cyrilzakka/clinical-trials huggingface dataset:
ADVM-022 Intravitreal Gene Therapy for Wet AMD

ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice.

This open-label, multicenter, dose-ranging study will evaluate 2 dose levels in up to 30 subjects (15 per dose) with active choroidal neovascularization (CNV) secondary to AMD. Subjects who are under active anti-VEGF treatment and have demonstrated a meaningful response to anti-VEGF therapy will be considered for participation in this study. The primary endpoint for this study is safety and tolerability of ADVM-022. All subjects will continue to be assessed for 104 weeks following treatment with ADVM-022.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 50
* Diagnosis of neovascular (wet) AMD
* BCVA ETDRS Snellen equivalent between ≤20/32 and ≥20/320 for each cohort
* Subjects must be under active anti-VEGF treatment for wAMD and received a minimum of 2 injections within 4 months prior to screening
* Demonstrated a meaningful response to anti-VEGF therapy
* Willing and able to provide consent

Exclusion Criteria:

* History of retinal disease in the study eye other than wet AMD
* Fibrosis or atrophy, retinal epithelial tear in the center of the fovea in the study eye, or any condition preventing visual acuity improvement
* History of retinal detachment (with or without repair) in the study eye
* History of vitrectomy, trabeculectomy, or other filtration surgery in the study eye
* Uncontrolled glaucoma in the study eye
* Any prior treatment with photodynamic therapy or retinal laser for the treatment of wet AMD and any previous therapeutic radiation in the region of the study eye
* Any previous intraocular or periocular surgery on the study eye within 6 months
* Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months
* Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg
A Phase 2 Study Evaluating ABT-751 in Combination With Taxotere in Advanced Non-Small Cell Lung Cancer

To determine the efficacy of ABT-751 when administered in combination with standard docetaxel in subjects with advanced or metastatic NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically documented NSCLC
* Locally advanced (Stage III) or metastatic (Stage IV) NSCLC
* Only one prior anti-tumor treatment regimen in the non-curative setting (i.e., 2nd-line therapy)
* Only one prior anti-tumor treatment regimen in the curative setting
* Progressive disease following the previous anti-tumor treatment regimen
* Measurable disease by RECIST criteria
* Brain metastasis must be stable and well-controlled

ECOG performance score 0-2All anti-tumor therapy discontinued at least 3 weeks prior to study entryAll adverse events from prior treatment are resolved or stableAdequate hematologic, renal, and hepatic functionFemales must not be pregnantWilling to take adequate measures to prevent pregnancyLife expectancy of at least 3 monthsAble to complete the Quality of Life questionnaireVoluntarily signed informed consent

* Only one prior anti-tumor treatment regimen in the curative setting
* Progressive disease following the previous anti-tumor treatment regimen
* Measurable disease by RECIST criteria
* Brain metastasis must be stable and well-controlled
* ECOG performance score 0-2
* All anti-tumor therapy discontinued at least 3 weeks prior to study entry
* All adverse events from prior treatment are resolved or stable
* Adequate hematologic, renal, and hepatic function
* Females must not be pregnant
* Willing to take adequate measures to prevent pregnancy
* Life expectancy of at least 3 months
* Able to complete the Quality of Life questionnaire
* Voluntarily signed informed consent

Exclusion Criteria:

* Greater that Grade 1 neurological findings
* Allergy to sulfa medications
* Previous treatment with ABT-751 or docetaxel
* Receipt of more than one investigational agent for NSCLC
* Significant weight loss (\>10%) within 6 weeks of study entry
* Glucose-6-phosphate dehydrogenase deficiency or porphyria
* Significant systemic disease that would adversely affect participation
* Class 3-4 New York Heart Association classification status
* Other cancers except in situ carcinoma of the cervix, basal or squamous cell skin cancer, or any other cancer considered adequately treated and cured by the investigator
Can Additional Preoperative Skin Cleaning on Face, Neck and Chest With Chlorhexidine Reduce Cutibacterium Acnes Contamination on Sutures in Arthroscopy Rotator Cuff Repair?

