cyrilzakka/clinical-trials huggingface dataset:
Assessment of the Effect of Convalescent Plasma Therapy in Patients With Life-threatening COVID19 Infection

* This clinical trial proposal is based on the FDA protocol for emergency use of convalescent plasma for treatment of COVID-19 cases, and on the WHO guidelines for use of convalescent plasma in other infectious diseases.
* This Clinical trial is to be applied in Cairo University quarantine hospital. The collection, testing and storage of convalescent plasma will be done inside CUH main blood bank.

The concept of this clinical trial is built on the collection of convalescent plasma from individuals who had recovered from documented infection with SARS-CoV-2, to be used for patients with- or at high risk of progression to- severe/life-threatening clinical conditions due to SARS-CoV-2 infection.

An informed consent is required to join this clinical trial; patients will be transfused with one or two units of ABO compatible convalescent plasma. Those patients will be followed up and the clinical and laboratory data will be compiled, including adverse events related to the administration of convalescent plasma (CP).

Other data to be collected retrospectively will include patient demographics, acute care facility resource utilization (total length of stay, days in ICU, days intubated, and survival till discharge from an acute care facility).

This study will be done inside Cairo university hospitals, it will involve a number of CP donors who were recovered from COVID-19 infection and were treated at Cairo University isolation hospital. The CP donation process will take place at CUH blood bank ,the number of the donors will be determined at the end of the study as it will vary according to the donation process .

The study will also include sixty seven /life threatening COVID-19 patients admitted to Cairo University isolation hospital.

Eligibility Criteria:
Inclusion Criteria:

* Must have laboratory confirmed COVID-19 and admitted to Cairo University isolation hospital.
* Admitted to acute care facility.
* Must have severe or immediately life-threatening COVID-19:

Severe disease is defined as:

* dyspnea,
* respiratory frequency ≥ 30/min,
* blood oxygen saturation ≤ 93%,
* partial pressure of arterial oxygen to fraction of inspired oxygen ratio \<300, and/or
* lung infiltrates \> 50% within 24 to 48 hours (CT finding)

Life-threatening disease is defined as:

* respiratory failure,
* septic shock, and/or
* multiple organ dysfunction or failure

Exclusion Criteria:

* Pregnancy
* Autoimmune disorder
* Participated in a CP trial in the past 6 months
Botulinum Type A Toxin in the Treatment of Lateral Canthal Lines (Crow's Feet)

Despite the wealth of information in the literature regarding the cosmetic applications of botulinum type A toxin (BoNT-A), and the widespread use of the BoNT-A for cosmetic applications, the number of randomised, controlled clinical trials is small. Much of the published information is based on open-label studies or anecdotal data. Of the robust trial data that is available, the vast majority relates to the treatment of glabellar lines, and there is little data available regarding the use of BoNT-A in lateral canthal lines. This study aims to determine the optimum dose for the use of BoNT-A in this area.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients, 18 to 65 years of age.
* In the opinion of the Investigator moderate to severe lateral canthal lines (crow's feet) during maximum smile on both sides of the face.
* In the opinion of the Investigator mild to severe lateral canthal lines (crow's feet) at rest on both sides of the face.

Exclusion Criteria:

* Any prior surgery affecting the orbicularis oculi muscle, prior blepharoplasty or brow lift, or any prior cosmetic procedures or scars that may interfere with the evaluation of the study results.
* Previous insertion of any non-absorbable material in the periorbital region or facial treatment with augmentation material within 12 months prior to screening.
* Any prior treatment with botulinum toxin (of any serotype).
* Previous treatment with lasers for skin resurfacing or treatment with deep chemical peels within 12 months prior to screening.
* Inability to substantially lessen the lateral canthal lines by physically spreading them apart.
* Facial conditions that could affect safety or efficacy results such as: active infection or other skin problem in the periorbital area (e.g. acute acne lesions or ulcers); history of facial nerve palsy; marked facial asymmetry; ptosis; excessive dermatochalasis; deep dermal scarring; thick sebaceous skin; photodamage etc.
Multiple Dose Escalating Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ASP1941

This study determined the safety of ASP1941 after a single and multiple once-daily doses for 10 days in healthy subjects. In addition, the Pharmacokinetics (PK) and Pharmacodynamics (PD) of ASP1941 were assessed.


