cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Role of Intravitreal Tissue Plasminogen Activator in Treatment of Refractory Diabetic Macular Edema

Purpose: to evaluate the effect of intravitreal injection of tissue plasminogen activator(tPA) in treatment of refractory diabetic macular edema(DME).


Eligibility Criteria:
Inclusion Criteria:

1. type 2 diabetes
2. Non proliferative diabetic retinopathy(NPDR) stage of diabetic retinopathy
3. patients with refractory DME CSME (patients with the last MPC at least 3 months before and no improvement was observed in BCVA, macular thickness inOCT, clinical examination and fundus photographs of patients )
4. Absence of PVD in the B-scan
5. Absence of PVD in OCT of macular area and optic disk
6. Absence of PVD in slit lamp biomicroscopy(SLE)
7. the last PRP session was at least 3 months ago.
8. Absence of traction on macula in clinical examination and OCT

Exclusion Criteria:

1. One eye patients
2. Patients who are candidates for intraocular surgery.
3. Patients with the history of glaucoma or ocular hypertension
4. Patients with a history of vitrectomy in the study eye
5. Not being able to refer for the next visits
6. Eyes with cataract that makes the assessment of the macula impossible.
7. Intraretinal hemorrhage at fovea that will interfere with OCT.
8. BCVA ≤ 0.1
Utility of PCD Diagnostics to Improve Clinical Care

This is a study evaluating the utility of current Primary Ciliary Dyskinesia (PCD) diagnostic tests, including nasal nitric oxide testing.

This study is a prospective data collection of individuals referred to the investigators clinical center for considerations of PCD. Participants sign informed consent to have clinical information entered into a secure electronic database. As part of this study, participants may have nasal nitric oxide (nNO) testing performed. nNO testing is a research procedure, but it is a test with growing utility for making a diagnosis of PCD when performed in the right clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Referred to center for PCD diagnosis considerations
* Ability to perform study procedures
* Age greater than 2 years of age

Exclusion Criteria:

* Age less than 2 years of age Inability to perform informed consent
HIS Bundle Pacing Synchrony Comparing HIS Pacing to Intrinsic Conduction While Using the Medtronic ECG Belt System

The HBP Synchrony Using ECG Belt study is a prospective, non-randomized single site physician-initiated research study. The study will collect ECG Belt data from up to 30 subjects at one single center. The target population will include subjects with a currently implanted Medtronic cardiac implantable device who have a HIS placed lead. The purpose of the study is to characterize the electrical dispersion using the ECG Belt provided by Medtronic in patients who have a HIS placed lead and understanding the amount of synchrony with intrinsic conduction compared to HIS pacing.


Eligibility Criteria:
Inclusion Criteria:

* Patient has previously been implanted with a Medtronic IPG/ICD and a HIS placed RV lead
* Patient has intrinsic AV conduction
* Normal EF, defined as EF \>50%, as shown on recent echo within last 12 months
* Patient is willing and able to comply with the protocol
* Patient is 18 years of age or older

Exclusion Criteria:

●Patient is ventricular pacer dependent
Pilot Study of Tetomilast in Chronic Obstructive Pulmonary Disease (COPD) Associated With Emphysema

Phase 2a multicenter, randomized, double-blind, placebo-controlled study to assess the pharmacodynamics, efficacy, and safety of tetomilast in patients with emphysema.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 40-75 yrs old,inclusive.
* Rating of greater than or equal to 1 on the Goddard scale in assessment of emphysema severity by HRCT.
* FEV1: FVC greater than 70% predicted.
* At least 1 documented COPD exacerbation within the past year but not within 8 weeks of randomization.
* Current or former smokers with a cigarette smoking history of at least 20 pack-years (or equivalent) and whose smoking status has not changed 60 days prior to screening.

Exclusion Criteria:

* Patients with asthma, active tuberculosis or bronchiectasis.
* A respiratory tract infection within 30 days prior to the screening visit.
* Any malignancy within the last 5 years with the exception of non-melanomatous skin cancer.
* Uncontrolled cardiovascular, endocrine, blood, or nervous system disorders.
* Uncontrolled condition with COPD exacerbation of level 2 or 3 in the 8-week period prior to randomization.
* Systemic use of corticosteroids or other immunosuppressive agents within 30 days of the screening visit.
* Subjects taking anticoagulants.
Prevention of Oral Mucositis After Using Chamomile Oral Cryotherapy Versus Oral Cryotherapy in Pediatric Cancer Patients Receiving Chemotherapy.

oral mucositis is a painful situation that significantly affects patients' quality of life with the severe cases being associated with ulcerated mucosa and secondary infection which may lead to life-threatening sepsis.Chamomile infusion in cryotherapy was used to aid in reduction of chemotherapy induced mucositis and to enhance the effect of standard cryotherapy alone by its anti-inflammatory, antifungal and antibacterial effect. The occurrence of oral mucositis is a significant complication of chemotherapy with prevalence of up to 80% in pediatric patients.The study is to be conducted at the in and outpatient clinics at the Department of Pediatric Oncology, National Cancer Institute,Egypt. A Structured interview questionnaire sheet will be filled with personal, medical and dental history. Intraoral examination will be carried out using sterile latex gloves, masks, plain mouth mirrors, sterile gauze and wooden tongue depressor. Patients who will agree to participate in the study will watch a video explaining how to perform oral hygiene.Preparation of the interventions is done in the clinic with 400 ml of distilled water with or without the infusion of 10 g of chamomile flowers."Chamomile classic infusion, Royal Herbs" .Ice cubes will be prepared in special ice trays placed in the chemotherapy center for this purpose.Patients will be instructed to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session. Follow ups are done at the 8th,15th and the 21st day of interventions application.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with healthy and intact oral mucosa.
2. Patients diagnosed with bone tumor (osteosarcoma) for the first time.
3. Patients receiving Methotrexate as part of their chemotherapeutic regimen.
4. Both male and female patients undergoing chemotherapy at In and Out patient units of Pediatric Oncology department.
5. Age of patient ranging (6- 18) years old.
6. Legal representatives of patient must be able to read, understand and provide informed consent to participate in the trial.
7. Patients with no history of dental discomfort related to cold or hot food or beverage intake.

Exclusion Criteria:

1. Administration of antiviral or antifungal therapy and/or any other treatment for oral mucositis before enrollment in the study.
2. Presence of advanced or severe periodontitis (pocket depth more than 6mm).
3. Patients who were supposed to receive head and neck radiotherapy as part of their treatment.
Impact of Endometrial Compaction on Clinical Pregnancy Rate in Frozen Embryo Transfers

To find out if the percentage of endometrial compaction is correlated to clinical pregnancy rate in down regulated frozen embryo transfer cycle. Endometrial compaction is the change in endometrial thickness between the end of the estrogen only phase and the day of embryo transfer. In concept, the compaction of the endometrium after progesterone initiation indicates that the endometrium is responsive to progesterone and could therefore be used as a proxy for endometrial receptivity predictability of FET cycle outcome


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing down regulated cycles frozen embryo transfer.
* Women at age group 20-35 years old.
* Day 5 embryos will be transferred.

Exclusion Criteria:

* Chromosomal abnormality in either partner (As this could lead to cycle cancellation).
* Uterine malformation or any intrauterine condition affecting the pregnancy outcomes of FET, such as endometrial polyps, uterine cavity adhesion, history of endometrial tuberculosis, hydrosalpinx with a reflux into uterine cavity (As the might not be candidates for IVF cycle till correction).
* Recurrent implantation failure, defined as 2 or more previous failed trials (Other confounding factors might of present which could affect the results).
* Cycles of patients with persistent endometrial thickness \<7mm during treatment protocol (Due to cycled cancelation).
GO TEAM: Glucose Optimization Through Technology Assisted Management

Black/African American children and young adults with type 1 diabetes are less likely to use diabetes technologies, such as continuous glucose monitors, insulin pumps, and automated insulin delivery systems, compared to White children and young adults. The investigators are working to find ways to make sure that all patients with type 1 diabetes are equally able to use these technologies. The purpose of this study is to find out if a new computer program for the diabetes team, along with a smartphone app (called Glucosano) for patients/parents, as well as a community health worker, are accepted and used by Black/African American patients and parents living with type 1 diabetes, and if this can help decrease racial disparities in the use of diabetes technologies.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported as Non-Hispanic Black
* Clinical diagnosis of T1D requiring treatment with insulin at the time of consent
* Not currently (within the past 3 months) using an automated insulin delivery system \\
* Willingness to wear a continuous glucose monitor for 10 days at 3 different time points, and willingness to consider use of a personal continuous glucose monitor

Exclusion Criteria:

* Clinical diagnosis of Type 2 or monogenic diabetes
* Completed high school
* Non-English speaking guardians
* Automated insulin delivery system use within the past 3 months
* Custody of children and family services
Personalized Risk Stratification Model of Follicular Lymphoma Patients

The study aims at developping and validating an integrated clinico-molecular model for an accurate identification of FL patients who are progression free and progressed, respectively, at 24 months after treatment.

Already existing and coded tumor biological material and health-related personal data will be retrospectively collected. FL diagnosis will be confirmed by central pathology review. Tumor somatic mutations, immunoglobulin gene rearrangement and mutation status will be analyzed by targeted deep next generation sequencing of tumor genomic DNA. Gene expression profiling will be performed by targeted RNA-Seq of biopsy-derived RNA.

An immunohistochemistry panel assessing both tumor phenotype and microenvironment cellular composition will be assessed by Tissue macroarray. FISH will be performed to characterize the most recurrent follicular lymphoma chromosomal translocations.

The adjusted association between exposure variables and progression free survival will be estimated by Cox regression. This approach will provide the covariates independently associated with progression free survival that will be utilized in the development of a hierarchical molecular model to predict progression free survival at 24 months. The hierarchical order of relevance in predicting 24 months progression free survival among covariates will be established by recursive partitioning analysis. Overall, this approach will allow the development of a multilayer dynamic model for anticipating progression within 24 months from treatment.

The model developed in the training set will be tested in the validation sets and the model performance (c-index and net reclassification improvement) in the validation set will be compared with that in the training set. The accuracy of the multilayer model in predicting progression free survival at 24 months will be compared against the FLIPI using c-index and net reclassification improvement.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of FL after January 1st, 2004 (chemoimmunotherapy era)
* Availability of tumor material collected before initiation of medical therapy
* Availability of the baseline and follow-up annotations

Exclusion Criteria:

* None.
Hypnotic and Anti-nociceptive Components of Magnesium

The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol.

The aim of our study is to evaluate the effect of magnesium on the hypnotic effect of propofol. To achieve this, the investigators will analyse the effect of magnesium on the brain concentrations of propofol required to achieve a State Entropy value between 50-60, which corresponds to the recommended depth of anaesthesia. Our study will also evaluate the intraoperative anti- nociceptive effect of magnesium using pupillometry and its two indices, PPI and PRD

Eligibility Criteria:
Inclusion Criteria:

* Adult \> 18 years
* Patients of both sexes
* Any patient scheduled for thyroidectomy at the University Hospital of Liege

Exclusion Criteria:

* Heart failure with left ventricular ejection fraction \< 35
* Renal insufficiency (clearance \< 40 mL/min)
* Neuromuscular diseases
* Atrioventricular block
* Pregnancy
Internet-based Support for Informal Caregivers of Patients With Head and Neck Cancer - Carer eSupport

The aim of this randomized controlled trial is to investigate the effects of internet-based support (Carer eSupport) on preparedness for caregiving in informal caregivers of patients with head and neck cancer. The main question\[s\] it aims to answer are:

* What are the effects of internet-based support on informal caregivers preparedness for caregiving?
* What are the effects of internet-based support on informal caregivers burden and wellbeing?

Informal caregivers who are randomized to Carer eSupport will have access to Carer eSupport for 18 weeks and they will be asked to complete questionnaires (outcome measures) at:

* baseline (before randomization)
* 18 weeks (post-intervention) and at
* 3 months after the intervention is completed (long term follow-up).

Informal caregivers in the intervention group will be compared to informal caregivers who receive standard care support regarding preparedness for caregiving, caregiver burden and wellbeing.


Eligibility Criteria:
Inclusion Criteria:

* Informal caregivers who have been identified as an informal caregiver by a patient who have consented to that the informal caregivers is approached.
* Informal caregivers of patients with head and neck cancer who are about to start radiotherapy or have undergone at most five radiotherapy treatment session. Radiotherapy may be combined with surgery and/or medical oncological treatment.

Exclusion Criteria:

* Informal caregivers who do not understand and read Swedish or suffer from cognitive impairment, and informal caregivers with who need support or treatment that cannot be provided by Carer eSupport.
Comparing Articular Noise and Its Perception Between Two Different Types of Total Knee Arthroplasty

Some patients complain of articular noise (such as clicking, snapping, cracking or popping) after a total knee replacement. Controversy remains about whether there is a correlation between articular noise and worse outcomes following a knee replacement. A study by Nam et al. on 1540 patients revealed an association between noise and residual symptoms 30 days after they received a total knee replacement. Conversely, a study by Kuriyama et al. on 60 patients revealed no correlation between noise and patient satisfaction after 1 year of receiving a total knee replacement. The incidence of noise following a knee replacement has rarely been studied as a primary outcome. Like pain, it could be considered an important patient-reported outcome to assess patient satisfaction. The study aims to compare the prevalence of patient-perceived noise of an ultra-congruent total knee prosthesis (Score 2, Amplitude) versus a posterior-stabilized total knee prosthesis (Anatomic, Amplitude).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients receiving a primary TKA
* Signed informed consent
* Patients affiliated to a social security scheme
* Patients willing and able to comply with study protocol requirements based on the investigator's judgment.

Exclusion Criteria:

* History of knee surgery on the concerned/studied knee (except arthroscopic surgery)
* Patients presenting coronal deformities \> 20°, varus laxity \> 10° and/or valgus laxity \> 15°
* Patients receiving revision TKA
* Pregnancy or breast-feeding
* Patients with protected status under articles L1121-6, LL121-8 and L1122-2 of the French Public Health Code
* Unable to comply with study procedures, based on the investigator's judgment.
Development of a Specific Measure for Assessing Adherence in Adult Patients With Hemophilia.

Research project for the development, construction and validation of a questionnaire of adherence to treatment in adult patients with hemophilia. It aims to build a scale according to five relevant dimensions of adherence to treatment: 1) physician-patient relationship, 2) knowledge of the disease, 3) previous bleeding problems, 4) knowledge of future consequences and difficulties, and 5) benefits of treatment.

* Descriptive study for the construction of a multidimensional scale of adherence to treatment in adult patients with hemophilia.
* Validation of a scale specific measure for patients with hemophilia that includes 5 dimensions that may affect adherence to treatment: a) the doctor-patient, b) regarding knowledge of the disease, c) the previous hemorrhages, d) knowledge future sequels, e) difficulties with treatment.
* Statistical and psychometric analysis of the adherence questionnaire for adult patients with hemophilia.
* Description of the theoretical framework that justifies the completion of the questionnaire, and the choice of the dimensions and items that make up the measurement scale.
* The questionnaire obtained in this project will identify the actual degree of patient adherence to multidisciplinary treatment, taking as gold standard, compliance with pharmacological treatment (the difference between the treatment prescribed and consumed).

