cyrilzakka/clinical-trials huggingface dataset:
Influence of Sagittal Imbalance of the Spine on Gait Pattern in Adult Spinal Deformity

This study intends to investigate the changes in gait pattern in adult spinal deformity (ASD) patients with sagittal imbalance. It will investigate the gait kinematics in patients who have a mismatch of their spinopelvic parameters, and a positive sagittal balance. The investigators hypothesise that patients with abnormal spinopelvic parameters may demonstrate a pathological gait pattern.

With an ageing population, ASD presents as a significant health issue with increasing incidence. Most of the earlier literature concentrated on radiographic measurements of the deformity in the coronal plane, and its surgical correction. However, recent publications have demonstrated that sagittal spinopelvic alignment plays a critical role in pain and disability in patients with ASD, and is a primary determinant of health related quality of life measures. There is substantial evidence that restoration of these parameters after spinal reconstructive surgery is correlated with good clinical outcome.

Maintenance of the ideal sagittal alignment allows an individual to maintain an erect posture with minimal energy expenditure. When there is progressive loss of lumbar lordosis, compensatory mechanisms involving the pelvis, hips and knees occur to extend adjacent segments of the kyphotic spine to allow for compensation of anterior translation of the axis of gravity. However, this compensatory mechanism may potentially result in adverse effect. One of the main disabilities in ASD patients with sagittal imbalance is their decreased walking tolerance. The change in the spinal alignment along with these compensatory mechanisms may result in an inefficient gait worsening their walking tolerance.

Few studies in the literature have investigated the changes in gait pattern in patients with sagittal imbalance. Of those, the patient group was heterogeneous, and the only criterion of sagittal imbalance was a positive sagittal vertical axis (SVA), which the investigators now know is not a complete assessment of the sagittal alignment. The investigators propose to study the change in gait pattern in individuals with abnormal spinopelvic parameters, and how this may affect their quality of lives.

Eligibility Criteria:
Inclusion Criteria:

All patients diagnosed with ASD, fulfilling the following radiographic criteria based on whole spine lateral film are eligible for recruitment:

* SVA bigger than 47mm
* Pelvic tilt (PT) bigger than 22deg
* Pelvic incidence (PI) - lumbar lordosis (LL) bigger than 11deg

Exclusion Criteria:

* If the aetiology of the ASD of the patient is neuromuscular origin
* other pathologies that may affect their gait such as previous trauma or surgeries to the pelvis or the lower limbs and joint replacements
* inability to walk without aids for short distances
ZD1839 (Iressa™) In Combination With Docetaxel As First-Line Treatment In Patients With Metastatic Breast Cancer

This is a multicentre, randomised (2:1), double blind, non-comparative phase II trial of ZD1839 and placebo in combination with chemotherapy in patients with metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer at a metastatic stage.
* Uni- or bi-dimensionally measurable lesions (10 mm or 20 mm) according to the Response Evaluation Criteria in Solid Tumours (RECIST) criteria
* World Health Organisation (WHO) performance status (PS) of 0 to 2
* Life expectancy of greater than 12 weeks
* Normal cardiac function (left ventricular ejection fraction \[LVEF\] by isotopic examination greater than or equal to 55%)

Exclusion Criteria:

* Symptomatic lepto-meningeal metastasis
* Concomitant infectious disease
* Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
* Incomplete healing from previous oncologic or other surgery
* Absolute neutrophil count (ANC) less than 1.5 x 109/litre (L) or platelets less than 100 x 109/L
* Serum creatinine greater than 1.5 times the ULRR or clearance \< 60 ml/min
* ALT or AST greater than 2.5 times the ULRR
* ALP \> 5 times the ULRR
* ALP \> 2.5 times the ULRR and ALT or AST greater than 1.5 times the ULRR
Genotype, Clinical Features and Imaging of Neuroradiological Abnormalities in CADASIL

The project aims to retrospectively and prospectively analyze a population of CADASIL patients in order to study the natural history of the disease by correlating the symptom spectrum with genetic risk and specific neuroradiological and biological markers

- Stratifying patients according to their disease risk, this could contribute to the discovery of personalized therapeutic targets.


