cyrilzakka/clinical-trials huggingface dataset:
Safety and Intraocular Pressure (IOP) Lowering Effect of AL-59412C

The purpose of this study was to assess the safety and efficacy of AL-59412C injected intravitreally relative to Vehicle.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary open-angle glaucoma or ocular hypertension.
* Retinal pathology (eg, retinal degeneration), anterior ischemic optic neuropathy, or vascular occlusion resulting in poor vision in the study eye.
* Able to discontinue all intraocular-lowering (IOP) medications according to the minimum washout period, based upon the class of medication.
* Mean washed out IOP ≥ 24 millimeters mercury (mmHg) to ≤ 36 mmHg at 8 AM in the study eye on two separate Eligibility Visits.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Lens/corneal/vitreal opacity preventing adequate posterior segment visualization of the study eye.
* Current or recent (within 30 days) use of any drug that may prolong the QT interval.
* Poor vision resulting from advanced glaucoma in the study eye.
* Intraocular surgery within the past 6 months in the study eye.
* Ocular laser surgery within the past 3 months in the study eye.
* Other protocol-defined exclusion criteria may apply.
The Jintronix Interactive System for Upper Extremity Rehabilitation Training Post Stroke

Stroke is a leading cause of death and disability worldwide.Hemiplegia, weakness of one side of the body, is a common consequence of stroke that can lead to significant functional impairments. Loss of arm function occurs in up to 85% of stroke survivors. The impact of arm-related limitations on activities of daily living, leisure activities or work is significant as the arm plays a central role in a person's life from the ability to perform basic activities of daily life to carrying out family and social roles. Guidelines indicate that rehabilitation can improve upper extremity (UE) motor control and functional status post stroke. Virtual reality (VR) and computer games are recent technologies that, as they become more accessible and affordable,are increasingly being used in rehabilitation to allow patients to engage in repetitive practice of specific tasks. A number of published reviews and meta-analyses have examined the use of VR and video games for post-stroke rehabilitation, focusing on or including UE rehabilitation. The authors agree that there is limited but promising findings that VR and video-games, when combined with traditional rehabilitation, have a positive impact on recovery post-stroke.

The goal of the study is to assess the feasibility, safety, and acceptability of the Jintronix system, as well as provide preliminary evidence regarding the clinical efficacy for post-stroke rehabilitation.This is a pilot parallel randomised single-blinded controlled trial, with patients who have had a stroke randomly allocated to one of two groups: (1) usual rehabilitation services and additional training with Jintronix system (treatment group) or (2) usual rehabilitation services only (control group).

Eligibility Criteria:
Inclusion Criteria:

* having had an ischemic or hemorrhagic stroke for the first time;
* having residual mild to moderate UE impairment (score 3-6 on the Chedoke-McMaster arm component, as long as exergames can be played);
* being in subacute stage (within 6 months post-stroke);
* receiving usual out-patient rehabilitation services at one of the two selected rehabilitation sites, located in the greater Montreal area in Canada.

Exclusion Criteria:

* being medically unstable;
* having severe cognitive or communication deficits;
* having visual impairments limiting use of the exergame;
* having any medical contraindication for shoulder movements;
* having severe balance deficits limiting sitting safely independently;
* having previous upper limb impairment limiting potential recovery;
* having any other impairment that limited use of the exergame.
Use of a Point-of-Care Platelet Function Assay for the Prediction of Atherothrombotic Events

1. To evaluate the role of VerifyNow test as prognostic marker in routine clinical practice using drug-eluting stents.
2. To determine the add-on-effect of VerifyNow test beyond on conventional risk factors (clinical, lesions, or procedural factors).
3. To compare the prognostic utility of VerifyNow test with several biomarkers.

Predictive role of a point-of-care assay (VerifyNow test) has not been well evaluated in large number of patients receiving drug-eluting stents as a routine practice.

