cyrilzakka/clinical-trials huggingface dataset:
Assessment of Cerebral Blood Flow Asymmetry in Cardiac Surgery Patients Undergoing Hypothermic Circulatory Arrest

Cerebral oxygen desaturation during cardiac surgery measured using near infrared spectroscopy (NIRS) derived cerebral oximetry has been associated with significant postoperative morbidity. If significant desaturation occurs during this period, it may represent an ideal opportunity to further optimize the postoperative care of these patients.

Selective antegrade cerebral perfusion (SACP) is a commonly used technique for maintaining cerebral blood flow (CBF) during the use of hypothermic cardiac arrest (HCA) for aortic arch reconstruction. However, even with an intact Circle of Willis, asymmetric CBF is a common occurrence during HCA when SACP is used. The investigators have previously shown that ultrasound guided extrinsic compression of the left carotid artery can increase left cerebral oxygen saturation, and improved symmetry of CBF; however, this has not been investigated formally. In this study, the investigators will firstly formally assess the incidence and severity of asymmetrical cerebral flow between the left and right hemispheres in patients undergoing aortic arch repair (n=20). CBF will be assessed indirectly through regional cerebral oxygen saturation (rSO2) measured via near-infrared spectroscopy-derived cerebral oximetry. In addition, a number of clinical outcome parameters (up to 30 days post-op) will be evaluated. The investigators expect that significant left-side cerebral hypoperfusion will consistently be observed in patients undergoing aortic arch repair using SACP.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Age 18 years or older
* Surgery requiring cardio pulmonary bypass
* Ascending aorta or arch repair surgery
* Surgery requiring hypothermic circulatory arrest

Exclusion Criteria:

* Off-pump cardiac surgery
* Skin condition preventing the use of cerebral oximetry pads
Carotid B-mode Ultrasound Study to Compare Anti-Atherosclerotic Effect of Torcetrapib/Atorvastatin to Atorvastatin.

The Torcetrapib project was terminated on December 2, 2006 due to safety findings.

To look at ultrasound images taken in the carotid arteries and to look at various lipids in the blood of people with mixed hyperlipidemia

For additional information please call: 1-800-718-1021

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mixed hyperlipidemia
* At least 18 years of age

Exclusion Criteria:

* Women who are pregnant or lactating, or planning to become pregnant.
* Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid (high doses)
* Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors
* Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluationof response, or render unlikely that the subject would complete the study
The Comparison of Proprioception and Gait Function Among Different Rotational Designs in Knee Arthroplasty

The symptoms of knee osteoarthritis include knee joint pain, impaired proprioception, and etc. Knee arthroplasty is commonly recommended for the patient with severe knee osteoarthritis to relieve pain and regain function. But the effects of arthroplasty on the proprioception and gait performance, which were related to the risk of falling, were not fully understood. Recently, the concept of enhancing the rotational movement has been introduced into the design of the knee joint prosthesis for mimicking the kinematic performance of the healthy knee. However, study on the functional performance after using these rotational designed arthroplasties was still scarce. So, the purpose of this study aims to evaluate the differences in the proprioception, balance function and gait performance among different designs of the knee arthroplasties with mobile bearing (MB), medial congruent (MC) and posterior stabilized (PS) design. This study is divided into the retrospective and prospective parts.

Investigators will enroll the patients who already replaced their knee joint by one of the above knee arthroplasties for the retrospective part; other patients who plans to receive one of the above knee arthroplasties, twenty participants for each design and each part. The assessment of proprioception, balance function and gait performance will be performed before the knee arthroplasty, and followed at the post-surgery time points of six weeks and three months. The one-way ANOVA will be used to compare the group differences in the retrospective part, and the two-way mixed model ANOVA for the prospective part.

Ultimately, the results of this study could help to have better knowledge of the treatment effects from the different designed knee arthroplasties.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as knee joint osteoarthritis and will receive knee joint arthroplasty.

Exclusion Criteria:

* Already receiving a knee joint arthroplasty surgery
* Can not walk independently for 20 m
* Can not stand for 5 min
* With neurological degenerative disease
* Lower limb received any surgery within recent 2 years
Effectiveness of Nano-silver Fluoride and Silver Diamine Fluoride for Arresting Early Childhood Caries

Aim of the study: To evaluate and compare the clinical cariostatic efficacy of NSF with 38% SDF solution after sex and twelve months in arresting ECC lesions.

