cyrilzakka/clinical-trials huggingface dataset:
Comparison of Custom and Standard Total Knee Replacements

Total knee arthroplasty (TKA) is the most common surgery in North America and the second most common in Europe. One of the most critical issues for stability and durability of the interventional is the prosthesis-bone geometric fit, where a required a perfect match; the recent availability of custom 3D implants can overcome this problem. In order to further improve a TKA surgery, it is in fact, it is possible today to completely customize the procedure for each individual patient, with cost and time now accessible. This intervention can be performed with the use of instrumentation specific to the patient (so-called resin 'cutting templates' referred to as PSI, "Patient Specific Instrumentation") to make cuts accurate bone cuts in accordance with a specific 3D preoperative plan . Also the design and fabrication in of the components prosthetic components themselves, in metal and polyethylene, is done by means of 3D printing. Based on the unique anatomy of each patient, the precise sagittal orientation and axial rotation of the components of the prosthesis customized for the surgeon, it is possible to plan and perform the surgery quickly and in accordance with the exact specifications of the individual patient. These procedures should also make it possible to greatly reduce the instrumentation and the sizes that need to be available in the operating room, reducing time and costs associated with transportation and storage . The objective of this study is to compare primary TKAs performed with a customized procedure (prostheses customized for each patient based on his or her reconstructed knee morphology by tomographic scans, and implanted via cutting guides customized for the patient) with standard primary TKAs, considering: the objective radiological results, the subjective results of the patients and the costs of both procedures.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects older than 40 years and younger than 70 years (≥ 40 age ≤ 70 years) candidates for primary cemented total knee replacement.
* Consenting patients and able to complete scheduled study procedures and follow-up evaluations.
* Patients who have signed the "informed consent" approved by the Ethics Committee.

Exclusion Criteria:

* Social conditions (homeless patients, with restrictions on personal freedom)
* ASA 3
* Deep venous insufficiency Lower limbs
* History of Erisipelas lower limbs
* Neurological or psychocognitive disorders
* Neurological diseases
* Post-traumatic arthritis
* Axial deformities of the knee \>10°
* Personal or family history of DVT or EP
* Prosthetic and/or arthrodesis surgeries at another joint of the lower extremities lower limb except that candidate for knee prosthesis
* Pregnant women
* Patients with rheumatic diseases
Symfony vs Vivity in Dim Light

The purpose of this study is to evaluate the visual outcomes of the Symfony lens and the Vivity lens under mesopic lighting conditions in adult patients undergoing routine cataract surgery. Participants will be asked to read a visual acuity chart at different distances in dim light.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is undergoing bilateral lens extraction with implantation of an EDOF IOL with a target refraction of plano OU.
2. Gender: Males and Females.
3. Age: 50 years and older.
4. Willing and able to provide written informed consent for participation in the study
5. Willing and able to comply with scheduled visits and other study procedures.
6. Scheduled to undergo standard cataract surgery in both eyes, with 1 to 30 days between surgeries.
7. Potential postoperative visual acuity of 0.2 logMAR (20/32 Snellen) or better in both eyes.

Exclusion Criteria:

1. Severe preoperative ocular pathology
2. Uncontrolled diabetes.
3. Use of any systemic or topical drug known to interfere with visual performance.
4. Contact lens use during the active treatment portion of the trial.
5. Any concurrent infectious/non-infectious conjunctivitis, keratitis, or uveitis.
6. Clinically significant corneal dystrophy.
7. Corneal irregularities potentially affecting visual acuity (i.e., keratoconus, corneal opacities.
8. History of chronic intraocular inflammation.
9. History of retinal detachment.
10. Pseudoexfoliation syndrome or any other condition that has the potential to weaken the zonules.
11. Previous intraocular surgery.
12. Previous corneal refractive surgery (i.e., LASIK, PRK, RK).
13. Subject who declined any type of presbyopia correcting IOL due to concerns with visual disturbances (i.e., halos)
14. Previous keratoplasty
15. Severe dry eye
16. Pupil abnormalities
17. Subject who may reasonably be expected to require a secondary surgical intervention at any time during the study (other than YAG capsulotomy, i.e., LASIK)
18. Any clinically significant, serious, or severe medical or psychiatric condition that may increase the risk associated with study participation or may interfere with the interpretation of study results.
19. Participation in (or current participation) any ophthalmic investigational drug or ophthalmic device trial within the previous 30 days prior to the start date of this trial.
Proximal Tibial Osteotomy Osteoclasis In Infantile Genu-Varum

Genu-varum is a common problem encountered in pediatric orthopedic. Correction of pathological deformity is mandatory to ensure normal load transfer through the knee. In this study, the investigators describe a new technique of osteotomy osteoclasis in order to evaluate if it is an effective and reliable method in management of infantile genu varum

Seventy children with 122 legs suffering significant infantile genu-varum were treated by percutaneous osteotomy-osteoclasis technique. The mean age was 46 months. Genu varum was bilateral in 52 children and unilateral in 18 with a mean preoperative proximal medial tibial angle 66.67 ± 2.670. Under general anesthesia, transverse osteotomy osteoclasis was performed below the tibial tuberosity. Follow-up radiograph was done within the first post-operative week and then every two weeks to assess alignment and consolidation.

