cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Correlation Between Vein Size Inferior Cava and Right Atrial Pressure in Pediatric Age and Creation of a Possible Predictive Model

The goal of this observational study is to demonstrate the presence of a correlation between echographic measurements of the inferior vena cava (IVC) normalized for the pediatric population and right atrial pressures (RAP) measured by central venous catheter (CVC) so as to create a predictive model of the value of right atrial pressures using echocardiographic parameters in the pediatric population. This study is single-center longitudinal and involves retrospective and prospective data collection.

Primary objective:

- To build a mathematical predictive model of RAP specifically for paediatric patients from echocardiographic parameters analysed on a retrospective cohort.

Secondary objectives:

* To evaluate the accuracy on the paediatric patient of the mathematical model in use for the estimation of RAP in adult patients in a prospective cohort.
* To test the mathematical model built in this study in a prospective cohort of patients OUTCOME With regard to the primary objective, a new patient-specific model will be built paediatric patient from different methods of ultrasound measurement of the IVC (maximum and minimum diameter expressed as z-score, ratio between the two diameters, ratio between maximum diameter and systolic diameter of the aorta).

systolic diameter of the aorta), as well as the patient's auxo-anthropometric values collected by means of the retrospective data.

With regard to secondary objectives, the mathematical model in use for the patient will be applied adult patient to estimate the RAP in our patients and the value obtained will be compared with the value measured.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients aged 0-18 years undergoing central venous catheter (CVC) placement in the course of the diagnosis performed at our center
* Obtaining informed consent from parent/guardian in case of minors

Exclusion Criteria:

- Patients with univentricular cardiac physiology, nonsinus heart rhythm, mechanical ventilation, Inferior vena cava thrombosis and patients with isomerism
Recombinant Human Thrombopoietin (rhTPO) in Management of Chemotherapy-induced Thrombocytopenia in Acute Myelocytic Leukemia

Chemotherapy-related myelosuppression usually occurs in AML patients, which induces severe thrombocytopenia and haemorrhage, a leading cause of death. This clinical trial aims at evaluating efficacy and safety of rhTPO in management of chemotherapy-induced thrombocytopenia in acute myelocytic leukemia.

The investigators are undertaking a parallel group, multicentre, randomized controlled trial of 80 adults with chemotherapy-induced thrombocytopenia from 8 medical centers in China. AML patients with PLT count \<30×10\^9/L during the previous cycle of chemotherapy are randomized into two groups that one receives rhTPO at 1.0μg/kg·d subcutaneously for 7\~14 consecutive days and the other receives no rhTPO or other thrombopoietic factor. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

* AML patients with PLT count \<30×10\^9/L during the previous cycle of chemotherapy to minimize the risk of clinically significant bleeding.

Exclusion Criteria:

* allergic history to biological agents; history of thrombotic or hemorrhagic diseases; M3 or M7 subtype; pregnancy; hypertension; cardiovascular disease; diabetes; liver and kidney function impairment;
Prospective Evaluation of Radiotherapy Using Magnetic Resonance Image Guided Treatment

The purpose of PERMIT is to collect information on the treatment of radiotherapy patients using a new radiotherapy machine that includes magnetic Resonance (MR) imaging (MR linac) to guide treatment. The aim is to use this information to support the introduction of MR Linac into clinical practice.

PERMIT will collect details on patients treated on the MR linac plus details on their side effects and other outcomes. This information plus technical and imaging information will be combined with information from other centres using this machine. By doing so this will help us learn how best to use the MR Linac in the future and design new radiotherapy protocols


Eligibility Criteria:
Inclusion Criteria:

1. Radiotherapy treatment suitable to be delivered on the MR Linac.
2. Patient provides written, informed consent and/or authorization.
3. Patients between the ages of 5 and under 16 years old may enter protocol with parental/guardian consent.

Exclusion Criteria:

1. Contra-indications to MR imaging.
2. Radiotherapy not suitable for delivery on the MR Linac e.g. those with extended field lengths (exceeding 20 cm).
Effect of rTMS on the Abnormal Executive Function of ASD Children

In this study, the investigators will explore the effects of repetitive transcranial magnetic stimulation (rTMS) on executive function deficits in high function autism spectrum disorder. Half of the participants will be chosen by chance to receive continuous theta burst stimulation (cTBS) while the other half will be chosen by chance to receive sham stimulation. And finally the sham group individuals also receive cTBS. Based on results from a recent unpublished pilot data, the investigators propose that cTBS treatment will induce a significant improvement in executive function performance compared to sham treatment.

