cyrilzakka/clinical-trials huggingface dataset:
Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and vitamin D receptor (VDR) immunoreactivity in the primary tumor.

Eligibility Criteria:
Inclusion Criteria:

1. Older than 18 years and younger than 80 years of age.
2. Histologically proven malignant melanoma, stage one B (IB) to three (III) Not participating in other clinical trial.
3. The only treatment for melanoma is surgical treatment.
4. Complete resection of melanoma.
5. Single primary invasive cutaneous melanoma
6. Signed ethical committee approved informed consent
7. Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference

Exclusion criteria

1. Pregnant/lactating women or planning on becoming pregnant during the study
2. Known hypersensitivity to vitamin D or its components.
3. Pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m2 or renal dialysis.
4. Liver failure or chronic liver disease with liver enzymes \> 2 fold upper limit of normal (ULN).
5. History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
6. History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
7. History of small intestine resection.
8. History of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma.
9. Chronic alcohol abuse.
10. Medical or logistic problems likely to preclude completion of the study.
11. Taking medication that predisposes to hypercalcemia (digoxin, lithium, thiazide diuretics) or taking medication that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists)
12. Intake of vitamin D supplements within 6 months prior to entry of the study.
IBI310 in Combination with Sintilimab in Patients with DNA Mismatch Repair Deficient (dMMR)/microsatellite Instability High (MSI-H) Locally-advanced or Metastatic Colorectal Cancer

The main purpose of this study is to assess the efficacy and safety of IBI310 in combination with sintilimab in patients with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) locally advance or metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed colorectal adenocarcinoma
2. Imaging confirmed locally-advanced or metastatic colorectal cancer
3. Measurable disease by CT or MRI
4. MSI-H confirmed by central lab
5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

Exclusion Criteria:

1. Prior treatment with an anti-Programmed Death Receptor (PD)-1, anti-PD-L1, anti-PD-L2, anti-Cytotoxic T-Cell Lymphoma-4 Antigen (CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways
2. Subjects with active,known or suspected autoimmune disease
3. Subjects with a history of primary immune deficiency
4. Subjects with severe infectious diseases
Outcomes of Oncology Therapy in the Elderly: Trajectory of Functional Decline and Correlates of Change

The proposed project will document the degree of function decline, assess the relationship between function and cancer- related symptoms and evaluate relationships between function and quality of life. Participants are evaluated before therapy, after therapy and again 3 months post therapy to evaluate functional change. Knowledge gained will help us plan interventions around the time of cancer therapy to help older adults preserve or improve function.

The study looks at functional change of elderly cancer patients. Approximately 52 cancer patients age 65 or older will be asked to participate. Cancer patients asked to participate will be receiving cancer therapy with the intention of providing a cure. Functional change will be assessed from the time of diagnosis, through therapy to the early post therapy time frame. A comprehensive model explaining reasons for function change is used as the framework for choosing variables to measure. Components of function that will be measured include a 6 minute walk test, lower extremity muscle strength, a Short Physical Performance Battery assessing function of legs and a test that simulates typical household activities. Surveys will be used to subjects own assessment of their activity and function. The four most common cancer-related side effects will be measured and include fatigue, sleep impairment, shortness of breath and pain. Some markers in the blood may be abnormal and be related to declines in function. They will also be measured. Differences in function over time will be determined and relationships between function, cancer-related side effects and quality of life will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 or older
* Diagnosis of a malignancy requiring chemotherapy as part of intent to cure oncologic therapy or diagnosis of prostate cancer requiring 6 months or less of androgen deprivation therapy as part of oncologic treatment.
* A planned oncologic regimen of at least 3 months but not more than 9 months excluding surgery. This will include most solid tumors and lymphoma.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Prior treatment for malignancy other than basal or squamous cell skin cancer
* Evidence of metastatic disease
* Individuals with acute and chronic leukemias and individuals receiving anti-estrogen therapy only as their primary oncologic treatment.
* Dementia, psychotic condition or other central nervous system impairment limiting compliance
* Medical conditions that limit ability to walk at least 4 meters.
Power Training Versus Strength Training in the Elderly

The inexorable decline in motor skills during aging provides the investigators with an elderly population with various functional limitations. Among these, the ability to walk, being associated with the risk of falling has been studied by several authors. The adoption of strength and power training as an intervention strategy to reduce the negative effects arising from the physiological or pathological process of aging has been widely discussed in these studies. However, the effects of these interventions on biomechanical gait indicators have not been fully debated yet. Therefore, this study aimed to compare the effects of these two training protocols on functional capacities and biomechanical gait parameters of elderly women.

