cyrilzakka/clinical-trials huggingface dataset:
Optical Coherence Tomography Angiography and in Fluorescein Angiography in Diabetic Retinopathy

Diabetic retinopathy (DR) is the leading cause of decreased vision in working age people. Patients with DR can develop macular edema and proliferative retinopathy which are major causes of visual impairment \[1\]. The potential of OCTA regarding diagnosis and follow up of DR has been shown in previous studies \[2-4\]. At present fluorescein angiography (FA) represents the gold standard in the diagnosis and staging of DR \[5\]. With FA vascular lesions like micro aneurysms (MAs), the size of areas of non-perfusion and of the foveal avascular zone (FAZ) and retinal neovascularisations can be reliably identified \[6\]. Al-though the capabilities of FA are well known, its use also contains some risks related to the intravenous injection of the dye, which can cause nausea, vomiting and allergic re actions and even anaphylactic shock \[7\]. Besides that, it also requires time and trained personnel \[8\]. Image acquisition by OCTA in contrast is not as time consuming and can be performed without taking any risks. Additionally, it provides a 3 dimensional cross sectional view of the retinal and choroidal layers with micro meter depth resolution, providing depth selective information of the retinal vasculature. This facilitates accurate diagnosis and follow up of retinal vascular diseases since significant insights into both morphology and perfusion status can be obtained simultaneously. Although various artifacts appear in OCTA images, a qualitative assessment is mostly possible \[9\].Early changes to be seen in OCTA in patients with non-proliferative DR are vascular remodelling bordering the FAZ, vascular tortuosity, narrowing of capillary lumen and capillary dilatation. These changes cannot be seen in the same manner in FA \[10\].In this study we investigated the size of the FAZ and the count of MAs in patients with DR.


Eligibility Criteria:
Inclusion Criteria:

* All Pts with confirmed type 2 diabetes of at least 6 months. Best corrected visual Acuity of 6/60 or higher (using asnellen chart) in each eye

Exclusion Criteria:

* Dense media opacities interfere with image FFA as dense cataract . Previous TTT mainly retinal laser photocoagulation or intra vitreal injection. History of ocular disease as glaucoma and retinal vascular occlusion . Previous ocular surgery.
Prediction of Neonatal Respiratory Distress Syndrome in Preterm Fetuses by Assessment of Fetal Lung Volume by Vocal and Pulmonary Artery Resistance Index a Pilot Study

The investigators will measure fetal lung volume by VOCAL and pulmonary artery resistance index in preterm fetuses and correlating the results with postnatal respiratory distress of the preterm neonates.


Eligibility Criteria:
Inclusion Criteria:

* preterm labour

Exclusion Criteria:

* twins
Lenvatinib Plus VIC-1911 in Lenvatinib-unresponsive or Lenvatinib-resistant HCC

This is a prospective clinical study aiming to test the safety and efficacy of lenvatinib in combination with Aurora kinase A inhibitor VIC-1911 in participate with lenvatinib-unresponsive or lenvatinib-resistant hepatocellular carcinoma(HCC).


Eligibility Criteria:
Inclusion Criteria:

(1) Unlimited gender, aged 18-75 years; (2) Meets American Association for the Study of Liver Diseases (AASLD) or European Association for the Study of the Liver (EASL) clinical diagnostic criteria of hepatocellular carcinoma; (3) Barcelona Clinic Liver Cancer (BCLC) Stage C, and there is at least one measurable tumor in the liver (long diameter ≥ 1cm);(4) Lenvatinib unresponsive or lenvatinib resistant after standard treatment; (5) Child-Pugh A or scored 7 B; (6) Eastern Cooperative Oncology Group performance status score \<= 1; (7) Platelet count \>= 60x10\^9/L, Prothrombin time prolonged \<= 6 seconds.

Exclusion Criteria:

(1) Uncorrectable coagulopathy with obvious bleeding tendency; (2) Patients need long-term anticoagulant or anti platelet therapy and cannot stop the drugs; (3) Patients with unstable or active ulcer or gastrointestinal bleeding; (4) Heart disease requiring treatment or not well controlled high blood pressure; (5) Hepatic encephalopathy or refractory ascites requiring treatment; (6) There is a clear active infection; (7) Receiving radiotherapy/chemotherapy/interventional therapy for tumor within 4 weeks before the start of the study; (8) Severe insufficiency of important organs, such as severe cardiopulmonary insufficiency; (9) Other accompanying anti-tumor treatments; (10) The investigator assessed that the patient was unable or unwilling to comply with the protocol.
Surgery Without Neoadjuvant Chemoradiotherapy Compared With Neoadjuvant Chemoradiotherapy for Rectal Cancer With Negative Circumferential Resection Margin Based on MRI Assessment, a Perspective Multicenter Randomized Controlled Trial

For now, neoadjuvant chemoradiotherapy is routinely performed for T3N1-2M0 rectal cancer. However, there are lots of complications following neoadjuvant chemoradiotherapy, such as Wound-related complications, anastomotic leakage, anastomotic stenosis, sexual dysfunction, testicular or ovary failure. Patients undergoing resection for rectal cancer had low rates of local recurrence and long disease-free survival regardless of whether an APR, CAA or low AR was performed. The main purpose of preoperative radiotherapy is to lower the local recurrence. For the T3N1-2M0 rectal cancer with negative circumferential resection margin based on MRI assessment, we suppose might not necessary to receive neoadjuvant chemoradiotherapy, for operation can achieve the negative circumferential resection margin.