Eligibility Criteria:
Inclusion Criteria:

* Body weight between 60-100kg, body mass index (BMI) between 20-30 kg/m2, inclusive

Exclusion Criteria:

* Fasting Plasma Glucose (FPG) \> 6.4 mmol/l
* HbA1c \> 6.2%
* Abnormal pulse of blood pressure at screening, as judged by the investigator
Evaluating the Short-term Efficacy of Two Oscillation Techniques in Hypersecretive Mechanically Ventilated Patients

Although mechanical ventilation (MV) is life-saving, it is associated with several complications. The establishment of an artificial airway impairs the cough reflex and mucociliary function, leading to the accumulation of secretions in the tracheobronchial tree. This increases the risk of pneumonia and lung atelectasis. Usual care for mechanically ventilated patients includes airway suctioning via the tracheostomy tube, which clears only a limited portion of the airway and is ineffective at removing peripheral airway secretions.

To address this, airway clearance guidelines recommend various airway clearance techniques (ACTs) for mechanically ventilated patients to enhance mucus removal. However, the lack of standardized, effective evaluation criteria makes selecting the optimal ACT a challenge.

The aim of this randomized cross-over study was to compare the effectiveness of oscillation and lung expansion (OLE) versus high-frequency chest wall oscillation (HFCWO) on lung aeration and ventilation distribution, as assessed by EIT, in medically complex, hypersecretive patients with tracheostomy tubes requiring long-term mechanical ventilation (MV).

Eligibility Criteria:
Inclusion Criteria:

* Eligible participants were patients aged ≥18 years with airway hypersecretion, admitted to the ICU,
* Requiring more than 48 hours of MV.

Exclusion Criteria:

* Malignant arrhythmia
* Acute myocardial ischemia
* Pneumothorax, pulmonary bulla, barotrauma, or other lung diseases,
* Hemorrhagic disease or coagulation abnormalities with bleeding tendencies
* Skin trauma on the chest
* Pulmonary embolism
* Presence of a permanent or temporary pacemaker
* Untreated spinal and rib fractures
* Any condition deemed inappropriate for study inclusion by the researchers.
Live Better at Home, Navarra ( VMNav )

Alternatives to institutionalization with adapted housing and community supports may allow institutionalized people who so desire to be deinstitutionalized and continue their life in the community. This transition can fulfill the wishes of these people and may improve the quality of their life and functionality.

Many older adults want to stay and be cared for at home, living in the community. However, long-term care facilities are increasingly becoming places where people live until death. Admissions are often conditioned by the characteristics of the support network rather than by the individual's clinical condition or dependency level. In addition, persistent problems around the cost and quality of housing with a lack of sufficient adapted housing and sheltered housing and inequalities in the distribution of social resources often limit the consolidation of personalized care and support planning.

Under this pretext, and if many people want to live at home for the rest of their lives, our research group aims to offer the possibility to nursing home residents from two nursing homes in Navarra of returning to the community by means of case management methodology and accommodation support. This completely innovative study aims to provide data to help the design and implementation of future studies addressed in this field.

The study consists of two stages:

1. A cross-sectional observational stage for the assessment. Objectives: Quantify the proportion of people who could return safely and quantify the proportion of people who would like to live in the community.
2. An analysis of factors related to the deinstitutionalization process and an intervention stage. Objective: assess the feasibility of this tailored intervention through case management methodology and study the impact of a deinstitutionalization process on participants for whom the transition is achieved.

In addition, this study will be accompanied by a sub-study with a pseudo-qualitative approach. The main objective of this part is to characterize the discourses associated with the willingness to return to the community and the deinstitutionalization process and to identify which evaluative elements concur (barriers and facilitators) and are prioritized in decision-making about a possible deinstitutionalization process. Qualitative research is needed for complex interventions to explore the obstacles and facilitators and to understand the intervention's components.

