cyrilzakka/clinical-trials huggingface dataset:
Prospective Study Measuring Clinical Outcomes of Knee Arthroplasty Using the VERASENSE™ Knee System

The primary objectives of this evaluation are: 1) To attempt to refine the current clinical understanding of "balance" 2) To determine if patients with quantifiably balanced knee joints exhibit improved clinical outcomes versus patient with residual imbalance, as measured by the VERASENSE™ Knee System

Secondary objectives:

* Determine whether a difference in inter-compartment loads and soft tissue tension exists between the physicians intra-operative feel compared to the quantifiable data measured by the VERASENSE™ Knee System
* Determine which ligament releases are performed by the surgeon to improve soft tissue balance while utilizing the information from the VERASENSE™ Knee System
* Evaluate range of motion, pain, physical function, activity level, and patient satisfaction between baseline (pre-operative) and post-operative follow-up as well as radiographic success and survivorship of the knee implants


Eligibility Criteria:
Inclusion Criteria:

* Subject must be a candidate for a primary total knee replacement
* Subject must be diagnosed with one or more of the following conditions: osteoarthritis, avascular necrosis, rheumatoid or other inflammatory arthritis post-traumatic arthritis
* Subject's joint must be anatomically and functionally suited to receive the selected implant
* Subject is 50 years of age or older (≥ 50 yrs) at the time of consent
* Subject is likely to be available for all study visits
* Subject is able and willing to sign the informed consent and follow study procedures
* Subject is not pregnant

Exclusion Criteria:

* Prior total knee arthroplasty
* Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is pregnant
* Subject has an active infection or joint sepsis
* Subject has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints)
* Ligament insufficiencies, prior surgeries such as ACL or PCL reconstructions, posterolateral reconstructions, osteotomies, tibia plateau fractures
* Range of Motion less than 90 degrees, flexion contracture of more than 20 degrees
FSL2 Post Approval Study for Pediatric and Young Adults Patients

This is a prospective, multi-center, non-randomized, single-arm study intended to characterize the safety of the FreeStyle Libre 2 Flash Glucose Monitoring System when used to manage diabetes in pediatric and young adult patient populations.

Approximately 550 pediatric and young adult subjects aged 4-30 years with type 1 or type 2 diabetes, who require daily blood glucose monitoring to manage their diabetes will be enrolled in the study. Subjects and/or their caregivers will utilize he FreeStyle Libre 2 Flash Glucose Monitoring System for managing diabetes for 6 months. Subjects and/or their caregivers will maintain a diary/log book of Adverse Events experienced during the duration of the study. Assessment of Adverse Events will occur via self reporting at each monthly visit and/or phone call.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be 4 - 30 years of age.
2. Subject must have a diagnosis of type 1 or type 2 diabetes mellitus for at least 3 months prior to enrollment.
3. Subject is currently using Self Monitoring of Blood Glucose (SMBG) for managing their diabetes.
4. Subject has completed participation in clinical study ADC-US-PMS-20194 or has at least six (6) months of medical history hypoglycemia or hyperglycemia requiring healthcare professional intervention.
5. Subject and/or caregiver must be able to read and understand English.
6. In the investigator's opinion, the subject and/or caregiver must be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol.
7. Subject and/or parent or guardian must be willing and able to provide written signed and dated informed consent and assent when appropriate.

   Exclusion Criteria:
8. Subject has previously used a continuous glucose monitoring system to manage their diabetes within the last six (6) months.
9. Subject has known allergy to medical grade adhesive or isopropyl alcohol used to disinfect skin.
10. Subject is known to be pregnant or is attempting to become pregnant at the time of enrollment.
11. Subject is on dialysis at the time of enrollment.
12. Subject has concomitant medical condition which, in the opinion of the investigator, could interfere with the study or present a risk to the safety or welfare of the subject or study staff.
13. Subject currently is participating in another clinical trial.
14. Subject is unsuitable for participation due to any other cause as determined by the Investigator.
Aloe Vera in Chronic Periodontitis With Type 2 Diabetes Mellitus

The present study is designed to investigate the effectiveness of AV gel local drug delivery as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic periodontitis (CP) and type 2 diabetes mellitus (DM).

