cyrilzakka/clinical-trials huggingface dataset:
Persona MC vs PS RCT With ROSA

A randomized, controlled study comparing two total knee implant devices, Persona medial congruent (MC) vs posterior stabilized (PS). These surgeries will be performed using the ROSA robotic system. Patients will be followed up to 5 years.


Eligibility Criteria:
Inclusion Criteria:

1. Patients ≥18 years of age
2. Patients scheduled an elective primary TKA for a diagnosis of osteoarthritis or inflammatory arthritis using the ROSA Knee System.
3. Patient is willing to cooperate and follow study protocol and visit schedule
4. Subject has access to a device is capable of pairing to the Apple Watch, supporting application updates and is compatible with the mymobility App.

Exclusion Criteria:

1. Patient is pregnant
2. Patient is unable to provide written consent
3. Revision TKA
4. History of prior infection in the affected knee
5. History of prior open surgery with significant hardware in place on the affected knee (i.e. prior distal femur or proximal tibia fracture or osteotomy)
6. Preoperative diagnosis of post-traumatic arthritis, avascular necrosis, or fracture
Neuroimaging Findings in Patients With COVID-19

This study aimed to discuss the neuroimaging findings and indications, epidemiological data, laboratory values, and the relationship of these variables with mortality in patients with COVID-19.

COVID-19 can present as neurological symptoms such as anosmia, headache, taste perversion, dizziness, syncope, and altered state of consciousness. It has been reported in previous studies that thromboembolic ischemic and hemorrhagic strokes associated with COVID-19 have been observed in the early period. It has been suggested that conditions characterized by neurological sequelae, such as encephalitis and encephalopathy, ataxic seizures, Guillain-Barré syndrome (GBS), demyelinating diseases, and neuromuscular disorders may occur in the longer term.In the present study, the investigators aimed to reveal the findings of neuroimaging analyses performed in patients followed up with a diagnosis of COVID-19 who had neurological symptoms, discuss the relationship of these findings with laboratory and epidemiological data, and emphasize that CNS involvement in these patients should not be overlooked. In this study, 436 patients with COVID-19 who underwent at least one neuroimaging procedure during April 2020-December 2020 due to neurological symptoms and whose diagnosis was confirmed by reverse transcriptase-polymerase chain reaction test were included. Although computed tomography was predominantly used for imaging, magnetic resonance imaging was also used when necessary. The patients were grouped based on imaging findings, and statistical evaluations were made between the groups.

Eligibility Criteria:
Inclusion Criteria:

* COVID-19 RT-PCR positivity-
* older than 18 years old

Exclusion Criteria:

* younger than 18 years old
Study to Assess Incidence of ONJ in Pts With Bone Mets Starting Zoledronic Acid Treatment

Prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw in cancer patient with bone metastasis starting Zoledronic acid treatment

Prospective observational multi central cohort study to assess the incidence of osteo necrosis of jaw (ONJ) in pts with bone metastasis starting Zoledronic acid treatment

Eligibility Criteria:
Inclusion Criteria:

1. Bone metastasis from multiple myeloma, solid tumors, or other malignancy for which intravenous bisphosphonate has clinical indications in the treatment of metastatic bone disease.
2. All participants must be planning to receive zoledronic acid (as their sole bisphosphonate therapy) within 30 days after registration. Patients previously treated with bisphosphonate therapy are eligible if the following criteria apply:

   1. Patients may have previously received at most 3 doses of intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid for low bone mass (osteopenia or osteoporosis) within 3 years prior to registration or
   2. Patients may have received intravenous bisphosphonate therapy with ibandronate, pamidronate or zoledronic acid to treat metastatic bone disease within 90 days prior to registration. Patients receiving any of these regimens for metastatic bone disease prior to 90 days before registration are not eligible, or c. Prior oral bisphosphonate therapy at any time prior to registration is allowed.
3. No pre-existing diagnosis of ONJ.
4. No history of radiation to the maxillofacial area administered for therapeutic intent in the treatment of cancer.
5. Zubrod performance status of 0-3.
6. Willing and physically able to comply with the study procedures and assessments.
7. Can concurrently participate in other therapeutic and non-therapeutic clinical trials.
8. No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for 5 years.
9. Must be informed of the investigational nature of this study and must sign and give written informed consent.
Effect of Reducing Uric Acid on Insulin Sensitivity and Oxidative Status

The purpose of this study is to learn more about what is the effect of uric acid on oxidative stress and on the way the body metabolizes sugar in obese people. Understanding this may lead to better diseases such as diabetes.