In addition, additional predictive effect of a point-of-care assay, as compared to conventional clinical factors or other biomarkers, might be clinically interesting and important.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with established coronary artery disease receiving PCI with stent implantation

Exclusion Criteria:

* Cardiogenic shock
* Patients using concomitant medication known to affect platelet function other than aspirin (i.e. nonsteroidal antiinflammatory agents, dipyramidole, upstream glycoprotein IIb/IIIa inhibitors)
* patients with a known platelet function disorder or a whole blood platelet count of less than 150000/μL.
Written Versus Verbal Brief Cognitive Behavioral Exposure Therapy

The purpose of the study is to compare the efficacy of two different versions of a brief online exposure therapy program for PTSD: written versus verbal trauma narrative recounting in reducing PTSD symptom severity. Both treatments will be delivered through an interactive online program with coaching from a trained peer support specialist. Treatment will be a variable length, such that 4 to 8 sessions will be delivered, depending on each participants' rate of PTSD symptom recovery.


Eligibility Criteria:
Inclusion Criteria:

* Able to read/write English
* Internet connection allowing stable access to the Vets Prevail website
* A clinically significant PCL-5 score of 31 or above.

Exclusion Criteria:

* A score on the suicidality item of the PHQ-9 of 3 or higher.
Human Use Condition Study- Evaluation of Implanted Leads in Humans

The purpose of this study is to evaluate different types of leads (wires) that are connected to your pacemaker (an implanted device which assists your heart function) to understand how the shape and motion of your previously implanted lead changes in the body.

The purpose of this study is to evaluate different types of leads (wires) that are connected to the pacemaker (an implanted device which assists enrolled subject's heart function) to understand how the shape and motion of the previously implanted lead changes in the body.

Eligibility Criteria:
Inclusion Criteria:

Patients with RV leads included in the scope of this study whose system has been implanted for at least 3 calendar months Patients at least 18 years of age and capable of providing informed consent Patients who can physically perform range of arm motion and breath-holding described in the imaging protocol Patients who are willing and able to comply with instruction related to the imaging protocol

Exclusion Criteria:

Planned lead modification Patients with abandoned leads (includes: RV/RA/LV) Patients undergoing second or subsequent pulse generator change Patient has permanent atrial arrhythmias Limited life expectancy or medical condition that would not allow completion of the study Patient is known to be pregnant or breastfeeding at time of consent Limited range of mobility of the implant location arm Patient is unable to climb on and off an examination table unassisted Patients deemed hemodynamically unstable
Acceptability, Representations and Experiences of an Application and Captors Which Suggest a Walking Itinerary

ParcourSenior is a project lead by School of Mines from Saint-Etienne, Gérontopôle AURA and "Senior Autonomie" to promote walking in a city environment. To enable that, we have two tools at your disposable. The first one is sensor which can measure physicals abilities. The second one is an application which proposes individual itineraries based on physical abilities. This application concern people whom want to walk alone, with supportive people or with new people encounter in this app. Both tools are in the process of being created. The current study focuses on needs, expectations and desire of the elders and professionals about both of these tools. After, we plan to focus on the acceptability of these devices. A qualitative study with focus groups is carried out to evaluate the needs and expectation follows by individual interviews to evaluate the project: acceptability, fears and use's perception.

This research tend to study the acceptability of an application and captors which can propose a Walking itinerary of older 65 people.

Eligibility Criteria:
Inclusion Criteria:

* For first group : people aged 65 and over
* For natural caregivers : people who help in daily life a close relative
* For Professional : people who work with older person

Exclusion Criteria:

* Person with a neurological disease
* Person under guardianship or curatorship
Safety and Exploratory Efficacy Study of UCMSCs in Patients With Fracture and Bone Nonunion

The purpose of the present study is to evaluate the safety and exploratory efficacy of the umbilical cord mesenchymal stem cells for patients with fracture and bone nonunion.


Eligibility Criteria:
Inclusion Criteria:

* Every patient with non union in the site of bone fracture and nonunion.
* Age more than 18 and less than 60 years old.
* Nonunion or delayed union.

