cyrilzakka/clinical-trials huggingface dataset:
A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema

This study is designed as a Multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injections of IBI324 in subjects with DME


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.
2. Male or female subjects with age of 18\~80 yrs.
3. Diagnosis of diabetes mellitus(type 1 or 2), and current regular use of insulin or other injectable drugs or oral anti-hyperglycaemic agent for the treatment of diabetes.
4. Visual impairment was caused by DME involving the macular fovea.
5. Central macular sub-field thickness (CST) ≥320μm according to OCT.
6. BCVA score of 24-73 letters using ETDRS charts (in 4 meters) in the study eye.
7. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 3 months after the end of treatment.

Exclusion Criteria:

1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.
2. PDR in the study eye.
3. Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye.
4. Active rubeosis in the study eye.
5. The equivalent spherical lens≤-8.00D in the study eye.
6. The intraocular pressure\>21 mmHg in the study eye.
7. Active ocular or periocular inflammation/infection in either eye.
8. Prior any treatment of following in the study eye:

   * Intravitreal anti-VEGF treatment within 3 months prior to baseline;
   * Intraocular glucocorticoid injection within 3 months prior to baseline;
   * PRP, local/grid laser photocoagulation within 3 months prior to baseline;
   * Any intraocular surgery (e.g. cataract surgery) within 90 days prior to baseline;
   * The eyes were treated with lasik posterior capsulotomy or glaucoma filtration, radiotherapy 30 days before baseline;
9. Currently untreated diabetes mellitus or previously untreated DM subjects who initiated oral or injectable antidiabetic medication or insulin \<90 days;
10. HbA1c of \>10% within 28 days prior to baseline;
11. Presence of any systemic disease: including but not limited to unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;
12. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;
13. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;
14. Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;
15. Other conditions unsuitable for enrollment judged by investigators
Bevacizumab Combined With Carboplatin Plus Paclitaxel Chemotherapy to Treat Metastatic Mucosal Melanoma

Mucosal melanoma is rare and associated with extremely poor prognosis.No effective treatment for advanced mucosal melanoma patients.Investigators conducted a randomized phase II study in patients with previously untreated metastatic mucosal melanoma to characterize the efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.

Mucosal melanoma is rare and associated with extremely poor prognosis.It is the second most common subtype in Asians.No effective treatment for advanced mucosal melanoma patients.Malignant melanoma is a highly vascular tumor in which vascular endothelial growth factor(VEGF) is strongly expressed and seems to play an important role in disease progression.A randomized phase II study evaluated the activity of Bevacizumab in combination with carboplatin plus paclitaxel(CPB arm) in patients with previously untreated advanced melanoma.Overall response rates was 25.5%,median overall survival time(OS) was 12.3 months in the CPB arm. Investigators conducted a randomized phase II study in patients with previously untreated metastatic mucosal melanoma to characterize the efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed mucosal melanoma with metastases and has no received any systemic treatment.
2. ECOG performance status 0, 1
3. Estimated life expectancy of 12 weeks or greater
4. Age 18 years or older, male or female
5. At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
6. Adequate organ function
7. Without symptoms of brain metastases and stable in neuro-functions.
8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures

Exclusion Criteria:

1. Mutations in C-KIT or BRAF-V600E, asked for other target treatments
2. Pregnant or lactation women
3. Acute infections without control.
4. Heart disease history, cardiac function class≥NYHA II.
5. HIV positive or chronic HBV/HCV in active stage.
6. Brain metastases or primary tumor with positive symptoms
7. Need anti-epileptic treatments
8. Organ transplantation history
9. Hemorrhagic tendency or related history
10. Renal dialysis patients
11. Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
12. Current treatment on another clinical trial
13. The other improper situations which investigator judged.
Longitudinal Prospective Study of Neurocognition & Neuroimaging in Primary BT Patients

In this proposal, the investigators introduce a novel, translational study to prospectively examine primary brain tumor patients undergoing fractionated radiation therapy to the brain. Quantitative neuroimaging, radiation dose information, and directed neurocognitive testing will be acquired through this study to improve understanding of cognitive changes associated with radiation dosage to non-targeted tissue, and will provide the basis for evidence-based cognitive- sparing brain radiotherapy.

Background: Fractionated radiation therapy (RT) is a mainstay in the treatment of primary and metastatic brain tumors. However, RT to the brain is associated with an inevitable decline in neurocognitive function in up to 90% of patients who survive more than 6 months after irradiation. Radiation to the brain results in an inevitable decline in neurocognitive function, mediated by tissue injury to white matter, cortex and subcortical areas. With quantitative magnetic resonance imaging (MRI) techniques, investigators can directly and non-invasively measure such changes.