It has been hypothesized that oxidative stress is involved in the pathogenesis of insulin resistance associated with obesity. Circulating uric acid (UA) is the body's major endogenous plasma antioxidant. Therefore, the investigators evaluated whether alterations in serum UA concentration affect: 1) systemic and skeletal muscle oxidative stress, 2) total antioxidant capacity, and 4) skeletal muscle insulin sensitivity during a hyperinsulinemic-euglycemic clamp.

Eligibility Criteria:
Inclusion Criteria:

* obese (BMI 30-45 kg/m²);
* serum UA concentration either ≥5 mg/dL or ≤4.0 mg/dL (297 µmol/L)\],

Exclusion Criteria:

* renal dysfunction (serum creatinine \>1.5 mg/dL);
* pregnancy or lactating;
* take urate-lowering agents, thiazide diuretics, prednisone or medications containing aspirin or other salicylates;
* history of xanthinuria, type 2 diabetes or other significant organ system dysfunction;
* have G6PD deficiency;
* use hormone-replacement or oral-contraceptive therapy;
* smoke tobacco;
* anemic (Hb \<10 g/dl)
A Study Assessing the Safety and Efficacy of Adding Ipatasertib to Paclitaxel Treatment in Participants With Breast Cancer That Has Spread Beyond the Initial Site, and the Cancer Does Not Have Certain Hormonal Receptors

This multicenter, randomized, double-blind study will estimate the efficacy, safety and tolerability of ipatasertib combined with paclitaxel compared with placebo combined with paclitaxel in participants with inoperable locally advanced or metastatic triple-negative breast cancer (mTNBC), as measured by progression-free survival (PFS) in all participants and in participants with phosphatase and tensin homolog (PTEN)-low tumors.


Eligibility Criteria:
Inclusion Criteria:

* Histologically documented triple-negative adenocarcinoma of the breast that is inoperable locally advanced or metastatic and is not amenable to resection with curative intent
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Availability of a representative formalin-fixed, paraffin-embedded (FFPE) tumor specimen, required prior to randomization
* Measurable disease, according to the RECIST v1.1
* Adequate hematologic and organ function within 14 days before the first study treatment
* For female participants of childbearing potential, agreement (by both participant and partner) to use an effective form of contraception for the duration of the study and for 6 months after last dose of study treatment

Exclusion Criteria:

* Any previous therapy, including chemotherapy or hormonal or targeted therapy, for inoperable locally advanced or metastatic triple-negative adenocarcinoma of the breast. Participants may have received prior neoadjuvant or adjuvant chemotherapy and/or radiation treatment for locally advanced triple negative adenocarcinoma, provided all treatments were completed greater than or equal to (\>/=) 6 months prior to Cycle 1 Day 1. Locally recurrent disease must not be amenable to resection with curative intent
* Any radiation treatment to metastatic site within 28 days of Cycle 1, Day 1
* Known Human Epidermal Growth Factor Receptor 2 (HER2) positive, erythrocyte receptor (ER) positive, or progesterone receptor (PR) positive breast cancer
* Previous therapy with Akt, PI3K, and/or mTOR inhibitors
* Major surgical procedure, open biopsy, or significant traumatic injury within 30 days prior to Cycle 1, Day 1 or anticipation of need for a major surgical procedure during the course of the study
* Known presence of the brain or spinal cord metastasis, as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening or prior radiographic assessments
Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray in Elderly Patients With Nocturia

The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.

Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration

Eligibility Criteria:
Inclusion Criteria:

* Male \& female greater or equal to 75 years of age, history of nocturia

Exclusion Criteria:

* CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome
* Unexplained pelvic masses
* Urinary bladder surgery or radiotherapy
* Sleep apnea
Performance Evaluation Platform for Seniors.

Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne.

Monocentric prospective non-randomized observational study with subgroup analysis on the assessment of the day hospital at the Aging Biennial Hospital of Saint-Etienne.

The main objective is to investigate the factors limiting or encouraging adherence to recommendations in a population aged over 65, fragile or pre-fragile, autonomous and living at home or in a shelter.

Patients will benefit from a multidisciplinary assessment including a geriatric assessment standardized by a geriatrician, an evaluation by a dietician, an evaluation by an occupational therapist. They will then be exposed to a personalized plan of care in the form of a recommendation.

Patients will be followed at home to evaluate the implementation of their personalized care plan at 3 months of their assessment day at the day hospital, then at 6 and 9 months. The study will take place over a period of approximately 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Person affiliated or entitled to a social security scheme
* People aged 65 and over who participated in a consultation to age well at the day hospital of the St-Etienne university hospital during the study period.
* Elderly people who received an information about the study and who co-signed, with the investigator, a consent to participate in the study

Exclusion Criteria:

* Seniors who refused to participate
* Elderly people under legal protection measures
* Severe cognitive impairment
Evaluation of a New Hysteroscopic Grasper for Endometrial Biopsy in Post-menopausal Patients

Hysteroscopic endometrial biopsy is usually performed through the classic spoon grasper. Recently, a new hysteroscopic grasper with knurled terminal end and cutting jaws was designed, in order to improve feasibility of the procedure, reduce its duration and the discomfort for the patients.

This study aims to compare the outcomes of the three hysteroscopic graspers for endometrial biopsy in post-menopausal patients.

Diagnostic hysteroscopy is currently the gold standard method to evaluate uterine cavity and tubal ostia, allowing also the visualization of vaginal walls and the cervical canal. Compared to the other available diagnostic techniques, hysteroscopy has the advantage of directly visualization the anatomical area to be investigated and allows to perform biopsy. The possibility of hysteroscopy-guided biopsy sampling is particularly important in order to get histological diagnosis. As recently suggested, the hysteroscopic biopsy of the endometrium has diagnostic accuracy of 90% for post-menopausal endometrial cancer.

Currently, most diagnostic hysteroscopies are performed in outpatient setting, without anesthesia, using modern hysteroscopes with a 1.67 mm working channel. In particular, endometrial biopsy is usually performed through the classic spoon grasper or alligator grasper. Recently, a new hysteroscopic grasper with knurled terminal end and cutting jaws was designed, in order to improve feasibility of the procedure, reduce its duration and the discomfort for the patients.

This study aims to compare the outcomes of the three hysteroscopic graspers for endometrial biopsy in post-menopausal patients.

Eligibility Criteria:
Inclusion Criteria:

* Physiologic menopause
* Vaginal bleeding or endometrial thickness (\>5 mm)

Exclusion Criteria:

* Hormonal replacement therapies
* Other known causes of vaginal/cervical bleeding
* Suspected or known cancer(s)
* Premature or iatrogenic menopause
* Uterine cervix stenosis
Genetic Testing for Men With Metastatic Prostate Cancer

This research study provides genetic testing to men with prostate cancer that has spread to other parts of the body (metastatic prostate cancer) and will look for inherited genetic mutations in about 30 cancer-risk genes. The researchers seek to learn about the participant's opinions and concerns about genetic testing, to determine if this is an acceptable way to deliver testing and to potentially help guide the participant's treatment. Neither treatment nor any decisions related to treatment will take place on this study, but researchers will share each participant's genetic testing results with that participant.

OUTLINE:

Participants receive web-based or hard-copy questionnaires and saliva collection kits via mail or in person. Participants also provide saliva samples to be mailed back to Color Genomics for genetic testing once complete. Participants then receive phone-based genetic counseling if they are identified to have an inherited mutation in a deoxyribonucleic acid (DNA) repair gene. All participants have access to phone-based genetic counseling whether or not they are not found to have a mutation.

After study completion, participants are followed up at 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent form (ICF) providing agreement for germline genetic testing, use and release of health and research trial information
* Documented evidence of metastatic prostate cancer;

  * Oncologist note within 4 months
  * All computed tomography (CT), bone, positron emission tomography (PET) scan reports within 12 months
  * All prostate-specific antigen (PSA) values within 12 months
  * All available pathology reports from diagnosis, prostatectomy, and/or metastatic biopsy
* Willingness to provide basic demographic information, family cancer history, and treatment history
* Willingness and ability to complete patient reported outcomes questionnaire (on-line or hard copy) at enrollment, and at 6-month follow-up
* Willingness and ability to provide saliva sample

Exclusion Criteria:

* Unable or unwilling to provide all of the necessary information for eligibility, e.g. decisionally impaired
* Incomplete inclusion criteria
* Study team members
EFFECT OF KINESIO TAPING ON POST-C-SECTION PAIN AND COMFORT

Kinesio taping gently stretches the skin and creates a gap between the dermis and fascia, increasing lymphatic and vascular flow and reducing pain without restricting movement. It is used to provide rehabilitation after surgical operations. This study will be conducted to determine the effect of kinesio taping on the mother\&#39;s pain and comfort after cesarean section. It is planned to include 60 women who gave birth by cesarean section in the obstetrics and gynecology department at Şırnak State Hospital. Research data will be collected with the visual analog scale and postpartum comfort scale. If the data shows normal distribution, Unrelated Samples t Test, Related Samples t Test and Repeated Measures ANOVA (Repeated Measures) tests will be used.


