cyrilzakka/clinical-trials huggingface dataset:
Outcomes of Clareon PanOptix in Patients With Prior Myopic Refractive Surgery

This study is a Single center, single arm, prospective, observational study of clinical outcomes following bilateral cataract surgery and Clareon PanOptix implantation. Subjects will be assessed preoperatively, and at 1 and 3 months postoperatively. Clinical evaluations will include administration of the QUVID and IOLSAT questionnaires, manifest refraction, topography, as well as measurement of visual acuities at distance, intermediate, and near.


Eligibility Criteria:
Inclusion Criteria:

* Adults (45 years or older) who have confirmed age-related cataracts and are eligible for bilateral cataract surgery.
* Prior binocular myopic photorefractive keratectomy (PRK) or myopic LASIK.
* Patients who have regular corneal astigmatism less than or equal to 0.6 D and are candidates for the PanOptix spherical IOL.
* Patients who have regular corneal astigmatism and are candidates for PanOptix toric IOL T3
* Postoperative visual potential of monocular 20/25 or better, in the surgeon's judgement.

Exclusion Criteria:

* Any ocular comorbidity that might hamper postoperative visual acuity:

  * Corneal abnormality including corneal dystrophy, irregularity, and degeneration.
  * Moderate or severe dry eyes that can't be relieved after treatment.
  * History of or current anterior and posterior inflammation of any etiology.
  * Retinal pathology such as AMD, diabetic retinopathy, vein occlusion, etc.
  * Glaucoma of any kind.
  * Pregnancy or lactation.
* Any ocular surgery other than corneal myopic refractive surgery (LASIK and PRK).
* Patients with physical or intellectual disability (e.g. Down's Syndrome, Parkinson's Disease, unable to fixate)
* Apple Kappa/chord mu ≥ 0.6.
* Higher order corneal aberrations at pupil diameter of 4mm: \> 0.6 total RMS, \> 0.3 coma, \> 0.3 trefoil (to exclude irregular corneas)
* Any patient requiring a limbal relaxing incision.

The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Investigation of the Transmission Pathways of Reflux in Patients With Chronic Venous Insufficiency

Chronic venous insufficiency (CVI) is one of the most common medical problems in adults that occurs secondary to the reflux of blood through incompetent valves of lower extremity veins. The most common involved valve is the valve located at the saphenofemoral junction. Although the pathway of reflux transmission is not the same in all patients, the removal or ablation of the greater saphenous vein (GSV) is considered a standard treatment in these patients. However, in patients whose reflux is transmitted to branches other than GSV, this treatment leads to the unnecessary destruction of a competent segment of GSV in addition to remaining at least some segments of incompetent veins. So, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency. This cross-sectional study will be conducted with a descriptive-analytical approach. .

Chronic venous insufficiency is one of the most common medical diseases in adults, which severely affects the quality of life of affected patients. What causes symptoms in this disease is the reflux of blood through incompetent valves located in the lower extremity veins. The most common cause is saphenofemoral valve insufficiency.

Although the pathway of reflux transmission is not the same in all patients, the removal of the greater saphenous vein (GSV) is considered a standard treatment according to the guidelines. This treatment leads to unnecessary destruction of the great saphenous vein and failure to correct the pathology in patients whose reflux exited the GSV along its transmission pathway. According to this issue, in this study, the investigators intend to investigate the different pathways of reflux transmission in chronic venous insufficiency patients who are candidates for GSV ablation/stripping because of saphenofemoral junction insufficiency according to the ultrasonographic exam. This cross-sectional study will be conducted with a descriptive-analytical approach on approximately 50 participants. Before surgery, patients are subjected to ultrasonographic mapping to check the pathway of reflux transmission and their related information is recorded. Other demographic information will also be recorded in the relevant checklist. Finally, the data will be analyzed in SPSS software.