Eligibility Criteria:
Inclusion criteria:

* patients of either sex older than 18 years of age;
* finding of a pathogenic mutation on genetic analysis of NOTCH3;
* in the absence of unambiguous mutation, presence of characteristic deposits (GOM) within small vessels at skin biopsy

Exclusion criteria:

* do not meet the diagnostic criteria of CADASIL;
* are unable to give consent for the study due to aphasic or cognitive impairment or because they are deceased at the time of enrollment and their next of kin refuse to give consent for study participation.
Quantitative Non-Invasive Brain Imaging Using QUTE-CE MRI

This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI and validate the method with first-in-human studies.

This trial will evaluate a non-invasive brain imaging technique QUTE-CE MRI using Ferumoxytol as a contrast agent, and validate the method with first-in-human studies. Subjects who are already scheduled to receive ferumoxytol infusion will undergo MRI scans after the infusion. The ferumoxytol infusion itself is not a part of the study. The project will provide brain angiograms and establish a human cerebrovascular atlas that will enable future quantitative diagnosis of cerebrovascular abnormalities by revealing abnormal regions of the brain that characterize disease, a tool which doesn't currently exist, and which could lead to many exciting discoveries and clinical applications in neurology.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 to 80;
* Able to understand written consent document and HIPAA authorization prior to initiation of study related procedures.

Exclusion Criteria:

* Known allergy to ferumoxytol or any intravenous iron preparation;
* Iron saturation above the upper limit of normal;
* Individuals with a contraindication to MRI, such as the presence of metallic prostheses or implanted metal device (e.g., infusion pump, defibrillator);
* Individuals with known clinical conditions that may lead to iron overload including hemochromatosis, cirrhosis, or sickle cell disease;
* Individuals with any serious medical condition that the investigator believes may place them at increased risk for an adverse event.
A Clinical Study of MK-4482 in Chinese Healthy Male Participants (MK-4482-009)

The goal of the study is to learn what happens to MK-4482 after single and multiple doses in healthy Chinese participants over time. Researchers also want to learn about the safety of MK-4482, including how well people tolerate it.


Eligibility Criteria:
Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

- Has a Body Mass Index (BMI) of 19 to 24 weight (kg)/height (m)2, inclusive, and body weight of ≥ 50 kg at the screening visit.

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has a history of clinically significant abnormalities or diseases.
* Has history of cancer.
* Has a history of significant multiple and/or severe allergies.
* Had any major surgery.
* Has participated in another investigational study within 3 months prior to the screening visit.
The Effect of Clopidogrel and Ticagrelor With and Without Acetylsalicylic Acid (ASA) on Hemostatic System Activation at the Site of Plug Formation in Vivo in Man

Background: Coronary heart disease is the most common cause of death in industrialized countries. Revascularisation by percutaneous coronary angioplasty or thrombolysis is the main principle for treatment of the acute coronary syndrome. To inhibit platelet activity patients are routinely given acetylsalicylic acid (ASA) and clopidogrel, a second-generation thienopyridine. Recently, ticagrelor, a novel cyclopentyl-triazolo-pyrimidine with several pharmacological advantages, has demonstrated greater efficacy but a higher bleeding risk than clopidogrel. Coronary thrombus formation is a complex process and the antithrombotic mechanisms of platelet function inhibitors are incompletely understood. Studies in venous blood or in vitro do not truly reflect the in vivo circumstances as they often do not take into account flow conditions or the interaction between endothelium, blood cells and coagulation factors. Results from animal models may not be relevant for the prothrombotic mechanisms in humans. We have developed a technique that allows investigating hemostatic system activation directly at the site of thrombus formation in vivo in humans.

Aim: to compare the inhibitory effects of clopidogrel and ticagrelor (with and without concomitant ASA) on hemostatic system activation under circumstances close to the in vivo situation.

Design, patients and interventions: prospective, randomized, double-blind, placebo controlled parallel-group study with a 2x2 factorial design including 112 healthy volunteers who will be randomised to 4 treatment arms: ticagrelor or clopidogrel + placebo, ticagrelor or clopidogrel + ASA.

Outcome variables: Indicators of platelet and coagulation activation \[ß-thromboglobulin and thromboxane B2 as well as prothrombin fragment F1+2 and D-Dimer, respectively\] will be measured before and at several time points during a 8 day period in venous blood and in blood emerging from a standardized injury of the microvasculature to determine bleeding time (shed blood).

Statistical considerations: Sample size calculation is based on the percent change in the main outcome variable "β-TG in shed blood" from baseline to 2 hours after treatment start. Statistical analysis is based on the full analysis set, including all randomized subjects who received at least the starting dose of the study medication and for whom blood collections at baseline and at 2 hours after treatment start have been performed.


Eligibility Criteria:
Inclusion Criteria:

* young, healthy males

Exclusion Criteria:

* history of bleeding
* any medication
* known intolerance to study drug(s)
Real-World Registry Assessing the Clinical Use of the Lutonix 035 Drug Coated Balloon Catheter

The objective of this patient registry is to assess the clinical use of the Lutonix 035 DCB PTA Catheter in a heterogeneous patient population in a real world and on-label clinical application.

The registry is a prospective, multicenter, single arm post-market real-world registry in the U.S. assessing the clinical use, safety and outcomes of the Lutonix 035 DCB Catheter in the Superficial Femoral Artery (SFA) and Popliteal Arteries (PA). Registry subjects will be followed for up to three year's post-index procedure.

Eligibility Criteria:
Inclusion Criteria:

1. The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Institutional Review Board (IRB) for the site.
2. The subject agrees to comply with the protocol-mandated follow-up procedures and visits.
3. The subject is ≥ 21 years old.
4. The subject must have a lesion(s) that can be treated with available Lutonix 035 DCB Catheter according to IFU.

Exclusion Criteria:

1. The subject is unable or unwilling to provide informed consent.
2. The subject is unable or unwilling to comply with the patient registry protocol follow-up procedures and visits.
3. The subject has another medical condition or is currently participating in an investigational drug or an investigational device study that, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confounds the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of patient registry procedures and follow-up.
New Concepts in Diabetic Macular Edema (DME)

Intravitreal ranibizumab injection procedure is simple and effective. In management of chronic DME there is no clear anatomical endpoint. Visual stability is the primary aim. Argon focal laser therapy can be the safe second choice. The combined therapy is successful and practical for chronic DME patients.

Settings and Design: Randomized clinical study

Subjects and Methods:

investigators randomly assigned 150 adults (the average age was 59.32 years ±2.79) with chronic diabetic macular edema involving the macular center for repeated ranibizumab injections (group A-75) or focal/direct argon laser after repeated ranibizumab injections (group B-75). The outcomes were the changes in visual acuity letter score and the central subfield thickness (CST) from baseline to one year. visual-acuity Letter score, and CST were analyzed with independent t-test and Mann Whitney-test. General linear model with multivariate analysis was used for visual acuity letter score, and CST in both groups.

Eligibility Criteria:
Inclusion Criteria:

* focal maculopathy
* diffuse macular edema
* diffuse macular edema with ischemic changes

Exclusion Criteria:

* ischemic maculopathy that was associated with grades of non-proliferative changes, or capillary drop out zones presented in the periphery of the macula
* patients with history of stroke or transient ischemic attack
* hypersensitivity to ranibizumab or any component of the ranibizumab formulation
* uncontrolled glaucoma in either eye (intraocular pressure \[IOP\] \>24 mmHg with medication)
* evidence of vitreomacular traction (in either eye)
* active proliferative diabetic retinopathy (study eye)
Ankle Fracture vs Ankle Fracture-Dislocation

The purpose of this study is to compare outcomes of patients with an ankle fracture to those with ankle fracture-dislocations. We hypothesize that long-term clinical outcomes for patients sustaining ankle fracture dislocations are poorer than those without dislocation.

Orthopaedic literature has very limited data regarding outcomes following ankle fracture dislocations. Increased knowledge of the long-term consequences of these injuries could usher in changes to treatment paradigms, potentially resulting in improved outcomes. Thirty patients will be enrolled into two arms of this prospective study: isolated ankle fractures and ankle fracture dislocations. Patients will be followed through their operative and postoperative course and clinical and radiographic assessments will be analyzed. We plan to compare the clinical, radiographic, and functional outcomes of patients with ankle fractures to those with ankle fracture-dislocations. We also plan to identify factors that contribute to or predict poor clinical, functional, and/or radiographic outcomes in patients with ankle fractures and fracture-dislocations.

Eligibility Criteria:
Inclusion Criteria:

* Patients who sustain an isolated bi-malleolar or trimalleolar ankle fracture or an ankle fracture-dislocation requiring open reduction internal fixation
* Patients ages 18 and over
* The subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study
* Open and closed fractures (excluding Gustilo grade 3)
* English must be patient's primary language

Exclusion Criteria:

* Previous injury or significant osteoarthritis to the affected ankle
* Current ipsilateral or contralateral lower extremity injury with the exception of a contralateral ankle fracture or fracture-dislocation
* Retained hardware from a previous injury at or around the tibia-talar joint of the affected extremity
* Patients under the age of 18
* History of inflammatory arthropathy
* Traumatic Brain Injury or Spinal Cord Injury preventing weightbearing on the lower extremities
* The subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements
* Patients with Gustilo grade 3B and 3C open fractures
Huaier Granule on Reducing the Level of Tumor Markers in Patients With Early-stage Breast Cancer

This is a prospective, single center, single-arm, phase IV study， to evaluate the effect of Huaier Granule on reducing the level of tumor markers in early-stage breast cancer patients.

This clinical trial is expected to include 379 patients in the follow-up stage after breast cancer surgery who visited the Breast Surgery Department of Fudan University Shanghai Cancer Hospital from October 2022 to October 2024. Excluding cases where tumor markers (CEA/CA125/CA153) exceed the normal upper limit level in the case of recurrence and metastasis. All participants received treatment with Huaier granules for 1 year, or experienced intolerable toxicity, withdrew from the study for any reason or died, whichever occurred first.

The main research indicator is the recovery rate of tumor markers (CEA/CA125/CA153) to normal.

Eligibility Criteria:
Inclusion Criteria:

* 18 ≤ age ≤ 75 years old, regardless of gender.
* Postoperative pathological diagnosis of breast cancer.
* Imaging or pathological examination without evidence of recurrence or metastasis.
* If tumor markers are elevated, it is necessary to go to the corresponding department for medical treatment or issue a corresponding examination when necessary to exclude recurrence, metastasis or the second primary tumor of breast cancer.
* One or more tumor markers in CEA/CA125/CA153 exceed the upper limit of normal values.
* The liver and kidney functions meet the following conditions: AST and ALT\< 3 ULN, total bilirubin ≤ 2 ULN, and blood creatinine\<1.5 ULN;
* Other laboratory tests meet the following requirements: Hb ≥ 9g/dl, platelet count ≥ 60 × 10\^9/L, absolute neutrophil count\>1.0 × 10\^9/L.
* The patient's ECOG physical state score is 0 or 1.
* The subjects participated in this study voluntarily and signed an informed consent form.

Exclusion Criteria:

* Diagnosed as any other malignant tumor within the 5 years prior to enrollment, except for malignant tumors with low risk of metastasis and death (5-year survival rate\>90%), such as fully treated basal cell or squamous cell skin cancer or cervical cancer in situ.
* Imaging or pathological confirmation of recurrence and metastasis.
* Serious infections (CTCAE\>Level 2) occurred within the first 4 weeks of enrollment, such as severe pneumonia, bacteremia, and infection complications that require hospitalization; Symptoms and signs of infection or the need for oral or intravenous antibiotic treatment within 2 weeks prior to enrollment, excluding the use of prophylactic antibiotics.
* Suffering from severe acute and chronic diseases.
* Suffering from severe diabetes whose blood sugar cannot be effectively controlled.
* Patients who are unable to take oral medication, those who are allergic to the ingredients of Huaier granules, and pregnant or lactating women.
* Drug abusers, or those who suffer from psychological or mental illnesses that may interfere with research compliance.
* The researcher believes that it is not suitable to participate in this study.
Healthy Body & Mind Program for Older Adults Living With Osteoarthritis and Cognitive Decline

The goal of this pilot randomised clinical trial is to compare a 12-week Healthy Body \& Mind Program to usual care in older adults living with cognitive decline and osteoarthritis.