The purpose of our study was to investigate whether preoperative skin cleaning on face, neck, and chest with chlorhexidine could reduce suture contamination of C. acnes in arthroscopic rotator cuff repair. We hypothesized that preoperative skin cleaning on face, neck and chest with chlorhexidine can reduce C. acnes contamination on sutures in arthroscopic rotator cuff repair.


Eligibility Criteria:
Inclusion Criteria:

* primary arthroscopic rotator cuff repair

Exclusion Criteria:

* younger than 18 years
* having previous shoulder surgeries or shoulder infection episodes
* having a history of allergy to chlorhexidine
* who refused to participate
Hyperbaric Oxygen in Patients Who Had a Stroke

Prospective clinical assessment of 40 Hyperbaric Oxygen (HBO) treatments in 10 completed stroke patients.

10 patients having suffered a stroke and having being rehabilitated will be treated with 40 consecutive Hyperbaric Oxygen Treatment (HBOT) after a minimal delay of 3 months after stroke. They will be neurologically assessed before and 3 months after HBOT. Rivermead mobility index will be also assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic cortical stroke in chronic stage (≥ 3 months) with residual motor deficits confirmed by imaging with brain CT scan and/or brain MRI

Informed consent

Exclusion Criteria:

* Neurological issue:

  * inability to understand the informed consent form
  * Hemiplegia
* Hyperbaric issue:

  * Claustrophobia
  * inability to put on face mask
  * uncontrolled epilepsy
  * dementia or psychological disturbance
  * previous pneumothorax
  * pregnancy
Feasibility Study of an Intervention Therapeutic Education for Patients Treated With Androgen Deprivation

The purpose of the study is to build and assess the feasibility of a therapeutic education program, constructed in collaboration with the urologists of the University Hospital of Saint Etienne. The aim of this therapeutic education program is to delay the onset or to reduce the amplitude of the development of insulin resistance and side effects of androgen deprivation therapy in patients treated with androgen deprivation in the context of an evolutive prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients supported in consultation Urology at the University Hospital North Saint Etienne.
* Aged over 18 years
* Having an evolutive prostate cancer
* Patient treated with LHRH agonist for at least 6 months - Affiliated with the national health insurance system
* And having completed the worksheet informed consent to participate in the program.

Exclusion Criteria:

* Refusal of participation, protected or under guardianship patients.
* Patients unable to understand the study or unable to follow the educational sessions.
* Patient (s) with documented cognitive or psychiatric history.
* Geographical remotness (more than 100 Kms.)
Multidisciplinary Approach to Nutritional Support for Oncological Patients - NUTRACARE PROJECT

Malnutrition correlated to increased perioperative morbidity occurs in patients with gastrointestinal malignancies.

Adherence guidelines for nutritional assessment and support in oncological patients is unfortunately very low.

The aim of the study is to improve clinical practice by using and testing the digital platform NUTRACARE in 5 different Centers.

After being informed about the study, all the patients undergoing elective surgery or first cycle of neoadjuvant or adjuvant therapy giving written informed consent will be screened by the surgeon or the oncologist and the NRS-2002 (Nutrition Risk Screening) will be administered.

Patients who will be assessed at risk will be notified to the center nutritionist.

Eligibility Criteria:
Inclusion Criteria:

* \<18 years
* ECOG grade 0-2
* Patients undergoing elective surgery or first cycle of chemotherapy (neoadjuvant or adjuvant) for staged I-III colorectal, hepatobiliary-pancreatic and oesophago-gastric cancers

Exclusion Criteria:

* \>18 years
* Pregnancy
* Emergency
* ECOG ≥ 3
* M+
* Peritoneal involvement
* Inability to provide informed consent
* Informed consent refusal
A Randomized Controlled Trial Comparing Urea Loaded Nanoparticles to Placebo: a New Concept for Cataract Management

Cataract is the leading cause of vision loss and blindness in the world,surgery is the only available option to correct the problem and the major reasons for low cataract surgical rates include low demand because of fear of surgery, high cost of surgery and poor visual results but new research raises the hope that someday, cataracts could be cured with simple eye drops. This is the first report for preparing urea-loaded NPs eye drops for cataract therapy. Enhancement of the urea efficacy is accomplished by using polymeric NPs based on the amphiphilic block copolymer Pluronic®F-127 (PF) which is a hydrophilic nontoxic copolymer widely used as a pharmaceutical excipient for its stabilizing properties and capability to increase the solubility.

