cyrilzakka/clinical-trials huggingface dataset:
Correlation Between the Visual Acuity & the OCT Pattern of Macular Edema Secondary to RVO

Correlation between changes observed in OCT and VA in patients with retinal vein occlusion whether the patient's VA improves when macular edema improves in OCT or not ??

Central retinal vein occlusion (CRVO) is a common retinal vascular disorder. Clinically, CRVO presents with variable visual loss; fundus may show retinal hemorrhages, dilated tortuous retinal veins, cotton-wool spots, macular edIn view of the devastating complications associated with the severe form of CRVO, number of classifications were described. All of classifications take into account the area of retinal capillary nonperfusion and development of neovascular complications.

CRVO can be divided into 2 clinical types, ischemic and nonischemic. In addition, a number of patients may have an intermediate presentation with variable clinical course. On initial presentation, it may be difficult to classify a given patient, since CRVO may change with time.

A number of clinical and ancillary investigative factors are taken into account for classifying CRVO:

Nonischemic CRVO is milder form of disease. It may present with good vision, few retinal hemorrhages and cotton-wool spots, no relative afferent pupillary defect, and good perfusion to the retina. Nonischemic CRVO may resolve fully with good visual outcome or may progress to the ischemic type.

Ischemic CRVO is the severe form of the disease. CRVO may present initially as the ischemic type, or it may progress from nonischemic. Usually, ischemic CRVO presents with severe visual loss, extensive retinal hemorrhages and cotton-wool spots, presence of relative afferent pupillary defect, poor perfusion to retina, and presence of severe electroretinographic changes. In addition, patients may end up with neovascular glaucoma and a painful blind eye.

Eligibility Criteria:
Inclusion Criteria:

* Patients with macular edema related to vein occlusion .
* Patient's Age above 18 years old .
* Patients able to sit on OCT device .

Exclusion Criteria:

* Significant cataract .
* Media opacities as vitreous haemorrhage .
* patients with macular edema related to CRVO treated by laser photocoagulation .
* patients with glaucoma .
* Patients with chronic uveitis.
Wearable Enhanced Fitness Tracking for Metastatic Breast Cancer Patients Using Endocrine Treatment and Palbociclib

Combining a fitness tracker technology with real-time patient-reported outcome monitoring associated with interventions through a health care app is a novel strategy to evaluate metastatic breast cancer patients using Palbociclib and endocrine treatment.

Measure the quality of life of patients with metastatic breast cancer treated with Palbociclib and endocrine therapy using the Functional Assessment of Cancer Therapy - Breast and EuroQol -5D - European quality of life in five dimensions and compare the group using the Wecancer digital health app with the group using Wecancer and the physical activity monitoring smartwatch.

Eligibility Criteria:
Inclusion Criteria:

* Female patients ≥ 18 years of age diagnosed with hormone receptor-positive/ human epidermal growth factor receptor 2- negative metastatic breast cancer undergoing treatment with Palbociclib combined with aromatase inhibitors (letrozole, exemestane or anastrozole) or fulvestrant as first-line therapy, or in treatment with Palbociclib and fulvestrant as second-line or posterior-line therapy in the metastatic setting; may be using ovarian suppression if the patient is premenopausal.
* The patient must be on treatment for at least three (3) months with Palbociclib and endocrine therapy.
* Evidence of a signed and dated informed consent document, physically or digitally, indicating that the research participant was informed about all relevant aspects of the study;
* The patient agrees not to participate in another study with drug intervention while on treatment.
* Have performance status according to the Eastern Cooperative Oncology Group
* Have access to a compatible smartphone and 3G or 4G internet connection

Exclusion Criteria:

* Patients considered to be at poor medical risk due to uncontrolled serious medical disorder, non-malignant systemic disease, or active uncontrolled infection. Examples: uncontrolled ventricular arrhythmia, recent myocardial infarction (within 6 months), stroke, gastrointestinal bleeding, or any psychiatric disorder that precludes informed consent; between others.
* Patients who have a life expectancy of \< 3 months.
* Treatment with any product under investigation during the last 28 days;
* Another acute or chronic medical or psychiatric condition or severe laboratory abnormality that could increase the risk associated with participation in the study or that Page 10 de 21 Version 6.0 could interfere with the interpretation of the study results and, in the investigator's judgment, would make the research participant unsuitable for inclusion in the study. study.
* Illiterate patients or those with a low level of education that may prevent the correct use of the Wecancer application and/or the watch with monitoring of physical activity.
Exploratory Study of EBV DNA Titre Clearance Whilst on Proton Beam Therapy

How does plasma Epstein-Barr Virus (EBV) DNA level change during definitive radiation therapy for nasopharyngeal carcinoma (NPC) in the teenage and young adult cohort and does it correlate with outcomes?

Children with NPC achieve superior survival outcomes compared to adults (10) and the prognostic value of plasma Epstein-Barr Virus (EBV) DNA has not been studied in children. Integration of MRI into early treatment response assessment will add further prognostic value and permits response-adapted therapy which can improve quality of survivorship children through toxicity reduction. It also allows identification of patients who either have had or are likely to have a suboptimal response to treatment, facilitating the potential consideration of treatment escalation.

The sample size of this study is not intended to change clinical practice, but rather provide a basis for international collaboration to achieve larger patient numbers.

Eligibility Criteria:
Inclusion Criteria:

* Children and young adults (8-30 years old)
* Pathologically confirmed EBV-positive nasopharyngeal carcinoma
* Stage I-IVA (AJCC 8th Edition)
* Planned to commence curative-intent radiation therapy

Exclusion Criteria:

* Recurrent NPC
* Concurrent or previously treated EBV-associated malignancy
* Prior radiation therapy
* Contraindications to MRI
* General anaesthetic requirement for MRI
Effect of Foot Reflexology on Postpartum Afterpains

This study will be conducted to determine the effect of foot reflexology on afterpains after normal labor.

Afterpains are among the most prevalent complaints after natural vaginal delivery. Non-pharmacological treatment modalities to relieve afterpains are an important care priority as they can lead to maternal and neonatal complications including anxiety, sleep disturbances, emotional disorders, depression, inability to care for the baby and continue breastfeeding, delays in early breastfeeding, reduced maternal ability to perform daily chores.

It was reported that pain in the early hours postpartum is one of the most important factors contributing to chronic postpartum pain and depression. Furthermore, pain and stress increase adrenaline release and decrease oxytocin release, thus leading to the cessation of the oxytocin reflex and disrupting breast milk production in addition to causing discomfort for the mother.

Since afterpains is a common problem that affects the physical and mental well-being of mothers, it requires the attention of healthcare providers. There is only one study that investigated the effect of reflexology on the pain level of afterpains after normal vaginal delivery. Moreover, no study investigated the effect of reflexology on either the behavioral response toward pain or the pressure pain threshold. Therefore, this study will be conducted to provide physiotherapists with updated scientific Knowledge concerning the effect of foot reflexology on afterpains after normal labor. This Study may expand the role of physiotherapy in women's health.

Eligibility Criteria:
Inclusion Criteria:

* They will be multipara (2-3).
* They will be normal vaginal labor

Exclusion Criteria:

* High-risk pregnancy.
* Post-partum hemorrhage.
* Neonatal birth weight over 4 kg.
* Over distension of the uterus.
* Cesarean section.
Speech and Swallowing Characteristics of Patients After Laryngectomy and the Effect on Quality of Life

Swallowing and speech difficulties will be observed in patients post laryngectomy. These difficulties will cause decreased in quality of life.

This study will explore the characteristics of speech and swallowing problems of patients who underwent laryngectomy.The relationship between swallowing disturbances and speech difficulties will be studied and the effect of each problem on quality of life will be messured.

Eligibility Criteria:
Inclusion Criteria:

* patients post total laryngectomy with voice prothesis

Exclusion Criteria:

* patients who can not read and respod to questions
CC486-CHOP in Patients With Previously Untreated Peripheral T-cell Lymphoma

This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with PTCL who have received no prior systemic therapy. The study has a sample size of 20, and follows two-stage minimax design for primary efficacy analysis.

Study Summary:

This is a phase II, multi-center study to determine the efficacy and safety of first-line CC-486 plus CHOP in patients with Peripheral T-cell Lymphoma (PTCL) who have received no prior systemic therapy. The main objective is to determine the complete response rate (CR) of CC486-CHOP in PTCL. CR rate after cycle 6 will be used for the purpose of interim efficacy analysis.

* The study includes 6 cycles (\~18 weeks) of treatment and 2 years of follow-up. The projected end date is 12/31/2022. Patients achieving complete remission will be evaluated every 6 months for 2 years or until disease progression. Patients who have disease progression will be contacted every 6 months to assess for survival status.
* Standard dose CHOP will be provided on day 1 of each cycle and repeat every 3 weeks for a total of 6 cycles.
* CC486 at 300 mg daily will be administered orally from day -6 to day 0 for cycle 1 priming, and on days 8-21 following cycles 1-5.
* Patients in CR/PR following 6 cycles of treatment have the option to proceed to consolidative autologous stem cell transplant.
* Will continue on treatment as long as they are responding to therapy and not experiencing unacceptable side effects.

Eligibility Criteria:
Inclusion Criteria:

- Histologically confirmed diagnosis of PTCL of the following subtypes: Nodal T-cell lymphoma with T-follicular helper (TFH) phenotype (tumor cells must express 2 or 3 TFH-related antigens, including PD1, CD10, BCL6, CXCL13, ICOS, SAP and CCR5)\* Angioimmunoblastic T-cell lymphoma Follicular T-cell lymphoma PTCL/NOS, T-follicular helper (TFH) variant PTCL-NOS Anaplastic large cell lymphoma, ALK negative Anaplastic large cell lymphoma, ALK positive with IPI \> 2 Adult T-cell leukemia / lymphoma

* No prior systemic therapy for lymphoma
* Measurable disease defined by a tumor mass ≥ 1.5 cm in one dimension and measurable in two dimensions
* ECOG performance status ≤ 2

Exclusion Criteria:

* Known central nervous system (CNS) involvement by lymphoma
* Active viral infection with HIV or hepatitis type B or C (seropositive HBV patients are eligible if they are negative for HBV DNA by PCR and receive concomitant antiviral therapy).
* Prior history of malignancies other than PTCL unless the patient has been disease free for ≥ 5 years from the signing of the ICF.
Postoperative Skin Surface Tension Relaxing in Prevention of Facial Surgical Skin Scarring

The purpose of this study is to evaluate the efficacy and safety of early postoperative skin surface reduction in improving scar formation after facial surgery.

Primary measurement: the mean scar width calculated by standard photos with rulers.

Secondary measure: the probability of scar hyperplasia.

Eligibility Criteria:
Inclusion Criteria:

* The incision is not shorter than 3cm
* Skin type is III/IV

Exclusion Criteria:

* Any medical history of facial surgery, not included injection therapy, external medication or fat graft
* Unsuitable for device use due to anatomical location of incision, eg. lips, eyelids and ear
* Patients with a history of keloid or family history of keloid
* Patients with serious skin disorders, eg. serious psoriasis or dermatitis
* Patients with severe systemic or congenital disease which may affect the patient's safety in this study
Bevacizumab for Central Retinal Vein Occlusion Study

Central retinal vein occlusion is a leading cause of severe visual impairment. Until now, no treatment has been available to improve visual acuity. The present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.


Eligibility Criteria:
Inclusion Criteria:

* CRVO with duration \< 6 months
* Visual acuity of 20/800 to 20/50

Exclusion Criteria:

* CRVO with duration of \> 6 months
* previous treatment with anti-angiogenic drugs
A Study to Compare the Effects of Different Sized Particles on Cells in the Nose

The goal of this study is to see how the type and size of particles found in air pollution affects inflammation in the nose in people who are skin test positive to at least one allergen. It has been observed that pollution makes allergies worse. It has also been suggested that very small particles may affect allergies more than larger particles.

Cough, bronchitis, asthma, and chronic obstructive pulmonary disease are all associated with elevated pollution particle levels. Researchers believe that particulate pollutants can exacerbate allergy and inflammation and affect asthma and allergy prevalence. In an urban setting such as the Los Angeles Basin, particles generated by vehicular traffic are thought to be important risk factors. Recently, the Environmental Health Centre of Southern California confirmed that there is a strong association between traffic near homes and schools and development of asthma. This study will help researchers describe the effects of various size pollution particles in causing inflammation in the nose.

There will be a total of 20 study visits. The study procedures include physical exams, symptom score for nose, nose washes and nose challenges with particulate matter. The particulates will be given in a random order and include the following: saline (sterile salt water), inert carbon particles (Carbon Black), diesel exhaust particles (DEP), small (fine) particles or very small (ultrafine) particles. These last two (fine and ultrafine) particles are obtained from concentrated normal Los Angeles air. The particulate will be sprayed into the nose with a standard nasal spray.

Eligibility Criteria:
Inclusion Criteria:

* Previously determined high inflammatory responders to Diesel Exhaust Particles
* Previously determined atopy as demonstrated by allergy skin testing
* Asymptomatic on day of challenge.

Exclusion Criteria:

* History of lung problems (including asthma), bleeding, neuromuscular, liver, kidney or heart disorders.
* History of anaphylaxis.
* Recent upper respiratory infection (less than 4 weeks prior to study) or other active infection.
* Active smoker or smoker in the past 2 years.
* Treatment with topical nasal steroids (\< 1 month), systemic steroids (\<1 month), oral antihistamines (\< 1 week) prior to any nasal challenge.
* Use of leukotriene receptor antagonist (\< 1 month ) prior to any nasal challenge
* Intranasal antihistamine or cromolyn use \< 1 week prior to any nasal challenge .
* History of treatment with allergy immunotherapy.
* Inability to perform nasal lavage.
* Inability to give written informed consent
* Pregnancy
Evaluation of Continuity of Care of Children With Special Health Needs

