cyrilzakka/clinical-trials huggingface dataset:
Premium Trifocal IOL Comparative Analysis

Short and long-term analysis of the refraction correction and optical image quality of modern premium intraocular lenses (IOLs) with the establishment of a database for quality assurance and optimization the computation constants of the lens power.

Since the investigational lens, like conventional IOLs, is a posterior chamber lens which is widely implanted following cataract extraction, phacoemulsification is adopted. To assess the binocular vision, the investigational lens will be mono- or bilaterally implanted.

Clinically retro- and prospective, non-randomized, uncontrolled, open study at several centers: University Eye Clinic Heidelberg (leading center), Practice Center Ahaus in the Eye Clinic Ahaus, Breyer, Kaymak \& Klabe Eye Surgery in Düsseldorf, nordBLICK Eye Center Kiel.

Main objectives:

1. Functional results (refraction and visual acuity results) Secondary goals:
2. Deviation target vs. achieved postoperative refraction (for constant optimization of the IOL calculation)
3. Subjective patient satisfaction
4. Visual quality (e.g. scattered light, contrast vision, spherical aberrations)
5. Stability of the results achieved postoperatively

Eligibility Criteria:
Inclusion criteria

* Availability, willingness and sufficient cognitive awareness to comply with examination procedures
* Bilateral implantation of one of the following IOL models
* Alcon PanOptix (TFNT00)
* PhysIOL FineVision (POD F)
* PhysIOL FineVision (POD F GF)
* Uneventful cataract surgery with first clinical outcomes in the expected range
* Patient included in Premium IOL study protocol by signed informed consent

Exclusion criteria

* Age of patient \<45 years
* Irregular astigmatism
* Postoperative manifested astigmatism of \>1.0 D
* Difficulty for cooperation (distance from their home, general health condition)
* Clinically significant glaucoma
* Clinically significant macular degeneration, clinically significant macular edema or proliferative diabetic retinopathy
* Patients with keratoconus or keratectasia
* Any ocular comorbidity having a significant effect on the postoperative clinical outcomes
* History of ocular trauma or prior ocular surgery including refractive procedures
* Capsule or zonular abnormalities that may affect postoperative centration or tilt of the lens (e.g. pseudoexfoliation syndrome, chronic Uveitis, Marfan's syndrome)
* Pupil abnormalitis (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic/scotopic conditions)
* AMD
* Intraoperative complications like capsular rupture etc.
* Patients who do not give informed consent
Clinical Utilization of Newly Approved Oncology Medications

The efficacy and safety of different medications vary from one individual to another and from one ethnic group to another. Therefore, strong interest in the study of pharmacogenomic and pharmacoepidemiology has evolved recently.

There are multiple examples of oncology drugs being more effective in certain ethnic population compared to other. For example, irinotecan combined with cisplatin was very effective drug in the management of small cell lung cancer in the Japanese patients while an identical study done in the US revealed no major benefit to this combination in American population

Another example is having more benefit drawn from tyrosine kinase inhibitors (Erlotinib or Gefitinib) in Asian patients.

Immunotherapy is a new class of cancer treatment that works to harness the innate powers of the immune system to fight cancer. Because of the immune system's unique properties, these therapies may hold greater potential than current treatment approaches to fight cancer more powerfully, to offer longer-term protection against the disease, to come with fewer side effects, and to benefit more patients with more cancer types

Immunotherapy includes treatments that work in different ways. Some boost the body's immune system in a very general way. Others help train the immune system to attack cancer cells specifically. Immunotherapy has become an important part of treating some types of cancer. Newer types of immune treatments are now being studied, and they'll impact how we treat cancer in the future.

Recently, multiple immunotherapy treatment been approved with a couple of EGFR resistant medications.

Many new oncology drugs are being used in Middle Eastern countries including Saudi Arabia for different indications without being studied in the Middle Eastern population. These medications' efficacy and safety profiles may differ from those patients studied for drug development and approval due to difference in population's characteristics.

The goal of this study is to observe, summarize and report the patterns of the use of these drugs and describe their efficacy and safety profile in the early phases of their use.

The investigators aim is to build on the existing experience and knowledge by utilization of classic methodology and approaches on a larger scale and more effective way to paint picture of the performance of a certain therapy in the real life world. The use of prospective design will help evaluate the efficacy and safety of therapies already used in practice, generate new hypothesis, and/or determine the outcome of certain diseases.

