louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01204320: A COMparison Between PAClitaxel-coated Balloon and pacliTaxel-eluting Stent in the Treatment of In-Stent Restenosis (COMPACT-ISR)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Stable Angina
Unstable Angina
Keywords: Restenosis
POBA
Stenting
Paclitaxel
Lead sponsor: Ospedale San Donato
Sponsor class: OTHER
First posted: 2010-09-17
Enrollment: 154
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 a multicentric randomized comparison between paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in patients with stable or unstable angina with the evaluation of restenosis by Quantitative Coronary Analysis.

Detailed description: The purpose of this study is to determine the late luminal loss by Quantitative Coronary Analysis at 6 month-follow up after paclitaxel-coated balloon angioplasty or paclitaxel-eluting stent implantation in the treatment of in-stent restenosis.

Eligibility criteria: Inclusion Criteria:

* informed consent
* \>18y
* Stable Angina or Unstable Angina
* Single restenotic lesion in a previously stented coronary artery

Exclusion Criteria:

* Acute Myocardial Infarction within 72h
* Serum Creatinine\>2.0 mg/dL
* Contraindications to ASA, Heparin, Clopidogrel, Ticlopidine, Abciximab, Tirofiban, Paclitaxel
* Contraindications to contrast media
* Life expectancy \< 2y
* Target Lesion length \> 30mm
* Target Lesion diameter \<= 2.5 mm
* Target stenosis \< 70%
* Massive Calcifications in the target segment
* Evidence of intra-coronary thrombus

Primary outcomes:
measure: Late Luminal Loss defined as the difference between the minimal luminal diameter after stenting and at follow-up by Quantitative Coronary Analysis
timeFrame: 6 months
Secondary outcomes:
measure: Binary restenosis defined as >50% diameter stenosis by QCA
timeFrame: 6 months
measure: Major Adverse Cardiac Events
timeFrame: 6, 12 months
measure: Target Lesion Revascularization
timeFrame: 6, 12 months
Other outcomes:
Locations:
city: Arezzo
country: Italy
facility: San Donato Hospital
state: AR
Study officials:
affiliation: Cardiovascular Department - San Donato Hospital
name: Leonardo Bolognese, MD
role: STUDY_CHAIR
References:
Clinical trial NCT01126320: Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated Patients Using the AnapnoGuard System
Official title: Frequency of Ventilator Associated Pneumonia (VAP) in Mechanically Ventilated ICU Patients Using the AnapnoGuard System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ventilator Associated Pneumonia
Keywords: VAP
Lead sponsor: Hospitech Respiration
Sponsor class: INDUSTRY
First posted: 2010-05-19
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Ventilator Associated Pneumonia (VAP) is a common complication experienced by mechanically ventilated patients and within the framework of Respiratory Intensive Care Units. The AnapnoGuard system, developed by Hospitech Respiration Ltd. is a ventilation guard system that includes a number of unique characteristics. This study was designed to test the frequency VAP in mechanically ventilated ICU patients using the AnapnoGuard System.


Eligibility criteria: Inclusion Criteria:

* ICU patients;
* Patient was connected to AnapnoGuard system up to six hours from intubation;
* Age - above 18.

Exclusion Criteria:

* Pneumonia;
* Aspiration Pneumonia;
* Chronic or Severe Pneumonia;
* Chronic Obstructive Pulmonary Disease (COPD) requiring permanent home-based antibiotic treatment;
* Interstitial Lung Disease (ILD);
* Post Lung Transplant State;
* Immunosuppression.
* Patients ventilated in prone position
* Patient who was ventilated 3 months prior to being enrolled in the study
* Pregnant women

Primary outcomes:
measure: VAP occurence
timeFrame: 2 years
Secondary outcomes:
measure: Adverse events occurence
timeFrame: 2 years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: RAMBAM Medical Center
Study officials:
affiliation: RAMBAM Medical Center, Haifa Israel
name: Yaron Bar Lavi, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02181920: Metamizol for the Treatment of Neoplastic Chronic Pain
Official title: Analgesic Effect of a New Metamizol Oral Pharmaceutical Form for the Treatment of the Neoplastic Chronic Pain: Randomized, Double-blind Crossover Clinical Trial Between Metamizol, Diclofenac and Placebo
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study to evaluate the efficacy of metamizole in reducing morphine requirements in patients with moderate to severe chronic cancer pain in comparison to administration of placebo or diclofenac.


Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with neoplastic chronic pain requiring morphine treatment

Exclusion Criteria:

* Karnofsky index less than 30%

Primary outcomes:
measure: Change in morphine requirement
timeFrame: Baseline, 9 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06193720: The Impact of Arnica Montana Following the Surgical Extraction of Impacted Third Molars
Official title: The Impact of Arnica Montana on Postoperative Pain, Swelling and Trismus Following the Surgical Extraction of Impacted Third Molars: A Split Mouth Randomized Clinical Double Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Edema
Pain
Trismus
Lead sponsor: Saint-Joseph University
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 10
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim: The aim of this study is to evaluate the action of the homeopathic plant Arnica Montana on postoperative edema, pain and trismus after surgical extraction of impacted wisdom teeth.

Materials and Methods: The study is a double-blinded clinical trial recruiting patients undergoing surgical extraction of symmetrically impacted maxillary or mandibular third molars (right and left side). Patients receive alternately and randomly the verum (Arnica Montana 12 CH) or the placebo, in the form of capsules, to be taken 1 day prior to surgery and for 7 days postoperatively. Clinical parameters are collected and include: pain score, maximum mouth opening and facial measurements to assess edema's intensity.


Eligibility criteria: Inclusion Criteria:

* Symmetrically impacted bilateral third molars (mandibular or maxillary).
* Young patients aged between 16 and 40 years old.
* No consumption of tobacco or coffee.
* Consent to the terms and conditions of the study.
* Good oral hygiene.
* ASA 1.

Exclusion Criteria:

* Not symmetrically impacted third molars
* Patients with health problems

Primary outcomes:
measure: Pain VSA
timeFrame: at 0,1,2,3,4,5,6,7 days after surgery
measure: Amount of face Swelling
timeFrame: at 0,2,7 days after surgery
measure: Trismus intensity
timeFrame: at 0,2 and 7 days after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Saint Joseph University
Study officials:
References:
Clinical trial NCT00413920: Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
Official title: A Multicenter Randomized Open Label Study to Assess Efficacy and Safety of a Steroid Avoidance Regimen in Comparison to a Treatment With Steroids, in Combination With Enteric-coated Mycophenolate Sodium (EC-MPS) 2.16 g/d for 6 Weeks and Cyclosporine Microemulsion, in de Novo Adult Renal Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Steroids avoidance,
enteric-coated mycophenolate sodium (EC-MPS),
de novo renal transplantation
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2006-12-20
Enrollment: 222
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will investigate the efficacy and safety of a steroid avoidance regimen in comparison with steroid treatment in combination with an initially higher dose of enteric-coated mycophenolate sodium (EC-MPS) and cyclosporine microemulsion in de novo renal transplant recipients. Patients will be randomly allocated to receive either EC-MPS or steroids in combination with EC-MPS. Patients of both treatment groups will receive monoclonal antibody induction therapy and a perioperative bolus of steroids and cyclosporine.


Eligibility criteria: Inclusion Criteria:

* Primary donor kidney transplant
* Panel reactive antibody (PRA) ≤ 20%

Exclusion Criteria:

* Multi-organ transplantation including dual kidneys or previous transplant with any other organ different from kidney
* Non-heart beating donor or kidney from a non-compatible donor

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Number of Participants With the Occurrence of Treatment Failures at 6 Months Post-transplantation
timeFrame: 6 months post transplantation
Secondary outcomes:
measure: The Number of Participants With BPAR, Clinical Acute Rejection (AR) and Treated AR at 6 Months
timeFrame: Month 6
measure: Number of Participants With Treatment Failure, BPAR, Clinical Acute Rejection (AR) and Treated AR at 3 Months
timeFrame: Month 3
measure: Number of Participants With Subclinical Histological Rejections
timeFrame: Month 3
measure: Number of Participants With Treatment Failure at 3 Months by Graft Recovery Status
timeFrame: Month 3
measure: Number of Participants Requiring Steroids in Non-steroid Treatment Group
timeFrame: Months 3 and 6
Other outcomes:
Locations:
city: Poitiers
country: France
facility: C.H.U. La Milétrie
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT06101420: Potassium Copetitive Acid Blockers Efficacy in H.Pylori Eradication
Official title: Efficacy of Potassium Competitive Acid Blockers (P-CABs) Versus Proton Pump Inhibitors (PPIs) in the First and the Second Lines Eradication Regimens for H. Pylori in Egyptian Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Helicobacter Pylori Eradication
Keywords: P-CABs
Vonoprazan
H.pylori eradication
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial assessed the efficacy of potassium competetor acid blocker (P-CAB) in the eradication of H.pylori

Detailed description: The aim of this study is to compare the effectiveness of Vonaprazan based therapy vs.Proton Pump Inhibitor (PPI)based therapy for the eradication of H.Pylori infection in treatment naive and treatment experienced Egyptian patients.This prospective, non- randomized, controlled study was conducted on symptomatic patients admitted at Tropical Medicine Department at Ain Shams University Hospitals and those presenting at outpatient clinic. The study was conducted in the period from the 1st of January 2022 to the 1st of June 2023.

