cyrilzakka/clinical-trials huggingface dataset:
Rotation of Hydrophobic Acrylic Lenses - Rayner RA0800C & Alcon Clareon & Hoya Nanex & Hoya Vivinex XY1-EM & RayOne EMV Toric

The investigational devices are approved intraocular lenses (IOL) intended to be implanted after phacoemulsification in individuals suffering from age-related cataract with the need of cataract surgery. Within the study, three different IOLs will be investigated and separately evaluated. Cataract surgery with IOL implantation will be performed in subjects who have signed an informed consent form. Postoperative examinations will be postoperative refraction, visual acuity, slitlamp examination, and rotation of the IOL within 1 hour, 1 week, 1 month and 4-7 months.

In the Alcon Clareon toric and RayOne EMV toric groups, patients receive a toric IOL according to their preoperative astigmatism


Eligibility Criteria:
Inclusion Criteria:

* Uni- or bilateral age-related cataract necessitating phacoemulsification extraction and posterior IOL implantation
* Age: 45 to 95
* Need for spherical IOL correction between 10.00 and 30.00 D
* Need for spherical IOL correction between +6.00 and +30.00 D (Alcon Clareon toric group)
* Need for spherical IOL correction between +10.00 and +25.00 D (Rayner RayOne EMV toric group)
* Preoperative pupil dilation in mydriasis ≥ 7.0 mm (Hoya, Rayner groups)
* Astigmatism of at least 1.0 Diopters (Alcon Clareon toric and Rayner RayOne EMV toric groups)
* Pupil dilation \>5.5mm (Alcon Clareon toric Rayner RayOne EMV toric group)

Exclusion Criteria:

* Preceding ocular surgery or trauma

  * Recurrent intraocular inflammation of unknown etiology
  * Uncontrolled glaucoma
  * Uncontrolled systemic or ocular disease
  * Blind fellow eye
  * Microphthalmus
  * Corneal abnormality (Corneal scaring)
  * History of uveitis/iritis
  * Iris neovascularization
  * Proliferative diabetic retinopathy
  * Pregnancy
  * Lactation
  * Females of childbearing age will be asked if pregnancy is possible
Safety Assessment of Intravitreal Mesenchymal Stem Cells for Acute Non Arteritic Anterior Ischemic Optic Neuropathy

In this study the investigators propose to perform a Phase II Clinical Trial which seeks to evaluate the safety of cell therapy as a new treatment for patients who suffer from acute non-arteritic anterior ischemic optic neuropathy (NAION). If it is successful, a later study to assess efficacy will be performed.

This disease has an age-adjusted incidence rate of 10/100.000, and in many cases it results in blindness. Currently, there is no available treatment and second eye involvement occurs in approximately 15-25% of the cases.

All this background originates a particularly dramatic outcome for the patient. Therefore, it seems justified to evaluate new therapies that maintain or improve the visual function in these patients.

The Project includes a clinical trial whose purpose is the assessment of the safety of intravitreal administration of allogenic mesenchymal stem cells (MSC) in patients with NAION, a product in clinical research phase (PEI No. 15-007) already approved for other human clinical applications (PEI No. 15-007).

It can be considered that the therapy with intravitreal injection of MSC is a treatment option in patients with acute NAION, since through the paracrine properties of these cells (secretion of neurotrophic, immunomodulatory and anti-apoptotic factors) it may prevent or reduce the progression of axonal degeneration caused by this disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute unilateral NAION (within two weeks after the first symptoms) with at least two of the following:

  1. Sudden and unpainful monocular vision loss
  2. Visual field defects
  3. Dyschromatopsia.
  4. Ocular nerve head edema.
  5. Afferent relative pupil defect.
* Patients ≥ 50 years old, able to freely give informed consent.
* Best corrected visual acuity (BCVA) ≤ 0,1 in study eye.
* Pseudophakia in study eye.
* Preserved pupil sphincter muscle motility
* Signed informed consent form before any study procedure.
* Signed data protection consent form before any study procedure.

Exclusion Criteria:

* Giant cell arteritis evidence (clinical history, Erythrocyte sedimentation rate (ESR), C-Reactive Protein)
* Evidence of any other etiology that may justify the optic neuropathy (even in the non-study eye)
* History of systemic vasculitis, multiple sclerosis, collagenopathies or previous cancer treatments.
* Hypersensitivity or allergy to any compound used in the study, including investigational medicinal product (IMP).
* Positive pregnancy test at baseline
* Participation in any other research study within 2 months

Ophthalmic exclusion criteria

* History of uveitis or active ocular inflammation
* History or evidence of glaucoma or high intraocular pressure ( ≥ 24 mmHg in either eye).
* Mean opacities or retinal pathologies in the study eye.
* Any previous vitreous or glaucoma surgery in the study eye
* Cataract surgery within 3 months in the study eye
Prevention of Postsurgical Chronic Pain in Children and Adolescents (PREVENDOL)

Chronic postsurgical pain is a health problem with a great societal impact: approximately 20% of all children and adolescents undergoing surgery will develop chronic pain. Importantly, the risk and protective factors that are known (e.g., anxiety, catastrophizing, pain beliefs and pain coping) are modifiable, thus there is a huge potential for the development of both preventive and protective programs to avoid the transition from acute to chronic pain or reduce the impact in the lives of patients when it has already developed.