Eligibility Criteria:
Inclusion Criteria:

1. Tumor within 12 cm of the anal verge
2. T3N1-2 as determined by preoperative MRI examination
3. negative circumferential resection margin determined by preoperative MRI examination
4. Absence of distant metastases
5. Absence of intestinal obstruction

Exclusion Criteria:

1. With distant metastases
2. With intestinal obstruction
3. Pregnancy or lactation
4. With operation contraindication
5. With mental disorder
Comparison of Two Basal Insulin Therapies for Patients With Type 1 Diabetes

The purpose of this study is to examine the efficacy and safety of insulin lispro protamine suspension (ILPS) as compared to insulin detemir as basal insulin combined with mealtime insulin therapy in patients with type 1 diabetes. A gatekeeper strategy will be employed for sequentially testing the secondary objectives.

Phase 3b, randomized, multicenter, multinational, open-label, two-arm, active control, parallel study to determine safety, efficacy, and noninferiority of basal analog insulin lispro protamine suspension (ILPS, also referred to as NPL \[neutral protamine Hagedorn\]), injected two times a day, compared with basal analog insulin detemir, injected two times a day, as measured by change in hemoglobin A1c (HbA1c) from baseline (Visit 2) to 32 weeks in adult patients with type 1 diabetes when used in combination with bolus insulin lispro, injected three times a day.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes for one year or more
* Age 18 years or older
* Body mass index (BMI) less than or equal to 35 kilograms per square meter (kg/m2)
* Have a hemoglobin A1c (HbA1c) 1.2 to 2.0 times the upper limit of the normal (ULN) reference range within 30 days prior to Visit 1 or collected and analyzed at a local laboratory at Visit 1
* As determined by the investigator, are capable and willing to do the following:

  * perform self monitoring of blood glucose (SMBG),
  * complete patient diaries as required for this protocol,
  * use the insulin injection device(s) according to the instructions provided,
  * are receptive to diabetes education,
  * comply with the required study visits.

Exclusion Criteria:

* Have taken any oral antihyperglycemic medications (OAMs) within 3 months prior to Visit 1.
* Have had more than one episode of severe hypoglycemia, as defined in the Abbreviations and Definitions section of the protocol, within 6 months prior to entry into the study
* Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable or women who are breastfeeding
* Are receiving chronic (lasting longer than 14 consecutive days) systemic glucocorticoid therapy (excluding topical, intra-articular, intraocular, and inhaled preparations) or have received such therapy within the 4 weeks immediately preceding Visit 1.
* Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
A Non-interventional Study of Ability and Willingness to Pay for BIAsp 30 in a Real World Population With Type 2 Diabetes Mellitus (T2DM)

The purpose of this study is to collect information about the participant's ability and willingness to pay for NovoMix 30 using a modern device, which is prescribed to the participant by the study doctor for Type 2 Diabetes Mellitus according to routine clinical practice. The study aims to obtain data that can guide prescribers' understanding of the ability and willingness to pay for NovoMix 30 FlexPen or Penfill among participants in the growing middle class in India and Egypt. The decision to prescribe NovoMix 30 FlexPen or Penfill has been made independent from this study.


Eligibility Criteria:
Inclusion Criteria: - The decision to initiate treatment with commercially available BIAsp 30 has been made by the patient and the treating physician before and independently from the decision to include the patient in this study - Patients selected by their physician for participation in the study, who are likely to be able and willing to pay for the BIAsp 30 treatment for at least 12 weeks from baseline visit as assessed by the treating physician - Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol) - Male or female greater than or equal to 18 years at time of informed consent - Diagnosed with T2DM and treated with BHI in vials for at least three consecutive months at time of informed consent Exclusion Criteria: - Previous participation in this study. Participation is defined as having given informed consent in this study - Concurrent participation in any other clinical trial or study - Patients previously treated with insulin analogues - Known or suspected hypersensitivity to study product (or any of the excipients of the study product; a full list of excipients is provided in Summary of product characteristics (SmPC) of NovoMix® 30) or related products - Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation - Patients who are unable to read or write (illiterate)
Effects of Topical Dynamic Phototherapy on the Microbiota of Chronic Wounds

The main objective of this study is to estimate the change in the relative numbers of commensal or low virulence potential bacteria before and after one session TDP.