BACKGROUND: Advances in the field of alternative medicine have promoted widespread use of herbal agents, like Aloe vera (AV), for both medical and dental therapy. AV has anti-inflammatory, antioxidant, antimicrobial, hypoglycaemic, healing promoting and immune boosting properties. The present study is designed to investigate the effectiveness of AV gel local drug delivery as an adjunct to scaling and root planing (SRP) in the treatment of subjects with chronic periodontitis (CP) and type 2 diabetes mellitus (DM).

MATERIAL AND METHODS: A total of 60 subjects with probing depth (PD) ≥5mm and clinical attachment level (CAL) ≥3mm were randomly divided into two groups. Group 1 was treated with SRP + placebo gel local drug delivery (LDD) and Group 2 with SRP + AV gel LDD. Clinical parameters including full mouth plaque index (PI), modiﬁed sulcus bleeding index (mSBI), probing depth (PD) and clinical attachment level (CAL) were recorded first at baseline and then at intervals of 3 months and 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Well-controlled type 2 DM
* Chronic periodontitis with moderate to deep pockets \[probing depth (PD) ≥5mm and clinical attachment loss (CAL) ≥3mm\]
* No history of antibiotic or periodontal therapy in the preceding 6 months.

Exclusion Criteria:

* Any known disease/condition or on any medication that can affect the periodontal status
* Known or suspected allergy to herbal medications
* Systemic antimicrobial therapy
* Aggressive periodontitis
* Smokers
* Alcoholics
* Immunocompromised patients
* Pregnant or lactating females
GLORIA-AF Registry Program (Phase II/III)

In this part of the Registry Program patients with non-valvular atrial fibrillation (AF) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events.

For administrative purposes the study is divided into three protocol numbers: 1160.129 for all non-EU (European Union) and non-EEA (European Economic Area) countries, 1160.136 for EU and EEA countries and 1160.171 for Switzerland. The total number of patients enrolled in three protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.


Eligibility Criteria:
Inclusion criteria:

1) Patients newly diagnosed with non-valvular atrial fibrillation (NVAF) at risk for stroke.

Further inclusion criteria apply

Exclusion criteria:

1. Presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention;
2. Patients who have received more than 60 days of vitamin K antagonist (VKA) treatment in their lifetime;
3. AF with a generally reversible cause;
4. Patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a VKA) is indicated.

Further exclusion criteria apply
Assessing Reproductive Outcomes in Young Female Cancer Survivors Through a National Fertility Preservation Registry

The FIRST project is a national fertility preservation registry for young women facing cancer treatments. The investigators will examine how different cancers and treatments affect the reproductive health of young survivors. This prospective cohort study seeks to recruit young women close to time of cancer diagnosis and treatment. Participants will answer a yearly questionnaire on their current health. A subset of participants will provide dried blood spots to measure reproductive hormones. The primary goal of the study is to determine the risk of infertility and time to pregnancy in young female cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with cancer or exposure to cancer treatment
* English speaking
* Ability to consent to the study
AMG 176 With Azacitidine in Subjects With Myelodysplastic Syndrome /Chronic Myelomonocytic Leukemia

The main objective is to assess the safety, tolerability, and efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of Higher-Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia (HR-MDS/CMML).

This study is a Phase 1 clinical trial designed to assess the safety, tolerability, and efficacy of AMG 176 as monotherapy and in combination with the 7-day regimen of azacitidine for the treatment of HR-MDS/CMML. Participants will be treated with intravenous (IV) AMG 176 and IV or subcutaneous (SC) azacitidine.

Eligibility Criteria:
Inclusion Criteria:

* Age \>= 18 years of age
* For Part 1, participants have R/R MDS post-HMA failure, defined as prior receipt of 4 cycles of HMA therapy (including but not limited to decitabine, azacitidine, investigational HMAs such as SGI-110, and oral HMAs such as oral decitabine and cedazuridine \[ASTX727\] and oral azacitidine \[CC-486\]) with failure to attain a response or progression of disease or relapse at any time after prior response to HMA therapy

  a. Note: participants with HR-CMML (CMML-1 or 2 by World Health Organization \[WHO\]) are eligible. Hydroxyurea administration will be allowed on the study to lower the white cell count to \<= 10 000/μL prior to the initiation of therapy
* For Part 2, participants will be divided into 2 cohorts:

  1. HMA Failure Cohort: participants with R/R MDS post-HMA failure. Participants who have previously received venetoclax are eligible and will be stratified accordingly in the HMA failure cohort;
  2. Newly Diagnosed Cohort: Participants with treatment-naïve newly diagnosed HR-MDS (revised International Prognostic Scoring System \[IPSS-R\] score \>3.5) are eligible for enrollment only after all prior cohorts have been completed. Hydroxyurea administration will be allowed on the study to lower the white cell count to \<= 10 000/μL prior to the initiation of therapy. Participants with HR-CMML (CMML-1 or 2 by WHO) are eligible

Exclusion Criteria:

* Participants with newly diagnosed MDS with Revised International Prognostic Scoring System (IPSS-R) lower-risk category (IPSS-R score \< 3.5)
* Participants with CMML-0 by WHO
* History of other malignancy within the past 2 years prior to enrollment (with some exceptions as listed in full list of criteria)
* Excluded prior and/or concomitant therapies as listed in the full list of criteria
* Participants who are fit and deemed eligible by the investigator for intensive salvage therapy
Development and Validation of a Scale Measuring Preoperative Expectations in Parkinson's Disease

Subthalamic nucleus deep brain stimulation (STN-DBS) has become a choice treatment for fluctuating Parkinson's disease (PD) patients, inducing remarkable improvement in motor symptoms. However, as PD is a complex neuropsychiatric disease, it has been hypothesized that in some patients, non-motor features, i.e. dysfunctional expectations for the result of neurosurgery, could interfere with postoperative result of DBS, even in case of motor improvement. Recent literature highlights the necessity to take these preoperative expectations into account, but to our knowledge, no specific scale investigating these cognitions in this PD-specific condition is available. So, the investigators developped the DBS-PS, a self-scale constructed to measure preoperative expectations for DBS, with 11 questions and visuo-analogical responses (1 to 10), theorically divided in three domains investigating the expectations concerning symptoms of PD, postoperative social-life and leisures, and postoperative familial and marital sphere. The investigators would like to validate this new-developped scale in the preoperative subthalamic nucleus deep brain stimulation population through patients recruited in the Predistim study, whereas the investigators did not recruite sufficiently patients through the PsyParkinson study, the one in which the DBS-PS scale was developed. The DBS-PS constitutes an interesting basis for the consideration of these cognitive and affective factors in preoperative PD patients.


Eligibility Criteria:
Inclusion Criteria:

* Parkinson's disease patients included in the Predistim study and having completed the DBS-PS scale during the preoperative phase

Exclusion Criteria:

* Parkinson's disease patients not included in the Predistim study or not having completed the DBS-PS scale during the preoperative phase
A Study to Evaluate Safety, Tolerability and Pharmacokinetics of MKND-201 in Healthy Volunteers

MKC-NI-001 is a Phase 1, first-in-human, randomized, double-blind, placebo-controlled study of nintedanib inhalation powder (MNKD-201) in healthy adult volunteers. The trial consists of a Single Ascending Dose (SAD), followed by a Multiple Ascending Dose (MAD) with a primary objective to evaluate the safety, tolerability, and pharmacokinetics (PK) of MNKD-201 compared to placebo in healthy adult participants.


Eligibility Criteria:
Key Inclusion Criteria:

* Is ≥40 and ≤65 years of age at the time of signing the informed consent form.
* Has a negative urine test for selected drugs of abuse and negative alcohol test at screening and upon admission to the CRU on Day -1. Note: Participants should not consume poppy seeds within 24 hours before urine drug screening because this can falsify the results of the opiate urine drug test.
* Is willing to adhere to the restrictions and requirements specified in the protocol.
* Has a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) test (i.e., the virus that causes COVID-19) on Day -1.
* Is capable of performing spirometry, as required by the study procedures.

Key Exclusion Criteria:

* Has a history of significant lung disease (e.g., pulmonary fibrosis, cystic fibrosis, COPD, emphysema, chronic pulmonary infection, recent upper or lower respiratory tract infection in the prior 8 weeks, history of lung surgery or procedure, etc.)
* Has endocrine, thyroid, or respiratory disease, diabetes mellitus, coronary heart disease, GI disease, or history of any psychotic mental illness.
* Has a history of hepatic disease or has abnormal liver function tests (i.e., aspartate aminotransferase \[AST\] \> 1.5 × upper limit of normal \[ULN\] or alanine aminotransferase \[ALT\] \> 1.5 × ULN) at screening.
* Has renal impairment (estimated glomerular filtration rate \[eGFR\] \< 60 mL/min/1.73 m2), as calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI), at screening.
* Has any history of pulmonary malignancy.
* Has a history of substance abuse or dependency or history of recreational drug use over the last 2 years (by self-declaration).
Multicentre Medical-economic Study Evaluating the Efficacy of Adding ZOlédronique Acid to STERéotaxique Radiotherapy in the Treatment of Vertebral Metastases

Hypo-fractured radiotherapy in stereotactic conditions (RSHF) of bone metastases allows high doses to be delivered to the affected bone segment while sparing adjacent healthy tissues as well as possible. In addition, it not only reduces pain and prevents spinal cord compression, but also improves long-term control of metastatic disease.

Zoledronic acid reduces bone complications. The economic literature shows that stereotactic radiotherapy, like zoledronic acid, are cost-effective strategies in these indications. The objective of this research project is to evaluate the efficiency of adding zoledronic acid to stereotactic radiotherapy in the treatment of vertebral metastases.


Eligibility Criteria:
Inclusion Criteria:

* Cancer with inoperable thoracic and/or lumbar vertebral metastasis;
* Age ≥ 18 years old ;
* Life expectancy greater than 1 year;
* OMS or PS ≤ 2 ;
* Effective contraception for women of childbearing age;
* Patient information and free, informed and written consent, signed by the patient and investigator;
* Patient affiliated or beneficiary of the social security system.

Exclusion Criteria:

* Cancer with inoperable thoracic and/or lumbar vertebral metastasis;
* Painful patient unable to maintain a lying position for 30 minutes despite analgesic treatment;
* Patient who has received external irradiation from the proposed irradiation area \> 20 Gy ;
* Signs of neurological compression;
* Spinal cord compression or epidural damage requiring surgery before radiotherapy;
* Clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any excipient;
* History of osteonecrosis of the maxilla or bone exposure or delayed healing after dental surgery;
* Previous (less than 2 years) or ongoing treatment with a bisphosphonate;
* Creatinine clearance \< 30 ml/min;
* Pregnant or breastfeeding woman;
* Patient protected or under guardianship or incapable of giving consent;
* Impossibility to submit to the medical follow-up of the trial for geographical, social or psychological reasons.
Evaluation of AXR-270 for the Treatment of Posterior Blepharitis Associated With Meibomian Gland Dysfunction

This study will evaluate the safety, tolerability and efficacy of AXR-270 Cream in treating posterior blepharitis associated with Meibomian Gland Disease (MGD)

AXR201901 is a multicenter, randomized, double-masked, vehicle-controlled study of AXR-270 cream and AXR-270 vehicle in subjects with signs and symptoms of posterior blepharitis associated with meibomian gland dysfunction

Eligibility Criteria:
Inclusion Criteria:

Male or female, 18 years or older

Have a clinical diagnosis of moderate to severe MGD (total MGD score between 5 and 14 on a scale with a range between 0 and 15; and clinical severity score of eyelid margin vascularity of at least 2 (moderate))

Have a score of ≥35 on Eye Discomfort using VAS

Have a tFCS score between 3 and 14 on the NEI scale

Have a Schirmer score of \>7 mm

Have a OSDI score \>30

If female, then subject should be non-pregnant and non-lactating

Exclusion Criteria:

Subjects with iritis, uveitis in either eye

Subjects with conjunctivitis, keratitis, severe anterior keratitis not related to MGD

Subjects with lid abnormalities

Subjects with ocular fungal, viral or bacterial infection

Subjects unable or unwilling to withhold the use of eyelid scrubs

Subjects with glaucoma and serious systemic disease
The Impact of Daily Intake of Short-chain Fatty Acids on Cardiometabolic Risk Factors in Individuals at Risk for Metabolic Syndrome

During this study, the effect of short-chain fatty acids on blood lipaedemia, glycemia, anthropometrics, blood pressure and energy expenditure will be investigated.

The goal of this study is to investigate the impact of consuming every day a drink enriched with short-chain fatty acids for 12 weeks on the cardiometabolic health in individuals at risk of metabolic syndrome. This means the investigators are looking for people with overweight and disrupted cholesterol, high blood pressure or elevated blood glucose. The individuals will consume for 12 weeks a drink either enriched with SCFA or a control drink (randomly allocated). Before and after this period (study visit 1 and 4), a study visit will take place in which metabolic parameters will be measured such as blood pressure, body weight, waist- and hip circumference, body composition, energy expenditure, glucose, insulin and blood lipids. After 4 and 8 weeks, anthropometrics, blood pressure and body composition will be measured during a short study visit (study visit 2 and 3).

Eligibility Criteria:
Inclusion Criteria:

* male and female participants
* central obesity ( BMI ≥ 25 kg/m² or waist circumference ≥ 80 cm for women/ ≥ 94 cm for men)
* One additional risk factor for metabolic syndrome:

  1. Insulin resistance (HOMA-IR ≥ 1.7 or fasting glucose ≥ 100 mg/dl)
  2. Triglyceride concentration ≥ 150 mg/dl
  3. HDL-cholesterol \< 40 mg/dl for women/ \< 50 mg/dl for men
  4. Systolic blood pressure ≥ 130 mmHg or diastolic blood pressure ≥ 85 mmHg
* knowledge of English

Exclusion Criteria:

* gastrointestinal disorders such as IBD, IBS, celiac disease, chronic constipation, chronic diarrhoea
* history of abdominal surgery, except for appendectomy
* Use of antihypertensive, cholesterol lowering, glucose-regulating drugs and corticosteroids
* Use of antibiotics 3 months prior to the start or during the study
* Use of probiotics and prebiotics 2 weeks prior to the start of the study/ during the study
* Being on weight loss, gluten-free, lactose-free or vegan diet
* Pregnancy, lactation or wish to become pregnant
* Previous or current substance/ alcohol dependence or abuse
* Hyper- or hypothyroidism
* Allergy or intolerance to oat milk
Prevalence and Effect of Lifestyle Modification on Clinical Outcomes and Cost-effectiveness Ratio for Sarcopenia

The purposes of this study were to investigate the prevalence and risk factors for sarcopenia in Chinese adults and elderly, and evaluate the effect of Lifestyle Modification Project (LMP) on Clinical Outcomes, Quality of Life and Cost-effectiveness Ratio.


Eligibility Criteria:
Inclusion Criteria:

* age\>=18 year The participants must have basic cognitive function and communication Must be able to provide a written informed consent

Exclusion Criteria:

* age\<18 year Concurrent severe cardiac disease, unstable diabetes mellitus,uncontrolled chronic disease,liver and renal failer, which may significantly interfere with study compliance.

Participants received any drugs or supplements known to influence effcet size,such as protein powder, calcium, or vitamin D before the 3 months preceding the study. Participants with electronic or mental device