Eligibility Criteria:
Inclusion Criteria:

* All patients with cancer or hematological malignancies receiving new oncology medications (defined as a medication in the first five years of their introduction to the ME market
* Patient accepts to participate in study and signing consent form

Exclusion Criteria:

* None
A Prospective, Single-Center Study Evaluating the Efficacy and Safety of Glofitamab Combined With Orelabrutinib and Bortezomib in Patients With High-Risk Mantle Cell Lymphoma

The aim of this study is to evaluate the efficacy and safety of Glofitamab combined with Orelabrutinib and Bortezomib in patients with high-risk mantle cell lymphoma


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Age ≥ 18 years at the time of signing Informed Consent Form and willingness to comply with study protocol procedures
* Participants with MCL
* Meets any of the following high-risk criteria: blastoid/pleomorphic morphology; high Ki-67 (≥ 30%); TP53 aberration; del(17p); complex karyotype; MIPI score ≥ 6.2; early progression after first-line treatment (\<24 months); presence of other high-risk genetic mutations (KMT2D, NSD2, NOTCH1, CDKN2A, NOTCH2, SMARCA4, CCND1)
* Life expectancy ≥ 12 weeks
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
* At least one bi-dimensionally measurable (≥ 1.5 cm) nodal lesion, or one bi-dimensionally measurable (≥ 1 cm) extranodal lesion, as measured on CT scan
* No bone marrow involvement: ANC ≥ 1.0 × 10\^9/L; bone marrow involvement: ANC ≥ 0.5 × 10\^9/L
* No bone marrow involvement: PLT ≥ 75 × 10\^9/L; bone marrow involvement: PLT ≥ 25 × 10\^9/L
* No bone marrow involvement: Hgb ≥ 8 g/dL; bone marrow involvement: Hgb ≥ 7 g/dL
* Adequate renal function, defined as measured or estimated creatinine clearance ≥ 30 mL/min

Exclusion Criteria:

* Contraindication to any of the individual components of Glofit-Orela-Borte
* Known active infection at the time of enrollment
* Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen \[HBsAg\] serology): Patients with occult or prior HBV infection (defined as negative HbsAg and positive hepatitis B core antibody \[HbcAb\]) may be included if HBV DNA is undetectable, provided that they are willing to undergo DNA testing on Day 1 of every cycle and every three months for at least 12 months after the last cycle of study treatment and appropriate antiviral therapy
* Positive test results for hepatitis C (hepatitis C virus \[HCV\] antibody serology testing): Patients who are positive for HCV antibody are eligible only if PCR is negative for HCV RNA
* History of other malignancies that could affect compliance with the protocol or interpretation of results
* Active autoimmune disease requiring treatment
* Primary or secondary CNS lymphoma at the time of recruitment
* Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or renders the patient at high risk from treatment complications
Effect of Product Related Factors on Platelet Concentrate Transfusion Response in Patients With Hematologic Malignacies

Platelet concentrates (PCs) characteristics, such as storage duration, ABO compatibility, dose and source, may have an impact on transfusion responses and outcomes. Because of the relative scarcity of PCs the selection of a specific PC for issue to the patient remains a challenging process. Regulatory agencies do not fully address these characteristics in their recommendations for prophylactic transfusions.

The aim of the study was to analyse the effect of product-related factors in a real life setting, in order to determine which ones are the most relevant when selecting PCs for patients in prophylactic conditions. Two different endpoints are studied: the corrected count increment and the platelet transfusion time intervals.


Eligibility Criteria:
Inclusion Criteria:

* Inpatients in the hematology department between January 2001 and December 2012
* Hematologic malignancy
* At least one platelet transfusion (with platelet count ≤ 25 G/L)
* Age 18 and over at time of first transfusion

Exclusion Criteria:

* More than one hematologic malignancy
* Non-malignant haematological disorder
Concentrated Growth Factors Applied in Maxillary Sinus Floor Elevation Via a Lateral Window Approach

To investigate the effects of concentrated growth factors applied in maxillary sinus floor elevation via a lateral window approach with simultaneous implant placement on repair of bone defects and new bone formation.

Maxillary sinus floor elevation via a lateral window approach is the most effective method of overcoming the shortage of bone mass deficiency in atrophic maxillary posterior region. Bone transplantation is considered to be a prerequisite for the success of maxillary sinus floor elevation. Platelet-rich plasma and platelet-rich fibrin have been used to accelerate bone formation, regeneration, and repair. However, few in-depth studies are reported on the effects of concentrated growth factors on new bone formation.

