cyrilzakka/clinical-trials huggingface dataset:
Role of Positron Emission Tomography/ Computed Tomography (PET/CT) and in Bone Metastases.

The aim of this study is to detect bone metastases by PET/CT examination in cancer patients.

Bone is a fertile soil for dissemination of metastatic tumor cells which can cause either osteolytic ( destructive) or osteoblastic (sclerotic) or mixed lesions in advanced cancer. Bone metastases are most common throughout the axial skeleton, this leads to major complications referred to as skeletal-related events (SREs), the most frequently are the need for radiotherapy and pathological fractures, associated with increase life morbidity and decrease overall survival.

Seeking accurate image modalities provides definite staging, determining the optimal strategy of treatment and precise evaluation to decrease the burden of complication.

PET/CT is superior than 2-dimensional planar providing a better image quality and enables quantitation of tumor metabolism. Acquisition and fusion of PET with CT also allow for localization and morphologic evaluation of abnormalities, leading to increased specificity. The National Comprehensive Cancer Network (NCCN) guideline recommended PET/CT imaging in cancers with high risk skeletal metastases, PET has advantage than CT in diagnosing osteolytic lesions; but combining PET with CT, increase the detection of osteoblastic lesions.

CT is recommended to evaluate structural integrity in revealing cortical integrity and the extent of structural destruction.

Eligibility Criteria:
Inclusion Criteria:

* patients diagnosed with different types of malignant tumor, suspected or diagnosed to have bone metastases and will do PET/CT examination
* patients diagnosed with different types of malignant tumor, with accidently discovered bone metastases during PET/CT examination.
* patients conscious to provide informed consent.

Exclusion Criteria:

* pregnant women.
* patients with blood sugar \> 200 mg/dL.
* patients unable to sleep in a fixed position for 20 minutes.
* severely ill patients who aren't capable of complying with study procedures or comatose patients.
Effect of Duloxetine on Opioid Use After Total Knee Arthroplasty

Post-discharge pain after total knee arthroplasty remains problematic; many patients have excessive pain at the 2 week time point (and often thereafter). Reduction in opioid use has become a national goal, due to the 'epidemic' in opioid misuse.

In addition to enrolling non-opioid users, we will enroll up to 15 chronic opioid users.


Eligibility Criteria:
Inclusion Criteria:

* Age 25 to 75 years
* Planned use of regional anesthesia
* Ability to follow study protocol
* English speaking (Primary outcome obtained via telephone call and secondary outcomes include questionnaires validated in English only)
* Patients planning on being discharged home or to a rehabilitation center that has agreed to participate

Exclusion Criteria:

* Current Use of duloxetine or other SNRIs, SSRIs, MAOIs, Tricyclic antidepressants, triptans (sumatriptan, rizatriptan, naratriptan, eletriptan, almotriptan, frovatriptan), lithium, buspirone, St. John's Wort
* Hepatic insufficiency

  o Hepatoxicity is reported as a side effect of duloxetine. "Median time to detection of transaminase elevation was about two months" (package insert 5.2
* Renal insufficiency (ESRD, HD, estimated creatinine clearance \< 50 ml/min)

  * Severe CRI may impair duloxetine clearance
  * CLcr=\[(140-age (years)\] x weight (kg)x0.85 (for female patients)/\[72xserum creatinine (mg/dL)\]
* Patients younger than 25 years old and older than 75
* Patients intending to receive general anesthesia
* Allergy or intolerance to one of the study medications
* Patients with an ASA of IV
* Chronic gabapentin/pregabalin use (regular use for longer than 3 months)
* Patients with major prior ipsilateral open knee surgery.
* Chronic opioid use (taking opioids for longer than 3 months)

  * However, patients using chronic opioids may enroll in a parallel pilot study entitled 'effect of duloxetine on opioid use after total knee athroplasty among patients exposed to opioids- a pilot study'. The chronic opioid users will be allowed to continue their customary analgesics. The pilot study is otherwise identical to the main study.
  * This study will enroll up to 15 chronic opioid users. After that, all chronic opioid users are excluded.
Initial Hemato-immunological Profile on the Evolution of Immunological Thrombopenic Purpura.

