cyrilzakka/clinical-trials huggingface dataset:
Laser Treatment for the Improvement of Scars and Scleroderma

In this study, the investigators seek to evaluate the effects of a laser treatment on the redistribution/regeneration of collagen on the clinical, microscopic, and molecular profiles of hypertrophic scars and scleroderma.

This study is designed to evaluate the efficacy of laser treatment for the improvement of the clinical appearance of disorders of collagen metabolism, including hypertrophic scars and scleroderma. The investigators will be performing a prospective cohort study. The entire lesion will receive laser treatment only.

The investigators plan to have 20 patients (10 patients with hypertrophic scars and 10 patients with scleroderma) complete the study.

Subjects must be equal to greater than 18 years old, but may be any gender or Fitzpatrick skin type. They must have one of the following: at least one extragenital hypertrophic scar, or at least one extragenital area of scleroderma . Subjects must not have received any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months. Those on anti-inflammatory or immunosuppressive medications will also be excluded.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must be able and willing to provide written informed consent and comply with the requirements of the study protocol;
2. In good general health, based on answers provided during the screening visit;
3. Subject must be able to read and understand English;
4. Any gender and any Fitzpatrick skin type;
5. Age equal to or greater than 18 years old;
6. Subjects in the hypertrophic scar branch must have at least one extragenital hypertrophic scar (defined as abnormal proliferation of scar tissue that forms at the site of cutaneous injury and does not regress and grows beyond the original margins of the scar) large enough to treat for both the control and experimental arm (at least 4cm in length for spit scar treatment) or two similar hypertrophic scars (at least 4cm2 for each);
7. Subjects in the scleroderma branch must have eligible extragenital lesions; large enough to treat for both the control and experimental arm or two similar scleroderma areas (at least 4cm2 area for each);

Exclusion Criteria:

1. Participation in another investigational drug or device clinical trial in the past 30 days;
2. Are pregnant or lactating;
3. Use of any prescription or in-clinic medications or treatments, such as intralesional corticosteroids or excision, on the eligible scars/scleroderma in the previous 3 months;
4. History of allergic reaction to topical or local anesthesia;
5. Regular intake of high doses of anti-inflammatory drugs (aspirin \>81 mg/day, ibuprofen, corticosteroids, etc.) or immunosuppressive drugs;
6. Clinically significant abnormal findings or conditions which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.
Geriatric Determinants of General Repercussion of Radiotherapy for Patient Over 75 Years With Prostate Cancer

The investigators propose to carry out a prospective analysis of physical impact, psychological, cognitive and social of radiotherapy in all patients over 75 years bearer of localized prostate cancer with an indication of curative radiotherapy. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities . The quality of life of patients will be evaluated by the QLQ C30 (Quality of Life Questionnaire) European Organisation for Research and Treatment of Cancer (EORTC) before starting treatment, at the end of radiotherapy (2 months) and at 6 months. This short follow-up period seems appropriate in this elderly population and will allow an answer within 2 years to the problem raised in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Man with a histologically proven prostate cancer
2. Indication of a curative intent radiotherapy
3. Age ≥ 75 years
4. Patient who signed an informed consent

Exclusion Criteria:

1. Patient with metastatic prostate cancer
2. Patient unable to submit to monitoring of the protocol for social, geographical or family reasons
3. A person who is not affiliated to a social security scheme or of such a scheme
4. Patient under trusteeship
Urine Sample Collection for Validation of the AnchorDx UriFind™ Bladder Cancer Assay

The AnchorDx UriFind™ Bladder Cancer Assay is designed to detect 2 DNA methylation biomarkers in urine specimens from patients 22 years or older suspected of having bladder cancer. Results from the assay are intended for use, in conjunction with current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients.