Eligibility Criteria:
Inclusion Criteria:

Phase 1:

* To have a place within the recruitment period for an indefinite period of time in one of the participating centers.

Phase 2:

* To express willingness to be deinstitutionalized and return to community.
* To obtain a favorable report in phase 1 from the project team on the feasibility and safety of returning to community.

Exclusion Criteria:

* Refusal to sign the informed consent form by the resident or, failing that, by the legal representative.
* The existence of a judicial authorization for involuntary admission of the resident to the residential facility.
A Comparison of Risperidone and Aripiprazole for Treatment of Patirnts With Methamphetamine-Associated Psychosis

Methamphetamine-associated psychosis (MAP) has been considered a pharmacological or environmental pathogen model of schizophrenia (SCZ) due in part to similarities in clinical presentation (i.e. paranoia, hallucinations, disorganized speech, and negative symptoms), response to treatment (e.g.neuroleptics),and pathologic mechanisms (e.g. central dopaminergic neurotransmission) of both conditions. Both risperidone and aripiprazole are second generation antipsychotics，but have different pharmacological effects of antipsychotic treatment.This study was designed to examine the acute efficacy, safety, and tolerability of risperidone and aripiprazole for patients with MAP.

Methods:A Multiple-Center, Randomized, Double-Blind.

Eligibility Criteria:
Inclusion Criteria:

1. Patients,Diagnostic and Statistical Manual of Mental Disorders 4thed. (DSM-IV) criteria for Methamphetamine-Associated Psychosis.
2. Must sign a Information consent form.
3. Required to provide detailed address and phone number

Exclusion Criteria:

1. Serious organic disease.
2. Suicide ideation or hurt others.
3. Taking antipsychotic within two weeks before.
4. drug allergy to Risperidone or Aripiprazole.
5. pregnancy and breastfeeding women.
Relative Bioavailability Study of Naproxen Delayed-Release Tablets (375 mg)

The purpose of this study is to demonstrate the relative bioavailability of Naproxen delayed-release tablets (375 mg).


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Pupillometry Dynamic Measures in Patients Without Ocular or Neurological Disease

Retrobulbar optic neuritis (NORB) is the damage to the optic nerve caused by inflammation. It causes a rapidly progressive and painful visual loss, often among young subjects. Diagnosis confirmation is important to start proper treatment, because a NORB is often the first symptom of multiple sclerosis. This diagnosis, based on a set of arguments, is difficult to define by a non-expert ophthalmologist.

The pupillary light reflex is a way to test the visual afferent pathways. If it is subject to a large inter-individual variability, the dynamics of the pupillary light reflex and its latency are more reproducible. An easy way to study the dynamics of the pupillary light reflex is to study the pupillary cycle time (PCT). In the case of NORB, elongation of the conduction in the visual afferent pathways related to demyelination plate increases the latency of the pupillary light reflex and decreases the frequency of the PCT.

Our hypothesis is that PCT dynamics measures would be a reliable indicator and easy to evaluate some pathologies affecting the integrity of the nerve. The validation of a decrease in the frequency of the PCT in NORB, compared to the frequency observed in subjects ophthalmological or neurological disease, could help developing methods to study the conduction of the visual pathways with portable devices used during the standard ophthalmologic consultation and quickly orientate patients to specialized centers.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* Subject without known ocular or neurological disease
* Ametropia inferior to 3 diopters for spherical correction and inferior to 1.50 diopter for astigmatism correction
* Matched for age and sex with one of the 22 subjects of the patients' unilateral NORB database

Exclusion Criteria:

* history of disease affecting pupillary motility
* anisocoria
* patient under legal protection
* pregnant or breast feeding patient
* patient's refusal to participate in the study
* no medical insurance coverage
Light Therapy in Disorders of Consciousness: Behavioral, Neuroimaging and (Neuro)Physiological Assessments.