Eligibility criteria: Inclusion Criteria:

* Age above 18 years of both genders.
* Symptomatic patients who has been diagnosed to be H. pylori positive stool by using H. pylori stool antigen test.
* Patients who did not receive H. pylori eradication regimens before were included in group I of the study (First line eradication regimen).
* Patients who received only one eradication regimen before were included in group II of the study (Second line eradication regimen).
* Patients signing an informed consent.

Exclusion Criteria:

* Patients refusing to sign an informed consent.
* Patients who were on PPIs, P-CABs and/or antibiotics starting one month before inclusion in the study .
* Patients who have chronic debilitating and advanced systemic diseases.
* Patients treated with low dose aspirin and/or non-steroidal anti-inflammatory drugs for a long time.
* Any lactating or pregnant female.

Primary outcomes:
measure: H.pylori eradication
timeFrame: six weeks
Secondary outcomes:
measure: Safety of Vonoprazan use
timeFrame: six weeks
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Medicine Ain Shams University
Study officials:
References:
Clinical trial NCT03522220: Augmentation of Neuronal Network Plasticity in Schizophrenia
Official title: Augmentation of Neuronal Network Plasticity in Schizophrenia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Healthy
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Current pathophysiological models of schizophrenia focus on disconnectivity of distributed neuronal systems to explain the multitude of psychic symptoms. However, therapeutic strategies targeting this specific pathobiology are lacking. Our recent work provides strong evidence that complex video-game training interventions facilitate fronto-hippocampal structural and functional connectivity within 2 months in healthy subjects. The planned project transfers this knowledge into a training study in schizophrenic patients to counteract disease-related disconnectivity. Underlying mechanisms and behavioral effects are extensively parametrized by resting state functional magnetic resonance imaging (fMRI), diffusion tensor imaging (DTI), spectroscopy and clinical short- and long-term outcome.


Eligibility criteria: Inclusion Criteria:

* clinically stabilized
* at least one schizophrenic episode in their lives
* International Classification of Diseases 10 (ICD-10) F20.x (and F25)

Exclusion Criteria:

* clinically relevant anemia
* MRI contraindication
* earlier electroconvulsive shock treatment
* significant somatic or neurological disease
* significant alcohol or substance abuse in the year before
* more than 1h video games per day more than 6 months before study start
* simultaneous major psychiatric disease (if symptomatic in the foreground)

Primary outcomes:
measure: T1 - MRI
timeFrame: 2 months (= training time and 2 months after training end)
measure: Cognition - Spatial Orientation
timeFrame: 2 months (= training time and 2 months after training end)
measure: Positive & Negative Symptoms in patients
timeFrame: 2 months (= training time and 2 months after training end)
Secondary outcomes:
measure: Resting State fMRI
timeFrame: 2 months (= training time and 2 months after training end)
measure: Spectroscopy - glutamate
timeFrame: 2 month (= training time and 2 month after training end)
measure: Diffusion Tensor Imaging (DTI)
timeFrame: 2 month (= training time and 2 month after training end)
measure: Biomarkers (BDNF & interleukin 1 & 6)
timeFrame: 2 month (= training time and 2 month after training end)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Clinic Hamburg-Eppendorf
Study officials:
References:
Clinical trial NCT06341920: BoneFit: Multimodal Prehabilitation for People Preparing for Orthopaedic Surgery
Official title: BoneFit: A Student-led Multimodal Prehabilitation Service for Orthopaedic Surgical Patients in Hull
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Orthopedic Disorder
Keywords: prehabilitation
optimisation
surgery
surgical preparation
Lead sponsor: University of Hull
Sponsor class: OTHER
Collaborators: name: Hull University Teaching Hospitals NHS Trust
First posted: 2024-04-02
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Intervention v control
Primary purpose: TREATMENT

Brief summary: To conduct a pilot feasibility study to determine the effect of a student-led prehabilitation service in people awaiting total hip or knee replacement surgery.

Detailed description: The aim of BoneFit is to provide local people living in the Hull region with a needs-based prehabilitation care package to improve their physical and mental health, quality of life \& reduce their length of hospital stay, complications and readmission rates to hospital following orthopaedic surgery (total hip replacement, or total knee replacement.

Currently, Hull University Teaching Hospitals do not offer a prehabilitation service for local patients. The University of Hull will partner with them to provide a student-led multimodal prehabilitation service for referred patients awaiting orthopaedic surgery.