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with hemophilia A or B.
* Patients over 18 years of age.

Exclusion Criteria:

* Patients with neurological or cognitive impairments that hinder oral and written comprehension.
* Patients who have not signed the informed consent document
Outcomes Data of Adipose Stem Cells to Treat Osteoarthritis

The purpose of this study is to determine the impact that treatment with a cellular concentrate derived from an individual's own fat, known as the stromal vascular fraction (SVF), has on joint pain and functionality in people with Osteoarthritis (OA). SVF contains components with "regenerative" properties, including stem cells that have shown promise for ameliorating specific disease conditions. This study is designed to evaluate joint pain and functionality changes in individuals with OA for up to 12 months following SVF treatment.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Over the age of 18
* Diagnosed with OA of the knee and/or hip
* Scheduled for intravenous and intra-articular administrations of autologous SVF
* Capable of understanding and willing to sign informed consent
* Willing and able to complete brief phone interviews
* Willing and able to complete online surveys

Exclusion Criteria:

* Co-morbidity with an autoimmune disorder
* Pregnant, may become pregnant, or breastfeeding
* Subjects for which baseline data is not available
Permissive Intrapartum Glucose Control

The purpose of this study is to assess whether permissive intrapartum glycemic control compared to usual care would lead to similar rate of neonatal hypoglycemia among people with diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Singleton gestation
* Presenting for intrapartum management (induction, labor, augmentation)
* Any diagnosis of Type 1 Diabetes Mellitus(T1DM), Type 2 Diabetes Mellitus (T2DM), or Gestational Diabetes
* English or Spanish fluency

Exclusion Criteria:

* Major fetal anomalies affecting glucose metabolism
* Multiple Gestation
* Incarcerated subjects
* less than 34 weeks gestation of pregnancy
* Planned cesarean delivery
* Utilizing insulin pump during labor
* Stillbirth
* Presenting in Diabetic ketoacidosis(DKA)
Ambulation Versus Standing on Postoperative Day 0

The purpose of this study is to determine the impact of the timing of physical therapy (PT) initiation on postoperative length of stay and the time to physical therapy clearance following total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* scheduled for primary TKA (Total Knee Arthroplasty) for any degenerative condition
* Anesthesia for TKA is Spinal + Regional block (Adductor Canal Block)

Exclusion Criteria:

* require assistive devices (walker, wheelchair) for ambulation preoperatively
* planning to go to a subacute nursing facility or acute rehab facility following surgery
* \< 18 yrs of age
* not willing to participate or unable to consent
Open Label Study Of SU011248 In Combination With Trastuzumab For Patients With Metastatic Breast Cancer

The current study is to evaluate: Overall response rate for the combination of trastuzumab and SU011248 in metastatic or locally recurrent breast cancer; evaluate safety and tolerability of the combination; measure duration of tumor control and survival; assess patient reported outcomes; assess PK in combination with trastuzumab and compare efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of breast cancer with evidence of 1) unresectable, locally recurrent, or 2) metastatic disease.
* HER2 positive disease (3+ by immunohistochemistry \[IHC\] or FISH-positive)
* Candidate for treatment with trastuzumab. Prior treatment with trastuzumab and or/ lapatinib in the neoadjuvant, adjuvant or metastatic disease setting is permitted. Treatment with hormone therapy in the adjuvant and/or advanced disease setting is permitted.

Exclusion Criteria:

* Prior treatment with \>1 regimen of cytotoxic therapy in the advanced disease setting. Adjuvant chemotherapy is permitted
* Prior exposure to trastuzumab if the patient had developed severe hypersensitivity reactions.
* Prior treatment on a SU11248 clinical trial.
* Uncontrolled brain metastases.