This study is a randomized, sham controlled study to evaluate the efficacy of cTBS as a treatment for executive function deficits in individuals with autism spectrum disorder between 6 and 16 years of age. The study duration is approximately 1 months, with the cTBS sessions lasting for 4 weeks, 5 times a week, for about 20min each. Several scales will be used to assess for symptom severity and adaptive functioning. The executive function will be evaluated by Behaviour Rating Inventory of Executive Functioning (BRIEF) questionnaire. Cognition will be assessed using functional near - infrared spectroscopy (fNIRS).

This study also involves a type of brain imaging known as magnetic resonance imaging (MRI) at the beginning and at the end of the 4 weeks daily cTBS to better understand the effects of cTBS on brain structure and function. Investigators will measure the size and connections of different parts of the brain to assess brain structure and blood flow.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with ASD. Diagnostic criteria: diagnosed by pediatric psychiatrists in accordance with the criteria in the Fifth Edition of Diagnostic and Statistical Manual of Mental Disorders (DSM-V), Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview-Revised (ADI-R);
* Have a diagnosis of high functioning ASD (HF-ASD) (i.e., are verbal with an Intelligence Quotient (IQ) ≥ 70)
* Are clinically stable as determined by their treating physician, with no medication changes over the past 4 weeks

Exclusion Criteria:

* Have metal or electronic instruments near the stimulation brain area of coil, such as, have intravascular stent in head, have metal objects in skull.
* Have cardiac pacemaker, cochlear implant, medical pump;
* Can not cooperate with examiner;
* Have intracranial foreign bodies by craniotomy, or intracranial deformity
* Have a history of substance abuse or dependence in the last 6 months or have a positive urine toxicology screen
* Have a concomitant major medical or neurologic illness
* Have had a seizure in the past, or have a first-degree relative with epilepsy
* Have an abnormal clinical EEG
* Are pregnant or likely to get pregnant during the next 4 weeks
* Have a history of rTMS treatment.
The RESTORE Study, A Randomized, Controlled, Masked (Reading Center) Prospective Study

To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.

Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.

Eligibility Criteria:
Inclusion Criteria:

* Any adult patient who is planned to undergo bilateral PRK surgery.
* Willing and able to comply with clinic visits and study related procedures
* Willing and able to sign the informed consent form

Exclusion Criteria:

* Patients under the age of 18.
* Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test).
* Active infectious ocular or systemic disease.
* Patients with active infectious ocular or extraocular disease.
* Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
* Patients with known hypersensitivity to Dexamethasone.
* Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
* Patients with a history of ocular inflammation or macular edema.
* Patients with allergy or inability to receive intracameral antibiotic.
* Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day
* Patients with a corticosteroid implant (i.e. Ozurdex).
* Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes.
* Patients who do not have 20/20 snellen visual acuity potential pre-operatively.
* MRSE greater than 6 diopters.
* Greater than 2 diopters anisometropia.
Game-Based Decision Aid to Educate Pregnant Women About Prenatal Screening

Significant barriers exist for effectively informing women about prenatal screening in the clinical setting. This project developed and evaluated the efficacy of a game decision aid among pregnant women about prenatal screening in a randomized controlled study.

Prenatal genetic screening has grown at a rapid rate and whole genome sequence of an unborn fetus is expected to be widely available in the next few years. However, significant barriers remain for effectively informing couples about their risks and options for identifying and managing chromosomal anomalies and heritable conditions during pregnancy. It is widely recognized that current standards for patient education in this domain are largely ineffective. Decisions about prenatal screening are based on pregnant couples' values and knowledge so clinicians are often challenged with being informative but non-directive. Prenatal screening has grown significantly in recent years because the American College of Obstetricians and Gynecologists recommends prenatal care providers now offer all women prenatal genetic screening in the first trimester of pregnancy, regardless of age, or genetic risk status. This has moved the focus of prenatal screening from a subset of higher risk pregnant couples to all pregnant couples and to an earlier time in pregnancy.

To address these information needs, we are undertaking a novel approach to inform couples about screening. "Gaming" tools have demonstrated promising outcomes for improved health care decision-making and compliance with health recommendations. In contrast to other computer applications for the dissemination of information, game technology goes beyond information delivery and engages users in different life choice scenarios. Further, these tools can assess whether the attractiveness (or unattractiveness) of different simulated choices can offer insights about one's values. In this value-laden context, the game allows individuals to explore their personal values in a non-directive fashion and allows a comparison of the game choices and values with an individual's reproductive partner.

The purpose of this application is to 1) develop a prenatal screening gaming application prototype (PS-GAP) and 2) conduct a preliminary assessment of the PS-GAP on knowledge, satisfaction, and decisional conflict about prenatal genetic screening for pregnant women and their partners.