Eligibility criteria: Inclusion Criteria:

* Waiting for unilateral total hip or knee replacement surgery for a minimum of 6 months;
* Able to provide informed consent;

Exclusion Criteria:

* Previous hip or knee surgery;
* Any medical conditions for which moderate to vigorous exercise is contraindicated;
* Patellar or hip joint instability;
* Any other disease/condition which severely effects functional performance e.g. stroke or Parkinson's disease;
* Chronic depression or significant psychiatric disorder;
* Enrolled in a clinical trial (or recently completed one);
* Cognitive impairment which would affect compliance to BoneFIt service;
* Patients unable or unwilling to commit to required study follow-ups
* Pregnancy;

Primary outcomes:
measure: Recruitment
timeFrame: 2 years
measure: Adherence and attendance
timeFrame: 2.5 years
measure: Acceptability
timeFrame: 3 years
Secondary outcomes:
measure: Physical fitness
timeFrame: 3 years
measure: Length of stay
timeFrame: 3 years
measure: Readmission rates
timeFrame: 3 years
measure: Overall quality of life
timeFrame: 3 years
measure: Knee or hip specific pain, function and quality of life
timeFrame: 3 years
Other outcomes:
Locations:
city: Hull
country: United Kingdom
facility: Hull University Teaching Hospitals
Study officials:
affiliation: Professor of Exercise Science for Health and Rehabiliation
name: Lee Ingle
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03650920: Hepatitis C Virus (HCV) Positive Liver Grafts in HCV Negative Recipients
Official title: Pilot Investigation Using HCV Positive Liver Grafts in HCV Negative or Previously Successfully Treated Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Liver Failure
Keywords: HCV
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2018-08-29
Enrollment: 89
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: To provide proof-of-concept data on the efficacy/safety of transplanting HCV positive donor grafts in HCV sero-negative liver recipients who are currently listed.


Eligibility criteria: Inclusion Criteria:

* Male or female
* Age 18 and older
* Active on the transplant list
* Donor organ with Antibody and nucleic acid test (NAT) positive for HCV
* Graft with F2 fibrosis or less at time of explant
* HCV negative recipient; this includes patients who never had HCV and those with HCV previously eradicated with antiviral therapy. The latter is defined as those with undetectable HCV viral load at least 3 months since stopping therapy.
* Willing and able to provide written informed consent or for those subjects where hepatic encephalopathy affects their ability to provide initial or ongoing consent, has an appropriate and legally-authorized representative willing and able to provide consent on behalf of the subject

Exclusion Criteria:

* Participants co-infected with HIV
* Donor previously treated with a non-structural protein 5A (NS5a) containing regimen (if treatment history of donor known)
* Known allergies or hypersensitivity to direct acting antiviral drug (DAA) or ribavirin (RBV)
* Pregnancy and/or actively breastfeeding

Primary outcomes:
measure: Patient survival rate
timeFrame: From the date of transplant through the last day of 15 month post transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Transplant Institute
state: California
Study officials:
affiliation: Loma Linda University
name: Michael L Volk, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Levitsky J, Formica RN, Bloom RD, Charlton M, Curry M, Friedewald J, Friedman J, Goldberg D, Hall S, Ison M, Kaiser T, Klassen D, Klintmalm G, Kobashigawa J, Liapakis A, O'Conner K, Reese P, Stewart D, Terrault N, Theodoropoulos N, Trotter J, Verna E, Volk M. The American Society of Transplantation Consensus Conference on the Use of Hepatitis C Viremic Donors in Solid Organ Transplantation. Am J Transplant. 2017 Nov;17(11):2790-2802. doi: 10.1111/ajt.14381. Epub 2017 Jul 1.
Clinical trial NCT02937220: Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants
Official title: Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Single Tooth Dental Implant
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2016-10-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the influence of superstructure material on crestal bone resorption and esthetic outcome of dental implants in patients with single missing tooth in the aesthetic zone.

Detailed description: The transfer of occlusal forces to the implant bone interface greatly influence the long term prognosis of implants and crestal bone resorption. Accordingly this study will investigate the influence of metal ceramic crowns and monolithic zirconia crowns on crestal bone resorption under loading. Also these crown materials greatly influence the final aesthetic outcome of the definitive restoration, which will be evaluated using the pink and white aesthetic scoring systems.

Eligibility criteria: Inclusion Criteria:

1. Patients above 18 years old.
2. Patients able to read and sign the informed consent document. 3. Medically free patients or with controlled systemic disease.

4. Patients with good bone quality and quantity evaluated using C.B.C.T. 5. Patients willing to return for follow-up examinations and evaluation. 6. Patients having single missing recently extracted premolar tooth.

Exclusion Criteria:

1. Young patients in growth stage.
2. Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
3. Pregnant women to avoid any complication that may occur in dental office.
4. Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
5. Psychiatric problems or unrealistic expectations.
6. Multiple adjacent missing teeth.
7. Patients with bad oral hygiene

Primary outcomes:
measure: P.E.S.
timeFrame: 1 year
Secondary outcomes:
measure: crestal bone resorption
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
References: