cyrilzakka/clinical-trials huggingface dataset:
Novel Quadrilateral Surface Plate for Acetabular Fracture

The novel plate could be used to manage acetabular fractures involving quadrilateral surface and posterior column, which may lower the intraoperative blood loss and reduce complication rate.

Stoppa approach was more minimally invasive than ilioinguinal approach for pelvic and acetabular fractures. Then, Stoppa approach was widely used clinically. For the fragments involving quadrilateral surface, the Kocher-Langenbeck approach was added because the fixation of posterior fragments could not be obtained with reconstruction plate through single Stoppa approach. Novel quadrilateral surface plate was used in this study to examine its fixed role for posterior fragments. Functional outcome and complication were recorded to compare with the results treated with reconstruction plate. If good results were obtained for the patients fixed with quadrilateral surface plate, it was meaningful to popularize the fixed method.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Fracture involving quadrilateral surface
* Operation was conducted within 14 days
* Fixed with quadrilateral surface plate through Stoppa approach

Exclusion Criteria:

* Presented with a pathologic acetabular fracture
* Neuropathic arthropathy,dementia and other disease processes which made postoperative compliance unreliable
* Refused to participate
* Follow-up insufficient 12 months
Combination Chemotherapy With or Without Epirubicin in Treating Women With Stage I or Stage II Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether combination chemotherapy plus epirubicin is more effective than combination chemotherapy alone for stage I or stage II breast cancer.

PURPOSE: This randomized phase III trial is studying combination chemotherapy alone to see how well it works compared to combination chemotherapy and epirubicin in treating women with stage I or stage II breast cancer who have undergone surgery to remove the tumor.

OBJECTIVES:

* Compare disease-free and overall survival of women with early stage breast cancer treated with adjuvant cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin.
* Compare the quality of life in a subgroup of these patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are stratified according to radiotherapy timing (concurrent versus sequential), nodal status (negative versus 1-3 versus at least 4), age (50 and under versus over 50), grade, and tumor size. Patients are randomized to one of two treatment arms.

* Arm I: Patients receive oral cyclophosphamide on days 1-14 and methotrexate IV and fluorouracil IV on days 1 and 8. Treatment repeats every 4 weeks for 6 courses.
* Arm II: Patients receive epirubicin IV on day 1 every 3 weeks for 4 courses followed by cyclophosphamide, methotrexate, and fluorouracil, as in arm I, for 4 courses.

Some patients may receive radiotherapy during or after chemotherapy. Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed in a subset of patients (N=500) before chemotherapy starts, at 3 months of treatment, at the end of chemotherapy, and at 6, 12, and 18 months after treatment.

Patients are followed annually for 10 years.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: Approximately 2,000 patients will be accrued for this study within 4 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histological confirmation of invasive, early stage breast cancer
* Prior complete excision of tumor required (wide local excision or mastectomy)
* Hormone receptor status:

  * Not specified

PATIENT CHARACTERISTICS:

Age:

* Not specified

Sex:

* Female

Menopausal status:

* Pre-, peri-, or post-menopausal

Performance status:

* Not specified

Hematopoietic:

* Adequate bone marrow function

Hepatic:

* Adequate hepatic function

Renal:

* Adequate renal function

Other:

* No prior cancer except for basal cell carcinoma or carcinoma in situ
* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* No prior chemotherapy

Endocrine therapy:

* Concurrent hormone therapy allowed

Radiotherapy:

* No prior radiotherapy
* Concurrent radiotherapy allowed

Surgery:

* See Disease Characteristics
* No more than 6 weeks since prior surgery to the breast
CyFluATG in Lower Risk MDS

To evaluate the efficacy of the conditioning regimen with cyclophosphamide, fludarabine, and antithymocyte globulin (CyFluATG) for allogeneic hematopoietic cell transplantation (HCT) in patients with lower risk myelodysplastic syndrome (MDS). The efficacy of the treatment will be measured in terms of engraftment and non-relapse mortality (NRM).

* This is a prospective, phase 2 extension study
* Conditioning regimen A. Cyclophosphamide 50 mg/kg/day i.v. daily on days -3 and -2 (for 2 days) B. Fludarabine 30 mg/m2/day i.v. daily on days -7to -2 (for 6 days) C. Antithymocyte globulin (Thymoglobulin) 1.5 mg/kg/day (for HLA-matched sibling donor HCT) or 3.0 mg/kg/day (for other alternative donor HCT) i.v. daily on days -3 to -1 (for 3 days) D. Methylprednisolone 2 mg/kg i.v. daily on days -4 to -1 (for 4 days)
* Harvest and infusion of donor hematopoietic cells A. Harvested peripheral blood mononuclear cells of donors via leukapheresis will be infused to recipients on day 0. Additional infusion on day 1 can be made based on the judgement of attending physician.
* GVHD prophylaxis A. Cyclosporine: 1.5 mg/kg i.v. every 12 hours beginning on day -1 and changed to oral dosing (with twice the i.v. dose) when oral intake is possible.

B. Methotrexate: 15 mg/m2 i.v. on day 1, and 10 mg/m2 i.v. on days 3 and 6.

Eligibility Criteria:
Inclusion Criteria:

* Patients with lower risk MDS A. International prognosticscoring system (IPSS) ≤ 1.0 and B. Bone marrow blast percentage \< 5% during the disease course before HCT
* Patients with appropriate hematopoietic cell donor A. HLA-matched sibling B. HLA-matched unrelated donor C. HLA-mismatched familial donor
* 18 years old or older, 70 years old or younger
* Adequate performance status (Karnofsky score of 70 or more)
* Adequate hepatic and renal function (AST, ALT, and bilirubin \< 3.0 x upper normal limit, and creatinine \< 2.0 mg/dL).
* Adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiogram)
* Signed and dated informed consent must be obtained from both recipient and donor.

Exclusion Criteria:

* Presence of significant active infection
* Presence of uncontrolled bleeding
* Any coexisting major illness or organ failure
* Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
* Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
* Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Regenerative Stem Cell Therapy for Stroke in Europe 1-RESSTORE1

Stroke is the second leading cause of death in the world population. When not fatal, stroke often results in disability, and secondary health problems affecting not only patients but also their families. Building on emerging preclinical and pilot clinical evidences, RESSTORE will focus on the clinical assessment of regenerative cell therapy to improve stroke recovery and patients quality of life.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and in the phase 1b (RESSTORE 1b, Dose-effect study).

* Male or female \> 18-year-old
* Hemispheric ischemic stroke (\> 1.5 cm on 2 imaging slices) (i.e. non "lacunar" stroke) Admitted to the stroke unit within the first 24h after stroke onset
* Patient must be included within 1st and 2nd day after stroke onset (signature of informed consent and randomization) (i.e. between 24 hours and 48 hours from stroke onset) and must be able to receive investigation treatment within the first week.
* NIHSS \> or equal to 7 including motor score (upper, lower limbs and hand) \> or equal to 3
* No decompressive craniectomy procedure planned or performed
* Patient able to follow a rehabilitation program
* Modified Rankin scale = 0 before stroke onset
* Obtained signed informed consent from patient or legally acceptable representative
* Negative pregnancy test for women of child-bearing age.

Non Inclusion Criteria:

Non-inclusion criteria are similar in the phase 1a (RESSTORE 1a, Toxicity study) and the phase 1b (RESSTORE 1b, Dose-effect study).

* Contraindication for MRI
* Coma (score of 2 or more on item 1a of the NIHSS related to awareness)
* Evidence on neuroimaging (CT or MRI) of a brain tumour, cerebral oedema with midline shift and a clinically significant compression of ventricles, cerebellar or brainstem infarction, or subarachnoid haemorrhage, or intracerebral parenchymal hematoma (petechial small haemorrhages are NOT a non-inclusion criteria)
* Severe leucoariosis
* Previous stroke
* Active endocarditis, pneumonia, AIDS, active hepatic disease due to HBV or HCV (a controlled infection is NOT a non-inclusion criteria)
* Active inflammatory and/or auto-immune diseases (such as Crohn disease, lupus, rheumatoid polyarthritis, renal or liver immune pathology)
* History of cancer
* Pre-existing dementia
* A health status, any clinical condition (eg, short life expectancy, and coexisting disease) or other characteristic that precludes appropriate diagnosis, treatment, or follow-up in the trial
* Surgical or endovascular procedure planned in the following 3 months
* Pregnancy / Breast feeding (women of childbearing age should have a negative pregnancy test prior to inclusion)
* Patients who are participating in another therapeutic trial or who have previously participated in a biotherapy trial
* Non-membership to a social security scheme
* Inability or unwillingness of the individual or their legal guardian/representa tive to provide written informed consent, according to national regulations.
Set up for in-Vivo Measurement of Dynamic Intraocular Pressure (IOP)

In this modern era, surgeons prefer to perform emulsification through small micro incisions. To accomplish this safely, surgeons raise irrigation bottle heights or use forced infusion systems.We believe that this sustained rise in the IOP during micro-incision phacoemulsification for a substantial period could be detrimental to the ocular structures. Therefore, intra-operative IOP pertaining to micro-incision cataract surgery is an emerging concern.

Conventional systems for measuring IOP generate an isolated graph of continuous pressure recording. Interpretation of the IOP fluctuations from these graphs requires a two step superimposition approach to characterize the IOP changes.

The aim of the present study was to describe a new setup for intra-operative monitoring of IOP in a clinical setting and validate it by correlating IOP differences arising with different phacoemulsification parameters in eyes undergoing microincision coaxial phacoemulsification.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing phacoemulsification for uncomplicated senile cataracts
* Cataracts from grade 1 to 3

Exclusion Criteria:

* presence of glaucoma,
* diabetic retinopathy,
* retinal vascular disease,
* high myopia (defined as AL \> 25mm),
* uveitis,
* previous ocular trauma or surgery
Evaluation of the Aspheric ReSTOR IOL After Routine Cataract Extraction

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal

The purpose of this study is to evaluate the visual outcomes and patient satisfaction after bilateral implantation of the aspheric ReSTOR multifocal intraocular lens (IOL) and compare it to a historical control group of patients implanted bilaterally with the spherical ReSTOR multifocal.

Eligibility Criteria:
Inclusion Criteria:

* Subject must have an age-related cataract in both eyes.
* 40 years of age or older.
* Patient must desire cataract extraction.
* Expected maximum of 2 weeks and minimum of 1-week interval between first and second eye surgeries.
* Willing and able to comply with scheduled visits and other study procedures

Exclusion Criteria:

* Preoperative ocular pathology potentially affecting visual acuity.
* Keratometric astigmatism exceeding 1.50 diopters.
* Planned postoperative refraction for mono-vision.
* Uncontrolled diabetes.
* Use of any systemic or topical drug known to interfere with visual performance.
* Contact lens use during the active treatment portion of the trial.
* Any concurrent infectious/non infectious conjunctivitis, keratitis or uveitis.
* Pregnant or nursing mothers and females of childbearing potential not practicing a reliable and medically acceptable method of birth control.
* Any clinically significant, serious or severe medical or psychiatric condition that may increase the risk associated with study participation or study device implantation or may interfere with the interpretation of study results.
* Participation in (or current participation) any investigational drug or device trial within the previous 30 days prior to the start date of this trial.
* Intraocular conventional surgery within the past three months or intraocular laser surgery within one month in the operated eye.
* Other ocular surgery at the time of the cataract extraction.
Parecoxib In Post Surgery (Hemicolectomy) Pain

This is a phase III, multicenter, open label, pilot to evaluate the analgesic efficacy and safety of parecoxib 40 mg IV in the treatment of the pain following hemicolectomy in an optimal management of the surgical patient

The study was terminated prematurely due to recruitment issues on 31 January 2006. Safety concerns did not lead to the decision to terminate this study.

Eligibility Criteria:
Inclusion Criteria:

* patients hospitalised for resection of left/right colon;
* preoperative health graded as ASA \<3.

Exclusion Criteria:

* patients with any type of metastatic cancer, particularly metastatic colon cancer;
* patients with familial adenomatous polyps (sporadic adenomatous polyps are accepted);
Primary Antimicrobial Resistance Patterns of Austrian Helicobacter Pylori Clinical Isolates

Helicobacter pylori infects \~ 50% of the world's population and a quarter of the European population. H. pylori is responsible for a large proportion of gastric and duodenal ulcers and gastritis. Chronic infection with H. pylori is a risk factor for the development of stomach cancer and MALT (mucosa-associated lymphoid tissue) Lymphoma. The prospects of success for an antimicrobial eradication therapy is drastically reduced by the significant increase in antibiotic resistance in Austrian H. pylori isolates. The currently available data were obtained however from narrowly defined geographical regions and the clinical routine without information on patient selection. We suspect a considerable geographical variability of resistance patterns and a clinical bias for a preferential investigation of patients with unsuccessful, empirical eradication therapy. The objective of the proposed study is therefore an Austria-wide collection of data on H. pylori resistance in a prospective clinical study. The data thus collected will enable a significant improvement in current treatment recommendations.


Eligibility Criteria:
Inclusion Criteria:

* Undergoing a diagnostic gastroscopy for the first time in their lives or had a diagnostic gastroscopy for any reason \>10 years ago
* Older than 18 years of age
* Written informed consent

Exclusion Criteria:

* Previous H. pylori eradication therapies
* Antimicrobial treatment for other reasons than H. pylori eradication within 3 months prior to gastroscopy
Nicotine and Cannabis Vape Labeling Experiment - Spring 2025

This study assesses how the ways in which nicotine and cannabis vaping devices are labeled impact use susceptibility, anticipated effects, and health harm.

The primary objectives of the study: (1) Determine whether different device labels with the contained substance (nicotine or cannabis) affect adolescent use susceptibility, anticipated effects or impairment, and perceived health harms; (2) Determine whether device color/product flavor differentially impact the study outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be enrolled in a partnering high school.

Exclusion Criteria:

* Participants who cannot independently understand study consent and the study surveys are ineligible.
Evaluation of Retinal and Vascular Features in Coats Disease After Intravitreal Injections of Ranibizumab

This study evaluates the retinal and vascular features in patients affected by Coats disease under the effects of Ranibizumab intravitreal injections using optical coherence tomography and optical coherence tomography angiography

Coats disease is an idiopathic retinal vascular disorder, occurs in young males, and is characterized by retinal telangiactasias, numerous yellowish exudates in the subretinal space, macular edema, hemorrhages and, in advanced end-stage, by exudative retinal detachment.

Ranibizumab is a vascular endothelial growth factor antagonist represent an efficacy treatment acting on vascular hyperpermeability. The optical coherence tomography and optical coherence tomography angiography represent novel and non-invasive diagnostic techniques that allow a detailed analysis of retinal and vascular features. The study evaluates the changes in optical coherence tomography and optical coherence tomography angiography parameters at baseline and after three monthly injections of Ranibizumab in Coats disease.

Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years
* diagnosis of Coats disease
* treatment-naïve with Ranibizumab
* absence of other vitreoretinal and vascular retinal diseases
* absence of diabetes

Exclusion Criteria:

* age younger than 18 years
* No diagnosis of Coats disease
* previous treatments with Ranibizumab
* presence of vitreoretinal and vascular retinal diseases
* presence of diabetes
Overcoming Nutritional Barriers in Hemodialysis Patients

American hemodialysis patients are frequently malnourished. This contributes to dialysis patient mortality rates that are the highest in the industrialized world at 22% per year. Poor nutritional status probably also contributes to high health care costs (an average of two hospitalizations annually per patient and total Medicare expenditures of $11 billion per year) and diminished quality of life. The researchers' prior work identified several potentially modifiable nutritional barriers (e.g. poor appetite, inadequate dialysis dose, poor nutritional knowledge, low fluid intake, and needing help shopping and cooking) and pilot tested a promising approach to overcome these barriers.

This proposed community-based randomized controlled trial extends the researchers' prior work by targeting specific nutritional barriers with a tailored feedback and education intervention. Approximately 40 dialysis facilities in northeast Ohio will be randomly assigned to intervention and control groups, with approximately 100 malnourished patients enrolled from 20 intervention facilities and 100 from 20 control facilities. Baseline evaluation will include measures of nutritional status, specific barriers, inpatient expenditures, and quality of life. On a monthly basis for 12 months, intervention patients and their dietitians will receive tailored feedback and education on overcoming patient-specific barriers. They will then meet monthly to jointly formulate a care plan addressing these barriers. Control patients will continue to get usual care. Major analyses will compare changes in nutritional parameters in intervention vs. control patients with adjustment for nesting of patients within facilities.

The proposed project will test a novel intervention that targets patients and providers as they together make nutrition-related decisions. Overcoming specific barriers may lead not only to improved nutritional status but also to better patient survival, decreased health care costs, and increased quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Most recent albumin and mean albumin over last 3 months \<3.7 g/dL by bromcresol green method (or \<3.4 g/dL by bromcresol purple method)
* Age greater than or equal to 18 years
* On chronic hemodialysis at least 9 months

Exclusion Criteria:

* Mentally incompetent
* Cirrhosis
* AIDS
* Cancer
* Terminal illness
* Malabsorption
* Receiving total parenteral nutrition
Educational Program Plus Physiotherapy After Prostatectomy

Objective: to find out the effectiveness of therapeutic education program plus pelvic-perineal physical therapy in radical robotic prostatectomy men in terms of quality of life (QoL), urinary incontinence (UI), erectile dysfunction (ED) and muscle strength.

Design: Randomized, controlled and single blinded clinical trial. Participants will be randomly assigned in two groups. Experimental group: training pelvic-perineal physical therapy plus lifestyle education. Control group: training in pelvic-perineal physical therapy only. In the 2 groups several physical therapy measurements will be undertaken: 1st before physical therapy treatment, 2nd, 3 th and 4th after 3, 6 and 12 months after initial measurement.

Study subjects: Post radical robotic prostatectomy men, which have not been already treated with adjuvant treatment and pelvic-perineal physical therapy, and after reading, understanding and freely signing an informed consent form.

Sample size: 84 subjects will be included (42 subjects per group). To have a statistical power of 90% to detect an average difference of 10 points between two groups in the change of quality of life according to the questionnaire validated in Spanish SF-12, assuming a standard deviation of the change of 20 points based on the study from Hou et al, establishing an alpha risk of 0.05, in a bilateral contrast and assuming a 10% of drops outs.

Data analysis: Separate analyzes of each variable collected in the two groups will be carried out. For continuous variables, means, medians, standard deviations and quartiles will be calculated, depending on the assumption or not, respectively, of the assumption of their normality previously determined with the Shapiro Wilk test (S-W). Qualitative variables will be described with absolute and relative percentage frequencies. Effectiveness will be evaluated by comparing between the two groups of the change in outcome variables between measurements.


Eligibility Criteria:
Inclusion Criteria:

* Men had undergone radical robotic prostate surgery.
* Men reading, understanding and freely signing an informed consent form.

Exclusion Criteria:

* Participants who had received adjuvant therapies (chemotherapy, radiotherapy) before pelvic-perineal physical therapy treatment.
* Men with a history of pelvic organ surgery.
* Men with chronic diseases that affects their quality of life.
* Participants with psychiatric or neurological problems.
* Postoperative men with cognitive limitations to understand information, respond to questionnaires, consent and / or participate in the study.