Eligibility Criteria:
Inclusion Criteria:

* Age\>18.
* Chronic Venous Insufficiency with a clinical grade of 3 (varicosity) or more.
* Documentation of saphenofemoral junction insufficiency on Doppler ultrasound performed by a radiologist.
* Patient consent.

Exclusion Criteria:

- History of DVT
A Study of LY3127804 With Ramucirumab in Participants With Advanced Solid Tumors

The main purpose of this study is to evaluate the safety of the study drug known as LY3127804 given as monotherapy and in combination with Ramucirumab for participants with advanced or metastatic solid tumors. The study will also include a safety exploration for the combination of LY3127804 plus ramucirumab and paclitaxel


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of cancer that is advanced and/or metastatic.
* Have disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST ) version 1.1.
* Have adequate organ function.
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Have discontinued previous treatments for cancer for at least 28 days or 5 half-lives prior to study enrolment.

Exclusion Criteria:

* Have serious preexisting medical conditions.
* Have received treatment with a drug predominantly targeting Ang2 activity.
* Have symptomatic central nervous system (CNS) malignancy or metastasis.
* Have current hematologic malignancies.
* Have an active fungal, bacterial, and/or known viral infection.
* Have a corrected QT interval using Fridericia's correction (QTcF) of \>470 msec on screening electrocardiogram (ECG) at several consecutive days of assessment.
* Have a known sensitivity to mAbs or other therapeutic proteins.
* Have a history of hypertensive crisis or hypertensive encephalopathy or current poorly controlled hypertension despite standard medical management.
* Have a significant bleeding disorder or vasculitis or had a Grade ≥3 bleeding episode within 3 months prior to receiving treatment.
* Receive anticoagulation therapy at therapeutic dose.
* Have experienced any arterial or venothrombotic or thromboembolic events within 6 months prior to study treatment.
* Have liver cirrhosis with a Child-Pugh class B or worse or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis.
* The participant is pregnant prior to randomization or breastfeeding.
* The participant has sensory peripheral neuropathy ≥ Grade 2 (Part E only).
Clarithromycin Prophylaxis in Preterm Infants Colonisation With Ureaplasma Urealyticum and Mycoplasma Hominis

The purpose of this study is to determine of clarithromycin effect on developing of bronchopulmonary dysplasia in preterm babies.

The investigators planned that clarithromycin treatment in preterm babies who are under 1250 grams birth weight.

The investigators aimed with this treatment, the bronchopulmonary dysplasia rate of preterm babies may decrease.

Eligibility Criteria:
Inclusion Criteria:

* all infant must be under 1250 gram birth weight

Exclusion Criteria:

* Major congenital anomaly,
* CardiaC abnormality,
* without inform consent
Comparison of Intralesional Triamcinolone Versus Verapamil for Keloid Treatment

This study aims to compare the efficacy of intralesional triamcinolone and verapamil in patients presenting with keloid at our local setting. The results will guide us towards better management of keloids by choosing the more appropriate treatment. Adequate treatment will reduce significant emotional and physical distress in patients. We hypothesized that mean reduction in Vancouver Scar Score is higher in triamcinolone acetonide group compared to verapamil after three months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* size of keloid1-5 cm,
* on any site of the body,
* duration less then five years and
* baseline Vancouver scar score of more the or equal to 5

Exclusion Criteria:

* Pregnant or lactating women,
* family history of keloids,
* acromegaly, and
* congestive cardiac diseases
PET/CT and Bacterial/Fungal PCR in High Risk Febrile Neutropenia

Patients with acute leukaemia requiring induction or consolidation chemotherapy and those requiring a haematopoietic stem cell transplant are at high risk of fever and infection when they have low white cell counts (neutropenic fever). The causes of neutropenic fever are frequently unknown and patients are treated with broad antibiotics, without a clear target to what is being treated.