Eligibility Criteria:
Inclusion criteria:

* Infantile genu-varum
* PMTA≤70 not spontaneously corrected

Exclusion criteria:

* Active rickets or other metabolic disease
* Patients in whom the femur or the joint is the main site of the deformity
The Effects of Blackcurrant Supplementation on Eye Health

The purpose of this study is to evaluate the potential for supplementation with black currant to support eye health among otherwise healthy adult women who spend 6+ hours per day using digital screens.

Women who are informed about the study and provide informed consent will be randomized to one of two groups: supplement and placebo. Group assignment will be a 1:1 ratio to supplement (455mg of blackcurrant standardized to 50mg anthocyanins in 2 capsules/day) or placebo (2 capsules/day). Outcomes will be assessed at baseline and again on day 70.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 30-60
* Lives in the United States
* Employed full time in an online work environment OR enrolled full time in an online learning environment (average of 6+ hours per day)
* Ability to understand study instructions
* Ability to provide informed consent
* Residence within 100 miles of the study center

Exclusion Criteria:

* Low blood pressure
* Uncontrolled hypertension (i.e. systolic/diastolic blood pressure \> 140/90)
* Uncontrolled diabetes (i.e. fasting blood glucose \>180mg/dl)
* Any blood clotting disorder
* Ocular disease
* Best corrected visual acuity \<20/30
* Cataracts
* Renal disease
* Active hepatitis or cirrhosis
* Acute or chronic infectious disease
* Pregnant
* Breastfeeding
* Currently trying to conceive
* Surgical or other invasive procedure planned within the intervention period
A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib

The purpose of this study is to determine routes of excretion and single-dose PK parameters for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.

This is a Phase 1, open-label, single-dose study of 14C-labeled poziotinib to determine routes of excretion and single-dose PK parameters for poziotinib in patients with solid tumors with EGFR or HER2 mutations or EGFR/HER2 overexpression/amplification.

On Day 1, enrolled patients will be admitted to the inpatient unit and all predose assessments will be completed. Patients will be admitted to the inpatient unit for 9 days. On Day 2, a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally in the morning right after breakfast with at least 200 mL of water.

Over the following 168 hours, urine and feces will be collected and pooled at specified intervals for measurement of total radioactivity recovered and subsequent determination of the routes of elimination of poziotinib and its metabolites. Blood samples will be taken at specified time points for 168 hours after dosing for estimation of single-dose poziotinib PK parameters.

Eligibility Criteria:
Inclusion Criteria:

* Patient can be male or female and is at least 18 years of age
* Patient must be willing and capable of giving written Informed Consent and willing to stay in the research unit for 9 days.
* Patient has a life expectancy of at least 6 months.
* Histological confirmation of solid tumor cancer that is suitable for poziotinib therapy. These may include patients with any solid malignancy with either EGFR or HER 2 mutations or EGFR/HER2 overexpression/amplification. Brain metastases are allowed, if patient is clinically stable and does not require treatment with anticonvulsants or escalating steroid doses.

Exclusion Criteria:

* Patient has a diagnosis of primary and or metastatic hepatic or renal carcinomas.
* Patient is unable to take oral medication or has ongoing Grade ≥2 diarrhea due to any etiology including Crohn's disease and/or ulcerative colitis.
* Previous poziotinib exposure
* Patient has previously participated in a study utilizing 14C.
* Patient has any pathology or history of procedures expected to change absorption
* Patient has a PEG (Percutaneous Endoscopic Gastrostomy) tube
Prostate Cancer Localization With a Multiparametric Magnetic Resonance (MR) Approach

The primary objective of this prospective multi-centre study is to prove the diagnostic accuracy of in vivo 3T multi-modality Magnetic Resonance Imaging (high resolution T2-weighted MRI, DCE-MRI, MRSI and DWI techniques) in distinguishing carcinoma from other prostate tissue. The gold standard for distinguishing the tissue types is the analysis of whole-mount sections of the resected prostate by a genitourinary histopathologist.

Goal Proving that multi-parametric MR imaging in a multi-centre setting allows for localizing clinically significant (volume \> 0.5cc; Gleason \> 6) prostate carcinoma in the prostate.