Exclusion Criteria:

* Diagnosis of cancer.
* Pregnancy or breastfeeding.
* Patient positive by serology or PCR for HIV, hepatitis B or C infection the patient with Accompanied fracture such as hip fracture that could not weight bearing.
* Any medical or psychiatric condition that in the researcher´s opinion could affect the patient´s ability to complete the trial or hamper the participation in the trial.
* Patients do not sign the consent forms
Impact of the Preparation Method of Red Cell Concentrates on Transfusion Indices in Thalassemic Patients

This study compares the effects of Packed Red Blood Cells (PRBCs) prepared in two different ways on the transfusion indices in beta(ß)-Thalassemia transfusion-dependent patients. The two blood components types derive from the whole blood. In one case, the whole blood is leukoreduced with subsequent plasma removal. In the other case, plasma, buffy coat, and red blood cells (RBCs) are first separated and subsequently, the RBCs leukoreduced. Each type of blood components will be subsequently given to one-half of the patients for a 6-month period and to the other half for other 6-month at the randomization phase, for a total of 12 months of crossed-treatment per patient.

At Day Hospital Talassemia ed Emoglobinopatie of Ferrara, two different PRBCs are available. The two types of blood components are obtained from whole blood, pre-storage leukoreduced and suspended in saline-adenine-glucose-mannitol (SAGM). One method of preparation consists of the whole blood leukoreduction with subsequent plasma removal. The other method first separates plasma, buffy coat, and RBCs, and then the RBCs are leukoreduced. The two methods mainly differ in the final haemoglobin (Hb) content: the Hb level is lower (-13%, approximately) in the second method that also shows the advantage to produce platelets from the buffy coat. A PRBCs unit is not as strictly defined as a therapeutic medication dose (pill or vial): individual PRBCs units may substantially differ in their Hb content, much more than the average difference between the two types of preparations. The aim of this study is to document the extent of the average difference between the two types of preparations, and its impacts on the transfusion indices of ß-Thalassaemia transfusion-dependent patients. All patients will receive each blood component for a period of 6 months (crossover design), for a total of 12 months of transfusion treatment per patient.

Eligibility Criteria:
Inclusion Criteria:

* Patient with beta(ß)-Thalassaemia transfusion-dependent (ß-Thalassemia Major or ß-Thalassemia Intermedia transfusion-dependent, regularly transfused since at least 5 years

Exclusion Criteria:

* Patient not exclusively transfused at Day Hospital Thalassaemia and Haemoglobinopathies of Ferrara
* Patient with haemolytic auto-antibodies
* Patient transfused with washed Packet RBCs units
* Severe splenomegaly (\>18 cm on echography)
* Elevated blood consumption (\>200 mL/kg of pure RBCs in the last year)
* Patient receiving haemoglobin inducers in the last 6 months
* Any significant clinical pulmonary, cardiovascular, endocrine, hepatic, gastrointestinal, renal, infectious, immunological including significant allo- or auto-immunisation disease, considered not adequately controlled prior to the study
* Patient treated with erythrocyte exchange
* Pregnant females
Efficacy of R-Pdf/Gbb in Healing Wounds Caused by Third Degree Thermal and Electrical Burns

Platelet Derived Growth Factor (PDGF) is a potent mitogen for a wide range of cell types including fibroblasts, smooth muscle and connective tissue. Recombinant human platelet derived growth factor (R-Pdf/Gbb) has biologic activity similar to endogenous platelet derived growth factor (PDGF). Biologic activity of PDGF includes encouraging chemotaxis and proliferation of cells responsible for wound repair and it augments production of granulation tissue.

The growth factor rhPDGF is found effective in patients having diabetic foot ulcer grade III and IV. The nature of wounds in the third degree burns is similar so far as healing process is concerned.

The purpose of this study is to test the hypotheses that the application of R-Pdf/Gbb 0.01% gel on the third degree thermal and electrical burns will heal these wounds within 3 months and there will be improvement in general condition of the patients without any complications.