Objective/Hypothesis:

The purpose of this study is to examine radiation-induced imaging changes in normal brain tissue over time in primary brain tumor patients, and correlate these with neurocognitive outcomes. The overarching goal is to better identify sensitive brain regions so that future radiation techniques can be optimally designed to mitigate collateral damage.

Specific Aims:

1. To identify microstructural changes in subcortical white matter, hippocampus, and cortex associated with quantified regional exposure to fractionated brain radiotherapy using advanced quantitative neuroimaging imaging
2. To identify changes in neurocognitive functioning in primary brain tumor patients after brain radiotherapy

Study Design:

The investigators will prospectively enroll primary brain tumor patients undergoing fractionated partial brain radiation therapy. Patients will undergo volumetric and diffusion brain MRI (per clinical standard-of-care) and a neurocognitive battery of tests at baseline (pre-treatment), 3 months, 6 months, and 12 months post-treatment. Clinical data including age, gender, educational status, tumor size and histology, steroid use, antiepileptic drug use and chemotherapy will be recorded.

Eligibility Criteria:
Inclusion Criteria:

1. Patients 18 years or older
2. Karnofsky performance status (KPS) ≥70
3. Life expectancy of ≥1 year
4. Primary brain tumor patients who will receive fractionated partial brain RT
5. Able to complete neurocognitive assessments

Exclusion Criteria:

1. Inability to undergo MRI with contrast
2. Prior brain RT
Impact of the Use of CRP on the Prescription of Antibiotics in General Practitioners

Respiratory infections, including episodes of coughing with fever, are the main cause of outpatient antibiotic prescription, while a minority of them are linked to bacterial infections requiring antibiotic. These prescriptions are often performed by general practitioners. These unnecessary antibiotic contribute to increased bacterial resistance, side effects and unnecessary costs. Campaigns for the correct prescription of antibiotics have had a real but partial or transient success.

C-reactive protein micro-method (POCT-CRP) could help to differentiate between viral and bacterial infections and thus contribute to the proper use of antibiotics. The decrease in prescription of antibiotics is likely to have an even stronger positive impact in countries like France, where prescription is high.

The objective of this study is to evaluate the use of POCT-CRP in the general practitioner's office in case of suspected respiratory infection.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 3 years
* Clinical suspicion of respiratory infection defined by the presence of at least one respiratory sign among, cough, dyspnea, chest pain and auscultatory abnormality and at least one general sign among fever, sweat, headache, myalgia, impairment of general condition
* Affiliated to a social health insurance
* Signed consent

Exclusion Criteria:

* Duration of symptoms \< 24 hours
* Hospitalization or emergency assessment decision decided from the outset
* Signs of severity before the realization of POCT-CRP
* Patient previously included in the study for the same episode
* Antibiotic therapy within 7 days
* Chronic cough (more than 3 weeks)
Safety and Efficacy Study of Association Between Tretinoin and Clindamycin on the Treatment of Acne Mild and Moderate

The purpose of this study is to determine the safety and efficacy of association between tretinoin and clindamycin phosphate on the treatment of acne vulgaris mild and moderate.


Eligibility Criteria:
Inclusion Criteria:

* Individuals of both sexes with age greater than or equal to 12 years
* Subjects diagnosed with acne vulgaris in the face, except for the nasal area, range from mild to moderate, with the following requirements.

  * Mild acne = presence of fewer than 20 comedones or less than 15 lesions, inflammatory lesions or a total of less than 30 injuries.
  * Moderate acne = presence of 20 the 100 comedones or of 15 the 50 inflamatory lesions or a total of 30 the 125 lesions, with not more than lesions small nodule until 5,0 mm.
* Ensure that the existing injuries were not submitted any treatment for acne, topical or systemic, within the last 30 days.
* Be able to properly follow the determinations of the Protocol.
* Has provided a written voluntary consent to participate in the study, by signing the informed consent, before being subjected to any procedure.
* Under 18 years old, be accompanied by legal guardian in the process of obtaining the informed consent.
* Be mentally able to provide consent and be fulfilling all the requirements of the study.

Exclusion Criteria:

* Pregnant women or in periods of lactation.
* Women of childbearing age and sexual activity with not using safe contraceptive method, such as oral contraceptives, implantable, injectable or intra-uterine, introduced for at least 120 days.
* Women who are using oral contraceptives containing the hormone combination for acetate ciprosterone and etinolestradiol, association of drospirenone and ethinyl estradiol, or desogestrel.
* Clinical evidence or history of immunodeficiency.
* Any use of immunosuppressive drug and/or immunomodulating over the past 3 months, topical or systemic.
* Concurrent use of fotossentetizadores, neuromuscular blockers, medications that exacerbate the acne, blockers (filters) with solar alcoholic vehicle, spironolactone, flutamide or zinc salts.
* Prior use of systemic retinoid.
* Presence of acne medication and/or cosmetic.
* History of systemic metabolic disorder that can interfere with the integrity of the skin.
* History of inflammatory disease, intestinal or regional enteritis and/or symptoms similar.
* History of joy to any of the components of the formula (active principle or carrier).
* History of abuse of alcohol and/or illegal drugs.
* History of non-adherence to medical treatment earlier.
* Any clinical observation made by the investigator that prohibits participation in the study of the subject.
A Study of People With CD30 Positive Lymphoma in China

The main aim is to see how adult participants with newly diagnosed or relapsed/refractory CD30+ lymphoma responded to any previous treatment in China.