Three female groups, homogenized by age, body mass index and physical activity level, were formed: the control group (GC: n=8, 69±4 years old), the strength training group (GF: n=6, 67±4 years old) and the power training group (GP, n=7, 68±4 years old). No extra activity was induced to GC's routine. Meanwhile, GF and GP underwent 12 weeks of strength and power training, respectively, with three weekly sessions. While GF performed the exercises with moderate speed (70-90% of 1RM), the GP executed them in fast speed (40-60% of 1RM). A kinematic and electromyographic gait evaluation, as well as balance and functional capacity evaluations, were conducted prior and after the intervention period.

Eligibility Criteria:
Inclusion Criteria:

* sedentary women with no physical mobility limitations

Exclusion Criteria:

* attending less than 75% of the intervention sessions and not attending the final evaluation
Randomized Study on the Effect of Oesophageal Temperature on the Incidence of Esophageal Lesions After AF Ablation

It's a randomized pilot study to evaluate the incidence of esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation according to three different strategies of esophageal temperature monitoring.

These patients will be divided into 3 groups with different strategies of esophageal temperature monitoring: group 1 without monitoring, group 2 monitoring with single probe thermometer and group 3 monitoring with multi-probe thermometer.

The primary end point will be the incidence of esophageal lesions assessed by upper endoscopy.

This is a randomized pilot study on the effect of oesophageal temperature monitoring on the esophageal thermal injury after left atrial ablation for the treatment of atrial fibrillation (AF).

Sixty patients with paroxysmal AF or persistent and without previous AF ablation with indication of AF ablation will be selected to be included at the study.

After informed consent, these patients will be randomized in 3 groups with different strategies of esophageal protection for radiofrequency application in the posterior wall of the left atrium, by randomization in a ratio of 1: 1: 1 between groups.

Group I: no esophageal temperature monitoring technique. Group II: monitoring of esophageal temperature during radiofrequency applications in the posterior wall of the left atrium, with unipolar thermometer.

Group III: oesophageal temperature monitoring during radiofrequency applications in the posterior wall of the left atrium, with a multipolar and self expandable thermometer.

The primary end point will be the incidence of esophageal lesions assessed by upper endoscopy that will be done in all patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with paroxysmal or persistent AF, diagnosed by electrocardiogram, 24-hour Holter, or monitors of implantable or non-implantable events, with at least one episode of AF up to 12 months before the procedure. Patients should be willing and able to sign an informed consent form, and to undergo all procedures described in both the study protocol and the consent form.

Exclusion Criteria:

* Atrial thrombus in the left atrium, history of AF ablation, history of cardiac surgery, contraindication to anticoagulation, permanent AF, New York Heart Association functional class III or IV, stroke in the last 3 months, pregnancy, history blood clotting abnormalities, previous oesophageal surgery, or advanced chronic kidney disease (creatinine \> 2.5 mg/dl).
An fNIRS Study of Motor Cortical Activation in Stoke Patients

The investigators evaluate the activation and connectivity of patients' motor regions in the acute phase of ischemic stroke by fNIRS.

This study aims to analyze the progress of brain recovery from upper-limb deficit due to acute ischemic stroke, using Functional Near-infrared Spectroscopy(fNIRS) as the main neural imaging method. Fifty patients having experienced a stroke onset within seven days will be recruited from the emergency room. The fNIRS signals will be recorded bilaterally over the contralateral sensorimotor cortex, the premotor area, the supplementary motor area, the primary motor cortex for 14 days after being diagnosed. Then compute activation and connectivity of the regions. The motor function data measured by the assessment scales, as well as the behavioral record during the fNIRS motor tasks will be collected as well.

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of ischemic stroke should meet the diagnostic criteria of the "China Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke 2018".
* 18 years old≤ age ≤ 75 years old.
* Cerebral ischemic stroke onset within 7 days.
* First onset.
* Upper limb motor dysfunction.

Exclusion Criteria:

* Unstable vital signs.
* Complicated with other diseases in the nervous system.
* Combined with other serious disease states: circulatory system, respiratory system,
* motor system diseases, such as atrial fibrillation, heart failure, lung infection, severe liver and kidney dysfunction, lower limb venous thrombosis, etc.
* Upper limb dysfunction caused by other reasons, such as fractures, upper limb deformities, etc.
* Contraindicated to imaging tests, such as metal implantation, claustrophobia, and severe obesity.
* Those who cannot complete the examination due to other reasons, such as mental disorders, cognitive dysfunction, etc.
* Other causes: alcoholism; pregnancy; skull defects; soft tissue injuries at the site of examination; visual impairment, etc.
Safety, Tolerability and Pharmacokinetics of Different Multiple Doses of BI 207127 BID and Multiple Doses of BI 207127 Combined With Faldaprevir in Healthy Male and Female Subjects

The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects.