Objective 1

To determine the diagnostic accuracy (area under the receiver-operating characteristic curve) of 3-Tesla multi-modality non-endorectal coil (ERC) MR imaging in localizing prostate cancer, by correlating:

1. focal areas of low signal intensity on T2-weighted images;
2. the extent and degree of deviating metabolite ratios derived from MRSI. This can be the choline+creatine/citrate ratio or if possible, the choline / citrate ratio;
3. the extent and degree of apparent diffusion coefficient reduction on DWI;
4. the extent and degree of perfusion abnormality on DCE-MRI; with the presence or absence of cancer at (reconstructed) whole mount section histopathology.

Objective 2 Proving that multi-modality MR data allows for predicting tumor grade. The parameters from the different MR methods for a tumor focus can be correlated to the local Gleason grade of the corresponding lesion in the histopathological specimens.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven diagnosis of adenocarcinoma of the prostate
* Subject will sign a consent form prior to study entry
* Radical prostatectomy and histopathological exam planned
* The time interval between last biopsy and the MR exam must be at least 4 weeks
* The time interval between MR exam and radical prostatectomy should not exceed 12 weeks

Exclusion Criteria:

* Subjects who are unable to give valid informed consent
* Subjects who are unwilling or unable to undergo an MR exam, including subjects with contra-indications to MR exams
* Therapy or surgical procedure applied to the prostate or to other organs in vicinity to the prostate: among the therapies preventing inclusion are any form of radiation therapy, cryo-therapy, thermal-therapy, therapy based on any other medication (including hormonal therapy).
* Patients under hormone deprivation therapy.
Comparison of Small-gauge Vitrectomy and Conventional Vitrectomy for Proliferative Diabetic Retinopathy

Surgical outcome of vitreous surgery for proliferative diabetic retinopathy (PDR) with conventional 20, 23, and 25-gauge vitrectomy were compared.

The 424 eyes of 347 patients of PDR who underwent vitreous surgery for persistent vitreous hemorrhage or progressive proliferative membrane were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* The patients of proliferative diabetic retinopathy who underwent vitreous surgery and followed at least 6 months

Exclusion Criteria:

* The patients of proliferative diabetic retinopathy who underwent vitreous surgery but did not follow more than 6 months.
Prevalence of Glaucoma in Belgium: a Multicenter National Trial

To screen for the presence of glaucoma in a Belgian population over 40 years old using an AI algorithm developed for the detection of glaucoma based on fundus pictures.

In this study, we aim to detect individuals with glaucoma and refer them for further evaluation and treatment when necessary. In so doing, we want to get an estimation of the prevalence of glaucoma in the Belgian population of 40+ years.

A fundus picture will be acquired without pupil dilation. This examination will be followed by an intra-ocular pressure measurement. The results will be discussed with the participating subject by the present physician. For each subject, both eyes will be evaluated. In case of suspected glaucoma, the subject will be referred to an ophthalmologist for further evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 40 years or above

Exclusion Criteria:

* Aged under 40 years
* Insufficient knowledge of Dutch, French or English required to complete the imaging protocol and questionnaire
* Physical or mental inability to participate
Contributions to Hypertension With Androgen Deprivation Therapy

This study plans to learn more about contributors to high blood pressure in men who undergo androgen deprivation therapy (ADT) to treat prostate cancer. Prostate cancer is the most common non-skin cancer in men, affecting approximately 1 in 8 American men and its primary treatment is through the use of ADT. However, ADT increases the likelihood of developing heart disease including high blood pressure. This study will determine if dysfunction of the nervous system and/or kidneys occurs in men undergoing ADT, as these systems play a significant role in control of blood pressure. The results from this study will help us understand the ways in which ADT contributes to heart disease and help us develop therapies to prevent heart disease in prostate cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* -age 40+ years;
* resting blood pressure \<140/90 mmHg;
* fasted blood glucose \<126 mg/dL;
* testosterone ≥400 ng/dL;
* sedentary to recreationally active;
* nonsmokers;
* healthy as determined by medical history, physical exam, blood and urine chemistries and resting and exercise ECG during a physician supervised graded exercise treadmill test OR recent diagnosis of non-metastatic prostate cancer with plans to undergo androgen deprivation therapy;
* PSA \<4.00 ng/dL if in the non-cancer group;
* Gleason Score ≤7 if in the prostate cancer group;
* no use of medications that might influence cardiovascular function (e.g., antihypertensives, lipid-lowering medications);
* willing and able to be on GnRHagonist and AR inhibitor;
* not taking antioxidant vitamins, corticosteroids, or anti-inflammatory medications, or willing to stop use for four weeks prior to the start of the study;
* not using exogenous sex hormones for at least one year

Exclusion Criteria:

* -acute liver disease;
* chronic kidney disease, serum creatinine \>1.3 mg/dL, macroalbuminuria \>300 mg/g of proteinuria
* pre-existing or active cardiac, renal or hepatic disease, epilepsy or other seizure disorder;
* diabetes, active or chronic infection, disease that affects the nervous system;
* Gleason Score ≥8;
* thyroid dysfunction, defined as ultrasensitive TSH \<0.5 or \>5.0 mU/L, volunteers with abnormal TSH values will be re-considered for participation after follow-up evaluation by the PCP with initiation or adjustment of thyroid hormone replacement;
* tobacco use within the previous 12 months
Is the Lack of Prior Exposure to Sperm Antigens Associated With Worse Neonatal and Maternal Outcomes?