Eligibility Criteria:
Inclusion Criteria:

Clinical Validation Group:

1. 55 years or older, gender is not limited
2. Suspected of bladder cancer and are scheduled for bladder biopsy or trans-uretheral resection of bladder tumor (TUBRT)
3. Can receive standard of care, including urine cytology, cystoscopy, or surgery for bladder cancer diagnosis
4. Can provide at least of 75 ml of urine (prior to cystoscopy or surgery)

Exclusion Criteria:

1. History of urinary cancer
2. Neoadjuvant therapy
A Drug-drug Interaction Study Between BMS-663068 and Oral Contraceptives in Healthy Female Volunteers (DDI)

This is an open-label, single sequence, 4-cycle, 4-treatment, drug-drug interaction (DDI) study in healthy female subjects on oral contraceptives (OC). There is no formal research hypothesis to be statistically tested. It is expected that coadministration of BMS-663068 with OC will not affect the pharmacokinetics (PK) of either ethinyl estradiol (EE) or norethindrone (NE).


Eligibility Criteria:
Inclusion Criteria:

* Healthy female nonsmoking subjects, ages 18 to 40 years, inclusive with a body mass index of 18.0 kg/m2 to 32.0 kg/m2, inclusive
* Women of child bearing potential with intact ovarian function by medical history and history of regular menstrual cycles must have been on a stable regimen of combination oral contraceptives containing EE and progestin (28 day regimen) without evidence of breakthrough bleeding or spotting for at least 2 consecutive months prior to Day -1

Exclusion Criteria:

* Any significant acute or chronic medical illness

Other protocol defined exclusion criteria could apply.
The Effect of Huashibaidu Granule on Community-acquired Pneumonia in Children

The primary purpose of this study is to assess the efficacy and safety of Huashibaidu granule for the treatment of community-acquired pneumonia in children compared with placebo and to demonstrate the efficacy of Huashibaidu granule in improving clinical symptoms, removing pathogens, and shortening clinical course.

Subjects diagnosed as community-acquired pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)" at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited. For each enrolled patient, basic information as well as basic medical condition will be collected by investigators. The subjects will be randomly assigned to the Huashibaidu group and the placebo group.

During the study, patients will receive Huashibaidu granule or placebo two times a day for five consecutive days. Both groups of patients will receive conventional Western medical observation and symptomatic treatment, including empiric anti-infective therapy (antibiotics) and symptomatic treatment such as antipyretic, expectorant and asthmatic. Do not use other traditional Chinese medicines, proprietary Chinese medicines, and antiviral drugs. Expectorants other than Ambroxol cannot be used.

After enrollment, investigator will evaluate and score patients' clinical symptoms at day 0, 1, 2, 3, 4, 5. Detection of biomarkers associated with infection, screening of pathogen and imaging examination will be conducted at day 0. And pharyngeal swab will be collected by investigator for tNGS at day 0, 3, 5.

Eligibility Criteria:
Inclusion Criteria:

1. Han nationality.
2. Diagnosed as community-associated pneumonia in children according to "Guideline for diagnosis and treatment of community-acquired pneumonia in Children (2019 version)".
3. The first dose was given \< 5 days from the onset of pneumonia (onset time is defined as the time of the first symptoms or signs of lower respiratory tract infection).
4. The guardian agrees to participate in the study and signs the informed consent form.

Exclusion Criteria:

1. The subject has severe respiratory distress, cyanosis, consciousness disorder, refusal to eat or dehydration.
2. The subject has chronic respiratory diseases, airway malformations, congenital heart disease, immune system diseases and other serious underlying diseases other than asthma.
3. The subject has moderate to severe persistent asthma or is in the acute asthma exacerbation.
4. The subject with influenza virus, pertussis, tuberculosis, fungi, and parasitic infections.
5. The subject with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 1.5 times higher than normal values in blood biochemical detection items, abnormal renal function, or troponin.
6. The subject with any other reason that investigators consider unsuitable to participate in this study.
Retrospective Data Analysis of Data From the Zurich PH Registry