The Null hypothesis will be that no statistically significant difference will be detected between the two groups in the arrest of carious lesions in children with ECC.


Eligibility Criteria:
Inclusion Criteria:

* Children younger than 4 years old.
* The presence of at least one active carious lesion on a primary tooth, with scores 3 and higher (according to the International Detection and Assessment System- ICDAS II)
* Completion of an informed consent to participate in the study.

Exclusion Criteria:

* Children reporting spontaneous or elicited pain from caries or showing any signs of pulpal infection, swelling and/or abscess, obvious discoloration of the tooth and premature hypermobility.

  * Parental refusal to participate in the study.
  * Allergy or sensitivity to silver or any of the materials included in the study.
Mediterranean Diet as Treatment for Normal Weight Women With PCOS

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy of reproductive-aged women characterized by chronic anovulation, hyperandrogenism and insulin resistance. Available guidelines recommend lifestyle intervention although they do not suggest the best dietetic regimen for the treatment of PCOS. Thus, the purpose of this study is to compare the effectiveness of two nutritional protocols, namely Mediterranean Diet and standardized normocaloric Diet in normal weight women with PCOS.

PCOS is the most common endocrine disorder of reproductive age women, that is often characterized by chronic anovulation, hyperandrogenism and insulin resistance. The central importance of insulin resistance in the pathogenesis of the syndrome has been established by several in vivo and in vitro studies. No data are available for the best therapeutical approach for metabolic dysfunction of PCOS. In addition, although insulin resistance is a crucial pathogenetic factor for PCOS and lifestyle change program improves insulin resistance, no available data can also suggest whether non-obese women with PCOS benefit or did not from lifestyle change program including diet without calorie-restriction. Although there are not studies focused on the effectiveness and safety of Mediterranean diet in PCOS, several indirect studies performed in obese and/or insulin resistant subjects, seem to suggest a potential role of this diet in PCOS population and, in particular, on long-term PCOS-related health risk. In this study, the investigators' purpose is to compare two nutritional protocols in order to find the best dietetic approach for improving clinical, metabolic and hormonal outcomes in normal weight women with PCOS.

Eligibility Criteria:
Inclusion Criteria: Polycystic ovary syndrome (using ESHRE/ARSM 2007 criteria), 18 ≤BMI ≤ 25

Exclusion Criteria: Age \<18 or \>35 years, BMI less than 18 and higher than 25, Pregnancy, Hypothyroidism, hyperprolactinemia, Cushing's syndrome, nonclassical congenital adrenal hyperplasia, use of oral contraceptives, glucocorticoids, antiandrogens, ovulation induction agents, antidiabetic or antiobesity drugs or other hormonal drugs within the previous 6 months, neoplastic, metabolic (including glucose intolerance), hepatic, and cardiovascular disorder or other concurrent medical illness (i.e. diabetes, renal disease, or malabsorptive disorders, cephalea).

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SMS Maama Project COVID-19

The study's purpose is to demonstrate the ability of an mHealth platform as a feasible way of sharing information in a time of restricted movement in order to inform future studies.

The primary objective of this trial is to assess whether an mHealth platform increases maternal health knowledge in the areas of birth preparedness, pregnancy, and birth complications as measured by the pre- and post-surveys in comparison to routine antenatal care.

The secondary objectives of this trial are;

1. To provide knowledge of COVID-19 symptoms, transmission, diagnosis, and treatment, in a time of social distancing and learning.
2. To improve access and linkages to maternal health services and information as well as provide appropriate referrals for pregnant females.
3. Inform the adoption of mHealth into future health delivery plans.

Eligibility Criteria:
Inclusion Criteria:

* Own a personal mobile phone
* Attend ANC at Kisenyi Health Centre IV, Kawempe Hospital or Rubaga Hospital
* Are at least 24-26 weeks estimated gestational age
* Literate in English or Luganda
* Capable of sending/receiving text messages

Exclusion Criteria:

- Females who plan to travel out of Uganda during the study period
BI 6727 (Volasertib) Human ADME Trial in Various Solid Tumours

Investigation of absorption, distribution, metabolism and excretion (ADME) and assessment of safety, tolerability and preliminary therapeutic effects of \[14C\]volasertib in patients with advanced solid tumours.