Eligibility Criteria:
Inclusion Criteria:

* English speaking
* less than 15 weeks gestation
* attending first obstetric visit
* low risk pregnancy

Exclusion Criteria:

* Non-English speaking
* High risk pregnancy
* Past 15 weeks gestation
Register of Patients With haEmophilia A tReated With Afstyla®

Record real life data of patients with Hemophilia A and treated with Afstyla® to assess the effectiveness and the safety of the treatment used as prophylaxis, prevention of bleeding (e.g. surgery) or on-demand treatment during 3 years after patient inclusion

Haemophilia A is a congenital coagulation disorder caused by a deficiency or abnormality of coagulation factor VIII (FVIII).

The severity of the haemophilia depends on the magnitude of the FVIII deficiency and the clinical features depend on the site of the bleed.

The therapeutic management of this disease involves administering the deficient factor, FVIII to the patient. Depending on the severity of the disease and patient background, the management regimens are different (long term prophylactic treatment to prevent non surgical bleeds, prophylactic short term treatment to prevent surgical bleeds or treatment of acute bleeds on demand).

Several recombinant or plasma derived treatments are currently available. The CSL Behring Company has designed a new recombinant single chain B1FVIII, rFVIII (Afstyla®). This has increased affinity for VWF, resulting in improved stability and an improvement in its pharmacokinetic indices. OPERA is a non-interventional, prospective and national study which aim is to record real life data in haemophilia A French patients treated with Afstyla® in order to confirm the efficacy and safety of this proprietary product established in clinical development studies.

Eligibility Criteria:
Inclusion Criteria:

* Have given their agreement to take part in the observational registry after being informed in writing of the purposes of the study and after their data have been recorded (parent's agreement for minor patients);
* Be suffering from haemophilia A and being treated or having been treated with Afstyla® long term prophylactically, on demand or preventatively for a surgical procedure;
* Absence of inhibitor and/or treatment for immune tolerance at the time of inclusion

Exclusion Criteria:

* Refusal of the patient or the patient's legal representative to take part in the study;
* Existence of a contraindication to the use of Afstyla® treatment (known hypersensitivity to FVIII or hamster proteins);
* Simultaneous participation in an interventional clinical study.
* Presence of an inhibitor and/or ongoing immune tolerance.
Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for PTSD - COVID Related Substudy

This clinical trial is a sub-study to treat participants that were not eligible in the main study (HUM00152509/NCT03874793) to receive MBCT or MRT in hard hit COVID-19 areas with trauma history and current COVID-related distress.

The purpose of this treatment-only sub-study is to see how eligible participants with life history of any trauma and are currently experiencing elevated COVID-related stress are affected by two different PTSD therapies involving Mind-Body practices; Mindfulness based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy.

The targeted individuals will reside in areas (Washtenaw, Wayne, and Oakland counties in Michigan, etc.) that have been affected by COVID-19. Participants will have assessments before and after 8 weeks of therapy (remote MBCT or MRT).

This clinical trial is a sub-study to treat participants that were not eligible in the main study (HUM00152509/NCT03874793) to receive MBCT or MRT in hard hit COVID-19 areas with trauma history and current COVID-related distress.

The purpose of this treatment-only sub-study is to see how eligible participants with life history of any trauma and are currently experiencing elevated COVID-related stress are affected by two different PTSD therapies involving Mind-Body practices; Mindfulness based Cognitive Therapy (MBCT) and Muscle Relaxation Therapy.

The targeted individuals will reside in areas (Washtenaw, Wayne, and Oakland counties in Michigan, etc.) that have been affected by COVID-19. Participants will have assessments before and after 8 weeks of therapy (remote MBCT or MRT).

Eligibility Criteria:
Inclusion Criteria:

* COVID distress sample: resides in geographical area heavily impacted by COVID-19 have a history of trauma
* Has current elevated levels of COVID related stress and/or distress (worry, repetitive negative thinking) (COVID stress scale score \> 15, worry / repetitive negative thinking, Penn State Worry Questionnaire (PSWQ) score \>35 ).

Exclusion Criteria:

* PTSD
* Suicide risk
* Psychosis
* Life history of schizophrenia
* Current substance dependence
* Other factors that preclude safe and meaningful participation in the study, at discretion of the PI and study team
Effects Of CP-690,550 (Tasocitinib) On Cholesterol Metabolism In Patients With Active Rheumatoid Arthritis

The purpose of study is to explore the effect of CP-690,550 (tasocitinib) on cholesterol metabolism in patients with active rheumatoid arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Males or females, 18 years of age or older with active rheumatoid arthritis; Or male and female healthy volunteers 18 years of age and older

Exclusion Criteria:

* Pregnant or lactating women
* Clinically significant systemic disease (other than RA for RA arm)
* Use of lipid-regulating agents
A Phase 2 Study of Firi-cel in Patients with Relapsed/refractory Large B-cell Lymphoma

This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).