The main objective of this project is to develop and test a program to prevent the development of chronic postsurgical pain in children and adolescents undergoing surgery in order to improve their quality of life (and that of their families). That program will be implemented in a mobile application.

This proposal will be implemented in 3 phases:

1. Development of the preventive program of chronic postsurgical pain and its implementation in a mobile application
2. Usability test of the mobile application
3. Clinical trial to test the effectiveness of the preventive program

Eligibility Criteria:
Inclusion Criteria:

1. Having to undergo surgery
2. Being between 8 and 18 years old;
3. Having signed the informed consent
4. Having an ASA risk between I and III

Exclusion Criteria:

1. Not being able to understand Spanish
2. Having a physical and/or cognitive impairment that interferes with understanding the instructions and handling of the application (e.g., moderate to severe intellectual disability, blindness)
3. Participating in another clinical trial
4. Undergoing an urgent surgical intervention
5. Being hospitalized in intensive care due to the need for ventilation or hemodynamic support or other complications
6. Having an ASA risk of IV
7. Not having signed the informed consent
Maveropepimut-S (MVP-S) and Low-Dose CPA in Patients With Platinum-Resistant Ovarian Cancer

Phase 2, single arm, study to assess the efficacy and safety of maveropepimut-S (MVP-S) and low-dose cyclophosphamide (CPA) in subjects with recurrent, platinum resistant ovarian cancer.

A Simon two-stage statistical design to assess MVP-S in combination with low dose CPA in platinum-resistant epithelial ovarian cancer patients who have received no greater than 4 previous lines of anti-cancer therapy.

MVP-S, previously called DPX-Survivac, was recently evaluated in a small Phase 2 single arm study of ovarian cancer patients known as DeCidE1 (NCT02785250).

Eligibility Criteria:
Key Inclusion Criteria:

* Stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer, histologically diagnosed high-grade serous
* Platinum-resistant disease (relapsing within 3-6 months after completion of initial platinum-based treatment). Patients progressing at any time on or after ≥ 2nd platinum-based therapy are eligible.
* Received ≤ 4 prior lines of anti-cancer therapy for ovarian cancer, including at least one platinum-based therapy
* Evidence of progressive disease
* Measurable disease (RECIST v1.1) with at least one non-target lesion accessible by image-guided biopsy. No single lesion may be larger than 4 cm in diameter.
* Completed pre-treatment tumor biopsy and willing to undergo on-treatment tumor biopsy
* ECOG 0-1
* Live expectancy ≥ 6 months
* Meet protocol-specified laboratory requirements

Key Exclusion Criteria:

* Concurrent chemotherapy drugs, anti-cancer therapy or anti-neoplastic hormonal therapy, or radiotherapy
* Prior receipt of survivin-based vaccines/therapy, immune checkpoint inhibitors, IDO inhibitor, or cell-based therapy
* Non-epithelial tumor origin of the ovary, fallopian tube, or peritoneum
* Clinical ascites
* Concurrent second malignancy other than basal or squamous cell skin cancer, cervical carcinoma in situ, or Stage I or II caner in complete remission
* GI condition that might limit absorption of oral agents
* Recent history of thyroiditis
* History of autoimmune disease requiring treatment within the last two years (except paraneoplastic syndrome, vitiligo, or diabetes)
* History of bowel obstruction related to the disease
* Presence of a serious acute infection or chronic infection
* Uncontrolled concurrent illness or history of significant cardiac or pulmonary disfunction
* Myocardial infarction or cerebrovascular event within past 6 months
* Known central nervous system (CNS) or leptomeningeal metastasis (brain metastases)
* Clinically significant illness or major surgery within past 28 days or anticipated need for major surgery during study treatment
* Ongoing treatment with steroid therapy or other immunosuppressive
* Receipt of live attenuated vaccines
* Edema or lymphedema in the lower limbs \> grade 2
* Acute or chronic skin and/or microvascular disorders
Chemoradiation With Oxaliplatin and Fluorouracil (5FU) for Locally Advanced Pancreatic Cancer

The intention of this trial is to determine the maximum tolerated of the treatment combination and to evaluate its safety and efficacy.

