cyrilzakka/clinical-trials huggingface dataset:
Extracorporeal Photopheresis as a Possible Therapeutic Approach to Adults With Severe and Critical COVID-19

Optimal approach for adult patients hospitalized with severe and critical COVID-19 non-responsive to antiviral and immunomodulatory drugs is not well established. The study aim is to evaluate feasibility and safety of extracorporeal photopheresis (ECP) in this setting.

A prospective, single-center investigational study is olanned to be performed at a tertiary referral center for COVID-19. Patients with COVID-19 are screened, and severe or critical COVID-19 cases fulfilling pre-defined clinical and biochemical criteria of non-response for \>5 days despite remdesivir, dexamethasone and immunomodulation (tocilizumab, baricitinib, ruxolitinib) are consecutively enrolled. After inclusion, two ECP sessions on two consecutive days per week for 2 weeks are applied. Patients are followed up per protocol from study inclusion, and clinical, virological and radiological outcomes are assessed at end-of-treatment (EOT)+28 days.

Eligibility Criteria:
Hospitalized adult (≥18 years at diagnosis) patients with diagnosed COVID-19 of any illness duration are eligible, and screened for inclusion during daily on-site investigator visits. Patients are consecutively enrolled.

Inclusion criteria:

1. severe or critical COVID-19,
2. clinical and biochemical non-response for \>5 consecutive days, despite remdesivir, dexamethasone and immunomodulatory therapies (tocilizumab, baricitinib or ruxolitinib), with or without COVID-19 reconvalescent plasmatherapy, in absence of other causes.

Exclusion criteria:

1. pregnancy or breastfeeding,
2. allergy or contraindications to 8-methoxypsoralen,
3. pre-COVID-19 ECP,
4. written informed consent was not obtainable.

Clinical non-response is defined when ≥2 of the following are met, compared to baseline:

1. persistent fever (non-contact tympanal measurement of \>38.0°C) for ≥48 hours, despite antipyretics,
2. persistent or failing COVID-19 severity, according to World Health Organization criteria, by ≥1 stratum after ≥48 hours,
3. persistent or failing partial arterial oxygen tension (PaO2) / inspired oxygen fraction (FiO2), by ≥10% after ≥48 hours, despite respiratory support,
4. radiological progression by infiltrate extension on chest computed tomography (CT), by ≥10% after ≥48 hours,
5. novel requirement of invasive mechanical ventilation, as deemed necessary by an intensive care unit (ICU) team.

Biochemical non-response is defined when ≥2 of the following analytes show persistent or increasing levels by ≥20% after ≥48 hours, compared to baseline:

1. serum lactate dehydrogenase (LDH),
2. serum C-reactive protein (CRP),
3. serum ferritin
4. plasma interleukin-6 (IL-6),
5. D-dimer.
Clinical Study of UCB Combined With UC-MSCs in the Treatment of Bone Marrow Failure Disorders

The multicenter collaborative clinical study conducted a systematic clinical observation in the treatment of bone marrow failure diseases via UCB\&UC-MSCs , in order to observe its clinical efficacy and safety.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with bone marrow failure disorders, including aplastic anemia, pure red cell aplastic anemia, immune-related pancytopenia, paroxysmal nocturnal hemoglobinuria, myelodysplastic syndrome, acute arrest of hemopoiesis, and cytopenia of unknown significance;
2. Patients with no severe impairment of liver and kidney function (total bilirubin (TBIL): ≤ 1.5×ULN; ALT or AST: ≤ 2.5×ULN; Alkaline phosphatase: ≤ 3×ULN; Serum creatinine: ≤ 1.5×ULN);
3. The prothrombin time (PT) or activated partial thrombin time (APTT) or international normalized ratio (INR): ≤ 1.5×ULN in the absence of anticoagulant therapy;
4. The left ventricular ejection fraction (LVEF): ≥50% by cardiac echocardiography
5. Hepatitis B surface antigen (HBsAg) and Hepatitis B core antibody (HBcAb) were negative. If any of the above items is positive, the HBV DNA titer in peripheral blood must be lower than the detection limit or 1×10\^3 copys/ml;
6. Patients with no plans for stem cell transplantation;
7. Patients with ECOG 0-2;
8. Those who voluntarily participate in this clinical study and have signed an informed consent .