The collected data from the Zurich Registry for pulmonary Hypertension (PH) are evaluated in a retrospective analysis. This study examines the number of patients and their exact diagnoses who are treated at the University Hospital of Zurich and potentially other participating in the Zurich Registry. Other demographic parameters such as age, gender and body-mass-index are also part of the evaluation. Furthermore, the analysis will focus on the newest guidelines on PH. Therefore, it will be checked how many patients would fulfill the therapeutic goals in terms of New York Heart Classification (NYHA), 6-minute walk distance, sign of right heart failure and N-terminal pro-brain-natriuretic peptide(NTproBNP). Additionally, the study examines on how the patients are treated. Despite the different kind of Drugs, the focus lies on the combination therapy (single, double, triple) and the impact the therapy had on the patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients with pulmonary arterial hypertension (PAH)
* Patients with chronic thromboembolic pulmonary hypertension (CTEPH)
* All prevalent patients (diagnosed \>12 month ago) with PAH or distal CTEPH who had a consultation at the PH centre in Zurich between November 2015 and November 2016)

Exclusion Criteria:

-
Effects on Patient Satisfaction and Gait After Loss of Peroneus Longus Function

At the foot and ankle group at the Department of Orthopaedics, Uppsala University Hospital, the routine is to perform a tendon transfer of peroneus longus to brevis in case of a ruptured peroneus brevis tendon in the ankle. The reports of patient outcome from this surgery varies in different studies. The aim of the current study is to analyse how well the patients think their general health has improved after the surgery, and how they perceive that the foot function has changed after the surgery. In an objective way the changes in gait after surgery will be measured with gait analysis.

The patients are asked to fill in Short Form 36 (SF 36) and Foot and Ankle Outcome Score (FAOS) before surgery, six months and one year after surgery. At each visit a clinical examination is done by a foot and ankle surgeon, according to a protocol. At the same visit a gait analysis is performed with force plates, registration of speed and gait length and 3D recording. The surgery itself is performed according to the clinic's usual protocol and standardised, so all patients are treated in the same way. The physiotherapy is also done according to a protocol. The surgeon is not involved in the follow- up, this is done by another surgeon, and the gait analysis is done by a physiotherapist.

The patients are chosen from two groups: primary tear of the peroneus brevis tendon, requiring a longus to brevis transfer, and primary tear of the peroneus longus tendon, requiring removal of the tendon.

The first group has a sub-group: patients who are in need of a calcaneal osteotomy because of a severe varus hindfoot. The reason the study group is so heterogenous is that peroneus longus and brevis tears are very rare, and 10 patients are referred to the Orthoaedic deparment each year, that need this type of surgery. The sample size has been calculated to 30 patients (based on changes in force measurements during gate), but more patients need to be involved in the study in order to have 30 patients at one year follow up.

Eligibility Criteria:
Inclusion Criteria:

1. Tears of the peroneus longus and/or peroneus brevis tendon, verified on MRI.
2. Eligible for surgery of peroneal tendon tears

Exclusion Criteria:

1. Other injuries in the affected foot that might affect the gait.
2. Previous surgery in the affected foot that might affect the gait.
3. Neurological conditions in the lower extremities that might affect the gait.
4. Patient can not understand the questionnaires or can not understand Swedish
Evaluation of the Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With iVue SD-OCT

Evaluate the repeatability and reproducibility of iVue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.


Eligibility Criteria:
Inclusion Criteria:

Normal

* Able and willing to provide consent.
* Able and willing to complete required exams. Corneal conditions
* Able and willing to provide consent.
* Able and willing to complete required exams.
* History of refractive surgery, contact lens, dry eye or keratoconus.

Exclusion Criteria:

Normal

* History of refractive surgery, contact lens, dry eye or pathology.
* Blepharitis or meibomitis
* Unable to complete required exams. Corneal conditions
* Unable to complete required exams.
Nutrigenomics And Children Obesity: A Moderate Weight Loss Intervention Study