Previous studies have demonstrated that neoadjuvant chemoradiation can lead to improved survival with a portion of patients proceeding to resection. This trial will incorporate a similar trial structure using newer agents in patients who present with locally advanced unresectable pancreatic cancer. Specifically oxaliplatin will be used owing to its greater activity in comparison to cisplatin and favorable therapeutic index in combination with radiation compared to gemcitabine.

In summary, the primary outcome measure of the phase I portion of the trial is to determine the maximum tolerated dose of this combination. Following the determination of this dose, the phase II portion of the trial will characterize the toxicity of this regimen as well as evaluate for long-term efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented pancreatic adenocarcinoma deemed unresectable due to local involvement of vessels or organs
* Patients with a clear clinical diagnosis of localized pancreatic cancer deemed unresectable, who have undergone at least 2 biopsies which were not diagnostic of adenocarcinoma, may be entered at the discretion of the principal investigator.
* No prior chemotherapy or abdominal radiation therapy.
* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
* Clinically measurable or evaluable disease.
* Life expectancy of at least 12 weeks.
* Adequate bone marrow reserve, granulocyte count \>= 1500/uL, platelet count \>= 100,000/uL, hemoglobin \>= 9 g/dL.
* Adequate renal function with creatinine =\< 1.5 times upper limit of normal (ULN)
* Adequate biliary function with bilirubin \< 3.0 g/dL (including patients who have been bypassed or treated with percutaneous drainage), serum glutamic pyruvic transaminase (SGPT) (alanine transaminase) =\< 2.5
* Age \> 18 years
* Signed informed consent.
* No known allergy to one of the study drugs
* For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
* No prior malignancy within last 5 years
* No central nervous system metastases
* No peripheral neuropathy \> grade2
* No other serious concomitant illness

Exclusion Criteria:

* Active infection or uncontrolled infection
* Presence of metastatic disease.
* Inadequate organ function as discussed above.
* Pregnancy
* Serious concomitant systemic disorder.
* Use of any investigational agent within a month of treatment
Comparison of Tiotropium Absorption From Tiotropium Easyhaler and Spiriva HandiHaler

This is a pivotal study to investigate absorption of inhaled tiotropium from 2 Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler.


Eligibility Criteria:
Main inclusion criteria:

1. Healthy male and female
2. 18-60 years of age
3. Body mass index 19-30 kg/m2
4. Weight at least 50 kg
5. FEV1 at least 80% of the predicted value measured at screening
6. Written informed consent obtained

Main exclusion criteria:

1. Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, GI, pulmonary, metabolic, endocrine, neurological or psychiatric disease.
2. Any condition requiring regular concomitant treatment.
3. Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject.
4. Known hypersensitivity to tiotropium bromide, atropine or its derivatives or lactose.
5. Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness.
6. Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
Effect of Dexmedetomidine on Emergence Agitation in Children With or Without Tube Insertion Under General Anesthesia

The investigators are inviting your child to participate in this research study because your child is having myringotomy (putting a tiny incision in the eardrum with or without tube insertion) under general anesthesia.

The purpose of this study is to determine whether a single injection of Dexmedetomidine (study medication) decreases the frequency of awaking from anesthesia frightened or agitated in children having myringotomy surgery as compared to those children who receive placebo (sterile saltwater).

Emergence agitation (EA) is common in children, especially in the preschool age group who undergo general anesthesia. It has been described as a mental disturbance during the recovery from general anesthesia and can consist of hallucinations, delusions and confusion in the child. To the parent or caregivers this may be seen as moaning, restlessness, involuntary physical activity \& thrashing about in bed. Emergence agitation (EA) can result in the child losing their intravenous therapy (IV) access \& bodily injury. Some agitated children may retain vivid memories about their negative experience waking up from anesthesia. This can result in seeing new behaviors by the child such as anxiety, nighttime crying and temper tantrums. Dexmedetomidine given as an injection into the muscle of children is considered investigational, which means it hasn't been approved by the U.S. FDA for treatment of this problem in children.

Immediately following surgery measurements of eye contact, purposeful actions, aware of surroundings, restless and crying are observed and recorded using the Pediatric Anesthesia Emergence Delirium (PAED) scale in PACU.

Follow-up is made approximately 3 days after surgery by phone call or/and email with parent(s) to see if child has experienced any of the following: sleep disturbances, anxiety, eating disturbances, postoperative muscle pain or swelling at the injection site.

Eligibility Criteria:
Inclusion Criteria:

* ASA I or II (American Society of Anesthesiology classification ASA I means patients without systemic disease, ASA II means patients with one controlled systemic medical disease eg: Diabetes, Hypertension.)
* Between the ages of 1 and 10 years
* Undergoing BMT under general anesthesia.