Exclusion Criteria:

1. Patients who have suffered malignant tumors other than squamous cell carcinoma of the skin, basal cell carcinoma of the skin, malignant melanoma cured by surgery, and carcinoma in situ of the cervix in the past 5 years;
2. Patient with severe cardiac insufficiency (e.g. grade Ⅲ、Ⅳ by NYHA classification NYHA), and medically uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥110 mmHg);
3. Patients with severe mental illness;
4. Patients with clinically significant infection should be recruited with delay;
5. AST or ALT: above 3 times the upper limit of normal, creatinine, total bilirubin, or alkaline: phosphatase (ALP): above 1.5 times the upper limit of normal;
6. Patients with test positive for HIV, HCV or syphilis;
7. Patients with severe allergies or allergic to the active ingredients, excipients of the drug, or blood products in this clinical trials;
8. Patients who are pregnant or breastfeeding, or have a childbirth plan in the near future;
9. Patients receive allogeneic/autologous hematopoietic stem cell transplantation by the assessment of investigators;
10. There are other conditions that the investigators consider inappropriate for inclusion.
Impact of a Multidisciplinary Intensive Management Clinic on Outcomes in Multi-Ethnic Asian Incident Hemodialysis Patients

Patients with end-stage renal disease are most vulnerable in the early months following hemodialysis (HD) initiation. Data from the United States Renal Data System and Singapore Renal Registry showed high mortality rates in the first 3-12 months of dialysis. Comprehensive multidisciplinary intervention programs implemented in the initial 3-4 months of dialysis showed reduction in mortality and morbidity in incident dialysis patients in the United States.

Based on these models, the Hemodialysis Initiation and Transition (HIT) Clinic involving a renal physician, clinical pharmacist and coordinator was set up. The main aim of the clinic is to provide multidisciplinary, intensive and consistent care to patients in the first 3 to 4 months after HD initiation to focus on and streamline the management of dialysis issues and complications. These interventions would help patients achieve goal therapeutic targets, as well as reduce hospitalization rates and mortality, thereby improving their clinical outcomes and self-reported quality of life, and could result in economic and cost savings for the patients and healthcare system. The purpose of this study is to determine if the multidisciplinary, intensive and collaborative management of our multiethnic Asian patients newly-initiated on HD improves laboratory, clinical, economic and patient-reported outcomes.

Adult incident HD patients from NUH will be randomized to the HIT clinic or to conventional management. Information on demographics, medical/medication histories, laboratory data (dialysis adequacy, iron-deficiency anemia, mineral/bone disorder, malnutrition and diabetes), hospitalizations, deaths and medical costs will be obtained and compared between the 2 groups. Patient-reported outcomes will be measured using the Kidney Disease Quality of Life-Short Form, EuroQol 5 Dimensions, Family Functioning Measure, Oslo-3 Social Support Scale and Health Services Utilization questionnaires. Data collection will take place at baseline, 3 to 4 months and 12 months after the first visit, with a total study duration and follow-up period of 1 year.


Eligibility Criteria:
Inclusion Criteria:

* all patients who are newly-initiated on HD and who meet the following criteria will be included in the study:
* male or female 21 years of age or older with stage 5 CKD (eGFR \< 15 ml/min/1.73m2)
* newly-initiated on HD within the past 4-8 weeks of being seen in the NUH outpatient renal clinic

Exclusion Criteria:

* transient HD patients
* patients with poor cognitive function or are not able to complete the PRO questionnaires.
Clinical Evaluation of Toric Intraocular Lens

Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.

Effectiveness

* primary endpoint is visual acuity with pre-determined spherical correction.
* secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent, IOL rotation

Safety

* number and percentage of adverse event

Eligibility Criteria:
Inclusion Criteria:

* Patients with age of 40 years or older
* Patients with age-related cataract in one eye or both eyes.
* Patients willing to participate in the required postoperative study.
* Patient who can understand and sign the consent document.
* An eye whose pupil diameter after mydriasis is 5 mm or greater.
* An eye whose preoperative corneal cylindrical power is 1.0D or more.
* An eye whose postoperative astigmatism is predicted to be less than 0.5 D.
* An eye whose postoperative visual acuity with spherical addition is 0.8 D or more.