Eligibility Criteria:
Inclusion criteria:

* Inclusion Criteria 1. Patients with histologically or cytologically confirmed diagnosis of advanced, non resectable and / or metastatic solid tumour
* Inclusion Criteria 2. Male
* Inclusion Criteria 3. Age \>=18 and =\<70 years
* Inclusion Criteria 4. Written informed consent
* Inclusion Criteria 5. Eastern Cooperative Oncology Group (ECOG) performance score =\<2
* Inclusion Criteria 6. Recovery from Common Terminology Criteria for Adverse Events (CTCAE) Grade \>=2 therapy-related toxicities from previous chemo-, hormone-, immuno-, or radiotherapy

Exclusion criteria:

* Exclusion Criteria 1. Serious concomitant non-oncological disease considered by the investigator
* Exclusion Criteria 2. Active infectious disease
* Exclusion Criteria 3. Viral hepatitis, Human Immunodeficiency Virus (HIV) infection
* Exclusion Criteria 4. Clinical evidence of active brain metastasis during the past 6 months
* Exclusion Criteria 5. Second malignancy currently requiring active therapy
* Exclusion Criteria 6. Absolute neutrophil count less than 1,500/mm3
* Exclusion Criteria 7. Platelet count less than 100,000/mm3
* Exclusion Criteria 8. Total bilirubin greater than 1.5 mg/dL
* Exclusion Criteria 9. Aspartate amino transferase (AST) and / or alanine amino transferase (ALT) greater than 2.5 times the upper limit of normal (if related to liver metastases greater than five times the upper limit of normal)
* Exclusion Criteria 10. Serum creatinine greater than 1.5x Upper Limit of Normal (ULN).
* Exclusion Criteria 11. Known history of QT/QTcF-prolongation
* Exclusion Criteria 12. Patients who are sexually active and having a partner with childbearing potential and unwilling to use a medically acceptable method of contraception
* Exclusion Criteria 13. Treatment with other investigational drugs or participation in another clinical trial
* Exclusion Criteria 14. Chemo-, radio- immuno-, or molecular-targeted cancer-therapy within the past four weeks prior to start of therapy or concomitantly with this trial. This restriction does not apply to steroids and bisphosphonates.
* Exclusion Criteria 15. Alcohol abuse
* Exclusion Criteria 16. Life expectancy less than 12 weeks
* Exclusion Criteria 17. Potent Cytochrome P450 enzyme (CYP) 3A4 and P-glycoprotein inhibitors or inducers
* Exclusion Criteria 18. History of allergy/hypersensitivity
Corneal Endothelial Cell Density in Eyes Treated With a Fluocinolone Acetonide Intravitreal Implant

An Observational Change-From-Baseline Evaluation of Corneal Endothelial Cell Density in Eyes Treated with a Fluocinolone Acetonide Intravitreal Implant

This is a prospective, multicenter, open-label, single arm, observational evaluation of the corneal ECD change from baseline for subjects having the Retisert FA drug delivery system (0.59 mg) surgically implanted in the ocular vitreous chamber of at least 1 previously unimplanted eye for at least 1 year.

Eligibility Criteria:
Inclusion Criteria:

1. Are scheduled for surgical placement of a Retisert fluocinolone acetonide (FA) intravitreal implant in a previously unimplanted eye.
2. Are able and willing to comply with all treatment and follow up/study procedures.
3. Able and willing to provide informed consent or, for subjects 12-18 years of age, have the ability to understand and provide assent (when applicable) and whose parent/legally authorized representative has the ability to understand and provide written informed consent on the Institutional Review Board (IRB) approved informed consent form (ICF) and provide authorization as appropriate for local privacy regulations.
4. For female subjects:

Note: Should a subject conceive during the study, the pregnancy should be reported as soon as possible to the study Medical Monitor and Promedica International within 24 hours. The pregnancy will be followed up to term. The subject will continue in the studyregardless if pregnancy is reported on an AE/SAE form. If an Investigator becomes aware of a post study pregnancy 30 days after the study exit visit while Fluocinolone Acetonide Implant remains in the subject's study eye, then it should be reported as a post-marketing report

Exclusion Criteria:

1. Has previously, concurrently or anticipated enrollment in Bausch \& Lomb study 440, titled, "An Observational Bilateral Evaluation of Corneal Endothelial Cell Density in Subjects Who Have Had a Fluocinolone Acetonide Implant for at Least One Year."
2. Has severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study, based on the judgment of the Investigator.
3. Has participated in an ophthalmic drug or device research study within 30 days prior to Screening (Visit 1, Day -30 to -1) in this study
4. Is monocular (unable to detect hand motion at 6 feet in 1 eye).
5. Has a known corneal dystrophy or corneal transplant.
6. Has a history of ocular surgery in the eye scheduled for implant surgery, including laser procedures, within the 30 days prior to Screening (Visit 1, Day -30 to -1).
7. Had any type of intraocular drug delivery implant (eg, Retisert, Ozurdex \[dexamethasone intravitreal implant\]) in the study eye.
Uterine Artery Embolization With Microspheres in Patients With Leiomyoma.

To evaluate the therapeutic response to uterine artery embolization in 30 patients with leiomyoma using the microspheres Embosoft (Embosoft® - Scitech Medical).


Eligibility Criteria:
Inclusion Criteria:

* female patients from 18 to 50 years old;
* symptomatic uterine intramural leiomyomas or multiple symptomatic leiomyomas in the presence of intramural;
* patient agrees with study procedures;
* patient signs the informed consent form.

Exclusion Criteria:

* asymptomatic women;
* isolated adenomyosis, pediculated subserous myoma, submucous leiomyoma (50% of uterine cavity diameter), intraligamentous leiomyoma;
* leiomyoma diameter higher than 10 cm;
* leiomyoma above the umbilical scar;
* endometrial neoplasia or hyperplasia or presence of any malignancy
* pregnant or breast feeding women;
* active vasculitis;
* pelvic irradiation history;
* uncontrolled coagulopathies;
* renal insufficiency;
* contrast allergy;
* concomitant use of GnRH analogues.
Comparison DW-MRI vs FDG PET/CT in the Detection of Early Recurrence of Cervical Well-differentiated Thyroid Carcinoma

The purpose of the study is to evaluate the concordance between the 18F-PET/CT under thyrotropin stimulation and the diffusion-weighted Magnetic Resonance Imaging, in the detection of residual mass in 40 patients with partial response or relapsed differentiated thyroid carcinoma.

The schedule and the procedures of the study are the following ones :

* Baseline evaluation :

  * Clinical examination with neck echography after rhTSH stimulation
  * Normal whole body scan
* First visit (inclusion):

  18F-FDG PET/CT DW-MRI of the neck if possible performed shortly after the PET CT or within following days
* Following visits: at 6 months and 12 months

  * DW-MRI of the neck performed shortly after the PET CT or within following days.
  * Ultrasonography guided fine needle aspiration for cytology for detection of cervical metastases and identifying thyroglobuline in the needle washout fluid if needed and in case of positivity of either PET or DW-MRI exams.
  * Histological assessment of biopsies if performed

Eligibility Criteria:
Inclusion Criteria:

* Male or female,
* Subjects must be 18 years of age or older,
* Histologically confirmed papillary or follicular differentiated thyroid carcinoma with partial response or complete response, defined by

  * Thyroglobulin \> 2 μg/L under thyrotrophin stimulation, four months after at least two 131-I based treatments (3,7 GBq/100mCi or more if optimal conditions),
  * Negative extension assessment (total body bone scan, (3,7 GBq/100 mCi or more)), echography, CT scan ( neck, thorax, abdomen): no findings..
* Patient's Informed Consent form signed.

Exclusion Criteria:

* History of previous cancer within the least three years,
* Performance Status \> 2,
* Protected adults
* Any medical, psychological, social or disabling conditions that could interfere or jeopardize the patient's participation
* History of allergy to radio-iodine,
* Estimated GFR \< 45 ml/min /m² (MDRD method),
* Women of childbearing potential without contraceptive method,
* Uncontrolled diabetes mellitus,
* Hypersensitivity to FDG or to any radio-tracers,
* Contraindication to administration of Thyrogen® 0.9mg
* Intraocular foreign bodies or any metallic foreign bodies that contraindicates the MRI.
* Vascular clips, any object or implanted device that could interact with the ferromagnetic field,
* Coronary and peripheral clips, aortic stent grafts, prosthetic heart valves, annuloplasty rings, vena cava filters, cardiac pacemaker, implantable cardiovascular defibrillators....,
* Implanted insulin infuser
* Neurostimulator device
* Claustrophobia
* Agitation or psychological trouble
Analysis of the Kinematics of the Shoulder Complex in Sports "Overhead" Gestures Such as Kayaking Polo Throwing (Overhead)

The objective of this study is to analyze the throwing gesture specific to the kayak polo. A throw in a seated position with fixation of the pelvis (by the seat) and antepulsion of the hip ipsilateral to the throwing shoulder.