The secondary objectives of this study are:

* To estimate changes in several microbiological parameters over three time periods (before treatment, after applying the Metvixia® and after irradiation during a single TDP session).
* Describe the evolution of the size and appearance of the wound 7d after the start of treatment
* Describe the potential adverse events associated with a TDP session

Eligibility Criteria:
Inclusion Criteria:

* Patient correctly informed concerning study implementation, objectives, constraints and patient rights
* The patient must have given his/her informed and signed consent
* The patient must be insured or beneficiary of a health insurance plan
* The patient presents with one or more leg ulcers (artieral, venous or mixed)
* Afebrile patient without periulcerous erythema and who does not require antibiotic therapy
* Patient who has not received antibiotic treatment during the last 7 Days

Nota bene: Patients with multiple ulcers at different stages will be included for the wound corresponding to the highest stage. If the patient has multiple ulcers atn the same stage, the deepest wound will be considered.

Exclusion Criteria:

* The patient is participating in another interventional study, has participated in another interventional study with the past 3 months, or is in an exclusion period determined by a previous study
* The patient is under judicial protection, under tutorship or curatorship
* The patient refuses to sign the consent
* It is impossible to correctly inform the patient
* The patient is pregnant, parturient, or breastfeeding
* The patient has a contraindication for a treatment used in this study
* Patient with an infected leg ulcer treated with antibiotics
* Patients on curative anticoagulation
Asan Medical Center CCTA Registry

A total of 9269 adults who received CCTA scans for coronary disease evaluation during a general medical checkup at the Health Screening and Promotion Center in Asan Medical Center, Seoul, Korea between January 2007 and December 2011 were initially selected. All participants were provided with information about the potential benefits and risks of CCTA and made the decision to undergo the procedure at their own expense. They were also informed that their clinical and radiological data would be used for this study and gave their consent. Of these individuals, 7129 agreed to participate, and 6343 were enrolled in this CCTA registry.


Eligibility Criteria:
Exclusion Criteria:

1. a previous history of angina or myocardial infarction;
2. abnormal rest electrocardiographic results, i.e., pathological Qwaves, ischemic ST segments or T wave changes, or left bundle-branch blocks;
3. insufficient medical records;
4. structural heart diseases;
5. a prior history of open heart surgery or percutaneous coronary intervention;
6. a previous cardiac procedure; or
7. renal insufficiency (creatinine N1.5 mg/dL)
Prevalence of Early Childhood Caries in Egyptian Children With Serum Vitamin D Deficiency.

To detect the effect of vitamin D deficiency in the development of early childhood caries (ECC) among Egyptian children.

Justification for undertaking the trial:

American Academy of Pediatric Dentistry (2012), defined early childhood caries (ECC) as the presence of one or more decayed, missing teeth (resulting from caries), or filled surfaces in the primary tooth of child 6 years old or younger.

Early childhood caries is a chronic childhood disease, that decreasing quality of life, this include pain, disturbed sleep, poor aesthetics, difficulty in eating and speaking and behavioral changes that affect the child's self-esteem. (Guay, 2004).

Due to the rising incidence of dental carries in early childhood, contributory factors need to be investigated in order to facilitate treatment of such a large population of children in desperate need of dental care (Guay, 2004).These multiple risk factors include the lack of a dental home, poor oral hygiene, diet, and nutrition ( Najeeb et al., 2016).

Enamel is the most mineralized substance in the human body; it is mainly made of calcium and phosphate. Vitamin D plays an important role in increasing the absorption of calcium and phosphate from food. Which calcium and phosphate improve the strength of the teeth as make them able to fight the demineralization from bacteria (Youssef et al., 2011). Therefore, it is responsible of promoting the calcification of teeth, having a topical fluoride like effect, and in the forming of enamel, dentin, and bone. (Mellanby \& Pattison, 1928).

Vitamin D receptors are present on the cells of immune system and on the teeth. It binds to these receptors and increases the amount of good antimicrobial proteins as cathelicidin and other special defense in saliva (Youssef et al., 2011). These antimicrobial peptides have antibacterial neutralizing activity against periodonto pathogens as gram negative and gram positive bacteria and candida albicans, its effective in vitro against oral microorganisms such as streptococcus mutants, prophyromonas gingivalis and actinobacillus, so it prevents dental caries.( Potturu et al., 2014).

East, (1939) study concluded that children who consumed a high vitamin D diet, vitamin D played an indispensable role in 1) preventing the initiation of new caries, 2) inhibiting the spread of existing caries, and 3) arresting the caries. Likewise, an examination of children found a decreased caries prevalence in areas of increased vitamin D exposure.