Exclusion Criteria:

* Disorder of corneal endothelium
* Uncontrolled glaucoma
* Active Uveitis
* Diabetic retinopathy
* Retinal detachment
* Congenital ocular anomalies
* Choroidal hemorrhage
* Shallow anterior chamber
* Microphthalmus
* Corneal dystrophy
* Optic atrophy
* Ocular hypertension
* Amblyopia
* Previous history of corneal transplantation
* Active Iritis
* Corneal disorder
* Macular degeneration
* Retinal degeneration
* Clinically significant change in macula and/or retinal pigment epithelium
* Corneal irregular astigmatism
* Atopic disease
* Brittleness of Zinn's zonule, fractured zonule and lens luxation (including subluxation)
* Pseudo-exfoliation syndrome
* Iris neovascularization
* Long axis length eye (axis length : 28mm or more)
* Severe dry eye, abnormality of the lens surface
* Concurrent participation in another drug and device clinical investigation
* Patient with mental deficiency or psychiatric disorder and/or who is not capable of expressing the consent of participating in the trial
* Patient who is judged inappropriate by investigators or sub-investigators
Time Course of Neuro-ventilatory Efficiency During a Spontaneous Breathing Training

The TONES trial aims to evaluate the neuroventilatory efficiency (NVE = tidal volume / peak voltage of diaphragm contraction) measured during a zero-assist manoeuvre (ZAM, i.e. with PEEP but without pressure support). This novel parameter, NVE-ZAM, will be studied in a blocked, crossover, repeated measures design.

Possible confounders, such as activity of respiratory muscles other than the diaphragm, are included.

The investigators hypothesized that

* the NVE during a zero-assist maneuver has a low variability and high repeatability at the same level of PEEP (within subjects, within blocks)
* NVE-ZAM trends differ between participants (between subjects, within blocks) and between PEEP levels (within subjects, between blocks)

The primary aim is to study the variability and repeatability of the NVE-ZAM within subjects and within blocks.

Additionally, the effect of PEEP, muscle fatigue and recruitment of the accessory and expiratory muscles of respiration on the NVE-ZAM will be studied in an exploratory analysis (in multiple combinations of within and between subjects and/or blocks).


Eligibility Criteria:
Inclusion criteria:

* adult (18-80 yrs.)
* admitted to the ICU
* intubated and mechanically ventilated
* Edi catheter (Maquet, Solna, Sweden) in situ as part of their clinical care
* ventilated in a support mode (e.g. pressure support) with a support between 7 and 15 cmH2O, a PEEP ≤10 cmH2O and an Fi02 \<0.6, all since ≥6 hours.
* can participate in the trial as judged by their attending physician

Exclusion criteria:

* pregnancy
* refusal of participation
* pre-existing neuromuscular disorders (e.g., Guillain-Barré)
Effect of Radioiodine Therapy on Ovarian Reserve in Female Patients With Differentiated Thyroid Cancer

Thyroid carcinoma is the most common endocrine malignancy. Surgery is the standard therapeutic approach for patients with differentiated thyroid carcinoma (DTC), followed by radioiodine (RAI) therapy if indicated. For women with DTC, the effects of RAI therapy on gonadal and reproductive function are an important consideration. This study aimed to evaluate the effects of RAI therapy on ovarian function.


Eligibility Criteria:
Inclusion Criteria:

* Female patient in childbearing period.
* Female patient with differentiated thyroid carcinoma.
* Underwent thyroidectomy.
* Candidate for radioactive iodine therapy.

Exclusion Criteria:

* • Male patients.

  * Postmenopausal female patients.
  * Female patients with undifferentiated thyroid carcinoma.
  * Pregnant female patients.
  * Lactating female patients.
Ventilator Associated Pneumonia Multiplex PCR for Anti-Infective Regimens

Ventilator-associated pneumonia (VAP) remains one of the main nosocomial infections acquired in the intensive care unit (ICU). VAP is pneumonia occurring 48 hours after intubation. Today, bronchoalveolar lavage (BAL) is used for microbiological diagnosis, with bacterial culture and antibiotic susceptibility results within 48 to 72 hours. Multiplex PCR can detect DNA of a number of bacteriae, as well as the presence of resistance genes. However, its clinical value in the ICU remains to be demonstrated. We think that the use of multiplex PCR with a panel adapted to the microbiology of VAP, could be an interesting method for clinicians in ICU.

Ventilator-associated pneumonia (VAP) remains one of the main nosocomial infections acquired in the intensive care unit (ICU). VAP is pneumonia occurring 48 hours after intubation. Today, bronchoalveolar lavage (BAL) is used for microbiological diagnosis, with bacterial culture and antibiotic susceptibility results within 48 to 72 hours. Multiplex PCR can detect the bacterial DNA of a number of bacteria, as well as the presence of resistance genes. However, its clinical value in the ICU remains to be demonstrated. We think that the use of multiplex PCR with a panel adapted to the microbiology of VAP, could be an interesting method for clinicians in ICU.