This study aims to determine the hemato-immunological parameters predictive of the evolution of a Immune thrombocytopenic purpura (ITP) towards chronicity, and to identify possible differences between the child and the adult.

Immune thrombocytopenic purpura (ITP) is a rare autoimmune thrombocytopenia whose incidence is 2 to 5 cases / 100,000 inhabitants / year. The potentially serious haemorrhagic risk is the major issue of management. A recent international consensus conference classifies PTI according to the duration of thrombocytopenia: acute ITP (\<3 months), persistent ITP (3-12 months) and chronic ITP (\> 12 months) (Rodeghiero 2009). In the acute or persistent phase, polyvalent immunoglobulins (IVIG) and / or corticosteroids are proposed. In the chronic phase, splenectomy is a possible cure for 70% of patients. No predictor of treatment response is known.

The pathophysiology of ITP is multifactorial: platelet phagocytosis, mediated by autoantibody, macrophages of the reticuloendothelial system, and destruction in the spleen, genetic background and / or environmental factor favoring the role of certain lymphocyte subpopulations, cytotoxic or regulatory T, via their cytokine environment, abnormalities of thrombopoiesis.

ITP affects children as well as adults, but the evolutionary profile is very different. In children, ITP, which is often post-infectious, is acute in 80% of cases, whereas ITP in adults has a chronic evolution in 80% of cases. The primary diagnostic and therapeutic practices are similar. The reasons for these evolutionary differences are not known and little studied.

Is the orientation of the hemato-immunological response observed during the first episode of ITP different in children and adults? Do these differences explain the evolutionary specificities of the two age groups? Are there hematologic parameters predictive of a response to initial treatments?

Eligibility Criteria:
Inclusion Criteria:

* Minor patients aged 2 to 18 recruited at the Children's Hospital, in the service of Prof. Y. PEREL, Dr. N. ALADJIDI, CEREVANCE,
* Adult patients (\> 18 years old) recruited at the Haut-Lévêque hospital, Pr JL PELLEGRIN, Pr JF VIALLARD, GECAI,
* Patient with acute Immune thrombocytopenic purpura, seen at initial diagnosis or within 8 days (defined as thrombocytopenia \<100 G / L, after an infectious cause, drug or related to autoimmune disease, hematological malignancy or deficit Immune have been eliminated, Rodeghiero criteria, 2009).
* Patient who received immunoglobulins more than 4 weeks before inclusion
* Written consent given by the patient, if he is of age, or by the person (s) having parental authority
* Patient affiliated or beneficiary of a social security scheme

Exclusion Criteria:

* Patient who has received specific treatment from an Immune thrombocytopenic purpura
* Patient with secondary Immune thrombocytopenic purpura (hematological malignancy, autoimmune disease, immunodeficiency, pregnancy)
* Patient placed under the protection of justice
Efficacy and Safety of Peri-operative Pregabalin After Radical Cystectomy

This study compares analgesic efficacy, and safety of three different doses of peri-operative pregabaline to placebo following radical cystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Sixty patients between the ages of 18 and 60 years.
* American Society of Anesthesiologists (ASA) I-II physical status.
* undergoing radical cystectomy under general anesthesia.

Exclusion Criteria:

* Patients with a history of drug or alcohol abuse.
* patients with chronic pain or daily intake of analgesics.
* uncontrolled diabetes mellitus.
* uncontrolled hypertension.
* atherosclerotic heart disease.
* seizures.
* impaired kidney or liver functions,
* patients with body mass index ≥35 kg/m2, and whom
* patients that could not control a patient controlled analgesia (PCA) device.
Long-acting Parasternal Blocks for Analgesia After Cardiac Surgery

This is a randomized, double-blind, controlled clinical trial is to evaluate the duration of efficacy of parasternal blocks with the use of local anesthetic adjuncts for analgesia after coronary artery bypass grafting surgery.