The consumption of diets enriched in proteins (legumes and fish) or antioxidant (fruits and vegetables) could have beneficial effects beyond those of the caloric restriction on biomarkers of the inflammatory and oxidative status. OBJECTIVE: To address the effect of a 10-week dietary intervention aimed to weight loss in obese or overweight children (7-15 aged) on genomics, particularly the changes in the expression of genes related to the inflammatory status and oxidative stress. METHODOLOGY: 44 Navarra children and adolescents of both sexes from Pediatric Endocrinology Services at different Hospitals in Pamplona will be recruited. The effect of the intensive consumption of different groups of food will be evaluated: legumes and fish ( diets in proteins) and vegetable and fruits (rich diets in antioxidants). Before and after the intervention, the following items will be analyzed: (1) the diet of the subjects, (2) body composition and 3 magnitudes related to biological and development parameters, being: (3) lipid and metabolic phenotypic profile; (4) markers of the inflammatory status and oxidative stress, and (5) the genomic profile. The dietary programme will be implemented both in group workshops addresseded to patients and their family, and in individual sessions with the pediatricians and/or registered dieticians. Finally, the programme efficacy will be evaluated by the scoreboards integrated in the 5 variables already mentioned.

A longitudinal intervention study in 44 overweight and obese adolescents (23 females and 21 males; mean age 11.5 years) for 10 weeks based on a calorie restricted diet (20-40%) according to obesity degree.

Eligibility Criteria:
Inclusion Criteria:

* Children between 7 and 15 years
* Body Mass Index (BMI) higher to 97 percentile. (Cole et al, 2000)\*

  * Cole TJ, Belizzy MC, Flegal KM, Dietz WH. Br Med J 2000; 320: 1-6.

Exclusion Criteria:

* Use of prescription medication
* To suffer from any major psychiatry or neurological disease, bulimia nervosa, familiar hypercholesterolemia or any major cardiac, or respiratory metabolic disease.
HER2 PET Imaging in Breast Cancer Patients Using [68GA]ABY-025

This is an open-labeled, exploratory, single center study. Patients with a big primary breast cancer (≥ 3 cm) or metastatic first line, routinely have their HER2-expression determined by biopsy. Patients having a HER2-positive tumor will be recruited to the study. A \[18F\]FDG PET/ceCT scan is performed for the measurement of uptake in the tumour and diagnosis of possible metastases. Each subject will receive a single injection of the investigational product \[68Ga\]ABY-025, followed by measurement of uptake in the tumour or metastases and in normal organs. The investigations will be repeated after HER2 directed therapy.

see above

Eligibility Criteria:
Inclusion Criteria:

1. Subject is \> 18 years of age
2. Histologically or cytologically confirmed diagnosis of breast adenocarcinoma ≥ 3 cm determined by ultrasound, or locally advanced breast cancer (LABC: T3-4NxMx or TxN2-3Mx)
3. HER2-positiv breast cancer first recurrence
4. HER2-positiv breast cancer primary metastatic
5. HER2 status has been determined on biopsy material from the primary tumour and found to be HER2-positive, defined as a DAKO HercepTest™ score of 3+ or else 2+ and FISH positive
6. \[18F\]FDG PET/ceCT performed within 7 days before administration of IMP
7. ECOG performance status of =\< 2
8. Hematological, liver and renal function test results within the following limits:

   * White blood cell count: \> 2.0 x 10\^9/L
   * Haemoglobin: \> 5.0 mmol/L
   * Platelets: \> 50.0 x 10\^9/L
   * ALT, ALP: =\< 3 times Upper Limit of Normal
   * Bilirubin =\< 2.0 times Upper Limit of Normal
   * Serum creatinine: Within Normal Limits
9. A negative pregnancy test (serum beta-HCG) at screening for all subjects of childbearing potential
10. Subject is capable to undergo the diagnostic investigations to be performed in the study
11. Informed consent

Exclusion Criteria:

* 1. Known hypersensitivity to Dotarem® 2. Active known autoimmune disease or history of autoimmune disease 3. Active serious infection according to investigator evaluation 4. Known HIV positive or chronically active hepatitis B or C 5. Administration of other investigational medicinal product within 30 days of screening 6. Pregnant or breast-feeding 7. Women capable of childbearing not using a sufficient non-hormonal method of birth control 8. Other primary malignancies (including primary brain tumors) within the last 5 years before inclusion, with exception of sufficiently treated in situ carcinoma of the cervix, squamous carcinoma of the skin or sufficiently controlled limited basal cell carcinoma of the skin 9. Signs of any other disease, metabolic or psychological dysfunction, findings at physical examination or laboratory findings, which give reasonable suspicion of a disease or condition that would contraindicate use of the IMP, could influence the patient's compliance with the study routines or involves an increased risk for treatment-related complications.
Convolutional Neural Network for the Detection of Cervical Myelomalacia