Children and adolescents with special health care needs represent a small but relevant subset of the pediatric population due to high costs for the health care system, risk of lower quality of care, unmet health care needs, and negative health outcomes. Coordination of care and continuity of care are essential issues of appropriate care for these patients, as showed also by the "Special Needs Kids" project, carried out in Emilia Romagna. This project showed the potential for family pediatricians (FP) in Italy to serve as care coordinators and facilitate the implementation of integrated care pathways for children with special health care needs. In Friuli-Venezia Giulia (FVG), a system of "continuity of care" for patients with special needs was developed and implemented. This system integrate hospital and community care in a network involving also FPs, General Practitioner and different actors of social and health services. The aim of this study is to prospectively evaluate the continuity of care provided to children and adolescents with special health needs residing in the FVG region.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with special health care needs requiring continuity of care and integrated home care
* Age between 0 to 17 years
* Residence in FVG region
* Outpatient, inpatient or emergency care admission at the IRCCS Burlo Garofolo hospital, Trieste, Italy

Exclusion Criteria:

-
Nutrition Product Combine With Continuous Glucose Monitoring in Gestational Diabetes Mellitus Patients

A prospective, multicenter, randomized controlled trial including about 60 Gestational Diabetes Mellitus patients (GDM) in Beijing will be included to evaluate the effectiveness and safety of nutrition product (SANZ®KINGWILL) in GDM patients, based on Continuous Glucose Monitoring (San MediTech CGM-303).

This study will recruit pregnant women who were diagnosed as GDM by 75g Oral glucose tolerance test (OGTT) in 2nd trimester and followed up for 1month. A total of 60 GDM patients were expected to be enrolled. Using the double-blind method, they were randomly divided into two groups: experimental group and control group. Both of the two groups were provided medical nutrition treatment by nutritionist after GDM was diagnosed and CGM equipment (San MediTech CGM-303) was worn. Blood and urine samples were collected. At the following two days, oatmeal (SHIZHUANG) was used as extra meal at 10:00am and 15:00pm in both groups. In the next 4 weeks experimental group was provided with the domestic nutrition product (SANZ®KINGWILL), while existing products (GLUCERNA SR®) for control group as their extra meals at 10:00am and 15:00pm. In the last day, CGM equipment (San MediTech CGM-303) was removed and blood and urine samples were collected.

Eligibility Criteria:
Inclusion Criteria:

* 1. Women aged 22 to 40 years old 2. Diagnosed as gestational diabetes mellitus 3. Signed informed consent

Exclusion Criteria:

* 1. GDM patient who is no longer suitable to continue pregnancy. 2. Patients who use any hypoglycemic drugs or any type of similar products. 3. Patients who have diseases severely affected the nutrition product digestion and absorption.

  4. Patients with severe heart, liver, kidney dysfunction, mental retardation, dyscrasia, etc.

  5. Patients who cannot tolerate enteral nutrition. 6. Patients with other conditions which investigator believes they are not eligible for this study.
The Impact of Community Health Worker Training by US Health Volunteers on the Health of Rural Ugandans

There are many trials measuring the impact of service work on volunteers themselves, but few studies measuring the impact of service on the local people. The purpose of this trial is to determine whether US and Ugandan health volunteers can make a measurable impact on the health of rural Ugandan villagers.

The goal of this research is to measure a change in the behaviors of local villagers in the Mukono District (just east of Kampala, Uganda) following the implementation of the Ministry of Health's Village Health Team Program facilitated by US Health Volunteers. Our NGO (non-governmental organization), Omni Med, has partnered with the Ministry of Health in Kampala and Mukono to facilitate its Village Health Team (VHT) program. Our volunteers facilitate training of VHTs and then conduct follow up home visits with these VHTs. During the trainings and follow up visits we stress the health practices in the Ministry's training program that have been shown to make the biggest impact on local health such as: exclusive breast-feeding for 9 months, use of oral rehydration therapy (ORT), antibiotics for pneumonia, timely antimalarial use, use of insecticide treated nets (ITNs), clean water, improved sanitation, Vitamin A supplementation and vaccination, antenatal visits and tetanus immunization for pregnant women, etc. Our pre-trial assumption is that local villagers will use this knowledge to improve their own health; and that the VHTs are the ideal messengers to deliver this knowledge. While the Ministry has trained over 83,000 VHTs nationally, there are no objective studies measuring impact on host communities. This will be the first and could prove an important means to promote the program nationally and internationally.

The primary objective of this research is to measure the efficacy of the VHT program in Uganda. While this program has become a priority of the Ministry of Health, there is to date no clear randomized, prospective trial measuring its impact. This will thus fill a current gap using data obtained from 1190 households. A second objective is to demonstrate measurable results of a global service program. There is very little impact data despite huge interest in service from many in the world's wealthiest countries. A third objective is to provide an objective measure of efficacy to the United States Peace Corps, which despite 50 years of activities, has little data demonstrating its true value; several Peace Corps Volunteers are working in this program in Mukono.

Eligibility Criteria:
Inclusion Criteria: Household with children under age five -

Exclusion Criteria: No children under age five in the household

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