
city: Acireale
country: Italy
city: Milano
country: Italy
city: Naples
country: Italy
city: Palermo
country: Italy
city: Pavia
country: Italy
city: Pesaro
country: Italy
city: Rome
country: Italy
city: Amsterdam
country: Netherlands
city: Breda
country: Netherlands
city: Dordrecht
country: Netherlands
city: Leiden
country: Netherlands
city: Madrid
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References: