cyrilzakka/clinical-trials huggingface dataset:
Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer

In this trial we will evaluate ABI-007 with gemcitabine and epirubicin, utilizing the biweekly pegfilgrastim support, in order to further improve upon the effectiveness and favorable toxicity of this triplet.

Upon determination of eligibility, patients will be receive both induction neo-adjuvant regimen and a postoperative adjuvant regimen:

Induction Neo-adjuvant: Epirubicin + Gemcitabine + ABI-007 + Pegfilgrastim

Postoperative Adjuvant: Gemcitabine + ABI-007 + Pegfilgrastim

Upon completion of chemotherapy, all ER and/or PR+ patients will receive Tamoxifen or an aromatase inhibitor at physician discretion.

Eligibility Criteria:
Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Locally advanced/inflammatory adenocarcinoma of the breast
* 18 years of age or older
* Normal heart function
* Able to perform activities of daily living with minimal assistance
* No prior chemotherapy for breast cancer
* Adequate bone marrow, liver and kidney function
* No evidence or history of significant cardiovascular abnormalities
* Sentinel node or axillary dissection
* Sign an informed consent form

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Pregnant or breast feeding
* History of heart disease with congestive heart failure
* Heart attack within the previous 6 months
* Prior chemotherapy or hormone therapy for breast cancer
* History of active uncontrolled infection

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.
Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate

Using customized Xenograft bone shell with mixture of autogenous and xenograft particulate in modified cortical shell technique. by 3D printed model from The CT scans segmentation by special software

Using customized Xenograft bone shell by 3D printed model from The CT scans segmentation by special software ( Mimics ) . All surgeries were performed by the same surgeon .

All surgical procedures were performed under strict aseptic conditions, all patients received infiltration local anesthesia (Articaine 4% 1:100 000 epinephrine).

a midcrestal incision was made in the anterior region using No. 15 blade. A full thickness mucoperiosteal flap was raised to expose the underlying alveolar ridge. The residual remaining bone in the area was minimal, with a maximum measured ridge thickness of 3 or 4 mm. 'To reconstruct the lost alveolar bone, an xenograft bone shell approximately 1 to 2 mm thick was shaped, after 3D print the bone shell were fixed to the buccal defect, using screws . 'The space between the plate and the existing palatal bone wall was then filled using a combination of autograft bone chips and xenograft bone particles

. Periosteal releasing incision is done to obtain stress free primary closure. The flap will then be closed using interrupted 4/0 resorbable sutures. After 4 month will insert implant . After 3 month will insert final restoration which will be mostly PMF .

Eligibility Criteria:
Inclusion Criteria:

* patients with atrophic Anterior Maxillary Ridges

Exclusion Criteria:

* Heavy smokers
* Uncontrolled diabetic patients.
* Pregnant patients. Psychiatric patient
* pathology related to bone.
A Study to Evaluate the Effectiveness and Safety of Treatments, Either Alone or in Combination, for the Treatment of Moderate to Severe Atopic Dermatitis

Atopic dermatitis (AD) is a skin condition that may cause a rash and itching due to inflammation of the skin. The purpose of this study is to evaluate the clinical efficacy and safety of single therapies and/or combination therapies for moderate to severe AD through multiple substudies.

This study will consist of multiple sub-studies, Sub-Study 1 will have a randomized, placebo controlled period 1 followed by a lutikizumab treatment period 2 enrolling 80 participants at a 1 to 1 ratio.

In Sub-Study 1, participants will receive subcutaneous (SC) injections of lutikizumab or matching placebo every other week for 16 weeks followed by an additional 32 weeks of subcutaneous (SC) injections of lutikizumab every other week for a total of 52 weeks.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of AD with onset of symptoms at least 1 year prior to the Baseline Visit and participant meets Hanifin and Rajka criteria.
* Participant has applied non-medicated, additive-free bland emollient twice daily for at least 7 days before the Baseline Visit.
* History of inadequate response to topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or topical JAK inhibitors, OR systemic treatment for AD, OR participants for whom topical treatments are otherwise medically inadvisable (e.g., because of important side effects or safety risks).