Eligibility Criteria:
Inclusion criteria:

1. healthy male and female subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions
Erectile Dysfunction in Patients With Non Ocular Behçet's Disease

It was aimed to demonstrate whether erectile dysfunction is affected by BH pathogenesis and whether there is a relationship between erectile dysfunction and BD pathogenesis by assessing both sexual function and retinal micro-vascular blood flow in BH which may involve vessels from all calibrations and nature.

Patients with factors and results that could cause sexual dysfunction will be excluded from the study.An International Index of ErectileFunction (IIEF) questionnaire will be applied to a total of 35 patients under 45 years old who met the inclusion criteria. IIEF's erectile function,sexual desire,sexual satisfaction,orgasmic function and general satisfaction sub parameters and Optical Coherence Eye Tomography (OCTA) data will compared.

Eligibility Criteria:
Inclusion Criteria:

* Definitive diagnosis of Behçet Disease
* No comorbid disease known to be associated with erectile dysfunction, including hypertension and diabetes mellitus
* Not overweight or obese (BMI≤25 kg/m2)
* Non-smokers
* No alcohol and/or substance abuse
* No known psychiatric disorder

Exclusion Criteria:

* prostatic disorder
* medication that may influence on erectile function (antihistamines, ß-blockers, etc.)
* sacroiliac joint or chronic articular involvement
* family history of glaucoma
Regular Aquatic Activities and Pregnancy Outcomes

Aquatic activities is one of the most attractive physical exercise during pregnancy, especially during the third trimester.

The aim of this study was to evaluate the effect of moderate regular aquatic exercise during pregnancy on maternal and fetus outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Healthy pregnant women without any medical or obstetric complication to practice moderate exercise
* Being able to communicate in Spanish

Exclusion Criteria:

* Being interesting in the study after 16 weeks of gestation
* Having obstetric contraindications
* Not attended regular to the exercise program
The Role of Surgical Approach on Residual Limping After Total Hip Arthroplasty

Residual limping after total hip arthroplasty is empirically associated with the use of lateral approach but has been reported in litterature even with the use of posterior approach. The purpose of this clinical trial is to compare the risk of residual limping one year after total hip arthropasty between lateral and posterior approach.

The use of lateral approach has been empirically associated with increased risk of abductor insufficiency and limping after total hip arthroplasty compared with the posterior approach. However lateral approach remains a widespread technik because it provides a decreased risk of dislocation. In litterature, gluteus medius insufficiency has been reported even when the posterior approach has been used. In the early stage of postperative relhabilitation it is difficult to distinguish between between limping that resolves after abductor training and limping due to abductor injury/avulsion that is resistent to physiotherapy. The purpose of this randomized controlled trial is to compare the risk of persistent limping one year after total hip arthtoplasty between lateral and posterior approach and to identify patient-related risk factors for limping. Moreover it will validate ultra sound (U/S), magnetic resonance imaging (MRI) of the hip and gait analysis as diagnostic tools for early detection of limping that is going to persist one year after total hip arthroplasty.

580 patients will hip osteoarthritis be randomised to receive their total hip arthroplasty through an either lateral of posterior approach and will be followed at one year with physical examination (Trendelenburg sign) and patient.-reported outcome measures. Patients with a positive Trendelenburg sign at 3 months will undergo U/S and MRI examination as well as gait analysis and reassessed at one year with physical examination. The first 40 patients with negative Trendelenburg sign at 3 months will also undergo U/S, MRI and gait analysis. The specificity and sensitivity of U/S, MRI and gait analysis for positiv Trendelenburg sign will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* Primary unilateral osteoarthritis of the hip scheduled for total hip arthroplasty.
* Ability to understand and write swedish.

Exclusion Criteria:

* Impaired funktion of the contralateral hip or knees causing limping.
* Neuromuscular diseases
* Postoperative leg length discrepancy excceding 1 cm
* Postoperative discrepancy in femoral offset exceeding 25% of the femoral offset of the contralateral hip.
Image Fusion System for 3D Preoperative Planning in the Osteosynthesis and Osteotomy

Utility of image fusion system for the fracture and fracture malunion management will be evaluated.