This study will randomize patients to either standard pain control protocols or parasternal blocks after coronary artery bypass grafting-only surgery. This study will specifically examine the effectiveness and duration of analgesia of parasternal blocks with local anesthetic adjuncts, Dexamethasone 10mg and Dexmedetomidine 50mcg, added to the local anesthetic mixture

Eligibility Criteria:
Inclusion Criteria:

* Patients coming for elective and urgent coronary artery bypass (CABG)-only surgery.

Exclusion Criteria:

* Patients with a history of regular opioid use.
* Patients with a history of chronic pain.
* Patients unable to provide consent.
Technology of Intracranial Pressure Estimation by Single-Channel EEG in Brain Disease

If intracranial pressure can be measured non-invasively using single-channel EEG, clinicians will be able to easily monitor changes in intracranial pressure in patients with brain diseases in the clinical setting. Therefore, a more efficient treatment plan can be established and the prognosis of patients with brain disease can be expected to improve in the long term.

Study Objectives:

1. Accuracy evaluation of single-channel EEG-based estimated intracranial pressure and actual intracranial pressure in patients with brain disease
2. It is intended to improve the accuracy by analyzing and upgrading the correlation and concordance of the single-channel EEG-based estimated intracranial pressure compared with the actual intracranial pressure measurement of the patient.

Study design: Multi-center prospective clinical trial

The study procedure was explained to the caregiver of the patient with brain disease admitted to the emergency room or intensive care unit, who was or will be implanted with an intracranial pressure monitoring device and informed consent was obtained.

While the intracranial pressure monitoring device is being applied, EEG data and intracranial pressure data are simultaneously acquired by applying a single-channel EEG.

EEG-based intracranial pressure prediction model and actual intracranial pressure comparison analysis are conducted to evaluate the prediction model and upgrade it.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Patients have had or are planning to insert an intracranial pressure monitoring device due to brain diseases
* Emergency room or intensive care unit of the study hospital

Exclusion Criteria:

* EEG measurement is restricted due to trauma or head deformity
* The attachment of electrodes for EEG measurement interferes with the standard treatment
* Patients who do not agree to enroll to this study by patients or caregivers
Comparison of the Functional Properties of Two Injectable Materials in Posterior Teeth: Randomized Clinical Trial

Using two different injectable materials in class II cavities to compare functional properties


Eligibility Criteria:
Inclusion Criteria:

* 1-Adult patients (20-50) 2-Good oral hygiene Good oral hygiene (Plaque index ≤2 (Moderate accumulation with plaque in the sulcus)) 3-Patient approval 4-Absence of parafunctional habits and/or bruxism 5-No endodontic treatment or abscess 6- class II either mesial or distal (no MOD cavities)

Exclusion Criteria:

* 1. Systematic disease that may affect participation. 2. Xerostomic patients. 3. Bad oral hygiene (plaque index 2 or 3) 14 4. Heavy smokers 5. Patients undergoing or will start orthodontic treatment 6. Signs and symptoms of irreversible pulpitis.
Evaluating the Use of Patient Navigation to Promote Timely Diagnostic Evaluation During the COVID-19 Pandemic

The primary objective of this project is to evaluate the role of patient navigation in promoting timely follow-up of abnormal breast imaging findings in patient populations that have been most severely impacted by the novel coronavirus (COVID-19) pandemic. This project aims to assess the impact of patient navigation as an intervention tool in patient populations that are most at risk for delayed follow-up. The investigators hypothesize that patient navigation services may be an effective way to mitigate the impact of the pandemic by decreasing the risk of a delayed breast cancer diagnosis and promoting timely diagnostic follow-up.

Patients who meet the study selection criteria will be randomized into two groups in a 1:1 ratio: the usual care group and the intervention group. Initially, patients will be invited to participate in the study via a brief statement included in the patient result letter informing patients of their abnormal screening mammogram result. The patient navigator will then follow up with each patient who expresses interest in the study via telephone to reiterate the details of the project, answer any questions that the patients might have, and invite the patients to participate in the project if the patients meet the study inclusion criteria. Informed consent will be obtained from the study participants.