Deep learning technology has been used increasingly in spine surgery as well as in many medical fields. However, it is noticed that most of the studies about this subject in the literature have been conducted except of the cervical spine. In this study, we aimed to demonstrate the effectiveness of the deep learning algorithm in the diagnosis of cervical myelomalacia compared to conventional diagnostic methods.

Artificial neural networks, a machine learning technique, have been used in several industrial and research fields increasingly. The development of computational units and the increasing amount of data led to the development of new methods on artificial neural networks

Cervical myelopathy (CM) is a frequent degenerative disease of the cervical spine that occurs as a result of compression of the spinal cord. In evaluating of this disease and determining treatment options, the patient's clinic and radiological modalities should be evaluated together.

The current imaging procedures for CM are plain roentgenograms, computed tomography and magnetic resonance imaging (MRI). However, MRI in CM is more valuable in evaluating of the disc, spinal cord and other soft tissues compared to other imaging methods. Artificial intelligence technologies also used in many health applications such as medical image analysis, biological signal analysis, etc. In this study, we aimed to demonstrate the effectiveness of the deep learning algorithm in the diagnosis of cervical myelomalacia compared to conventional diagnostic methods.

Eligibility Criteria:
Inclusion Criteria:

* the patients with classical cervical myelomalacia sypmtoms such as neck pain and stiffness, weakness and clumsiness at the upper extremities or gait difficulties and radiological findings of spinal compression
* 30-80 years age.

Exclusion Criteria:

* Patients with a previous history of cervical spinal surgery and has a systematic disease (rheumatologic or neural disease) .
Dental Care and Initiation of Anti-osteoporotic Therapy

The initiation of bisphosphonate therapy for osteoporosis requires an assessment of the oral status to prevent the risk of osteonecrosis of the jaw. This recommendation is sometimes a hindrance to the initiation of treatment or may be responsible for a delay in treatment or even the failure to initiate treatment. However, in the case of a severe osteoporotic fracture (femoral or humeral neck fracture, vertebral fracture or pelvic fracture), treatment must be rapid because of the major risk of refracture in the short term (multiplied by 5 in the 2 years following the fracture).

In the rheumatology department of the Nice University Hospital, the investigator team take care of patients with osteoporotic fractures either directly in hospital or referred by the orthopedics department as part of a care program. For these patients, the team perform an etiological assessment, bone densitometry and evaluation of the oral status with dental panoramic and tele-expertise to determine if there is an indication to perform surgical care before starting the treatment.

Therefore, the investigator aimed to describe the number of patients requiring dental surgery befor the initiation of bisphosphonate or denosumab treatment before to introduce treatment for osteoporosis


Eligibility Criteria:
Inclusion Criteria:

* osteoporotic fracture requiring treatment with bisphosphonate or denosumab

Exclusion Criteria:

* osteoporotic fracture requiring teriparatide treatment
Durolane Versus Phosphate Buffered Saline (PBS) in Knee Osteoarthritis

The purpose of the study is to determine whether a single intra-articular injection of Durolane 4.5 mL is superior to a single injection of PBS 4.5 mL for the relief of joint pain in patients with osteoarthritis of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Body Mass Index (BMI) ≤ 35 kg/m2
* Symptomatic osteoarthritis (OA) of the knee
* K L severity grade 1 or 2
* If bilateral OA, contralateral knee K L severity grade 0 or 1

Exclusion Criteria:

* Has clinically apparent tense effusion of the index knee
* Has had surgery on the symptomatic knee within the previous 12 months or arthroscopy in the index knee in the past 3 months
* Has any painful orthopedic disorders of the back or hip
* Has a joint disorder other than osteoarthritis in the index knee