The R-Pdf/Gbb is recombinant human platelet-derived growth factor. It has been demonstrated that rhPDGF is effective in enhancing wound healing.

OBJECTIVE: The primary objective of the study is to determine the efficacy of R-Pdf/Gbb gel in treating wounds caused by III degree thermal and electrical burns.

HYPOTHESIS 1: That the applications of R-Pdf/Gbb 0.01% gel on III degree thermal and electrical burns will heal these wounds within 3 months.

HYPOTHESIS 2: Subjects, who having III degree thermal and electrical burns with the treatment of R-Pdf/Gbb 0.01% gel, will show improvement in general condition without any complications.

We aim to test these hypotheses by evaluating the clinical outcome in about 120 patients after three months of treatment with R-Pdf/Gbb 0.01% gel applied once daily.

Eligibility Criteria:
Inclusion Criteria:

* Patients willing to sign Informed consent.
* Patients of both genders.
* Patients between ages of 18 to 75 years.
* Patients having third degree wounds caused by thermal and electrical burns.
* Patients not willing to undergo skin grafting.
* Patients with multiple wounds are considered but each burn wound surface area will be less than 1-8 cm2.
* Wounds with adequate perfusion as assessed with the help of laser Doppler flowmeter.

Exclusion Criteria:

* Patient refuses to sign informed consent.
* Burnt wounds severity less/more than III degree (i.e. I, II, IV degree burns).
* Patients having known neoplasm at the site of application.
* Patients with low serum proteins.
* Patients with uncontrolled hyperglycemia.
* Patients who are taking Ibuprofen.
* Patients with known hypersensitivity to parabens.
* All other burns except thermal and electrical burns.
* Neurological or psychiatric pathologies.
* Women who are pregnant or nursing and women of child bearing age, who are not taking contraceptives or not willing to use them for the period of treatment.
* Local or systemic infection
* Conditions that would interfere with wound healing (diabetes, hypertension, inflammatory diseases treated by corticoids)
Wii Aerobic Training in Inhalation-injury Children Post-thermal Burn

Inhalation injury is a composite of multiple insults including: supra glottic thermal injury, subglottic airway and alveolar poisoning, and systemic poisoning from absorbed small molecule toxins. These contaminant insults independently affect each of the pulmonary functions as well as having a direct effect on systemic physiology. Further, anatomic characteristics can predispose patients to inhalation injury. For example, an infant will develop airway obstructions much faster than an adult due to reduced airway diameter. Understanding the contributions of each of these pathologies to the patient's disease is critical to managing inhalation injury.

Wii fit aerobic training gives similar results with traditional rehabilitation practices, it causes less energy costs. This suggests that it can be a suitable rehabilitation tool for adult and elderly people with low energy levels. A review showed that video games are safe and feasible in the children with lung complications. Children' balance, aerobic and cognitive functions, quality of life improved and depressive mood decreased. WII aerobic games also make children to communicate better with other family members.

This study will investigate the effects of Wii aerobic training in Inhalation-injury Children post-thermal burn. To assign patients to different treatment groups, a table of random numbers generated by a computer was used. Patients were allocated randomly into one of three groups using this method. This study will be carried out at the outpatient clinic of the faculty of physical therapy, modern university for technology and information, Om El masryeen hospital and Embaba general hosbital after referral from dermatologist. Children will perform these exercises in a room supervisor physiotherapist.

All parents of children will sign a written consent form after receiving full information about the purpose of the study, procedure, possible benefits, privacy, and use of data.

Eligibility Criteria:
Inclusion Criteria:

* Six weeks after deep second-degree thermal burn with inhalation injury (until complete healing) with 35%-40% total body surface area (TBSA), Burn size was measured using modified Lund and Browder charts.
* 12 Years to 17 Years (Child )
* Inhalation injury.
* All children suffering from retained secretions which did not respond to medical treatment.
* All children should be clinically and medically stable.
* All children should have the same medical treatment.