The primary role of the patient navigator will be to identify and address barriers to accessing timely diagnostic care. The patient navigator's duties will also include providing an array of services aimed at improving health care access and engagement, including appointment reminder phone calls, health education, assistance with scheduling appointments, providing information about available transportation options to the clinic sites (e.g., shuttle service provided by the institution), helping patients to connect with language interpretation services, providing assistance with resolving insurance issues, and motivating and coaching patients on the importance of timely follow-up of abnormal breast imaging results. The services provided by the patient navigator will be tailored to the specific needs of each patient and will be aimed at helping patients to overcome personal, cultural and systemic barriers to successfully completing follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have an abnormal screening mammogram (i.e. given a Breast Imaging-Reporting and Data System \[BI-RADS\] assessment category of 0) at the investigators' institution during the study period and have not yet undergone diagnostic evaluation

Exclusion Criteria:

* Any study participant who is unable to provide consent to participate in the study will be excluded.
Comparison of Noninvasive Blood Glucose Concentrations Relative to Finger Capillary Blood Glucose References

The purpose of the study is to prospectively evaluate a noninvasive, near-infrared based method for measuring glucose concentration relative to invasive blood reference measurements. The initial phase of the study will be focused on procurement of the data needed to develop a robust, accurate calibration. The second phase will be focused on performance evaluation of the system.

Currently, individuals with diabetes must use an invasive finger stick methodology for the determination of their blood glucose levels. Although current technology glucose meters use a smaller amount of blood than older generation meters, the pain and inconvenience associated with this invasive measurement is the number one reason cited for inadequate or infrequent blood glucose monitoring. In fact up to 67% of patients with diabetes fail to routinely monitor their blood glucose levels. A survey of 1895 patients showed that finger soreness was the most common reason given for self-reported noncompliance with testing recommendations, followed by pain, inconvenience, fear of needles, and "other" (including cost), (Diabetes Care August 2001 vol. 24 no. 8 1502-1503). The ability to make a painless blood glucose measurement using only light would address the pain and inconvenience issues associated with current technology glucose meters.

The initial application of the technology is associated with the monitoring of Gestational Diabetes. The International Association of Diabetes and Pregnancy Study Groups (IADPSG) recently released recommendations for diagnosing gestational diabetes, as well as clarifying the benefits of treatment (Diabetes Care, 2010;33:676-682). The IADPSG cited research that found significant graded relationships between increasing maternal glucose levels and the frequency of four primary and five secondary outcomes. For example, with a 1-standard deviation increase in maternal fasting, 1-hour, and 2-hour plasma glucose levels, there was a corresponding 38%, 46%, and 38% increased risk, respectively, in the primary outcome of birth weight \>90th percentile, and a 5%, 18%, and 16% increased risk, respectively, of the secondary outcome of premature delivery before 37 weeks gestation (N Engl J Med 2008;358:1991-2002).

Eligibility Criteria:
Inclusion Criteria:

* Female at least 20 years of age but not older than 50 years of age
* Female with Type I or Gestational diabetes based on ADA criteria
* Female with Type II diabetes and A1c of greater than 7.0 as measured on a Bayer A1C Now meter
* May include female healthy volunteers.

Exclusion Criteria:

* Subject requires hemo-dialysis
* Severe heart disease as evidenced by peripheral edema
* Liver disease as evidenced by jaundice
* Active alcohol or drug abuse
* Body Mass Index (BMI) \> 35 kg/m2
* Hand size too large to fit in the optical measurement instrumentation
* Middle finger width of less than 5 mm
* Skin damage at optical sampling site on hand
* Currently taking prednisone or other systemic steroids
* Tattoo at the optical sampling site
Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease

Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease Rating Scale, Falls, muscle strength.

The study is designed to determine the effects of Tai Chi training on balance and other functional outcomes in persons with Parkinson's disease.

Eligibility Criteria:
Inclusion Criteria:

Patients who have:

* A diagnosis of idiopathic PD, with a disease severity rating of stage I to IV on the Hoehn and Yahr scale (Hoehn \& Yahr, 1967)
* At least 1 score of 2 or more for at least 1 limb for either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS)
* Stable medication usage
* Not participated in a structured exercise program (i.e., not involved in any routine, organized physical activity program lasting 30 minutes or more per day, such as a gym program or regularly scheduled instructor-led exercise class) in the previous 2 months
* Ability to stand unaided or walk independently; had a personal physician's or neurologist's clearance for participation; and had a willingness to be assigned to intervention conditions.

Exclusion Criteria:

Patients who:

* Participate in any other behavioral or pharmacological research study
* Have cognitive decline (Mini-Mental State Examination score, ≤ 24) (Folstein et al., 1975)
* Have self-reported diagnosis of Alzheimer disease or other severe neurological (stage III and IV PD)
* Have evidence of progressive or debilitating conditions (metastatic cancer, severe heart or lung disease, crippling arthritis) or severe losses in vision and hearing that would limit their tolerance to testing and training procedures, that would interfere with study participation
* Are unavailable during the study period.
Serial [18F]Fluorodeoxyglucose ([18F]FDG )PET/CT as a Biomarker of Therapeutic Response in Anti-PD1/PDL1 Therapy

Evaluation of FDG PET/CT to image immunotherapy response in adult thoracic cancer.

Compare pre- and post-treatment primary tumor uptake for FDG-PET/CT and correlate with clinical markers of response. PET/CT tumor metabolic response will also be correlated will to progression-free survival and overall survival.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, at least 18 years of age
* Histologically confirmed non-small cell lung cancer or malignancy pleural mesothelioma with at least one site of disease \> 1 cm by at least one type of standard imaging (e.g.

CT, chest x-ray, MRI)

* Recommended to start anti-PD1/PDL1 therapy.
* Obtaining pre-PD1/PDL1 therapy clinical re-staging \[18F\]FDG-PET/CT scan at the Hospital of the University of Pennsylvania.
* Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures.
* Participants must be willing and able to comply with scheduled visits and imaging procedures in the opinion of the investigator or treating physician.

Exclusion Criteria

* Females who are pregnant or breast-feeding at the time of screening will not be eligible for this study. Female participants of child-bearing potential will have a urine pregnancy test at the time of the screening visit.
* Patients with only a single site of primary non-small cell lung cancer or malignancy pleural mesothelioma who have undergone or are recommended to undergo radiation therapy to that site will not be eligible, the inclusion of patients who may be undergoing radiation therapy to ancillary disease sites may be allowed to enter the study at the discretion of the PI if it is not felt to affect the ability to capture \[18F\]FDG information for at least one primary site of disease.
* Patients who have undergone cancer surgery removing a significant portion of active disease, in the opinion of an investigator, within 2 months prior to study enrollment will be excluded.
* Patients who have received prior immunotherapy.
* Patients with an active auto-immune disease (ie. Multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus, vasculitis).
* Inability to tolerate imaging procedures in the opinion of the investigator or treating physician
* Serious or unstable medical or psychological conditions that, in the opinion of the investigator would compromise the subject's safety or successful participation in the study.
* Unwilling or unable to provide informed consent
Pilot Trial Investigating Fermented Whey Supplementation in Healthy Adults

Pilot trial: 6-week single arm intervention. Healthy adults (male and female) consume Molkosan (fermented whey) twice a day (AM \& PM).

Molkosan® is made from fresh organic whey using a special fermentation process involving lactic acid producing bacteria (L+ lactic acid 70g/L). The company, A.Vogel (Roggwil, Switzerland) will provide the product and we will collect biological samples for analysis in a proof of concept study design that will provide preliminary data for future larger studies.

Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* BMI 18-40 kg/m-2

Exclusion Criteria:

* Diabetes
* Severe gastrointestinal disorders,
* Kidney disease,
* Thromboembolic or coagulation disease,
* Hepatic disease,
* Alcohol or any other substance abuse
* Gout
* Eating disorders
* Unregulated thyroid disease
* Dairy intolerance
* Antibiotic use within the last 3 months, including prescribed use
* Current prebiotic or prebiotic use