51 patients with cataract were included in this study that started at December 2014 to April 2016. All cases collected from out patients' clinic of Assiut University Hospital These patients were randomized into two groups. Group I(control) included 11 cases (22 eyes) used Balance Salt Solution (BSS) eye drops. Group II include 40 cases (67 eyes) were treated by the prepared eye drops of urea NPs solution.

Preparation of urea-loaded nanoparticles

First the investigators will test the safety of urea as eye drops by injecting urea in concentration of 96 ml/mol in the anterior chamber of 6 rabbit eyes and the other eye of each rabbit will be used as control. After 14 days enucleation of both eyes, then will prepare extracted eye tissue for examination by light and electron microscopes.

Urea solution will be then prepared for eye drops purpose by enhancing its efficacy using the polymeric NPs based on the amphiphilic block copolymer Pluronic®F-127 (PF) which is an A-B-A-type triblock copolymer consisting of polyoxyethylene (PEO) units (A) and polyoxypropylene (PPO) units (B) with a thermoreversible gelation property that has a hydrophilic nontoxic property widely used as a pharmaceutical excipient for its stabilizing properties and capability to increase the solubility.

The eye drop will be prepared by an ionic gelation method using the tripeptide antioxidant glutathione (GSH) with the pluronic®F-127 (PF) as carriers to urea delivery for the target of cataract therapy. Pluronic® F127 (PF127), which can be self-assembled into micelles upon increasing concentration or raising temperatures, is used to decorate the water-soluble urea via a chemical reaction. Next, the GSH is incorporated into the hydrophobic poly (propylene oxide) compartment of PF127 using electrostatic interactions between the positively charged GSH and the negatively charged PF. The prepared NPs were then characterized using transmission electron microscopy (TEM). The average size of urea-loaded PF 127/GSH NPs was 140 nm.

Eligibility Criteria:
Inclusion Criteria:

* All cases were immature cataract at different stages.

Exclusion Criteria:

* No complicated cataract included in this study either due to local or systemic diseases.
Smoking Prevention Through Social Connections Among Adolescents - ASPIRE

The central hypothesis of this study is that the addition of social influence strategies to a web-based program called ASPIRE will boost its success in lowering intention to use tobacco among adolescents and experiencing stronger positive social influence. The study will involve a nested group randomized controlled trial with adolescents from after-school programs and schools (e.g., the PK Yonge school) in Florida.


Eligibility Criteria:
Inclusion Criteria:

* All participants must be of ages 11 through 18 (11 and 18 included; age group for adolescents adopted by several National Institutes of Health)
* Are members of after school program or school
* All participants will be English speaking
* Adolescents with developmental disability, mental or physical, are not excluded from the study. However, they will only be able to participate if (1) they understand the information presented to them in the consent document, and (2) they believe they are capable to engage in the board game, use the internet, and answer survey questions.
* Pregnant adolescents will be eligible to participate in the research study as requested by the NIH based on 2 principles that will be discussed at time of consent.

Exclusion Criteria:

-When participants don't meet the inclusion criteria
Clinical Evaluation and Assesment of Ginigivitis Patients Treated by Yarrow Natural Extract in Compare to a Contro Group

A double-blind, prospective, randomized, intra-individual comparative, single-center clinical study was conducted. Participants were placed in parallel groups, and the study was performed in the Department of Operative Dentistry and Periodontology, Dental School and Hospital, Minia university to compare the antibacterial activity of yarrow Moringa herbal combinations nanoparticles in compared to Chlorhexidine as a potential treatment for gingivitis.