The aim of our study is to compare the percentage of appropriate empirical antibiotic therapy in the group benefiting from multiplex PCR on BAL prior to bacterial culture results compared to control group (bacterial culture alone=usual management) in patients with culture-confirmed VAP.

This is a multicenter, randomized, controlled, French study conducted in 8 university intensive care units (2 surgical units, 6 medical units) in the Grand-Est region of France. The multiplex PCR tested here is BioFire's FilmArray Pneumonia Panel Plus. It is performed solely on per-fibroscopic bronchoalveolar lavage (BAL) fluids in cases of suspected VAP.

Eligibility Criteria:
inclusion criteria :

* Adult patients, hospitalized in intensive care unit
* on mechanical ventilation for at least 48 hours
* Suspected VAP
* With an indication for bronchoalveolar lavage (BAL)

exclusion criteria :

* Patients under legal protection or without social security coverage
* Pregnant women
* Previous episode of VAP during the same hospitalization
Echocardiographic Analysis in Healthy Child.

· 2D Speckle Tracking echocardiography gained importance for the evaluation of ventricle contractility. Many indications have been developed in child population. However, the comparability of measurements between different software systems is not well defined. We choose to compare two software systems very often used in paediatric subjects : Echopac by General Electric and QLAB 9.0 by Philips. We offer a randomly second echocardiography to children which have normal heart. We compare Strain and Strain rate results between the two tests with a study of variability : ultrasound variability, operator variability, reader variability.

· We select children addressed to paediatric cardiologist for not serious reason (heart murmur, chest pain, sport capacity...), which had normal heart after evaluation. If they satisfied all inclusive criteria (0 to 17 years old, parental agreement, social security fund) and neither exclusive criteria (cardiac, respiratory or muscular problems, chronic diseases, drug with heart impact, poor image quality), we randomly execute a second echocardiography. Echocardiography are done with Vivid 7 ultrasound (General Electrics) and/or IE 33 ultrasound (Philips) by one or two trained operators. Strain loops are taken on three standard apical views (two, three and four-chamber views), short axis midventricular and aortic views, sub-costal short axis aortic view and sub-costal four-chamber apical views. Strain analysis are done in a second steps by one or two trained readers with adapted software : Echopac (General Electrics) or QLAB 0.0 (Philips). Strain and Strain rate results are collected for each ventricle in each dimension.We compare results between the two tests and done statistical analysis with a study of variability : ultrasound variability, operator variability, reader variability (correlation coefficient). We also done a feasibility study with use of "poor image quality"exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* child (0 to 17 years included)
* normal heart
* parental agreement
* affiliate with social security fund

Exclusion Criteria:

-
Pilot Study on the Evaluation of the Functionality, Safety and Reliability of New Tripping Devices for Lower Limbs.

The study aims to identify prognostic biomarkers of fall risk in patients with lower limb amputation

The protocol will involve both trans-tibial and trans-femoral amputation subjects, for a total duration of up to 5 sessions.

Initially, the fall detection algorithm will be evaluated on trans-femoral and trans-tibial amputees performing the test while wearing their prosthesis.

In a second step, the experimentally obtained prognostic markers of fall risk will be studied (i.e., using one or both of the perturbation platforms described below).

The markers thus obtained are to be validated by comparison with markers already established in clinical practice or in the literature.

Experimental platforms The platforms are composed of a mechanism to simulate and investigate the aid that the prosthetic system can provide in the event of a source of tripping and/or slipping.

Eligibility Criteria:
Inclusion Criteria:

* Trans-femoral or trans-tibial lower limb amputation;
* Functional medical classification: Level K3-K4;
* Subjects who have had a prosthesis for at least 1 year (experienced wearers);
* Informed consent signed by the subject

Exclusion Criteria:

* Significant medical comorbidities (severe neurological disease, cardiovascular disease diabetes/unstabilised hypertension, severe sensory deficits);
* Cardiac device wearers (PMK or AICD);
* Cognitive impairment (MMSE adjusted for age and schooling \<24);
* Inability or unwillingness to provide informed consent;
* Severe depressive symptomatology - Beck Depression Inventory (BDI-II \<19);
* Severe anxiety symptoms - State-Trait Anxiety Inventory (STAI-Y \<50).
Trial to Assess the Ocular Safety of Vorapaxar (SCH 530348) in Participants With Atherosclerosis (Study P05183)

This study is designed to evaluate the long-term ocular safety of SCH 530348 (vorapaxar) in participants with established atherosclerotic disease who are enrolled into the TRA 2°P - TIMI 50 Study (P04737) (NCT00526474).