Eligibility Criteria:
Inclusion Criteria:

* Loss of one or more maxillary molars in the posterior maxillary region
* Occlusogingival distance of \> 4 mm
* Residual bone height of 2-5 mm in the posterior maxillary region, no obvious maxillary sinus separation
* No problems with the lungs, heart, or brain
* Normal liver and kidney function
* Normal coagulation function
* Adequate prosthetic space
* No history of bruxism or temporomandibular joint disorders
* No tumors, cysts and polyps in maxillary sinus
* No acute or chronic maxillary sinusitis
* No acute periodontitis
* No oral mucosal disease
* Age 20-45 years
* Able to tolerate the stress of anesthesia and surgery

Exclusion Criteria:

* Residual bone height of \< 1 mm in the posterior maxillary region or presence of maxillary sinus mucosa rupture
* Poor control of complex periodontal disease
* Local inflammation or poor oral hygiene
* Poorly treated maxillary disease
* With severe bruxism
* With temporomandibular joint disorders
* Alcohol consumption and cigarette smoking (20 cigarettes/d)
* Have a history of chemotherapy and radiation therapy in face and neck
* Pregnant
* With coagulation disorders
* With autoimmune disease
* With severe osteoporosis
* With acute maxillary sinusitis
* Unable to tolerate simple surgery because of systemic diseases including severe diabetes mellitus and heart disease
* Unable to provide informed consent
RNA Precision Oncology in Advanced Pancreatic Cancer

The overall objective of this project is to determinate the feasibility of administering personalized therapy to subjects with advanced pancreatic cancer utilizing the novel OncoTreat platform. The primary objective of this study is to assess the feasibility of implementing the OncoTreat framework in patients with newly diagnosed, untreated metastatic pancreatic adenocarcinoma.

Pancreatic ductal adenocarcinoma (PDA) is a major health problem in the United States and throughout the world. Pancreatic ductal adenocarcinoma (PDA) has the worst prognosis of any major malignancy in the United States and, unlike other common cancers, annual deaths from PDA are rising. During 2017, it is estimated that 53,670 people were diagnosed with PDA and approximately 43,090 people died from PDA in the U.S. Despite recent advances, cytotoxic chemotherapy for PDA has been disappointing with response rates of 20-30% for the most active regimens and little activity for targeted therapies. Even among the small subset of patients who are suitable for surgical resection at the time of diagnosis, complete resection is followed by recurrence in \>90% of patients without further systemic therapy, with a median time to recurrence of 6.9 months. Thus all PDA patients require systemic chemotherapy and more effective regimens are urgently needed.

Previous versions of this record contained reference to an observational arm in error. The observational arm has been removed from the record for consistency with the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Be willing and able to provide written informed consent for the trial.
* Age ≥18 years of age on day of signing informed consent.
* Have histologically or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma or be willing to undergo a biopsy with confirmed pathology prior to starting therapy.
* Have untreated disease that is unresectable due to being metastatic or locally advanced without potential of surgery as assessed by the treating physician.
* Subjects who have documented disease recurrence greater than 6 months after completing neoadjuvant or adjuvant chemotherapy for limited disease will be eligible for the study.
* Have a predicted life expectancy of greater than 6 months.
* Subjects must have a plan to obtain a new core biopsy of a primary and/or metastatic lesion planned as part of routine care for which consent is obtained separately or (b) consent to be biopsied to satisfy the tissue requirements of this protocol.

Exclusion Criteria:

Has previously received neoadjvuant or adjuvant chemotherapy for pancreatic cancer unless greater than 6 months has passed since completion of adjuvant or neoadjuvant chemotherapy and initiation of therapy for recurrent or metastatic disease.
A Randomized Phase II Trial of Neoadjuvant Chemotherapy Compared With Chemoradiotherapy in Gastric Adenocarcinoma

This prospective, randomized phase II study is designed to evaluate weather neoadjuvant chemoradiotherapy is superior to neoadjuvant chemotherapy with both followed by surgery and postoperative chemotherapy for locally advanced gastric adenocarcinoma.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically proven locally advanced gastric adenocarcinoma in patients staged as cT3-4N0M0 or anyTN+M0
* No distant metastasis in liver,lung,bone,central nervous system(CNS),no peritoneal transplantation
* No prior abdominal or pelvic radiotherapy
* Karnofsky performance status(KPS)≥ 70, predictive life span no less than 6 months
* Patients must have normal organ and marrow function as defined below: Leukocytes: greater than or equal to 3,000 G/L; Platelets: greater than or equal to 100,000/mm3 .Hemoglobin:greater than or equal to 10g/L .Total bilirubin: within normal institutional limits; AST/ALT: less than or equal to 1.5 times the upper limit; Creatinine within normal upper limits
* Informed consent

Exclusion Criteria:

* Any prior chemotherapy or other cancer treatment prior to this protocol
* Patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer
* With any distant metastasis in liver,lung,bone,CNS,or peritoneal transplantation
* History of allergic reactions attributed to similar chemical or biologic complex to S-1 or Xeloda or Oxaliplatin
* Uncontrolled illness including, but not limited to, active infection, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness
* History of myocardial infarction within the past 6 months or history of ventricular arrhythmia
* History of prior radiation to the abdomen
* Pregnant or lactating females
Preoperative i.v. Iron Substitution in Patients With Colon Cancer

About 70% of colon cancer patients are anemic. Preoperative anemia in patients with colorectal cancer is associated with both impaired disease-free survival and overall survival. The purpose of this study is to compare the effects of preoperative iv iron substitution on postoperative recovery in preoperatively anemic (male Hb \<130, female Hb \<120) and iron deficient colon cancer patients in a prospective setup. As a primary outcome, the effect of iv-iron substitution on postoperative complications is investigated.

Randomized preoperative iron substitution for patient with iron deficient anemia

Eligibility Criteria:
Inclusion Criteria:

* Age\> 18 years
* Dg: Colon ca
* The planned measure: the colon resection
* Men: Hb \<130, women: Hb \<120 and iron deficiency (elevated TfR, low TrFesat or low ferritin)

Exclusion Criteria:

* hyperreactivity for Ferinject
* haemochromatosis
* refusal for participation
Atraumatic Care Practice From the Child and Parent Perspective

It is important for pediatric nurses to apply atraumatic care while providing care to children and their families. Pediatric nurses should use methods appropriate for the child's age and developmental period within the scope of atraumatic care.

The use of atraumatic care approaches such as supporting the active participation of the family in the care of the child, using therapeutic communication techniques with parents and children during procedures, providing emotional support, reducing pain during painful procedures, using techniques to distract the child's attention during medical procedures, informing parents about the procedures to be performed on their children, and supporting parents and teaching techniques to cope with stress is recommended to be used by the nurses.

Eligibility Criteria:
Inclusion Criteria:

* being able to speak Turkish
* being between 5-10 years of age
* having no visual, intellectual or neurological disabilities
* having the phlebotomy procedure carried out with a single attempt
* not having a disease that causes chronic pain
* being accompanied by either mother or father during the procedure
* not taking painkillers or sedating drugs before the phlebotomy procedure

Exclusion Criteria:

* being younger than 5 years or older than 10 years
* having visual, audio, or speech impairments
* having a disease that causes chronic pain
* with a history of sedative and analgesic use within 24 h prior to admission
* filling out the data collection forms incompletely
COVID-19 Follow up Intensive Care Studies

Since the SARS-CoV-2 infection is relatively new, the long term attributable burden related to COVID19 has not been investigated yet. To date, in patients with COVID-19 and their family members, there is little information on the functional status, cognitive ability, pattern of return to work, and health related quality of life after the ICU admission.

This study aims to describe the psychological wellbeing, physical - and social functioning of COVID-19 ICU survivors and their family members up to 12 months following ICU discharge.

Study design The COVID-19 Follow up Intensive Care Study (COFICS) is a single center, prospective cohort study performed at a University Medical Center in The Netherlands.

Study population The study population consists of all admitted critically ill COVID-19 patients with a \> 48 hours ICU admission at the ICU of a University Medical Center and a family member of the patient. Family members in this study can be partners, other family members, or friends who are identified by the patient as important.

Sample size All consecutive patients admitted to the ICU of the University Hospital for respiratory distress due to COVID-19 between March 19th 2020 and September 30th 2020 will be enrolled. With consent of the patient, family member(s) of participating patients will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Ability to speak and write Dutch
* Ability to conduct a telephone call
* Diagnosed with COVID-19 infection (only in patients)
* 48 hours ICU admission (only in patients)

Exclusion Criteria:

* Refuse to participate
* Serious language barrier
* Cognitive impairment
* Severe psychiatric disorder
* Chronic ventilator dependency (only in patients)
Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Dry Eye Disease

This is a Multicenter, Randomized, Double-Masked, Placebo-Controlled, Parallel Group Phase 2 Trial Evaluating the Safety and Efficacy of Pilocarpine Ophthalmic Topical Cream for the Treatment of Signs and Symptoms of Dry Eye Disease.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 years of age or older at the Screening Visit
* Willing and able to provide written informed consent on the IRB/IEC-approved informed consent form
* Diagnosis of dry eye

Exclusion Criteria:

* Sensitivity or known allergy to pilocarpine or any of the other excipients of the formulation
* History of eczema, dermatitis or skin sensitivity to over-the-counter personal care products such as lotions, creams, makeup, soaps, etc.
* History of, or active iritis or uveitis in either eye
* Pre-existing retinal disease in either eye that may predispose subjects to retinal detachment