In this randomized, double-blind, placebo controlled project, the investigators would like to assess the effect of a specific light, as compared to placebo light, on wakefulness (circadian rhythms, homeostasy, sleep-wake cycle), awareness (perceptual and self consciousness), cognition (attention, memory) and underlying brain activity (electrophysiology and neuroimaging)

The investigators will use behavioral (CRS-R, CAP, actimeter, brainstem reflexes), physiological (body core temperature, saliva, urine, heart rate, blood sample), neuroimaging and neurophysiological tools (PET, fMRI, TMS-EEG, resting-state and auditory paradigm EEG) before, during and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* disorder of consciousness
* 6 weeks post-injury

Exclusion Criteria:

* dysautonomia
* acute illnesses (infections with fever)
* medication that is known to affect circadian rhythmicity (melatonin)
* uncorrected sensorial deficits or documented history of significant neurological, neurosurgical, developpemental or psychiatric disorders
* previously known cerebral lesions prior to the brain's insult that lead to disorder of consciousness
* any contraindication to MRI, EEG, TMS-EEG, or PET (e.g., electronic implanted devices, active epilepsy, external ventricular drain)
* not medically stable
A Study To Find Out How Fesoterodine Works In Children Aged 6 To 17 Years With Bladder Overactivity Caused By A Neurological Condition

The objective of the study is to find out if the medicine fesoterodine is a useful treatment in children with bladder muscle overactivity caused by a neurological condition. Children will be aged 6 to 17 years old. This is done by finding out how well it works, what the body does to fesoterodine, what side effects are experienced and the safety of fesoterodine. It will be compared with the medicine oxybutynin, which is already available for treating the condition.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 6 to 17 years old
* Subjects with stable neurological disease and neurogenic detrusor overactivity
* Subjects using clean intermittent catheterization may participate

Exclusion Criteria:

* Concomitant medications which may increase the risk to subjects or confound study results
* Other medical conditions which may increase the risk to subjects or confound study results
* Contraindications to the use of fesoterodine or oxybutynin
Cost-effectiveness of Forced Aerobic Exercise for Stroke Rehabilitation

The purpose of this study is to investigate whether aerobic exercise improves the participant's ability to recover function in the arm and leg affected by the participant's stroke. The investigators are also calculating the cost effectiveness of the rehabilitation interventions.

The aims of the study are to determine the clinical efficacy and cost-effectiveness of combining aerobic exercise training with upper extremity motor task practice to improve motor recovery following stroke. It is hypothesized that the neurophysiologic impact of aerobic exercise may augment motor recovery associated with motor task practice. To test this hypothesize, 60 individuals with chronic stroke will be recruited to participate in this randomized clinical trial. Following screening and informed consent, all participants will undergo an exercise stress test to determine response to maximal exertion. Following the stress test, baseline clinical assessments will be obtained to quantify upper extremity function, gait, endurance, and self-reported quality of life. Additionally, variables to determine degree of disability will be obtained. Individuals will be randomized to one of two interventions: 45 min of forced-rate aerobic exercise paired with 45 min of upper limb repetitive task practice or two back-to-back 45-minute sessions of upper limb repetitive task practice. The interventions will occur 3 times per week for 8 weeks. Outcomes assessing motor function and disability will be repeated at mid-treatment, end of treatment, and at 4 weeks, 6-months and 12-months following end of treatment.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 6 months following single ischemic or hemorrhagic stroke confirmed with neuroimaging,
2. Fugl-Meyer motor score 19-55 in the involved upper extremity,
3. Ambulatory ≥ 20 meters with no more than contact guard assistance, and
4. 18-85 years of age.

Exclusion Criteria:

1. hospitalization for myocardial infarction, heart failure or heart surgery within 3 months,
2. cardiac arrhythmia,
3. hypertrophic cardiomyopathy,
4. severe aortic stenosis,
5. pulmonary embolus,
6. significant contractures,
7. anti-spasticity injection within 3 months of enrollment and
8. other contraindication to exercise
N2012-01: Phase 1 Study of Difluoromethylornithine (DFMO) and Celecoxib With Cyclophosphamide/Topotecan

This study will combine an oral drug called DFMO with celecoxib (also oral) and two IV chemotherapy medicines called cyclophosphamide and topotecan.