This study will prospectively enroll patients who are receiving chemotherapy for acute leukaemia or for a stem cell transplant and compare the diagnostic utility of bacterial and fungal PCR performed directly off blood drawn, to the standard blood culture. Patients who have persistent fever after 72 hours of antibiotics will then be randomized to have either the interventional scan (PET/CT) or the conventional scan (standard CT) to look for a source of infection. Diagnostic yield, change in management and outcomes will be compared between arms.


Eligibility Criteria:
Inclusion Criteria:

* About to have an allogeneic haematopoietic stem cell transplant, OR
* About to have an autologous haematopoietic stem cell transplant, OR
* Commencing induction or consolidation chemotherapy with curative intent for acute myeloid or acute lymphoid leukaemia

Exclusion Criteria:

* Current actively diagnosed infection prior to transplant or chemotherapy
* Allergy to intravenous contrast for CT imaging
* eGFR \<30
* Pregnant
A Study of Romosozumab (EVENITY®) in Postmenopausal Women in India With Osteoporosis at a High Risk of Fracture.

The primary objective of this study is to characterize safety and tolerability of romosozumab in postmenopausal women with osteoporosis and a high risk of fracture in India.


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with osteoporosis who are postmenopausal and have a high risk of fracture who provided inform consent (in-person or through their legally authorized representative) to participate in the use of romosozumab per local label in India.

Exclusion Criteria:

* Participants who experienced myocardial infarction or stroke within a year prior to entering this study.
Comparison of Bracket Bonding Variables Using 3D Printed Bonding Guide Versus Digital Indirect Bonding

The windowed direct-indirect bonding is a new bonding technique that could provide a simple and cheap method for fast and precise brackets bonding. There are still not enough studies to evaluate the effectiveness of this method in terms of accuracy, bonding time, bonding failure and cost.

This study is designed to answer these questions and compare the forementioned bonding technique with digital indirect bonding and finally provide the clinician a recommendation on the best bonding technique. This study introduces as well a new method of fabrication of the windowed template using Fusion Deposition Modeling (FDM) 3D printing technology.

This study will compare two bonding techniques, the windowed bonding technique and digital indirect bonding. They will be compared regarding accuracy, bonding time, bonding failure and cost. Patients will be selected according to the eligibility criteria, random sequence generation and blind allocation will be performed. ( A randomized clinical trial). Patients will be allocated to one of the groups either the windowed bonding or the digital indirect bonding.

Both groups will undergo similar steps initially. First, the patient's teeth will be digitized using an intraoral scanner. Then using 3 shape software, the model will be prepared and brackets will be positioned virtually on the 3D models. Then, in the windowed bonding technique, the windowed tray will be designed and later 3D printed, while in the digital indirect technique the model with the brackets will be 3D printed and a tray will be fabricated on the model manually.

After the fabrication of the tray, the brackets will be transferred to the patient using the tray or directly bonded using the windowed tray guide.

The patient's teeth will be scanned after bonding and this 3D model will be compared with the initial brackets setup that was made previously on the software.

Eligibility Criteria:
Inclusion Criteria:

* - Patients who need Orthodontic treatment with full dentition excluding 3rd molars.
* Fully erupted 5-5 with normal anatomy.
* The patient's age range is from 12 to 60 years of age.
* Both extraction and non-extraction cases are included.

Exclusion Criteria:

* - Patients with caries, fluorosis, enamel hypoplasia, restorations, or fractures.
* Patients with severe rotations.
POEM vs. Pneumatic Dilation for Esophageal Achalasia

The purpose of this study is to determine the efficacy and safety of peroral endoscopic myotomy (POEM) compared with pneumatic dilation in the treatment of esophageal achalasia.

Esophageal achalasia is an esophageal motor disorder, which is characterized by the absence of esophageal peristalsis combined with a defective relaxation of the lower esophageal sphincter (LES). The major symptoms of esophageal achalasia are dysphagia, chest pain, and regurgitation of undigested food.