The study sponsor will not be involved in how participants are treated, the study only consists of collecting demographic and clinical records information from the hospital clinical systems. Based on the diagnosis of the disease, participants will be assigned to one of the following groups and their information will be analyzed within that group respectively:

* Group A: Participants diagnosed with classical Hodgkin lymphoma (cHL).
* Group B: participants diagnosed with non-Hodgkin lymphoma (NHL), including systemic anaplastic large-cell lymphoma \[sALCL\], peripheral T-cell lymphoma-not otherwise specified \[PTCL-NOS\], angioimmunoblastic T-cell lymphoma \[AITL\], extranodal NK/T-cell lymphoma \[ENKTCL\], mycosis fungoides \[MF\], primary cutaneous anaplastic large cell lymphoma \[pcALCL\], diffuse large B-cell lymphoma \[DLBCL\], primary mediastinal B-cell lymphoma \[PMBCL\]).

This is an observational, non-interventional, retrospective study in participants with newly diagnosed or relapsed/refractory CD30+ lymphoma to describe the treatment pathways, outcomes, and resource use among adult participants.

The study will enroll approximately 2800 participants. The data will be collected from participants' medical records between January 1, 2018 and March 31, 2021 and recorded in the in case report forms (CRFs). Participants will be assigned to the following two observational cohorts based on pathological diagnosis:

* Cohort A: Participants with cHL
* Cohort B: Participants with NHL

This multi-center trial will be conducted in China. All participants will be observed for at least 6 months or until death, loss to follow-up, or end of the study, whichever occurs first.

Eligibility Criteria:
Inclusion criteria:

1. Who newly diagnosed with or refractory/relapsed with cHL, sALCL, CD30+ non-sALCL-NHL confirmed by immunochemistry with any CD30 expression (that is, PTCL-NOS, AITL, ENKTCL, MF, pcALCL, DLBCL, PMBCL) between January 1, 2018 and March 31, 2021 and only one CD30+ pathology report will be needed for CD30+ non-sALCL-NHL.
2. Who have received anti-lymphoma treatment between January 1, 2018 and March 31, 2021.

Exclusion criteria:

1. Whose demographics and clinical features are not available from medical records.
Pilates Exercises in Spanish Women With Fibromyalgia

To analyze the effects of a Pilates exercise program in Spanish postmenopausal women with Fibromyalgia

This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.

The study will define two groups:

* A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.
* An experimental group (GE) that after an initial evaluation will undergo a physical training program based on Pilates exercises.

Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.

Eligibility Criteria:
Inclusion Criteria:

* No menstrual activity for at least 12 months.
* Present Fibromyalgia.
* Do not participate in a weight loss program.
* Be able to understand the instructions, programs and protocols of this project.

Exclusion Criteria:

* Contraindications for conducting physical tests.
* Diseases that limit the static and dynamic balance and physical activity. -
* Central or peripheral vestibular or nerve alterations.
Dysphagia in Thoracic Surgical Patients

The proposed study seeks to determine the incidence of dysphagia and vocal fold mobility impairment (VFMI) in individuals undergoing throacic surgical procedures. It also seeks to determine the impact of postoperative swallowing impairment on health-related outcomes.

Swallowing impairment and VFMI are common, yet often overlooked, complications of thoracic surgical procedures. The true incidence of both dysphagia and VFMI in this patient population is unclear due to a lack of rigorous study using instrumental assessment techniques and validated outcomes in all patents undergoing thoracic surgery. The study is therefore aimed to determine the incidence of dysphagia and VFMI in this patient population and to characterize impairment profiles related to swallowing safety and efficiency. In addition, the study is also aimed to assess the relative impact of VFMI and dysphagia on health-related outcomes such as length of hospital stay, pneumonia, sepsis, reintubation, and discharge status

Eligibility Criteria:
Inclusion Criteria:

* adults aged 18 - 90 years old
* undergoing planned or emergent thoracic surgery via clamshell and/or extended thoracotomy
* confirmed negative COVID-19 test
* willing to participate in postoperative swallowing evaluation testing.

Exclusion Criteria:

* individuals under the age of 18.
* pregnant
* or those testing positive for COVID-19
* Additionally, the inability to demonstrate appropriate alertness and cognitive status following the procedure will exclude a participant from participating in this study to ensure protection of vulnerable individuals.
Evaluation of Comfort Behavior Levels of Newborns With Artificial Intelligence Techniques

This study; It will be carried out with the aim of developing the artificial intelligence method, which allows automatic determination of comfort levels of newborns.