* To find the highest dose of DFMO that can be given with celecoxib, cyclophosphamide and topotecan without causing severe side effects.
* To find out the side effects seen by giving DFMO at different dose levels with celecoxib, cyclophosphamide and topotecan.
* To measure the levels of DFMO in the blood at different dose levels.
* To determine if your tumor gets smaller after treatment with DFMO, celecoxib, cyclophosphamide and topotecan.
* To determine if specific gene changes in you or your tumor makes you more prone to side effects or affects your tumor's response to the combination of DFMO, celecoxib, cyclophosphamide and topotecan.
* To determine if the amount of normal chemicals in your body called polyamines go down in response to DFMO, celecoxib, cyclophosphamide and topotecan, and whether you are more likely to have a good response to the treatment if they do.


Eligibility Criteria:
Inclusion Criteria:

* Patients must be \> 2 years and \< 30 years of age when registered on study.
* Patients must have recurrent/progressive high-risk neuroblastoma, refractory high-risk neuroblastoma that had less than a partial response to standard treatment or persistent high-risk neuroblastoma that had at least a partial response to standard treatment.
* All patients must have at least ONE site of evaluable disease.
* Patients must have adequate heart, kidney, liver and bone marrow function.
* Patients who have bone marrow disease must still have adequate bone marrow function to enter the study.
* Patients with other ongoing serious medical issues must be approved by the study chair prior to registration.

Exclusion Criteria:

* Females of childbearing potential that do not have a negative pregnancy test.
* Patients that are pregnant, breast feeding, or unwilling to use effective contraception during the study
* Patients status post allogeneic stem cell transplant.
* Patients who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study.
* Patients with disease of any major organ system that would compromise their ability to withstand therapy.
* Patients who are on hemodialysis.
* Patients with an active or uncontrolled infection. Patients on prolonged antifungal therapy are still eligible if they are culture and biopsy negative in suspected radiographic lesions and meet other organ function criteria.
* Patients with active bleeding of the GI tract or patients who have symptoms associated with stomach irritation (known as gastritis).
* Patients who have had a seizure within 12 months prior to enrollment and patients receiving anti-convulsant therapy for a seizure disorder.
* Patients with known Aspirin-Hypersensitivity triad (asthma, allergic rhinitis, ASA hypersensitivity).
* Patients with known hypersensitivity to celecoxib or other NSAIDs, aspirin or sulfonamides.
Transabdominal Gastric Contrast Ultrasound

In this study, the clinical data of patients diagnosed with gastric cancer who were ready for surgery were examined by contrast-enhanced ultrasonography and gastric-enhanced CT before surgery. Based on the results of postoperative pathological examinations, the diagnostic accuracy of gastric filling contrast-enhanced ultrasonography and gastric contrast-enhanced CT in different stages of gastric cancer was compared and analyzed. Provide better guidance for follow-up clinical practice.


Eligibility Criteria:
Inclusion Criteria:

1. Age: 18\~80 years old, male or female;
2. Diagnosed with gastric cancer by histology or cytology;
3. No distant multiple metastasis;
4. ECOG score 0-2;
5. Heart, lung, liver and kidney function can tolerate surgery;
6. Patients and their families can understand and be willing to participate in this clinical study, and sign the informed consent.

Exclusion Criteria:

1. Previous history of malignant tumor or recent diagnosis combined with other malignant tumors;
2. Patients with gastrointestinal perforation, gastrointestinal bleeding, etc. requiring emergency surgery;
3. Patients with previous gastroduodenal surgery;
4. Preoperative neoadjuvant therapy;
5. Patients and their families refuse surgical treatment;
6. ASA grade ≥ IV and/or ECOG performance status score \> 2;
7. Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious underlying diseases who cannot tolerate surgery;
8. Have a history of serious mental illness;
9. Pregnant or lactating women;
10. Patients with other clinical and laboratory conditions considered by the researchers should not participate in this trial.