The main questions it aims to answer are:

* Does the Healthy Body \& Mind Program improve health-related quality of life in older adults living with cognitive decline and osteoarthritis (pre/post and intervention/control)?
* Does the Healthy Body \& Mind Program improve other health outcomes (cognition, pain, anxiety/depression, physical function) in older adults living with cognitive decline and osteoarthritis (pre/post and intervention/control)?

Participants will complete a co-designed and multidisciplinary 12-week program that includes physical activity and lifestyle education (nutrition, social activity and managing anxiety/depression). Researchers will compare outcomes between the intervention group and a wait-list control to see if there are difference in outcome measures (quality of life, cognition, pain, anxiety/depression, physical function).


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 55 or above.
* Montreal Cognitive Assessment score 18-25 indicating mild cognitive decline or mild dementia.
* Diagnosed with osteoarthritis.
* Able to safely undertake study assessments and complete exercise without assistance.

Exclusion Criteria:

* Montreal Cognitive Assessment score below 18.
* Display an abnormal cardiovascular response to exercise (as seen during the baseline exercise test) and your doctor does not provide medical clearance to exercise.
* Are unable to speak English and do not have a translator.
* Have orthopedic or neuromuscular limitations that prevent you from performing the exercise.
* Are deemed unsuitable for group exercise sessions following initial assessment by an Accredited Exercise Physiologist within the UNSW Lifestyle Clinic.
A Personalized, Digital Coaching Program After Stroke

The Belgian Stroke Council initiated a project to improve risk factor control and medication adherence in ischemic stroke patients by developing an individualized in-hospital initiated and post- discharge, digital coaching program addition to standard practice (strokecoach.be).

The overall aim of this project is to further improve subacute and chronic stroke care in the Belgian context with main focus on the patients' quality of life, stroke recurrence and secondary cardiovascular prevention. Main focuses are on patient-empowerment, shared-decision making and health literacy, as these items are linked with better therapeutic adherence and self-care for chronic diseases.

In case of a positive result, implementation of this individualized chronic stroke care program executed by a personal stroke coach, initiated during hospitalization and using a web-based intervention program, can easily be unrolled in other Belgian stroke units. The program can be cost-effective if better clinical outcome, stroke recurrence rates, number of in-hospital consultations, number of rehospitalisations are reduced. This will be evaluated in a in-depth healt-economic analysis.

Eligibility Criteria:
Inclusion Criteria:

Patients with an acute ischemic stroke hospitalized at a participating stroke center can be included during hospitalisation if fulfilling following three criteria: - they will return back home or be discharged to a rehabilitation center

* have a life expectancy of more than 6 months
* have experience with internet use (at least weekly checking emails) or a caregiver accepts to help with the digital platform.

Exclusion Criteria:

* Age \< 18 years
* Patients unable or unwilling to be followed post-discharge for 6 months
* Patients with a major neurologic post-stroke and no caregiver participation
* Cognitive impairment limiting use of digital platform and no caregiver participation
Re-linkage to Care of Patients With Hepatitis C

The purpose of this study is to identify patients with chronic hepatitis C virus (HCV) who were lost of follow up and relinkage them to hepatitis C care

The investigators will review electronic medical charts to identify patients with HCV diagnosis. Next, investigators will evaluate if these patients are routinely followed by liver specialists at the Institution. Those patients who were lost of follow up will be reached to evaluate their disease and eventually offer them to restart HCV care.

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years
* Patients clinically evaluated at least once in the participating medical center
* chronic HCV infection

Exclusion Criteria:

* There are no exclusion criteria