Exclusion Criteria:

* Use of the following AD treatments within the specified washout period prior to the Baseline Visit:

  -- Systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4) inhibitors, IFN-γ, and mycophenolate mofetil within 5 half-lives \[if known\] or within 4 weeks, whichever is longer;

  -- Any biologic treatments, (within 5 half-lives \[if known\]) or within 12 weeks (whichever is longer), or as specified below: \< 8 weeks for dupilumab; \< 12 weeks for nemolizumab; \< 16 weeks for tralokinumab and lebrikizumab.
* Phototherapy treatment, laser therapy, tanning booth, or extended sun exposure that could affect disease severity or interfere with disease assessments within 4 weeks.
* Herbal treatments (e.g., traditional Chinese medicines) within 4 weeks.
* Topical treatments (with the exception of non-medicated, additive-free bland emollients), including but not limited to TCS, TCIs, or topical PDE-4 inhibitors within 7 days.
* Topical JAK inhibitor within 14 days.
* Systemic JAK inhibitor (including but not limited to ruxolitinib, tofacitinib, baricitinib, upadacitinib, abrocitinib \[PF-04965842\], and filgotinib) within 5 half-lives \[if known\] or within 14 days, whichever is longer.
Platelet-activation and Optimal Inhibition in Patients With Atrial Fibrillation Undergoing Left Atrial Appendage Occlusion

The POPULAR-LAAO registry is an open-label observational prospective registry to investigate hemostatic processes following left atrial appendage occlusion.

This is an open-label observational prospective registry. The aim is to develop a better understanding of coagulation, platelet reactivity and prothrombotic factors in the first months after left atrial appendage occlusion, as occurrence of device-related thrombus and optimal postprocedural management remain a challenge after LAAO.

The study population will consist of patients with non-valvular atrial fibrillation (AF) at risk for cardio-embolic stroke scheduled for left atrial appendage occlusion. In these patients, blood samples for coagulation and platelet reactivity testing will be taken, which will be gathered prior to the procedure and 1 day, 14 days, 3 months and 6 months after the procedure. Data will be analyzed longitudinally and between groups based on patient characteristics.

Eligibility Criteria:
Inclusion Criteria:

* The subject is aged 18 years or older
* The subject is accepted/scheduled for left atrial appendage occlusion
* The subject has a CHA₂DS₂-VASc Score ≥2 (male) or ≥3 (female)
* The subject or legal representative is able to understand and is willing to provide written informed consent to participate in the trial.

Exclusion Criteria:

* Unable or unwilling to return for required follow-up visits and examinations
* Mechanical heart valves or valvular disease requiring surgery or interventional procedure
* Ongoing major bleeding or complicated or recent (\<72hours) major surgery
* Known large oesophageal varices or decompensated liver disease (unless a documented positive opinion of a gastro-enterologist)
* Severe thrombocytopenia (\<50,000/ml)
* High likelihood of being unavailable for follow-up or psycho-social condition making study participation impractical.
* Woman with child bearing potential who do not use an efficient method of contraception.
* Positive serum or urine pregnancy test for woman with child bearing potential
* Pregnancy or within 48 hours post-partum
* unsuitable LAA anatomy for occlusion or thrombus in the LAA at the time of procedure
* contraindications or unfavourable conditions to perform cardiac catheterization or transesophageal echocardiography (TEE)
* atrial septal malformations, atrial septal defect or a high-risk patent foramen ovale that may cause thrombo-embolic events
* atrial septal defect repair or closure device or a patent foramen ovale repair or any other anatomical condition as this may preclude an LAAO procedure
* Mitral valve regurgitation grade 3 or more
* Aortic valve stenosis (AVA\<1.0 cm2 or Pmax\>50 mmHg) or regurgitation grade 3 or more
* Planned carotid endarterectomy (CEA) for significant carotid artery disease
* Life expectancy of less than 1 year
Computer Assisted Learning (CAL) Module Use for Re-training of Blood Pressure Measurements by Physical Therapy Students

The purpose of this study is to determine the effectiveness of a Computer Assisted Learning Module for supplemental blood pressure measurement retraining for doctor of physical therapy students.


Eligibility Criteria:
Inclusion Criteria:

1. Current student enrolled in the DPT program
2. Student is in good standing academically
3. Student is enrolled in the Clinical Foundation Skills course for the first time
4. Student provided informed consent to participate

Exclusion Criteria:

1. Student not enrolled in the DPT program
2. Student is taking the Clinical Skills Foundation course for the 2nd time
3. Student is not in good academic standing
4. Student did not provide informed consent to participate
A Prospective Longitudinal Assessment of PD Functional Impairment and Disability Via Mobile Health Technology

The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in Parkinson's disease patients.

Mobile health technologies include the wearable sensor technologies that are body-worn and passively collect information and mobile devices like smartphones that can be frequently used by patients to actively or passively collect information. However, there has been limited comparison of different wearable technologies to validated clinical rating scales to allow us to come to a consensus about their utility in both clinical practice and research trials. Data from mobile health technologies in Parkinson's Disease (PD) have not been validated to use in the place of clinician rating scales. It is also not clear if the information obtained with the devices consistently correlates with change on the clinician scales and longitudinal motor decline. Technological challenges, such as the feasibility (safety, compliance) of use devices in patients with neurodegenerative disease, change in equipment and algorithms over time, collaboration with companies who may own patents, and other issues may also limit their use in healthcare and research. The purpose of this study is to compare data from a battery of novel mobile health technologies to standard-of-care validated patient questionnaires and clinician rating scales in PD patients. The hypothesis is that there will be an association between data from mobile health technologies and data obtained from validated questionnaires/scales, indicating that these technologies are a reliable means of monitoring motor symptomatology and functional impairment and disability over time. The primary aims of the study are to compare information on continuously-measured patient-reported PD-related functional impairment and disability changes from traditional validated questionnaires to continuously-measured health-related data from a battery of novel mobile health technologies, and to assess the feasibility (compliance, safety, satisfaction) of PD patients to use a battery of novel mobile health technologies.

Eligibility Criteria:
Inclusion Criteria:

* PD as defined by the UK Brain Bank Criteria
* Disease duration between 2-13 years
* Aged 35-68 years
* Hoehn \& Yahr stage 3 or less when in the levodopa-"ON" state

Exclusion Criteria:

* Atypical parkinsonism including 18F-dopa PET patterns consistent with this
* MMSE score of \< 24 or evidence for dementia using DSM-IV criteria
* Unable to do normal copying of interlocking pentagons and semantic fluency score \<20 over 90 secs
* Ongoing major medical or psychiatric disorder including depression and psychosis
* Other concomitant treatment with neuroleptics
* Significant drug induced dyskinesias (\>2 for any body part on the AIMS scale)
* Previous neurosurgery Unable to be imaged using MRI
Patient-Clinician Communication Skill Training: A Mobile Education Initiative

This study is a pilot test of The Art of Medicine Series, a smartphone-based educational tool to improve clinician-patient communication. Investigators will enroll clinicians (residents, fellows, attending physicians) and family caregivers (most often parents) from the Children's Wisconsin neonatal intensive care unit (NICU). Participants will then receive a series of links to short, animated videos sent to their phone by text message. Each video teaches best-practice communication techniques such as how patients can prompt teach back and how clinicians can avoid biased phrasing in delivering news. Over the 4-week intervention (the length of resident's rotation), clinicians will receive 15 videos and patients will receive 8 videos. Communication skills of clinicians and patients will be assessed pre and post intervention using validated measures and participants' engagement with the videos will be tracked with software in the website.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria - clinician:

* A resident, fellow, or attending physician
* On Team A rotation in the neonatal intensive care unit (NICU) of Children's Wisconsin.

Inclusion criteria - patient:

* A parent, grandparent, or other identified caregiver of a child on Team A of the NICU at Children's Wisconsin
* Expected to stay in the NICU for a further 3 weeks
* Have not previously participated in the study
* Are 18 years of age or older
* Able to speak and understand English.

Exclusion Criteria:

-
Bidirectional Cohort Study on Improvement of Quality of Life in Patients After Coronary Intervention With Kuanxiong Aerosol

The goal of this observational study is to compare in patients with Angina Pectoris after PCI for Coronary Heart Disease. The main questions it aims to answer are:

* To evaluate the effect of Kuanxiong Aerosol on the quality of life of patients with angina pectoris after PCI for Coronary Heart Disease.
* To evaluate the effect of Kuanxiong Aerosol on relieving angina pectoris and improving cardiac function.

The comparison group will received routine treatment .The experimental group will received sublingual spray of Kuanxiong Aerosol on the basis of routine treatment，two sprays per time，three times a day, for a continuous month. After 1 month of treatment, the quality of life, the improvement of cardiac function and the relief of angina pectoris were compared between the two groups. Researchers will compare two groups to see if Kuanxiong Aerosol can improve the quality of life, cardiac function, and reduce the frequency and duration of angina pectoris in patients with angina pectoris after PCI.


Eligibility Criteria:
Inclusion Criteria:

* Meet the diagnostic criteria for coronary heart disease
* Age 18\~80 years old, male and female, lower limbs can move freely
* Patients with coronary angiography or coronary CT angiography indicating that the rate of coronary artery large vessel stenosis is greater than 80%
* Patients with angina pectoris (angina pectoris frequency ≥3 times/week) after PCI according to the judgment of the treating physician
* According to the doctor\&#39;s judgment, patients who need to use conventional drugs (ACEI/ARB, β-blockers), and patients who need to use Kuanxiong Aerosol drugs on the basis of conventional drug therapy
* Patients voluntarily sign informed consent

Exclusion Criteria:

* Allergic to ingredients contained in Kuanxiong Aerosol
* Coronary artery bypass grafting was prepared during the trial
* Blood lipid and uric acid exceeding 1.5 times the upper limit of normal reference value; Uncontrolled severe hypertension with systolic blood pressure \&gt;180mmHg and/or diastolic blood pressure \&gt;110mmHg
* severe hepatic and renal insufficiency (ALT, AST or TBIL\&gt;1.5 times the upper limit of normal reference value, Cr \&gt;1.5 times the upper limit of normal reference value)
* Malignant tumors
* Severe arrhythmias (such as rapid atrial fibrillation, ventricular tachycardia, high atrioventricular block, etc.)
* Women who are pregnant or trying to become pregnant
* The researcher judged that it is not suitable to participate in this study
Comparison of Duration of CSF Leak in Post Traumatic Patients Managed by Early Lumbar Drain vs Conservative Treatment

As limited data is available locally and internationally regarding early Lumbar drain and its effect on duration of CSF leak we have decided to compare it conservative treatment. By providing CSF an alternative route for drainage, the fistula site will remain dry. Leakage site won't be facing CSF pressure, and this will promote early healing of the wound.

Cerebrospinal fluid (CSF)leak is caused by communication between the subarachnoid space and the air-filled spaces of the middle ear or para nasal sinuses and sometimes skin. CSF leaks can be divided into two types ,traumatic and non traumatic. The traumatic CSF leaks further divided into accidental and iatrogenic (post surgical procedures) 1. Almost 80% of CSF leaks are due to road traffic accidents, fall from heights and firearms injuries to brain and spine, 16% are iatrogenic, and 4% are non-traumatic 1,2. More than 50% of traumatic CSF leaks are evident within the first 02 days, 70% within the first week, and almost all present within the first 3 months \[2,3\]. It is estimated that in patients with skull base fracture 10-30% develops CSF leaks and 2% of all traumatic head injuries are associated with CSF leaks \[4\].With the help of conservative treatment most of the CSF leaks stop within 7-10 days 1,5. When the CSF leak doesn't stop after 7-10 days, a lumbar drainage (LD) is suggested3,7. LD(lumbar drain) is a recommended treatment method for the CSF leaks in skull base and spinal trauma, the indications for LD(lumbar drain ) placement are still controversial ,LD(lumbar drain) effect on early CSF leakage cessation is still arguable 2,3. Traumatic CSF leaks duration can be reduced by early( lumbar drain) placement . At tertiary level particularly in public hospital, our study will be helpful to document the benefits of early lumbar drain (LD) in traumatic CSF leakage patients and their hospital stay. This will also help to reduce the ambiguity regarding the protocol for early lumbar drain (LD) placement .

Eligibility Criteria:
Inclusion Criteria:

1. Age between 15-60 years in both genders.
2. Patients with craniospinal post traumatic or post operative CSF leakage for more than 24 hours.

Exclusion Criteria:

1. Patients with comorbid like Cardiovascular, Chronic Kidney Disease, Coagulopathies and Pregnancy
2. Previous history of chest or abdominal surgery.
3. Previous history of any lumbosacral surgery.
Improvement in Gross Motor Function and Muscle Tone in Children With Cerebral Palsy Related to Neonatal Icterus

The purpose of this study is to evaluate the safety and effectiveness of stem cells for cerebral palsy related to neonatal icterus

The purpose of this study is to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cells in 25 patients with cerebral palsy related to neonatal icterus at Vinmec International Hospital, Hanoi, Vietnam

Eligibility Criteria:
Inclusion Criteria:

* Cerebral palsy of any types caused by neonatal icterus

Exclusion Criteria:

* Epilepsy
* Hydrocephalus with ventricular drain
* Coagulation disorders
* Allergy to anesthetic agents
* Severe health conditions such as cancer, failure of heart, lung, liver or kidney
* Active infections
An Open Study to Evaluate the Efficacy, Safety of Clevudine Monotherapy or Adefovir and Clevudine Combination in Patients With Chronic Hepatitis B

This is an open study to evaluate the efficacy, safety of clevudine monotherapy or adefovir and clevudine combination in patients with chronic hepatitis B.


Eligibility Criteria:
Inclusion Criteria:

* Patient is 18 years and older.
* Patient is documented to be HBsAg positive for \> 6 months.
* Patient is HBV DNA positive with DNA levels ≥ 1×10\^5 copies/mL within 30days of baseline.
* Patient has ALT levels ≥ 1×ULN
* Patient who is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

* Patient is currently receiving antiviral, immunomodulatory, cytotoxic or corticosteroid therapy.
* Patients previously treated with interferon, peg-interferon or other immunomodulatory within the previous 6 months.
* Patients previously treated with clevudine, lamivudine, adefovir, entecavir, telbivudine, Tenofovir or any other investigational nucleoside for HBV infection.
* Patient with clinical evidence of decompensated liver disease (Total bilirubin \< 2.0mg/dL, Prothrombin time \< 1.7(INR), Serum albumin≥3.5g/dL)
* Patient is coinfected with HCV, HDV or HIV.
* Patient has a history of ascites, variceal hemorrhage or hepatic encephalopathy.
* Patient with clinical evidence of hepatocellular carcinoma
* Patient with previous liver transplantation
* Patient is pregnant or breast-feeding.
* Patient has a clinically relevant history of abuse of alcohol or drugs.
* Patient has a significant immunocompromised, gastrointestinal, renal,
* hematological, psychiatric, bronchopulmonary, biliary diseases excluding asymptomatic GB stone, neurological, cardiac, oncologic(except HCC)or allergic disease or medical illness that in the investigator's opinion might interfere with therapy.
* Patient has creatinine clearance less than 60mL/min as estimated by the following formula: (140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Effect of Rocuronium on the Acute Hypoxic Ventilatory Response in Patients With Obstructive Sleep Apnea

This study describe the effect of partial neuromuscular blockade of rocuronium on the acute hypoxic ventilatory response in patients with OSA before and after 3 month of CPAP treatment.


Eligibility Criteria:
Inclusion Criteria:

* Male with diagnosed moderate OSA (AHI 15-30), untreated, but planned for CPAP treatment. Healthy except for OSA and well controlled tablet treated hypertension where the treatment has not been changed during the last 3 month. None smokers. 18-70 years old. BMI \<35.

Exclusion Criteria:

* If they don´t fit the inclusion criteria