Eligibility Criteria:
Inclusion Criteria:

* a minimum of four natural uncrowned teeth in one quadrant present
* good general health
* can follow instructions

Exclusion Criteria:

* were pregnant or breastfeeding
* evidence of antibiotic use during the 4 weeks prior to the study
* were allergic to personal care/consumer products or their ingredients
European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes

This study is being carried out to find out how patients suffering from the acute manic phase of bipolar disease are currently managed with Quetiapine Immediate Release (IR) or Quetiapine Extended Release (XR) in the hospital setting in real life practice, including length of stay.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Bipolar Disorder (ICD-10).
* Admitted for acute bipolar manic episode from 1st October 2009 to 1st October 2010
* Patients treated with quetiapine IR or quetiapine XR during the hospitalization period.

Exclusion Criteria:

* Patients in which BD is not the main reason for hospitalization
* Patients admitted for acute bipolar mania episodes but finally diagnosed with mixed or bipolar disorder not otherwise specified (NOS) episodes
* Patients receiving both quetiapine IR and XR during the same hospitalization period.
Pharmacokinetics/Pharmacodynamics of NOX-H94 in the Human Endotoxemia Model

The purpose of this study is to assess the effect of the anti-hepcidin Spiegelmer NOX-H94 on iron homeostasis during systemic inflammation induced by endotoxin.

In the human endotoxemia model, intravenously administered lipopolysaccharide elicits an inflammatory response with release of pro-inflammatory cytokines, such as IL-6 and TNF-alfa, with subsequent induction of hepcidin. As a consequence of hepcidin induction, serum iron concentrations decrease.

This study in healthy subjects investigates the capacity of NOX-H94 to inactivate hepcidin and to prevent serum iron decrease in a pathophysiological model prior to studying the efficacy of NOX-H94 in patients with anemia of chronic disease.


Eligibility Criteria:
Main Inclusion Criteria:

* BMI between 18 and 30 kg/m², with a lower limit of body weight of 50 kg
* Healthy as determined by medical history, physical examination, vital signs, 12 lead electrocardiogram, and clinical laboratory parameters
* Serum iron and red blood parameters Hb, MCV, ferritin, serum iron, and total iron binding capacity within reference range

Main Exclusion Criteria:

* Use of any medication, recreational drugs or anti-oxidant vitamin supplements within 7 days
* Use of caffeine, nicotine, or alcohol within 1 day
* Previous participation in a trial where LPS was administered
* Surgery or trauma with significant blood loss or blood donation within 3 months
* History, signs or symptoms of cardiovascular disease (vaso-vagal collapse or of orthostatic hypotension, Resting pulse rate ≤45 or ≥100/min, Hypertension, Hypotension, ECG conduction abnormalities)
* Renal impairment: plasma creatinine \>120 µmol/L
* Liver function tests (alkaline phosphatase, AST, ALT and γ-GT) outside of the reference range or total bilirubin \>20 µmol/L
* Hemoglobin or iron parameters (iron, transferring saturation, ferritin) outside of the reference ranges
* History of asthma
* Immuno-deficiency
* Positive test of HIV type 1/2 antibodies, HBs antigen, HBc antibodies and HCV antibodies unless antibody titer is induced by vaccination
* CRP \> reference range or clinically significant acute illness, including infections, within 2 weeks
* Treatment with investigational drugs or participation in any other clinical trial within 30 days prior to study drug administration
* Known or suspected of not being able to comply with the trial protocol
* Inability to personally provide written informed consent and/or take part in the study
Deep Vein Thrombosis Prophylaxis Adherence: Enoxaparin vs Rivaroxaban

The objective of this study is to compare oral rivaroxaban with injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily.

This study is a randomized, controlled trial of orthopaedic trauma patients presenting to a single academic level one trauma center that require an extended course of venous thromboembolism event chemoprophylaxis. The goal is to compare oral rivaroxaban with our standard-of-care, injectable enoxaparin in orthopaedic trauma patients to determine if orally administered rivaroxaban once daily carries greater compliance and overall satisfaction than enoxaparin self-administered by subcutaneous injection once daily.

All patients included in the study would be treated with the standard enoxaparin 40 milligram injection while an inpatient. Upon hospital discharge, those requiring extended venous thromboembolism event chemoprophylaxis will be randomized to receive 20 days of either self-injected enoxaparin 40 milligrams or oral rivaroxaban,10 milligrams, a non-vitamin K oral anticoagulant. Both groups will then receive our current standard of care, aspirin 81 milligrams once daily for the remaining 3 weeks, for a total of 6 weeks of venous thromboembolism event chemoprophylaxis. Routine postoperative care will be provided by the treating surgeon.

