cyrilzakka/clinical-trials huggingface dataset:
Periprosthetic Bone Mineral Density After Total Hip Arthroplasty Performed Through a Minimally Invasive Anterior Approach (AMIS) With Either an AMIStem or a Quadra Femoral Component

This is a monocentric, prospective, randomized clinical survey to verify if the periprosthetic remodelling brought about either the AMIStem or the Quadra femoral component is equivalent.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are willing and able to provide written informed consent for participation in the study. Written informed consent must be obtained prior to the patient's surgery.
* Patients presenting with disease that meets the indications for use for Medacta implants defined by this study (on-label use (enclosure 2)).
* Patients must be willing to comply with the pre and post-operative evaluation schedule.
* Patients with only one lower limb arthroplasty

Exclusion Criteria:

* Patient with metabolic bone diseases, use of steroids or other drugs affecting bone metabolism
* Patients with osteoporosis (pre-op T-score \< -2,5)
* Patients with significant comorbidities
* Patients with both hip and knee arthroplasty
* Patients with restricted mobility
* Patient with severe hip contracture
* Those with one or more medical conditions identified as a contraindication defined by the labeling on any Medacta implants used in this study
Improving Medication Adherence in Comorbid Conditions

This study is designed to study how adults with Type 2 Diabetes and either high blood pressure and/or high blood cholesterol manage their treatment regimen. It is also called the Diabetes Management Study. Individuals need to be 40 years of age or older and on oral medication (pills) management for two of the three conditions of interest. They may also be on other treatment such as insulin, diet and/or exercise programs. Individuals will be followed for approximately 12 months. About 1/4 of the persons in the study will receive a telephone counseling program with a nurse focused upon their management of their treatment program.


Eligibility Criteria:
* Type 2 diabetes mellitus, hypertension and/or hyperlipidemia,
* On oral medication for two of the above conditions,
* Manage own medications,
* Must have access to a telephone,
* Not participating in other adherence education or counseling trials
Study of Talabostat + Docetaxel Versus Docetaxel in Stage IIIB/IV Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy

This Phase 3 study will compare the efficacy of talabostat plus docetaxel to docetaxel plus placebo in patients with Stage IIIB/IV NSCLC who have failed a platinum-based chemotherapy regimen.


Eligibility Criteria:
INCLUSION CRITERIA:

* Men or women age 18 years or older
* Histologically or cytologically confirmed NSCLC

  * Recurrent, locally advanced or metastatic, inoperable NSCLC (Stage IIIB/IV)
  * Patients with Stage IIIB NSCLC must have a cytologically documented pleural effusion
* Failed or relapsed after receiving a platinum-containing chemotherapy regimen as first-line therapy for advanced NSCLC
* Measurable disease on computerized tomography (CT) scan
* ECOG Performance Status of 0 or 1
* Expected survival ≥12 weeks
* Provide written informed consent

EXCLUSION CRITERIA:

* More than 2 prior chemotherapy regimens
* Clinically significant laboratory abnormalities, specifically:

  * Total bilirubin ≥ institutional upper limit of normal (ULN)
  * Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥1.5 x ULN concomitant with alkaline phosphatase \>2.5 x ULN
  * Serum creatinine ≥2.0mg/dL
  * Absolute neutrophil count \<1500/μL or platelets \<100,000/μL
* Untreated or symptomatic brain metastases
* Any malignancy within the 5 years immediately prior to the first dose of study medication with the exception of basal cell or non-metastatic squamous cell carcinoma of the skin, and carcinoma in-situ of the cervix
* A history of severe hypersensitivity to drugs formulated with polysorbate 80
* Any comorbidity or condition which, in the opinion of the investigator, may interfere with the assessments and procedures of this protocol
* Patients who are within 28 days of chemotherapy, radiation therapy, immunotherapy, or other investigational medication for NSCLC.
* Pregnancy or lactation. Women of childbearing potential and non-vasectomized men must agree to use a barrier method of contraception.
Cardiac Changes Associated With Acute Cerebro-vascular Stroke

Cardiovascular disease is regarded as main predisposing risk factor for cerebrovascular stroke.

Cardiac dysfunction can both worsen the pre existing cerebral damage and cause new brain injury Diseases of the heart and the brain are closely entangled. Vascular diseases of both organs share the same risk factors.


Eligibility Criteria:
Inclusion Criteria:

1. above 18 years
2. patients presented with cerebrovascular stroke 3-patients diagnosed as cardiac patients and have cerebrovascular stroke

Exclusion Criteria:

1-Less than 18 years
The Effect of a Retrofit Particle Trap on the Vascular Effects of Diesel Exhaust Inhalation

The purpose of this study is to determine whether a retrofit particle trap can reduce the adverse vascular responses to diesel exhaust inhalation

18 subjects healthy male volunteers will be recruited at Umeå University. In a randomised, double blind 3 way crossover trial, subjects will be exposed to filtered air, diesel exhaust (300mcg/m3) or filtered diesel exhaust for 1 hour during intermittent exercise.

2 hours following the exposure, thrombogenicity will be assessed using the Badimon chamber - an ex-vivo model of thrombosis formed under constant flow conditions.

Forearm blood flow in response to infused intra-brachial vasodilators will be measured using venous occlusion plethysmography 6 hours after the exposure.

Arterial stiffness will be measured using peripheral arterial applanation tonometry in the hour post-exposure.

Blood samples will be collected at timepoints over the 24 hours after exposure.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers

Exclusion Criteria:

* Intercurrent illness
* Smoking
* Significant occupational exposure to air pollution
* Regular medication usage
Transillumination Device for Peripheral Intravenous Placement in Patients With Sickle Cell Disease (PERFID)

The primary goal of this randomized, controlled, open-label study is to determine the efficacy of AccuveinV400 (a transillumination veins device) to facilitate peripheral intravenous (IVP) catheter placement during a vaso-oclusive crisis. The investigators hypothesized that the number of attempts to a successful placement of a peripheral IV, our primary outcome, would be shorter with the assistance of the Accuvein V400. It is also expected that AccuveinV400 will reduce the time of the procedure, the rate of failure, the technique-related pain.


Eligibility Criteria:
Inclusion Criteria:

* Sickle cell patients (all genotypes)
* Patients hospitalized for uncomplicated vaso-occlusive crisis (CVO) in Internal/general Medicine department
* Patients requiring the placement or replacement of a peripheral intra-venous catheter in the Department of Internal/general Medicine
* Patients arrived in the internal/general medicine department of the hospital between 9h and 18h and except weekends
* Signed informed consent.
* Affiliated to the French health care insurance.

Exclusion Criteria:

* Signs of shock
* Acute chest Syndrome
* Central venous catheter already present
* Indication to have a central venous catheter from the ourset
* Patient who has already participated to the PERFID study during the current hospitalization
* Refusal of the patient's participation
* Pregnant or lactating woman
* Patient under guardianship or curatorship
Activity Tracking Study in Healthy Volunteers (MK-0000-419)

In this study, researchers want to learn if a watch can be used to track physical activity in healthy people. The watch will collect the data and send it to a database using a data storage device.

The goal of this study is to measure:

* The number of people who wear the watch as instructed
* The number of working watches and data storage devices returned at the end of the study
* The number of watches that successfully sent data back to a database
* The overall daily activity for people including the number of daily steps taken and how much time is spent doing non-exercise activity and mild to intense exercise.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to:

* Is in good health
* Is willing to comply with study restrictions

Exclusion Criteria:

The key exclusion criteria include but are not limited to:

* History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* History of cancer
Prevalence of Tattoos and Piercings in Healthcare Using the Example of Obstetrics Workers

Tattoos and piercings as body decorations have developed into an art form over the last few decades and its social recognition is growing. However, critics also speak of an excessive lifestyle when tattooing or piercing.

The data from the questionnaires should examine how widespread tattoos and piercings are among medical staff and thus make a statement on acceptance.


Eligibility Criteria:
Inclusion Criteria:

* medical stuff in obstetrics
* minimum 18 years old

Exclusion Criteria:

* language barrier
* uncompleted questionnaire
Dapagliflozin and Hydrochlorothiazide in Recurring Kidney Stone Patients

Current prevention strategies in patients with recurrence of kidney stones show especially in high-risk patients a diversely and in the long-term not successful outcome in a sustainable number of cases. Recent studies have revealed that Dapagliflozin has the potential to decrease risk and incidence of urolithiasis events especially in patients suffering from Diabetes. The investigators propose that Dapagliflozin has the potential to increase the metabolic situation of hyperoxaluric patients with recurrence of urolithiasis. The investigators therefore test whether Dapagliflozin can decrease the oxalate excretion compared to the current strategy with Hydrochlorothiazide. The study may open up a new way of preventing urolithiasis in patients with high-risk of recurring urolithiasis.


Eligibility Criteria:
Inclusion Criteria:

• Calcium-oxalate stone formers with high risk of reoccurrence defined as:

* At least two symptomatic or surgically treated kidney stones within the last 10 years and/or
* Single stone kidney formers with risk factors including: a.) Positive medical family history on kidney stone formations of at least one blood related relative in the first degree or at least two blood related relatives in the second degree and/ or b.) Onset of kidney stone formations within the third life decade or earlier and/ or c.) Metabolic syndrome d.) Obesity (BMI ≥ 30 kg/m²)

Exclusion Criteria:

* Age \< 18 years
* Malabsorption disorder
* eGFR \< 30 ml/min/1,73 m2
The Response to Atropine Drops (RAD) Study

The purpose of this study is to examine the comfort of giving low concentration atropine eye drops.

After being informed about the study and potential risks, all participants giving written informed consent will answer questions about themselves and complete a 12-question survey about the need for drama. An examiner will then measure the sensitivity of the cornea (clear window on the front of the eye) by touching the cornea with a thin thread that shortens until it is first detected by the participant. After that, an examiner will place a drop of atropine in the right eye, and the participant will rate the eye comfort for 25 seconds using a computerized slide scale. Five minutes after the first drop, the examiner will put a drop in the left eye and the participant will rate the comfort for 25 seconds. The examiner will then repeat that process one more time with each eye. The drops placed in the eyes will be 0.01% atropine at room temperature from Lab A, 0.05% atropine at room temperature from Lab A, 0.05% atropine refrigerated from Lab A, or 0.05% atropine at room temperature from Lab B. The drops will be placed in the eyes in random order, so the participant won't know which one is being administered. At the very end, the participant will rate how likely s/he would be to take a low concentration atropine eye drop every day in each eye if it may delay the onset of nearsightedness from 1 (definitely not) to 10 (definitely would).

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older

Exclusion Criteria:

* None
Safety and Efficacy Study of a New Treatment for Recurrent Symptoms of Oral Herpes Virus Infection

The purpose of this study is to determine if a new treatment is effective for the treatment of recurrent symptomatic oral herpes virus infections.


Eligibility Criteria:
Inclusion Criteria:

* Clinical history of recurrent cold sores averaging 2 or more episodes per year
* Experiences prodromal symptoms (tingling, burning, itching) of cold sores
* Herpes Simplex Virus seropositive (by blood test)

Exclusion Criteria:

* Immuno-suppressed or taking immunosuppressant medication
* Use of antiviral therapy directly prior and during the study
An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions when initiating or switching to insulin therapy with NovoMix® 30 in subjects with type 2 diabetes under normal clinical practice conditions


Eligibility Criteria:
Inclusion Criteria:

* Patients with Type 2 diabetes
* Insulin-naive or previously treated by basal only insulin therapy

Exclusion Criteria:

* Patients who are unlikely to comply with the protocol
* Pregnancy or breastfeeding or intention of becoming pregnant
Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients

24 week open-labeled extension study to continue monitoring the same group of patients in the previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of tocilizumab.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had completed at least 5 out of the 7 visits scheduled for weeks 2, 4, 8, 12, 16, 20 and 24 in the tocilizumab Phase IIIb study(MRA230TW).
* Patients assigned in the Phase IIIb study(MRA230TW), who had received scheduled dose for at least 16 weeks but still failed to achieve adequate treatment response characterized by ACR20

Exclusion Criteria:

* Patients who have received a major surgery including joint surgery 8 weeks prior to the screening or are scheduled to be operated within 6 months after the enrolment.
* Patients with rheumatoid autoimmune disease other than RA, including but not limited to SLE(system lupus erythematosus), or significant systemic involvement secondary to RA.
* Patients who belong to the Class IV of the ACR classification criteria for functional status of RA. (ACR Amended Criteria for the Classification of Functional Capacity in Rheumatoid Arthritis; Class IV: Largely or wholly incapacitated with patient bedridden or confined to wheel chair, permitting little or no self-care).
* Patients with a history of hypersensitivity to human, humanized or murine monoclonal antibodies or patients with contraindication for them.
* Patients who currently have or have a history of recurrence of bacterial, viral,fungal, or mycobacterial infections or other infectious diseases; tuberculosis(TB),atypical mycobacterial disease, clinically significant granulomatous disease on chest radiograph, hepatitis B, hepatitis C, or herpes zoster and etc. However, a patient with hand \& foot fungal infections can participate.
Inflammatory Response and Gingival iNOS Levels in Diabetic vs. Non-Diabetic Periodontitis Patients

This study investigates the relationship between Type 2 diabetes mellitus (T2DM), glycemic control, and periodontal disease. Researchers analyzed the levels of inducible nitric oxide synthase (iNOS) and proinflammatory cytokines, such as tumor necrosis factor-alpha (TNF-α), interleukin-1 beta (IL-1β), and interferon-gamma (IFN-γ), in 118 participants. The participants were categorized based on their periodontal and diabetes control status.

This study is an observational analysis using a cross-sectional time perspective and explores the interplay between Type 2 diabetes mellitus (T2DM), glycemic control, and periodontal disease by evaluating the expression of inducible nitric oxide synthase (iNOS) and proinflammatory mediators (TNF-α, IL-1β, IFN-γ, and PGE2) in gingival tissues. A total of 118 participants were classified into six groups based on their periodontal health and glycemic control status, determined by HbA1c levels.

Gingival biopsies were collected and analyzed using ELISA to measure biomarker levels. The study found significant differences in inflammatory marker concentrations between groups, with poorly controlled T2DM participants showing markedly higher levels of iNOS and cytokines. This aligns with the hypothesis that poor glycemic control amplifies periodontal inflammation and oxidative stress, contributing to tissue destruction.

The findings underline the critical role of glycemic regulation in managing periodontal disease and suggest potential targets, such as iNOS, for therapeutic interventions. This study adheres to ethical standards, including informed consent and approval by the Ondokuz Mayis University Clinical Research Ethics Committee. The results emphasize the bidirectional relationship between diabetes and periodontal health, contributing to a better understanding of the systemic implications of periodontal inflammation.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be between 18 and 65 years of age (according to the World Health Organization definition of young and adult individuals).
* Diagnosed with periodontitis (Stage 2, 3, or 4) based on the 2017 Classification of Periodontal Diseases and Conditions.
* Diabetes control status determined by HbA1c levels: controlled diabetes: HbA1c ≤ 7, uncontrolled diabetes: HbA1c \> 7
* Must volunteer and sign an informed consent form for clinical evaluations and collection of tissue samples.

Exclusion Criteria:

* History of smoking.
* Presence of systemic or local diseases affecting the immune system (e.g., autoimmune disorders, HIV, hepatitis).
* Pregnant or breastfeeding individuals.
* History of antibiotic use or periodontal treatment within the last 3-6 months.
* History of immunosuppressive therapy or chemotherapy.
* Requirement for antibiotic prophylaxis.
* Severe systemic illnesses unrelated to diabetes (e.g., cancer, cardiovascular diseases).
Intracranial Rescue Stenting for Acute Ischemic Stroke, Predictors of Outcomes

The use of rescue intracranial stenting is thought to be associated with better outcomes than with patients received medical treatment only after failed thrombectomy as Reperfusion technique. This raised the questions about the factors that affect outcomes of rescue intracranial stenting angioplasty, so the best outcomes can be achieved.

Mechanical Thrombectomy is the first line therapy in acute ischemic stroke due to large vessel occlusion. Recently, there is an increasing number of patients with failed re perfusion after mechanical thrombectomy, due to preexisting high degree of intracranial stenosis or failed mechanical thrombectomy. This is associated with poor clinical and functional outcome for the patients.

The percentage of patients with failed mechanical thrombectomy is as high as 40-45% of all patients with ischemic stroke due to large vessel occlusion.

This group is in need for rescue intracranial stenting to achieve re-canalization of the occluded vessel and restore perfusion.

The results demonstrated superiority of medical management over stenting with less complications and this had almost put the intracranial stenting to rest for years.

The main complication related to rescue stenting are ischemic complications especially thromboembolic events related to thrombus detachment, symptomatic intracerebral hemorrhage and re-stenosis of cerebral arteries after stenting.

Recently, the results of the Chinese Angioplasty and Stenting for Symptomatic Intracranial Severe Stenosis trial and the Wingspan Stent System Post Market Surveillance Study (WEAVE trial) showed that most of complications are related to peri-procedural techniques. This raise the interest again in the efficacy of intracranial stenting as treatment modality for selected patients.

The use of rescue intracranial stenting is thought to be associated with better outcomes than with patients received medical treatment only after failed thrombectomy as Reperfusion technique. This raised the questions about the factors that affect outcomes of rescue intracranial stenting angioplasty, so the best outcomes can be achieved.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with acute ischemic stroke due to large vessel occlusion as confirmed by CT angiography or Magnetic resonance (MR) angiography.
2. Baseline NIHSS \>6.
3. Presenting within the first 6 hours from onset of symptoms.
4. First ever stroke or pre-stroke modified Rankin Score (mRS) ≤1.

Exclusion Criteria:

1. Patients with intra cranial hemorrhage.
2. Patients younger than 18 years.
3. Patients with acute ischemic stroke due to small vessel disease or vasculitis.
4. Patients with acute ischemic stroke due to occlusion of vessels of posterior circulation.
5. Patients who refused to be included in the study.
6. Patients with contraindications to intracranial stent placement (as total occlusion of artery).
Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis

Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel therapies are necessary to prevent or block the process of the disease. In this current prospective cohort, the investigators plan to organize four hospitals to determine the safety and efficacy of intravenous administration of umbilical mesenchymal stem cells in the treatment of patients with liver cirrhosis in next three years.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* aged 30-60 years
* clinical diagnosis of compensated or decompensated liver
* child-Pugh B/C (7-12 points)
* expecting lifetime is over three years

Exclusion Criteria:

* pregnant woman
* patient with severe vascular diseases
* patient with any organ failure
* patient with any tumors
* patient with HIV
* patient who has been transplanted
* patient treated with immunosuppressors
* patient for whom the follow-up is considered impossible
* patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
Validation of an Automatic Analysis Algorithm of the Probability of Glaucoma From Optic Disc Images

Clinical, cross-sectional and prospective study to assess the images of the posterior pole of the retina of patients from the Glaucoma Unit of the IOBA and the Hospital Clínico Universitario de Valladolid during the period between May and December 2021.

The aim of the project is to provide a sufficient number of images from posterior pole retinographies in patients with suspected glaucoma or with diagnosis of glaucoma in order to determine the sensitivity and specificity of an automatic glaucoma screening algorithm developed by the company Transmural Biotech S.L.


Eligibility Criteria:
Inclusion Criteria:

* Primary open angle glaucoma or ocular hypertension
* Signed informed consent
* Visual field examination within the last 12 months

Exclusion Criteria:

* Ocular or systemic pathologies that may interfere with the quality of the retinographic image or the results of the visual field
* Congenital anomalies of the papilla that seriously alter its structure
* High ametropia (\> 10 diopters)
* Pharmacological Mydriasis contraindication.