Currently, treatment options mainly focus on relief of the symptoms by reducing the LES pressure. Pneumatic dilation is the main endoscopic therapies for esophageal achalasia. However, the patients need repeat treatment to maintain therapeutic success and there is a risk of perforation (1%-3%). For surgery approaches, the laparoscopic Heller's myotomy (LHM) combined with Dor's antireflux procedure has gained considerable interest. The LHM can sustain therapeutic effects for long-term in approximately 80% of patients.

Recently, Inoue et al. succeeded in treating achalasia endoscopically with a method called peroral endoscopic myotomy (POEM) and achieved promising results in short-term. Technically, POEM derived from natural orifice transluminal endoscopic surgery (NOTES) and endoscopic submucosal dissection (ESD), in which a submucosal tunnel is created after submucosal injection, and then an endoscopic myotomy was made at the gastroesophageal junction.

However, the long-term efficacy and safety of POEM were not determined, and there was no prospective study that compared the POEM with other conventional treatment. Therefore, we aim to determine the efficacy and safety of POEM, compared with the pneumatic dilation, in the treatment of esophageal achalasia.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 75 years of age
* Patient with esophageal achalasia
* Eckardt score \> 3
* Signed informed consent

Exclusion Criteria:

* Severe cardio-pulmonary disease or other serious disease leading to unacceptable surgical risk
* Pseudo-achalasia, Mega-oesophagus (greater than 7 cm), or Oesophageal diverticula in the distal oesophagus
* Previous endoscopic Botox injection
* Previous oesophageal or gastric surgery
* Pregnancy or lactation women, or ready to pregnant women
* Not capable of filling out questionnaires
Study Of Single Ascending And Multiple Doses Of PF-04447943 In Japanese Subjects.

This study is designed to investigate the safety, tolerability, and pharmacokinetics of PF-04447943 after single and multiple-dose administration to healthy young adult and elderly Japanese subjects, respectively.


Eligibility Criteria:
Inclusion Criteria:

* For young cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 18 and 55 years, inclusive.
* For elderly cohort, healthy male and/or female Japanese of non-child bearing potential between the age of 65 and 85 years, inclusive.
* Body Mass Index (BMI) between 17.5 to 30.5 kg/m2, and a total body weight \>50 kg (110 lbs).

Exclusion Criteria:

* Pregnant or nursing women; women of childbearing potential.
* Males who are unwilling to abstain from sexual intercourse or use a condom with all child-bearing potential women for the duration of the study.
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)

The purpose of this study is to assess the safety profile of relatlimab plus nivolumab in combination with platinum doublet chemotherapy (PDCT) and to determine if nivolumab plus relatlimab in combination with PDCT improves overall response rate (ORR) when compared to nivolumab plus PDCT in participants with previously untreated Stage IV or recurrent non-small cell lung cancer (NSCLC).


Eligibility Criteria:
Inclusion Criteria

* Histologically confirmed metastatic non-small cell lung cancer (NSCLC) of squamous (SQ) or non-squamous (NSQ) histology with Stage IV A/B (as defined by the 8th International Association for the Study of Lung Cancer Classification) or recurrent disease following multi-modal therapy for locally advanced disease.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of less than or equal to 1 at screening and confirmed prior to randomization.
* Measurable disease by computed tomography (CT) or magnetic resonance resources (MRI) per response evaluation criteria in solid tumor version 1.1 (RECIST 1.1) criteria.
* No prior systemic anti-cancer treatment (including epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors) given as primary therapy for advanced or metastatic disease.

Exclusion Criteria

* Participants with EGFR, ALK, ROS-1, or known B-rapidly accelerated fibrosarcoma proto-oncogene (BRAF V600E) mutations that are sensitive to available targeted therapy.
* Untreated CNS metastases.
* Leptomeningeal metastases (carcinomatous meningitis).
* Concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization (ie, participants with a history of prior malignancy are eligible if treatment was completed at least 2 years before randomization and the participant has no evidence of disease).
* Prior treatment with an anti-programmed cell death protein 1 (PD-1), anti-programmed death-ligand 1 (PD-L1), anti-programmed death-ligand 2 (PD-L2), or anti-cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Safety of Nasal Influenza Immunisation in Egg Allergic Children

Egg allergy is common in early childhood, affecting at least one in 50 preschool children. Influenza ("'flu") vaccines contain egg protein, as the vaccine is cultured in hen's eggs. There is robust data to support the safety of influenza vaccines (containing low or negligible amounts of egg protein) in patients with egg allergy.