Eligibility Criteria:
Inclusion Criteria:

* • Orthopaedic trauma patients deemed by the attending, treating surgeon to require an extended duration of venous thromboembolism chemoprophylaxis beyond that provided as an inpatient.

  * Patients being discharged directly to home.

Exclusion Criteria:

* • Patients being discharged to a rehabilitation center or a skilled nursing facility.

  * A contraindication to anticoagulation such as traumatic or other hemorrhage, as determined by the treating surgeon and/or consulting services.
  * Ongoing venous thromboembolism treatment or extended prophylaxis (i.e. past history of multiple deep vein thrombosis/pulmonary embolism) for current or recent deep vein thrombosis, pulmonary embolism or other coagulopathic disorder
  * Chronic anticoagulation for atrial fibrillation or other medical disorder requiring chronic anticoagulation therapy.
  * Perceived low-risk patients requiring only aspirin or no pharmacological venous thromboembolism prophylaxis.
  * Pregnant, prisoner, under 18 years old, or do not speak English
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease

Gastroesophageal reflux disease (GERD) considered to be associated with mucosal damages in the esophagus and heartburn, which may sometimes interfere with daily activities due likely to reflux of acid gastric contents. While most of the patients given the diagnosis of GERD do not exhibit endoscopically obvious impairment in esophageal mucous membrane, they have subjective symptoms of non-erosive GERD including heartburn. But no drug has been launched in Japan, which targets non-erosive GERD. This study will examine the efficacy and safety of famotidine in subjects with non-erosive GERD.


Eligibility Criteria:
Inclusion Criteria:

* Patients have heartburn with non-erosive gastroesophageal reflux disease.

Exclusion Criteria:

* Patients have diseases which interfere with evaluation of the efficacy and safety in this study.
* Patients are receiving and/or have received prior to the enrollment the treatment which interfere with evaluation of the efficacy and safety in this study.
* Patients have severe cardiovascular, hepatic, renal and hematological disorders.
* Patients are allergic to or have a history of drug allergy to H2RA.
* Patients have or have a history of malignant tumors.
* Patients are pregnant or a lactating mother.
* Patients have participated in other clinical studies less than 12 weeks prior to submitting the informed consent.
Talocalcaneal Angle in Calcaneal Spur Formation

Calcaneal spur is one of the most common causes of chronic heel lower face pain without a traumatic cause. Obesity, sedentary life and advanced age play a role in its etiology. Mechanical overload is the main factor in the development of the disease. Impaired biomechanical factors in the foot cause repetitive microtraumas, traction periostitis and degenerative changes in the plantar fascia. The calcaneal spur is a result of this pathological process that creates pain. Many static radiological evaluation methods are used to evaluate the effect of foot anatomy in etiology. The talocalcaneal angle is one of them. It is the angle between the long axis of the talus and the long axis of the calcaneus. This angle shows the alignment of the back of the foot. It decreases with varus angulation of the back of the foot and increases with valgus angulation.

In this study, it was aimed to determine the place of the talocalcaneal angle values measured in the lateral radiographs of the foot in the etiology of painful calcaneal spur formation.

The study was designed retrospectively. In this study, talocalcaneal angles of patients with heel pain and epin on lateral foot radiograph will be compared with talocalcaneal angle measurements on lateral foot radiographs without epin calcanei. Measurements will be made by the same physician, 3 measurements will be made and the average value will be recorded.

It was aimed to investigate the effect of talocalcaneal angle on calcaneal spur formation.

Eligibility Criteria:
Inclusion Criteria:

Patients between the ages of 30-75 who applied to our outpatient clinic with the complaint of pain with pressing on the heel for at least 3 months.

• Patients with calcaneal spur detected in the lateral radiographs of the feet

Exclusion Criteria:

Those who complain of heel pain for less than 3 months, have any rheumatological disease, have a previous history of foot and ankle fractures