Exclusion Criteria:

* ASA III or higher (Patients with 2 or more medical systemic disease that is not under control, eg: uncontrolled Diabetes)
* Congenital diseases
* Coagulation disorders
* Known allergic reaction to dexmedetomidine
* Serious preexisting impairment of respiratory, cardiovascular, hepatic, renal, neurological or endocrine functions
* Severe upper airway infection
* Predicted difficult airway
* Preexisting psychiatric disorders
A Study to Investigate the Potential for AZD5672 to Affect the Electrical Conduction Pathways in the Heart

This study is being performed to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart. AZD5672 will be compared against a drug (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the electrical conduction of the heart.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50kg.
* Non-smoker

Exclusion Criteria:

* Marked QTc prolongation at baseline e.g. repeated demonstration of QTc interval \>450ms or marked shortening of QTcF \<350ms
* Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of the QTc Interval changes
* Use of concomitant medications that prolong QT/QTc interval
The Use of Direct Puncture Technique With Mini-PCNL

* A single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy.
* 60 patients
* Inclusion criteria:

  1. all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study
  2. ASA scale 1-3
  3. Solitary stone up to 2.5 cm
  4. Single access to the caliceal system
* Exclusion criteria:

  1. Active infectious process
  2. Coagulopathies
  3. Abnormalities of the urinary system

All patients will be randomized into 2 groups:

Direct puncture - patients who underwent directive puncture under ultrasound or Rg control. The number of patients is 30 people.

Non-direct puncture - patients who underwent a PCS puncture with retrograde contrast. The number of patients is 30 people.

Patients will be assigned a randomization number that matches their treatment. Block randomization using 10 blocks will be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.

Primary assessed indicators:

1. Gender
2. Age
3. Body mass index
4. Localization of the stone (side, pelvis, upper anterior cup, upper posterior cup, middle anterior cup, middle posterior cup, lower anterior cup, lower posterior cup)
5. Density of the stone
6. The presence of hydronephrosis

Indicators assessed during the operation - will be assessed by the physician-researcher:

1. Installation of the ureteral catheter
2. Duration of puncture
3. Puncture method (ultrasound, X-ray)
4. The success of the insertion of a flexible guidewire into the calyceal system
5. Problems during dilation of the puncture course
6. Visualization (Excellent, Moderate, Poor)
7. Type of drainage (stent, nephrostomic tube) at the end of the operation Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery.

In the postoperative period, the patient independently controls the intake of analgesics from the NSAID group (ketorolac 100 mg) (Patient-controlled analgesia). If the patient requires analgesics, the time of taking the drug will be recorded (pain relief on demand).

Secondary Assessment: Postoperative Assessment

1. Complications (Clavien)
2. Hemoglobin level 24 hours after surgery
3. Creatinine level 24 hours after surgery
4. Assessment of Stone-Free status after surgery by performing multislice computed tomography of the kidneys and urinary tract without intravenous contrast

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 70 years who are scheduled for mini-PCNL, ready to consent to the study
* ASA scale 1-3
* Solitary kidney stone up to 2.5 cm
* One access to the caliceal system

Exclusion Criteria:

* Active infectious process
* Coagulopathies
* Abnormalities of the urinary system
Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes

This study examines at-home monitoring of patient-generated phsyiologic health data and patient-reported outcomes. Patient-generated health data using at-home monitoring devices and smart device applications are used more and more to measure value and quality in cancer care. This trial may show whether at-home monitoring programs can improve the care of patients after hospital discharge from surgery.

PRIMARY OBJECTIVES:

I. To assess the feasibility and acceptability of remote perioperative monitoring in solid tumor cancer patients scheduled for gastrointestinal (GI), genitourinary (GU), gynecological (GYN) cancer surgery.

II. To explore patterns, trajectory, and changes in physiologic health parameter outcomes (weight, temperature, oxygen saturation, heart rate, blood pressure, daily steps) and patient-reported outcomes (PROs) (symptoms, quality of life \[QOL\]) from pre-surgery to the post-discharge period.

III. To explore the relationship between changes in physiologic health parameter outcomes/PROs and surgical outcomes (postoperative complications, readmissions).

IV. To explore changes in physiologic health parameters and PROs by open surgery versus minimally invasive (laparoscopic or robotic) surgery.

OUTLINE:

Patients undergo remote perioperative telemonitoring with home monitoring devices activity monitor beginning 7 days before surgery and up to 30 days after hospital discharge.

After completion of study, patients are followed up for 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients diagnosed with GI (esophagus, gastric, colorectal, hepatobiliary) GU (prostate, bladder, renal cell), or GYN (ovarian, endometrial, cervical) cancers
* Patients who are scheduled to undergo major abdominal/pelvic surgery for cancer treatment
* Ability to read and understand English
* We are targeting patients across all stages of disease
* All subjects must have the ability to understand and the willingness to sign a written informed consent

Exclusion Criteria:

* Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study