Eligibility Criteria:
Inclusion Criteria:

* free and informed consent signed
* Benefiting from a social protection insurance
* Over 18 years-old
* Male
* Having a level of expertise greater than or equal to the national level 4

Exclusion Criteria:

* Present during the study or have presented within the year any musculoskeletal pathology in the right and left shoulder.
* Have a body mass index greater than 30kg / m2 (to ensure sufficient accuracy to measure the movements of the scapula)
Internet-delivered Psychological Interventions for Tinnitus

Tinnitus can be very distressing for some individuals who experience it. The most studied intervention that works well for tinnitus distress is cognitive behavioral therapy (CBT). There is enough evidence to claim that internet-delivered guided CBT for tinnitus is as effective as CBT delivered face-to-face. The goal of this randomized controlled trial is to test the effectiveness of an internet-delivered cognitive behavioral therapy (CBT) for tinnitus and an internet-delivered mindfulness-based tinnitus stress reduction intervention by comparing them one against each other and a waiting list control group in the adult population experiencing tinnitus.

The main questions this study aims to answer are:

* Feasibility of delivering interventions for tinnitus distress over the internet.
* Is any of the two interventions more effective in reducing tinnitus-related stress than the waiting list control?
* Is the effectiveness of mindfulness intervention non-inferior to CBT intervention for tinnitus?
* Is participant engagement and dropout different in mindfulness and CBT interventions?

Participants will be randomly assigned to a CBT, Mindfulness, or control group and will be asked to engage with the materials prescribed to that group for eight weeks.


Eligibility Criteria:
Inclusion Criteria:

* Experience tinnitus for at least three months;
* Scores 28 or more on THI;
* Has the ability to use a computer (or smartphone or tablet) with a connection to the internet for the duration of the study;
* Comprehension and ability to write and speak in the Lithuanian language.

Exclusion Criteria:

* Inability to allocate sufficient time for participation in an 8-week intervention;
* Significant medical or psychiatric conditions which would prevent participation;
* Participation in other tinnitus interventions during the study.
Mechanics Analysis of Patients Having a Sigma Mobile Bearing TKA

Utilize previously developed mathematical model to determine in vivo knee mechanics (kinematics, forces, stresses, areas and sound) for subjects having a Sigma Posterior Stabilizing (PS) mobile bearing (MB) total knee arthroplasty (TKA). There are several hypotheses for this study, although the most prominent is: Subjects having a Sigma RP PS TKA will experience polyethylene bearing rotation at 10 years post-operative, similar to their previous evaluations at six months, two years and five years.

Additional hypotheses:

* Subjects having a Sigma RP PS TKA will experience full ideal femorotibial contact mechanics.
* Subjects having a Sigma RP PS TKA will experience optimal cam/post mechanics.
* Subjects having a Sigma RP PS TKA will experience continuous axial rotation in deep flexion.
* Subjects having a Sigma RP PS TKA will experience optimal distribution of tibio-femoral and cam/post contact forces over a broad area on the post.
* Subjects having a Sigma RP PS TKA will experience a smooth transition of the cam on the post, not an abrupt slide as seen with fixed bearing PS TKA.
* The use of the sound sensors will detect cam/post contact mechanics under in vivo conditions.

Eligibility Criteria:
Inclusion Criteria:

* At least six months post-operative
* Between 40-85 years of age
* Have a body weight of less than 250 lbs.
* Judged clinically successful with a AKS greater than 90
* Have the DePuy Sigma mobile bearing TKA
* Good-to-excellent post-operative passive flexion
* Must be willing to sign the IC and HIPAA forms.

Exclusion Criteria:

* Pregnant females
* Those not willing to sign the IC and HIPAA forms