Eligibility Criteria:
Inclusion Criteria:

* Evidence or a history of atherosclerosis involving the coronary, cerebral, or peripheral vascular systems

Exclusion Criteria:

* The study will include participants who meet none of the exclusion criteria for the parent protocol (P04737) and also the following:

  * history or evidence of age-related macular degeneration on baseline evaluation
  * history of diabetic macular edema, or evidence of treated diabetic retinopathy on baseline evaluation
  * history or evidence of other retinal diseases, including retinal injury, on baseline evaluation
  * history or evidence of retinal surgery, including laser photocoagulation, on baseline evaluation
  * history or evidence of glaucoma on baseline evaluation
  * history or evidence of high intraocular pressure of \>22 mm Hg on baseline evaluation
  * evidence of center foveal thickness of \>190 µm on baseline OCT examination
  * presence of vacuoles in the retina on baseline OCT
Acupressure in Hospitalized Patients

After written informed consent eligible hospitalized patients will be randomized to one of 3 arms (1:1:1:): control, sham, accupressure (3 points on the hand and wrist three times per day). Quality of recovery and other measures of patient satisfaction will be recorded.

After written informed consent eligible hospitalized patients will be randomized to one of 3 arms (1:1:1:): control (no touch), sham (light touch), acupressure (2 minutes moderate pressure each at PC6, LI4, and HT7 three times per day). Quality of recovery using the validated Quality of Recovery (QOR) 15 score and other measures of patient satisfaction (nausea score, pain score) will be recorded at baseline and after their 6 study sessions.

Eligibility Criteria:
Inclusion Criteria:

1. adults
2. patients at Stony Brook hospital
3. expected to be hospitalized for at least 3 days
4. able to sign informed consent and participate in the study

Exclusion Criteria:

1. Under 18 years of age
2. Do not have access to the 3 points on the hand and wrist due to skin breakdown, ulcers, cellulitis, broken bone, indwelling catheter within 5 cm radius of the pressure points.
3. Significant dementia or altered mental status that would prevent assessment of the QOR survey
4. Allergic reaction to ink
5. Stroke or other neurologic condition which precludes sensation in both upper extremities.
6. Ongoing use of regional anesthetic technique
7. Pregnancy
Cognitive and Behavioral Intervention for the Management of Episodic Breathlessness in Patients With Advanced Disease

Episodic breathlessness is a common and distressing symptom in patients with advanced disease such as cancer, chronic obstructive pulmonary disease (COPD) and chronic heart failure. Since the short duration of the majority of breathless episodes limits the effectiveness of pharmacological interventions (e.g. opioids), non-pharmacological management strategies play a major role. As non-pharmacological strategies patients use, for example, cognitive and behavioural methods such as breathing or relaxation techniques.

The aim of the study is to test a brief cognitive and behavioural intervention for an improved management of episodic breathlessness. Initially, a Delphi procedure with international experts has been used to develop the brief intervention consisting of various non-pharmacological strategies to enhance the management of breathless episodes.

In the single-arm therapeutic exploratory trial (phase II), the feasibility and potential effects of the brief intervention, such as patient-reported breathlessness mastery, episodic breathlessness characteristics, quality of life, symptom burden, caregivers' burden, and breathlessness in general will be examined. The results of the study form the basis for planning and implementing a subsequent confirmatory randomized control trial (phase III).


Eligibility Criteria:
Inclusion Criteria:

* In- and outpatients of the participating centers with episodic breathlessness due to a life-limiting progressive disease
* Recurrent breathlessness episodes despite optimal treatment of the underlying disease
* Eastern Cooperative Oncology Group (ECOG) status 0-3
* Estimated life-expectancy should be at least 8 weeks as judged by the treating physician
* Ability to understand, read, and respond to German language
* Informed consent

Exclusion Criteria:

* Episodic breathlessness due to reversible and treatable causes, such as acute pneumonia, pulmonary embolism, chronic hyperventilation syndrome, asthma or other reversible or unknown cause
* Cognitive impairment
* Severe current health impairments that do not allow participation after clinical evaluation by the treating physician