This study; It will be carried out with the aim of developing the artificial intelligence method, which allows automatic determination of comfort levels of newborns. Facial and body movements of newborns will be recorded by camera, and images will be processed in computer environment by using artificial intelligence techniques. As a result, it is planned to create a technology that determines the comfort level of the newborn quickly and simply and can be used by the mobile device.

Eligibility Criteria:
Inclusion Criteria:

* Parents' acceptance of their baby's participation in the study
* Having a baby born at 24-42 weeks

Exclusion Criteria:

* Having a baby born before 24 weeks of gestation or after 42 weeks of gestation.
* Has received analgesic, muscle relaxant or sedative drug treatment that may affect comfort and behavior (last 24 hours)
* Newborn has serious neurological damage
Comparaison of ESP Block and TAP Block

This study aim to compare the efficiency and the analgesic effect of Erector Spinal Plane Block versus TAP Block after laparoscopic cholecystectomy.

This study will include patients scheduled for laparoscopic cholecystectomy, ASA status 1 or 2. patients will be randomized in 2 groups to recieve post operative analgesia with -ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.

or

-TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%

Eligibility Criteria:
Inclusion Criteria:

* Adult patients
* ASA status I or II
* scheduled for laparoscopic cholecystectomy

Exclusion Criteria:

* laparotomy
* unplanned ICU admission
Protein Supplementation in Dialysis Patients

The mortality rate in chronic hemodialysis (CHD) patients remains excessively high and approaches 21% per year. Among the many factors that adversely affects patient outcome is uremic malnutrition, a unique form of deranged nutritional status. It is associated with increased hospitalization and death risk in CHD patients. Several measures have been identified to prevent uremic malnutrition in CHD patients, including efforts to optimize dialysis regimen and dietary protein and energy intake. A large number of CHD patients suffer from uremic malnutrition in spite of these aggressive measures. The inevitable protein catabolic effects of the hemodialysis procedure are important factors leading to increased prevalence of uremic malnutrition. Preliminary data suggest that oral nutritional supplementation administered during the hemodialysis procedure counteracts these protein catabolic effects and leads to net protein anabolism in the acute setting. In this proposal, we hypothesize that Pro-Stat, a high nitrogen, enzyme-hydrolyzed, tryptophan-fortified, collagen protein supplement will reverse the net protein catabolism observed during hemodialysis procedure.


Eligibility Criteria:
Inclusion criteria:

* On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program.
* Adequately dialyzed (Kt/V \> 1.2).
* Age 18-75

Exclusion criteria:

* Pregnant women.
* Severe unstable underlying disease besides commonly associated with end stage renal disease. Cardiac patients that are stable will be included.
* Patients hospitalized within the last month prior to the study.
* Patients with malfunctioning arterial-venous access \[recirculation and/or blood flow \< 500 ml/min for an arterial-venous graft (AVG) or \<400 ml/min for an arterial-venous fistula (AVF)\] Patients receiving steroids and/or other immunosuppressive agents.
Early Use of Ivabradine in Heart Failure

The aim of the work is to Evaluate the efficacy, quality of life and safety of early addition of ivabradine to B-blocker in reduced EF heart failure patients after acute decompensation compared to the standard treatment.

this study is a Prospective randomized open label study will be conducted on Egyptian patient with heart failure with reduced ejection fraction(rEF HF). Each of the eligible patients will be randomized to one of these groups, early administration of Ivabradine and B-blocker group or control group which follows American Heart Association treatment guidelines of rEF HF.

The objectives include the following:

1. Physical examination (heart rate, blood pressure, dyspnea and orthopnea symptoms)
2. NYHA class
3. Pro-NT-BNP serum level, ST2 serum level
4. Echocardiography (left ventricular ejection fraction)
5. Score of Minnesota Living with Heart Failure Questionnaire these objectives will be measured baseline, 2 weeks and after 3 months

Eligibility Criteria:
Inclusion Criteria:

1. Patient with acute heart failure either newly diagnosed or decompensated heart failure after stabilization
2. Patients \> 18 years old
3. Left ventricular ejection fraction less than 40 % of presumed irreversible etiology
4. Clinically stable 24-48 hours after admission
5. Sinus rhythm with heart rate above 70 bpm
6. No previous treatment with ivabradine

Exclusion Criteria:

1. Patients less than 18 years.
2. Arterial fibrillation before inclusion.
3. Ventricular dysfunction due to acute event (Myocarditis, AMI). 4- cardiogenic shock

5. Patients are taking drug interact with ivabradine. 6- carrier or candidate for pacemaker, heart transportation, cardiac surgery or other cardiovascular procedure