cyrilzakka/clinical-trials huggingface dataset:
Central-boost Ablative Radiation Therapy for Solid Tumors (CBART)

In the case of large tumors or tumors closely adjacent to organs at risk, ablative doses offered by stereotactic body radiation therapy (SBRT) could not be delivered. Therefore, a technique that could provide high radiation doses to tumors without increasing of risks of severe adverse effects is required.

Regarding the advanced stage tumor, especially tumors with large volumes or closely adjacent to organs at risk, patients are not candidates for surgical resection. Therefore, raduitherapy may be the optimal local therapy to ameliorate symptoms and be combined with systemic therapy, including chemotherapy, targeted therapy or immunotherapy. However, for those tumors, ablative doses could not be given due to large volumes and abutting to organs at risk.

In order to solve the problem, spatially fractionated radiation therapy (SFRT) is used. In details, it was performed based on grid or lattice, which creates several cylindrical high-radiation-dose areas in tumors. Nevertheless, the ablative dose areas are limited albeit with SFRT, which may not greatly improve tumor local. Hence, we create an inner and complete inner gross tumor volume that would be delivered ablative radiation doses, which is named as central-boost ablative radiation therapy (CBART). We aim to investigate the efficacy and safety of CBART in large tumors or tumors adjacent to organs at risk.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18-75 years.
* Pathologically confirmed lung, liver, pancreas or retroperitoneal malignant tumor.
* Oligometastasis in the case of metastatic tumor
* the shortest diameter ≥2cm or the distance from the tumor to the organs at risk less than 5mm
* ECOG of 0 to 1 point
* No abnormality in blood routine test, liver and kidney function test and coagulation test (White blood cell count ≥4.0×10\^9/L, neutrophil count ≥2.0×10\^9, hemoglobin level ≥100g/L, platelet count ≥100×10\^9/L, ALT and AST level \< 2.5 times the upper limit of normal, total bilirubin and creatinine level within the normal, international normalized ratio \<2)

Exclusion Criteria:

* History of radiotherapy for the lesion
* History of tumor within 5 years
* ECOG ≥2 points
* Significant abnormality in blood routine test, liver and kidney function test and coagulation test
* Active inflammatory bowel disease in the case of pancreas or retroperitoneal tumor
* Gastrointestinal bleeding or perforation within 6 months in the case of pancreas or retroperitoneal tumor
* Infections required antibiotics
* Heart or respiratory insufficiency
* Pregnant or breastfeeding women
Computer Assisted Planning of Corrective Osteotomy for Distal Radius Malunion

The investigators are comparing post-operative patient-rated functional outcome between patients who undergo corrective osteotomy for extra-articular malunited distal radius fractures with and without computer assisted pre-operative planning and virtual osteotomy.


Eligibility Criteria:
Inclusion Criteria:

* Adult (over 18 yrs of age)
* Extra-articular malunion of the distal radius
* Fluent in English

Exclusion Criteria:

* Pregnant patients
* prisoners
* patients with impaired decision making ability
* patients with a bony deformity in the distal forearm contralateral to the one with distal radius malunion
Exploratory Study to Investigate Efficacy of LAS41004 in a Psoriasis Plaque Test

The aim of the exploratory study is to compare the dose-related efficacy of LAS41004 in a Psoriasis Plaque Test (PPT).


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female patients between 18 and 75 years of age with a diagnosis of stable plaque-type psoriasis (psoriasis vulgaris) for at least 12 months
* Psoriatic plaques that are suitable to be defined as target area lesions by the following criteria:

oPsoriatic plaques must be located on the trunk and/or extremities. Plaques that are located on the head (incl. scalp), palms, sole of the feet, intertriginous or genitoanal areas are not suitable as target areas

* Comparable psoriatic plaques with at least "2" in each score (range 0-4) for the three distinct signs: scaling, erythema and induration
* No more than 3 points difference in total score (= sum of scores for scaling, erythema and induration; Range 0-12) of the chosen comparable psoriatic plaques
* Enough surface area to the psoriatic plaque to define eight clearly distinguishable (minimum distance between test areas: 1cm) test areas of at least 1 cm² size - Effective contraceptive methods for the duration of the study and for the 4 weeks after study drug discontinuation, for a patient of childbearing potential.

Key Exclusion Criteria:

* Too small a body surface area covered with psoriasis plaques that meet the specified inclusion criteria
* Any condition that may interfere with the study assessments or ultrasound measurements of the skin and/or may have an influence on the skin immune response (incl. open wounds)
* Current diagnosis of guttate, erythrodermic or pustular psoriasis
* Patients who have received any topical anti-psoriatic drug in the test area within the last 2 weeks before treatment with the IMP.
* Patients who have received topical products in the test area containing DEET (N,N-diethyl-m-polyamide), a common component of insect repellent products within 1 week before treatment with the IMP.
* Patients who have received systemic biologics within the last 6 months before treatment with the IMP or any systemic antipsoriatic treatment (corticosteroids, ciclosporin, methotrexate, fumaric acid esters, acitretin etc)within the last 3 months before treatment with the IMP.
* Significant skin diseases other than plaque-type psoriasis (psoriasis vulgaris), including but not limited to: skin disease due to tuberculosis or syphilis, rosacea, perioral dermatitis, acne vulgaris, skin atrophy, striae distensae, increased fragility of skin blood vessels, ichthyosis, ulcers, wounds and reaction after vaccination
* Significant skin infections (including but not limited to: herpes, varicella, mycotic skin infections, bacterial skin infections or parasitic skin infections)
* Excessive sunlight exposure within 28 days prior to study entry and during the conduct of the study
* Usage of any topical formulation (incl. cosmetics, emollients, etc) on the designated target areas during the course of the study
* Vitamin A intake \> 15,000 IU/day
A Phase 3 Study to Assess the Efficacy and Safety of PK101 in Patients With Knee Osteoarthritis

The purpose of this study is to compare the efficacy and the safety of PK101 in patients with knee osteoarthritis.

The primary purpose of this study is to evaluate the efficacy of PK101 compared with PK101-002 at Week 8 in osteoarthritis. Also evaluates the safety of PK101.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥40 and of age
* Patients who meets the American College Rheumatology (ACR) criteria and has lasted for at least three months after diagnosis of one-sided or bilateral knee osteoarthritis.
* Radiographic evidence of grade 1 \~ 3 osteoarthritis based on the Kellgren \& Lawrence radiographic entry criteria at visit 1
* Score of 100mm pain VAS ≤ 80mm at visit 1
* Written consent form voluntarily
* Score of 100mm pain VAS ≥ 40mm at visit 3
* Patients with an individual medication compliance of 70% or more of the IP administered during the Run-in period

Exclusion Criteria:

* Patients who has a history of hypersensitivity to components of IP, NSAIDs including COX-2 inhibitors, a history of hypersensitivity to aspirin, or allergic reactions to sulfonamides
* Patients with inflammatory, infectious, metabolic, septic arthritis or rheumatoid arthritis other than osteoarthritis
* Patients with a condition that can affect the joints
* Patients who have undergone arthroscopic surgery within 1 year , knee joint surgery within 5 years, synoviorthesis within 3 months prior to visit 1 to the target knee, or who have planned surgery during the trial period
* Patients who have used corticosteroids as follows:

  * Inj. of corticosteroid, including intraarticular administration, into the target knee within 3 months prior to visit 1
  * Oral corticosteroid administration within 1 month prior to visit 1
* Patients who have intraarticular injected hyaluronic acid or cell therapy products, gene therapy products, etc. for the treatment of osteoarthritis within 3 months prior to visit 1
Correlation of Aortic Versus Pulmonary ITV in Response to Vascular Filling

This is a multicenter study conducted in the emergency department of the Nantes University Hospital and the Confluent Private Hospital, over a period of 5 months, based on hemodynamic ultrasound.

For each patient admitted to an emergency department with a sepsis syndrome requiring vascular filling, the pulmonary ITV and the aortic ITV were measured at each phase of vascular filling.

This is a non-interventional study, the management of patients will not differ from usual practices and vascular filling should not be delayed in any case. Emergency doctors who are already experts in ultrasound, monitoring vascular filling by measuring the aortic ITV, will have to measure the pulmonary ITV after each filling of 250cc of Ringer's Lactate in 10 minutes with a limited amount of time.

The evolution of ITV measurements and vital parameters should be recorded for each patient.

In order to ensure quality, the emergency doctors will first receive a short training (presentation of the study and review of the measurements requested). In addition, measurement records will be analyzed at random.

At the end of this study, the correlation between the variation of the aortic and pulmonary ITV could be compared. The objective would be to promote the monitoring of these unstable patients via the pulmonary ITV. This measurement would be easier to perform than the aortic ITV, which is currently only performed by emergency doctors who are experts in hemodynamic ultrasound.


Eligibility Criteria:
Inclusion Criteria :

* Age\> 18 years
* Patient with suspected infectious syndrome
* qSOFA \>= 2
* Tachycardia\>120 and/or PAS \< 100mm Hg / MAP \<60 mmHg

Exclusion Criteria :

* Atrial fibrillation arrhythmia
* Vascular filling \> 500 ml before hemodynamic evaluation by echo cardiography
* Perfusion of catecholamine (norepinephrine, epinephrine, or dobutamine) at the time of inclusion in the study (before hemodynamic assessment by echo cardiography)
* Patient sedated and on positive pressure ventilation, including NIV
* Tamponade due to a compressive pericardial or pleural effusion
* Patient with known pre-capillary PAH \> 50 mmHg PAPS
* Presence of suspected acute valvulopathy requiring immediate cardiological expertise
* Absence of an acoustic window allowing the evaluation of the aortic or pulmonary ITV
* Minor patients, adults under guardianship, protected persons
Phase IV Study: Vunakizumab Efficacy and Safety in Moderate-to-severe Plaque Psoriasis

This is a multicenter, prospective, observational study of 1516 patients with moderate-to-severe chronic plaque psoriasis to evaluate the efficacy and safety of vunakizumab in patients with moderate-to-severe chronic plaque psoriasis. Approximately 50-100 clinical trial centers are planned to participate in the study. The study consisted of a 7-day screening period, a 52-week treatment period and an 8-week safety follow-up period.

The recommended dose of vunakizumab is 240 mg (120 mg in two injections), with subcutaneous injection at week 0, 2, and 4, followed by a dose every 4 weeks and a final injection at week 48 (the actual treatment regimen is based on the clinician's recommendation). After the corresponding assessment at 52 weeks, an 8-week safety follow-up period was entered until the end of the study.

The vunakizumab is a humanized IL-17A inhibitor with innovative binding epitopes, which accurately binds to IL-17A, the core pathogenic factor of psoriasis. However, there is still a lack of efficacy and safety data in a large sample size of the Chinese population after marketing. Therefore, this study is intended to observe the efficacy and safety of vunachizumab in a larger population. The clinical efficacy of vunakizumab on special sites and the influence of comorbidity on the treatment of psoriasis are also paid attention to. At the same time, the improvement effect of vunakizumab on the quality of life and mental health of psoriasis patients is explored through patient-reported outcome (PRO) and patient satisfaction survey, so as to develop a clinical program that can benefit psoriasis patients physically and mentally.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old at the time of signing the informed consent, regardless of gender;
* Moderate to severe plaque psoriasis was diagnosed;
* Plan to receive vunakizumab therapy as assessed by the investigator;
* The subject voluntarily signs informed consent before the start of any procedures related to the study, can communicate with the researcher smoothly, understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study; Patients voluntarily sign informed consent forms.

Exclusion Criteria:

* Previous treatment with biological agents: including but not limited to anti-tumor necrosis factor-α (TNF-α), anti-IL-17, anti-IL-17 receptor, anti-IL-12 /IL-23 or IL-23p19 antibody drugs;
* Severe hypersensitivity to vunakizumab active ingredient or any excipients;
* Patients with clinically important active diseases, such as active tuberculosis, active hepatitis, and active malignant tumors;
* Fertile women (defined as all women with physical conditions necessary for pregnancy) and men who are pregnant or unwilling or unable to use highly effective birth control during the study period and within 20 weeks after last receiving the study drug;
* Any other circumstances that the investigator believes will prevent the subject from following and completing the study protocol.
Phase 3 Clinical Trial of Teriparatide in Japan

To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine


Eligibility Criteria:
Inclusion Criteria:

* Japanese patients diagnosed with osteoporosis
* Aged 55 or older
* Patients who are at high risk for fracture

Exclusion Criteria:

* History of metabolic bone disorders other than primary osteoporosis
* History of malignant neoplasm in the 5 years, with the exception of superficial basal cell carcinoma or squamous cell carcinoma of the skin that has been definitively treated.
* Severe or chronically disabling conditions other than osteoporosis
Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal Women

Open-label Phase IV trial of Letrozole 2,5mg po/day for 120 days prior to surgery for patients with locally advanced breast in postmenopausal women expressing hormonal receptors ( ER and PR)


Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women
2. Primary locally invasive breast cancer
3. Histological confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive, defined by core biopsy immunohistochemistry with \> 10% positive malignant epithelial cells.
4. Post menopausal status
5. Tumor measurable by clinical examination, mammography and ultrasound

Exclusion Criteria:

1. Prior treatment with letrozole or tamoxifen.
2. Patients with bilateral breast tumors
3. Patients who are eligible for breast conserving surgery
4. Evidence of inflammatory breast cancer or distant metastasis.
5. Other concurrent malignant disease
6. Concomitant anti-cancer treatments such as chemotherapy