Exclusion Criteria:

* Children with any dysfunction that limit physical activity such as neurological disorders, chronic obstructive pulmonary disease, malignancy, cardiovascular diseases, orthopedic problems, such as fracture on the pelvic or limbs, a visual impairment, brain injury or hearing impairments and contractures.
* Children use non-invasive mechanical ventilation and intubation or need for intensive clinical support and/or transfer to the Intensive Care Unit.
* Children with other hormonal diseases
Clinical Evaluation of Detection of High Risk HPV in Urine

Cervical cancer is one of the most common tumors in women, which seriously threatens women's life quality and safety. Human papilloma virus (HPV) infection is the most common cause of cervical cancer. Traditional HPV testing is based on the cells sample shed from the cervix. Recent studies have shown that urine HPV detection can be used as a new HPV detection method. This study intends to include patients undergoing TCT /HPV test/colposcopy in the department of gynecological diseases of the hospital, and collect urine samples and cervical swab samples. Sanger sequencing and cervical swab HPV test results were compared to evaluate the accuracy and clinical validity of urine HPV test combined with clinical diagnosis results of cases.

The urine high-risk HPV detection reagent (PCR-fluorescent probe method) developed by Hangzhou Newhorizon Health Technology Co., Ltd. can qualitatively detect 14 high-risk HPV DNA in human urine samples, including HPV16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68, and can detect HPV 16 and 18.

This test adopts the comparative clinical research method, by collecting urine samples and cervical swab samples from the same subject for HPV nucleic acid detection. Among them, urine samples were tested for high-risk HPV nucleic acid testing and Sanger sequencing, and cervical swab samples were tested with HPV testing kits for cervical swabs that have been on the market. Combined with the clinical diagnosis results of the cases, the performance of the urine HPV detection technology is compared and evaluated.

For patients undergoing TCT testing/HPV testing/colposcopy in the gynecological clinic or colposcopy clinic of the hospital, the subjects will be screened through the admission criteria and signed an informed consent; the examiner is required to collect cervical swab samples and, at the same time, issue urine collection When the tube is given to the subject, the subject must collect urine samples by themselves according to the sampling instructions or under the guidance of medical personnel; the patient samples will be tested by Hangzhou Newhorizon Health Technology Co., Ltd.; the clinical examination report will be collected as the case materials of this study.

Eligibility Criteria:
Inclusion Criteria:

1. Women aged 20-65 years old;
2. Have a history of sexual life;
3. The patients were voluntarily enrolled in the group and signed an informed consent form.

Exclusion Criteria:

1. History of cervical conization, pelvic radiation and hysterectomy, acute inflammation of the reproductive tract, severe system disease or other malignant tumors;
2. Pregnant and lactating women;
3. The patient's compliance is poor or the researcher thinks it is not suitable for this study.
Accuracy of Pediatric Emergency Medicine Providers in Diagnosing Hip Effusions Using Point of Care Ultrasound

The purpose of this study is to determine if pediatric emergency medicine providers can accurately diagnose a hip effusion using point-of-care ultrasound (POCUS) compared to radiology ultrasound (RADUS).

The purpose of this study is to determine that the accuracy of trained pediatric emergency medicine providers to diagnose hip effusion using point-of-care ultrasound (POCUS) is non-inferior to the reference standard of radiology ultrasound (RADUS). Additionally, the investigators seek to compare how POCUS performs against other clinical tests or investigations for the diagnosis of septic arthritis. The investigators hypothesize that trained EM providers will be able to diagnose hip effusions with high (\>90%) accuracy compared to studies conducted by the Department of Radiology.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or younger
* Clinical presentation necessitating hip ultrasonography as determined by the evaluating clinician
* Study physician available at the time of presentation to ED
* Patient or legal guardian provides consent

Exclusion Criteria:

* Children who present when a study physician is not available or those for whom consent is not given.
* Children who have had hip ultrasound imaging prior to their ED visit. Children with prior hip/pelvis x-rays will not be excluded.