The objective of this study is to determine if the lack of exposure to sperm antigens is associated with worse maternal and neonatal outcomes in pregnancies obtained after ICSI (intracytoplasmic sperm injection)-TESE (testicular sperm extraction) for obstructive azoospermia.

The primary outcomes that will be investigated include:

* Maternal outcomes: live birth rate (LBR), abortion rate, and the rate of the main obstetrics complication, such as pre-eclampsia, gestational hypertension and diabetes mellitus.
* Neonatal outcomes: gestational age, prematurity rate, birth weight, sex ratio, 1- and 5-min APGAR, birth defects.

Several studies investigated the role of paternal factors in the development of preeclampsia; in particular, they analyzed the correlation between the vaginal exposure to male partner's semen and the incidence of preeclampsia, observing both a reduced risk of preeclampsia after prolonged exposure to the paternal seminal fluid and a higher incidence of preeclampsia in pregnancies conceived with a new father or with sperm donor. This leads to the hypothesis of an immunological role for sperm in inducing a mucosal immune tolerance-like status at the level of the uterus that could be critical in the subsequent implantation.

Previous studies also examined the neonatal outcomes from pregnancies obtained from surgically retrieved sperm, either epididymal or testicular sperm, and underlined that there is not overall increased risk in neonatal outcomes.

Our study aims at having a complete view on paternal, maternal and neonatal information and a follow up, that allows to correct possible confounders and to analyze a wider group of outcomes.

Eligibility Criteria:
Inclusion Criteria for case arm:

* primary infertility
* diagnosis of obstructive azoospermia
* ICSI-TESE cycles

Inclusion Criteria for control arm:

* primary infertility
* ICSI cycles with sperm from ejaculate

Exclusion Criteria:

* pre-gestational hypertension
* pre-gestational diabetes
Safety, Tolerability and Pharmacokinetics of KUC 7483 Tablets in Healthy Male Volunteers

Study to investigate safety, tolerability and pharmacokinetics of KUC 7483


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
   * No finding deviating from normal and of clinical relevance
   * No evidence of a clinically relevant concomitant disease
2. Age ≥30 and Age ≤60 years
3. BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
4. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice and the local legislation

Exclusion Criteria:

* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
* Inability to refrain from smoking on trial days
* Alcohol abuse (more than 60 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range of clinical relevance
Coronary Computed Tomographic Angiography in Intermediate-risk Chest Pain Patients

The aim is to determine whether a diagnostic strategy including early coronary computed tomographic angiography in intermediate-risk patients presenting to the Emergency Department with chest pain reduces the composite endpoint of death, readmission because of myocardial infarction or unstable angina requiring revascularization.

Patients presenting to the ED with chest pain or other symptoms suggestive of ACS, without acute MI but with an intermediate risk (HEART-score \>3) will after written informed consent be randomized to either a strategy with an initial CCTA or not.

Patients randomized to strategy including early CCTA will receive standard care according to responsible physician and perform a CCTA as soon as possible (in most cases within 24 hours, but at least within 21 days).The result will be presented to the responsible physician who will plan further care of the patients.

Patients randomized to a strategy not including early CCTA will receive further care (including examinations) according to responsible physician but not include early CCTA. These patients will often undergo a non-invasive functional test, such as Exercise-ECG, stress echocardiography or nuclear imaging according to local routines, but not always.

All patients should receive optimal prevention according to current guidelines. The responsible physician will be encouraged to initiate secondary prevention measures if examinations show signs of CAD.

The primary endpoint is composite of death, readmission because of MI or unstable angina requiring revascularization.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years.
2. Within 24 hours from presenting to the ED with chest pain or other symptoms suggestive of coronary artery disease (CAD)
3. HEART-score \>3 (according to http://www.heartscore.nl/)
4. Written informed consent obtained

Exclusion Criteria:

1. Any condition that may influence the patient's ability to comply with study protocol.
2. Acute MI
3. Known obstructive CAD (\>50%) or previous PCI or CABG.
4. Clear alternative diagnosis
5. Estimated glomerular filtration rate (eGFR) \< 30 ml/min/1.73m2
6. Major allergy to iodinated contrast media
7. Circumstances making high quality images unlikely.
8. Not a Swedish resident with a personal ID-number.
9. Pregnancy or breast feeding
10. Further investigation for CAD not indicated, due to limited life expectancy, quality of life or functional status
11. Previous inclusion in the trial