Other protocol-defined exclusion criteria may apply.
Train New Examiners Via Modified Gingival Margin Plaque

The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers 18-65 years of age
* Good general health
* Must sign informed consent form
* Must discontinue oral hygiene for 24-hrs.after initial appointment.
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria:

* Subjects unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures
* Moderate or advanced periodontal disease or heavy dental tartar (calculus).
* 2 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that can affect salivary flow
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this study.
* Use of tobacco products
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Presence of an orthodontic appliance.
* History of allergy to common dentifrice ingredients.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Women With Cancer: An Exercise Study to Promote Health

The purpose of the study is to evaluate the effect of an aerobic-resistance exercise program compared to a home based physical activity program on bone mass, body composition, metabolic risk factors and cardiovascular fitness in women with cancer who have completed therapy.

The proposed study will evaluate an endurance-resistive exercise intervention to attenuate the effects of menopause and cancer treatment (bone loss, increased body fat, decreased lean muscle mass, weight gain, decreased physical activity) in an at-risk population of female cancer survivors. Women with solid tumors (breast, gynecological, colo-rectal) and lymphoma who have completed primary and/or adjuvant therapy within the past three years and who are perimenopausal or early postmenopausal and any woman on an Aromatase Inhibitor will be recruited to participate in a randomized controlled trial (RCT) of a 12 month exercise intervention (N=75) versus a health promotion control group (N=75). The specific aims of the study are to: (1) examine the effects of an exercise intervention on bone mass (serum biomarkers, lumbar spine, hip DEXA) and body composition (whole body DEXA, weight, waist circumference), (2) examine the effect of an exercise intervention on metabolic risk factors (lipids, cholesterol, fasting glucose, insulin resistance, Hemoglobin A1-C, and blood pressure), and (3) examine the effects of an exercise intervention on functional status and cardiovascular fitness (exercise stress test).

Eligibility Criteria:
Inclusion Criteria:

* Female
* Cancer diagnosis
* Postmenopausal

Exclusion Criteria:

* Health condition contraindication to moderate physical activity
Dapagliflozin to Prevent Atrial Fibrillation Recurrence After Transcatheter Pulmonary Venous Isolation.

Transcatheter left atrial antral ablation, aiming at complete electrical isolation of the pulmonary veins (PVI), has become mainstay in atrial fibrillation (AF) treatment. This approach has been proved superior to medical rhytmh control strategy in maintaining sinus rhythm. Moreover PVI has been associated with significant survival benefit in patients with heart failure and reduced left ventricular ejection fraction. Nevertheless, despite progress in the field of catheter ablation, recurrence rates remain high.

Inhibitors of type 2 sodium- glucose co-transporter (SGLT2i) is a relatively recent addition to the array of anti-diabetic agents, becoming part of everyday clinical practice. However, although SGLT2i were first used solely as antidiabetics because of their glycosuric effect, further research demonstrated that these drugs may independently reduce cardiovascular events, especially in patients with heart failure, a benefit that was consistent among diabetic and non-diabetic patients. Moreover, pleiotropic effects have been observed, including a reno-protective action.

These findings suggest that SGLT2i mechanisms of action extend beyond the obvious increase in urinary sodium and glucose excretion. Various studies propose that these drugs promote favourable metabolic changes in myocardial energetics, while they also inhibit inflamation and sympathetic activation, resulting in restriction of induced fibrosis and structural remodeling, which are key elements in atrial fibrillation generation and maintenance.

These findings suggest that the use of SGLT2i could offer antiarrhythmic benefit by reducing and/or reversing structural and electrical remodeling, leading to the assumption that use of theese drugs could reduce recurrences after transcatheter AF ablation.


Eligibility Criteria:
Inclusion Criteria:

Age\>18 years Atrial Fibrillation (paroxysmal or sustained); Written informed consent; Glomerular Filtration Rate (GFR) \>45 ml/min/1.73m2 (Cockroft-Gault equation)

Exclusion Criteria:

Hypertrophic cardiomyopathy (Left ventricular wall thickness ≥15mm, not explained by abnormal pressure/volume conditions); Severe mitral valve stenosis (as defined in European Guidelines); Active malignancy; Participation in other intervention studies; Pregnancy or willing of pregnancy during the follow up period Guideline Class I or equivalent indication for treatment with a SGLT2 inhibitor

\*Eligible patients randomized in the active comparator arm will be also included in a prospective observational registry study regarding the role of SGLT2 inhibitors in post-ablation AF recurrence.