The fracture and malunion patients need osteosynthesis or osteotomy will be recruited. Image fusion group utilizes 3D preoperative planning and image fusion system. Control group utilizes only 3D preoperative planning. The age, sex, and fracture types will be matched between groups. In both groups, 3D preoperative planning will be performed in order to determine reduction, placement and choices of implants. In the image fusion group, the outline of planned image will be displayed on the monitor overlapping with fluoroscopy image during surgery. Reductions, implant choices/positions, and clinical outcomes will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Fracture paitents need osteosynthesis

Exclusion Criteria:

* Fracture patients under 18 years old
Preschool Bronchial Remodeling and Risk of Exacerbation

Bronchial remodeling is an abnormal tissue repair process of the bronchial wall components that characterizes severe asthma which can include epithelial abrasion, thickening of the reticular basement membrane (RBM), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (BSM) mass. We identified using latent class analysis two classes of patients. Compared to the second class, the first class was characterized by an increase in RBM thickness, blood vessel count, BSM mass and a decrease in RBM-BSM distance, mucus gland mass and bronchial fibrosis. We then hypothesized that this first latent class identified children at risk of asthma exacerbations.

Asthma is the most frequent chronic disease in children. Severe asthma is characterized by airway hyperresponsiveness, bronchial inflammation and bronchial remodeling 1. Bronchial remodeling is an abnormal tissue repair process of the bronchial wall components which can include epithelial abrasion, thickening of the reticular basement membrane (RBM), an increase in bronchial fibrosis, blood vessel count, mucosal gland mass and/or bronchial smooth muscle (BSM) mass. At preschool age (before 6 years old), asthmatic children constitute a heterogeneous population and several classifications have been proposed to identify distinct phenotypes according to the chronology of asthma 2, the triggers of asthma 3, the trajectory of lung function as measured by forced expiratory volume in 1 second (FEV1) 4 or according to a combination of clinical and inflammatory variables 5. More recently, we demonstrated for the first time using latent class analysis (LCA) that subgroups of severe asthmatic children could also be identified according to bronchial remodeling parameters (unpublished data). Indeed, we identified two latent classes of patients. Compared to the second class, the first latent class was characterized by an increase in RBM thickness, blood vessel count, BSM mass and a decrease in RBM-BSM distance, seromucosal gland mass and bronchial fibrosis (unpublished data). Since, previous studies showed that bronchial remodeling could have negative impact on the patients' outcomes, we therefore hypothesized that the latent classes identified from the bronchial remodeling data in severe preschool asthmatic children included in the "P'tit Asthme" study (NCT02806466) could identify children at risk of asthma exacerbations requiring systemic corticosteroids therapy.

Eligibility Criteria:
Inclusion Criteria:

* To have been previously included in the "P'tit Asthme" study (NCT02806466)
* To have performed bronchoscopy with analyzable biopsies
* To have been asthmatic at the inclusion in the P'tit Asthme study (NCT02806466)

Exclusion Criteria:

• To refuse the use of children data as expressed by representatives of parental authority
Comparison of Functional Recovery After Distal Intra-articular Radius Fracture With a Dorsal Tilt Treated With an Anterior Plate Versus a Posterior Plate

For les intra-articular fractures, plate osteosynthesis is the indicated technique. Despite the absence of consensus, in recent years, the use of open reduction associated with internal plate fixation has considerably developed. Indeed, this therapeutic option allows a more anatomical reduction and stable fixation.

First-generation posterior plates presented complications related to the size of the plate, notably tendon lesions. Over the last ten years, a new generation of thinner anterior plates has reduced these complications.

In the literature, few studies have compared these two techniques in terms of functional and radiological outcomes. The hypothesis of this research is that osteosynthesis using a posterior plate is more effective than that with an anterior plate in terms of functional recovery in patients older than 45 years.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have provided written informed consent
* Patients older than 45 years
* Patients presenting a closed intra-articular fracture of the distal radius with a dorsal tilt (stages B2, C1, C2 and C3)

Exclusion Criteria:

* Adults under guardianship
* Patients without national health insurance cover
* Pregnant or breast-feeding women
* Patients presenting other injuries in the same upper limb
* Patients presenting injuries of the wrist or hand (scapholunate injury, fracture of the carpal bone or fingers)
* Pre-trauma paralysis of the limb
* Open fracture
* Fracture with palmer tilt or extra-articular