Eligibility Criteria:
Inclusion Criteria:

* patients having C-section delivery in the 37th and 40th gestational weeks,
* patients giving birth to just a baby,
* patients with no chronic disease (such as allergy, diabetes, or hypertension),
* patients having no problems with communication,
* patients with no dermatological disease.

Exclusion Criteria:

* patients whose babies are in the neonatal intensive care unit,
* patients with deep vein thrombosis, open wounds, or skin irritation,
* patients who did not want to participate in the study,
Medium Chain Triglycerides Plasma Profile and Their Metabolites After Oral Peptamen Intake

Medium Chain Triglycerides (MCT) have been used for many years as a good source of lipid to decrease potential for fat malabsorption. However, the pharmacokinetics of MCT and of their metabolites have not been explored in details.

This is an exploratory study aiming at determining the plasma level of MCT and their metabolites after oral intake of Peptamen.

20 subjects will be given 250mL of peptamen 1.5 twice, with 4 hours of interval, on a single day.

Plasma kinetics of MCTs and their metabolites will be made over 8 hours from baseline

Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females
* Aged between 20 and 65 years old
* BMI in the normal range (18.5 to 25.0 kg/m2)
* Having signed his/her consent form

Exclusion Criteria:

* Clinically relevant digestive (including malabsorption or major surgery), renal, hepatic, pancreatic or metabolic disease (diabetes, hypo or hyperthyroidism, hypo or hypercorticism), as determined by the medical (screening) visit and a standard blood chemistry analysis (glucose, total cholesterol, ALDL, AHDL, triglycerides, ASAT, ALTI, gamma GT, RCRP, creatinine)
* Medically diagnosed anemia based on a blood formula
* Food allergy, lactose intolerance and intolerance to milk proteins (anamnesis)
* Smokers (anamnesis)
* Pregnancy (anamnesis)
* Under corticoids or hormone (adrenal, thyroid) treatment
* Alcohol intake: \> 2 units a day (anamnesis)
* Consumption of illicit drugs (anamnesis)
* Having given blood within the last month, or willing to make a blood donation until one month following the end of the study
* Subject who cannot be expected to comply with the study procedures, including consuming the test product
* Currently participating or having participated in another clinical trial during the last month prior to the beginning of this study.
The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Tourette Syndrome

The purpose of this clinical study is to verify the long term effectiveness and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with cognitive, behavioral, and functional disability of Tourette Syndrome.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is aged 18 or older
2. Patient Group with Tourette's syndrome, Diagnosis of Tourette Syndrome by DSM-IV

Exclusion Criteria:

1. Major Depressive Episode within the previous 6 months
2. Schizophrenia or other psychotic disorder.Participate in other clinical trial;
3. Has a life expectancy of \< 1 year.
4. The investigator and/or enrollment review committee, would preclude participation in the study.
Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology

To determine the sensitivity and specificity of the visual assessment of tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth


Eligibility Criteria:
Inclusion Criteria:

* Females, no child-bearing potential or negative urine pregnancy test on day of BAY94-9172 injection
* Exhibits visual, auditory, and communicative capabilities adequate to provide informed consent or assent and comply with study procedures
* Is willing and able to lie down in magnetic resonance imaging (MRI) and positron emission tomography (PET) scanners
* Is willing to donate their brain for postmortem examination in case of death
* The subject, or the subject and/or legally acceptable representative will be compliant and have a high probability of completing the study in the opinion of the investigator
* Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative
* The subjects who have participated in a previous florbetaben study e.g. study 311741 may be included in the present study. The MRI- and florbetaben PET scan do not need to be repeated if both scans were performed within twelve months prior to inclusion.

Exclusion Criteria:

* Has severe cerebral macrovascular (ie, multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI
* Has any contraindication to magnetic resonance imaging (MRI) examination, eg, metal implants or phobia as determined by the onsite radiologist performing the scan
* Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
* Has severe cardio-vascular instability requiring intensive care surveillance and/or therapeutic intervention (i.e. catecholamine infusion)
Assessment of Blood Glucose Monitoring Devices With New Insight Features

To investigate whether novel insight features in new BGMs can improve glycemic control.


Eligibility Criteria:
Inclusion Criteria Summary:

* Diagnosed with T1DM or T2DM for ≥ 3 month prior to screening
* Currently performing SMBG at home for diabetes management decisions
* Willingness to notify the study staff if they become pregnant during the study
* Willing to sign an informed consent

Exclusion Criteria Summary:

* Is unlikely to be compliant with the diabetes regimen in the opinion of study staff
* Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn
* Conflict of Interest