Eligibility Criteria:
Inclusion Criteria:

1. Children ages from two to five years
2. Both sexes.
3. Parent and children cooperation.
4. Healthy children.
5. Children with serum vitamin D deficiency.

Exclusion Criteria:

1. Children age more than 5 years.
2. Children had a complex metabolic or medical disorder.
3. Parents that will not sign the consent.
Atovaquone and Azithromycin Combination for Confirmed COVID-19 Infection

This study will evaluate anti-malarial/anti-infective single-agent and in combination for patients with confirmed COVID-19 infection. The first combination to be evaluated is atovaquone and azithromycin.

This is an open-label, non-randomized study to evaluate anti-malarial/anti-infective single-agents and combination therapies for patients with confirmed COVID-19 infection requiring therapy as determined by risk factors for complication (age, comorbid illness) or the presence of respiratory compromise. The first combination to be evaluated is atovaquone/azithromycin. Other combinations may be added to the study at future amendments as information of potential benefit arises. The first part of the study will enroll 25 evaluable male and female patients 18 years of age or older with confirmed COVID-19 infection.

Eligibility Criteria:
Inclusion Criteria:

* Male and Female patients age 18 years or older
* COVID-19 confirmed positive test results
* High risk for complications including with Medium (5-6) or High (More than or equal to 7) NEWS score
* Hematology criteria: ANC \>500 cells/mcl, HGB \>9 g/dl, Platelet count \>75,000/mcl
* Metabolic criteria: Serum creatinine \<2.0 mg/dl or calculated creatinine clearance (using Cockcroft-Gault) \>30 ml/min, AST/ALT \<5x ULN AND Total Bilirubin WNL (for patients with Gilbert's disease, direct bilirubin \<ULN)

Exclusion Criteria:

* COVID-19 negative test result
* Inability to adhere to study protocol requirements
* Inability to provide informed consent
* Other acute or chronic medical or psychiatric condition that in the judgment of the investigator would make the participant inappropriate to take part in the study
* Pregnant and breastfeeding individuals
* QTc interval greater than 470 msecs at baseline
* History of hypersensitivity to atovaquone and/or azithromycin.
* History of known intolerance to atovaquone and/or azithromycin
Effectiveness of KeraStat Gel for Improved Cosmesis of Partial Thickness Burns

A randomized, controlled, 30-subject, within-subject trial for examining the effectiveness of KeraStat Gel, as opposed to the institutional standard of care, silver sulfadiazine, in improving cosmesis of the healed wound.

The study seeks to determine whether the use of KeraStat Gel as the primary dressing for partial thickness burns results in improved cosmesis of the healed wound, and results in less painful dressing changes, faster reepithelialization, and reduction in need for excision and grafting. The study will enroll 30 subjects. The study design is a randomized, controlled, within-subject trial to compare the effectiveness of KeraStat Gel vs. standard of care (SOC), silver sulfadiazine (SSD). Each of two distinct burns will be randomized to the use of KeraStat Gel or SOC. Patients will be seen weekly for the first month and then at months 3, 6, and 12 post burn.

Eligibility Criteria:
Inclusion Criteria:

* Presenting with at least two comparable, discrete, and separate partial thickness thermal burns, as determined by the Investigator, measuring 50 - 1,000 cm2 each
* Study wounds identified are partial thickness depth
* KeraStat Gel and SSD can be applied to randomized study burn wounds as definitive care treatment within 24 hours from time of injury\]
* Overall total body surface area burned \< 20%

Exclusion Criteria:

* Pregnant or nursing
* Prisoner
* Presence of inhalation injury, as determined by the Investigator
* Injury requiring formal intravenous fluid resuscitation
* Concomitant non-thermal traumatic injuries
* Chronic medical conditions including, but not limited to, documented renal impairment (Cr \> 2.5 mg/dL), hepatic impairment (Total bilirubin \> 2.5 mg/dL), thromboembolic disorders, active infection in study wound areas, uncontrolled diabetes (HbA1C \> 7%), HIV infection, history of melanoma or systemic malignancy within the last 10 years
* Receiving corticosteroids, immunosuppressive agents, radiation or chemotherapy, topical growth factors, or any other medication the Investigator feels will affect wound healing
* Not expected to live at least 13 months post-burn
* Received an investigational drug or biologic within 3 months prior to injury
* Previously treated with a skin graft at either of the treatment sites
* Chemical or electrical burn
* Known or documented allergy to sulfonamides
* Proposed study wounds are full thickness
* Any condition the Investigator determines will compromise subject safety or prevent the subject from completing the study
Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults

The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.

Exclusion Criteria:

* Administration of an influenza vaccine within six months prior to study entry
* Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
* Administration of a Tdap vaccine at any time prior to study entry.
* Administration of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
* History of diphtheria and/or tetanus and/or pertussis disease.
* History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any component of the study vaccines.