A new influenza vaccine, known as LAIV (Live Attenuated Intranasal Vaccine) has recently been approved by a number of licensing boards and is given by a spray into the nose. This new vaccine has been available in the United States for several years and is highly effective and against influenza infection, with an excellent safety profile in children without egg allergy. However, LAIV is also grown in hen's eggs and contains egg protein, and there are NO existing data on the safety of LAIV in egg-allergic children.

The objective of this multicentre study is to assess the safety of intranasal LAIV in egg-allergic children, in order to demonstrate that these children can safely be given the new LAIV within a primary care health environment.


Eligibility Criteria:
Inclusion Criteria:

* Aged 2 - 17 years old
* Physician-diagnosis of egg allergy

Exclusion Criteria:

* Contraindicated as acutely unwell or current unstable asthma
* Use of asthma reliever medication in last 72 hours
* Recent administration of a medication containing antihistamine within the last 4 days
* Current oral steroid for asthma exacerbation or course completed within last 2 weeks
* Contraindications to ingredient in LAIV (notwithstanding allergy to egg protein)
* Previous allergic reaction to an influenza vaccine
* Children and adolescents who are clinically immunodeficient due to conditions or immunosuppressive therapy such as: acute and chronic leukaemias; lymphoma; symptomatic HIV infection; cellular immune deficiencies; and high-dose corticosteroids.
* Children and adolescents younger than 18 years of age receiving salicylate therapy because of the association of Reye's syndrome with salicylates and wild-type influenza infection.
Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes

Clinically, the gingival retraction dentistry itself has found wide uses. It has achieved the use of subgingival and gingival crowns in fixed prostheses, cervical abrasion in restorative dentistry, management of root caries and root sensitivity, and recently in the use of appropriate measurements to improve the marginal fit of implant prostheses.There are three different retraction procedures described in the literature: mechanical, mechanical-chemical (chemically impregnated cords or matrix in injectable form) and surgery (electrosurgical, laser, cauterization, etc.)The mechanical method of retraction cords is not always suitable for patients' existing pocket depth, the necessity of using different combinations in shallow or deep pockets, the potential for limited bleeding control in chemically impregnated cords and the toxicity values in those who interact with chemical have led researchers to search for alternative methods. Especially inflammed gingiva is very sensitive to mechanical and chemical trauma. Studies have reported that gingival inflammation, pain, pocket formation, gingival withdrawal, increased bleeding and wound contamination occurred following retraction cord application. However, it is a known fact that the impression material is distorted or the accuracy of the measurement is decreased with the measurements taken without retraction. Nowadays, CAD / CAM (computer-aided design / computer-aided manufacturing) devices, which are designed to overcome these problems and eliminate the errors related to the measurement material, are the first step to be taken with a clear measure.Gingival retraction is recommended to improve the success of scanners in all restorations performed at the gingival or subgingival endpoint. Therefore, in our study, crown restorations will be produced from hybrid blocks by means of CAD / CAM device in order to evaluate the interaction of gingival health with hybrid blocks and to provide the latest technology and standardization.


Eligibility Criteria:
Inclusion Criteria:

* Being systemically healthy
* To indicate crown restoration in mandibular molar teeth
* To be vital to the preparation of the crown of the teeth

Exclusion Criteria:

* Systemically unhealthy individuals
* Endodontic treatment of mandibular molar teeth
* Mandibular molar female individuals drawn for various reasons
* Pregnant women
* Periodontally unhealthy individuals