Firicabtagene autoleucel (firi-cel) is an autologous CAR T-cell therapy targeting CD22, a common B-cell antigen widely expressed in LBCL. This Phase 2 study is designed to evaluate the safety and the efficacy of firi-cel in patients with R/R LBCL that has progressed after CD19-directed CAR T-cell therapy. The study is designed to treat up to 123 patients with a single infusion of firi-cel.

Eligibility Criteria:
Key Inclusion Criteria:

* Aged ≥18 years
* Relapsed or refractory, histologically confirmed large B-cell lymphoma.
* Must have relapsed or refractory diseae after last therapy.
* For enrollment in cohort 1, patients must have previously received a CD19-directed CAR T-cell therapy
* For enrollment in cohort 3, patients must have received at least two prior lines of therapy including a bispecific T-cel engaging antibody therapy.
* Must have at least one radiographically measurable lesion.
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Adequate hematological, renal, and liver function
* Willing and able to remain within 1 hour of the treating center for at least 4 weeks after infusion.

Key Exclusion Criteria:

* Clinically significant concurrent medical illness
* Active fungal, bacterial, viral or other infection.
* Prior allogeneic stem cell transplant or allogeneic cell therapy

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Evaluation of the DPP II Assay in Laos

Fever is the most frequent symptom in patients seeking care globally. Several causative agents of febrile illness have been described with a high prevalence in South East Asia. They include malaria, dengue, Rickettsia, Leptospira and Burkholderia species. Since their introduction in the market, rapid diagnostic tests for malaria have driven patient management and care. Malaria negative cases are commonly treated with antibiotics without confirmation of bacteraemia. This can be explained by conventional laboratory diagnostic tests such as blood culture that usually require a skilled staff and appropriate facilities.

Several Rapid Diagnostic tests (RDTs) are currently in the market but only limited data on their performance are available, rendering them unsuitable to replace laboratory conventional tests. In addition, RDTs have been developed for single disease diagnosis and remain costly for Low and Middle Income Countries (LMIC).

Chembio, in collaboration with FIND (Foundation for Innovative New Diagnostics) and MORU (Mahidol Oxford Tropical Medicine Research Unit), has developed a multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect serum immunoglobulin M (IgM) and specific microbial antigen of the most common agents of Acute Febrile Illness (AFI) in Asia. The assay comes with a reader that provides results interpretation to the operator.

So far, DPP II assay performance has been estimated using a limited number of retrospective serum samples. More data are required to assess the performance of the assay using prospective serum samples. In addition, only limited data are available regarding the performance of the assay using blood samples. FIND will conduct a clinical trial to estimate the clinical performance of the assay in comparison to reference tests, using blood and serum samples and in intended settings of use.


Eligibility Criteria:
Inclusion Criteria:

* Participants \> 12 years old enrolled in the "Prospective study of the causes of fever amongst patients admitted to Mahosot Hospital, Vientiane, Lao PDR" (UI-2 study).
* Fever (≥ 37.5 °C)
* Illness duration \< 14 days
* Willingness to provide blood samples by venepuncture

Exclusion Criteria:

* Absence of consent (and assent for children) to participate to the "Prospective study of the causes of fever amongst patients admitted to Mahosot Hospital, Vientiane, Lao PDR" (UI-2 study).
* Non-infectious known or suspected cause of fever
* No left over blood sample or insufficient volume of left over sample
TiLoop® Bra for Breast Reconstruction

A new approach for single stage implant based breast reconstruction (BR) is the use of a titanium-coated polypropylene mesh (TCPM) as an alternative to acellular dermal matrix (ADM). These TCPM have a good biocompatibility and can be used in a similar way as ADM. This study addresses indications, limitations and complications of TCPM in implant based breast reconstruction.

An alternative to ADM is the usage of a titanium-coated polypropylene mesh (TCPM=TiLOOP(R) Bra), which is approved for breast reconstruction in Europe. The surgical approach is identical in comparison to ADM reconstruction and has been described previously. This titanium coated lightweight mesh consists of a monofilament structure and was initially invented for hernia repair which has a good biocompatibility. Observed cellular reactions like proliferation and apoptosis were at the lowest level when using this lightweight TCPM compared to not titanium-coated meshes (pure polypropylene (PP), pure lightweight PP mesh or PP mesh incorporating resorbable polyglactic acid). Histopathological analysis of an intraoperative sample of a TCPM after expander/implant BR demonstrated a well incorporated mesh with only weak inflammatory reactions. Preliminary data of in-vitro investigations at the investigators institute confirms the good biocompatibility of this TCPM in distinctive breast tissues (fibroblasts, fat cells, muscle cells) Although meshes are used in a large scale there are no sufficient clinical data regarding safety and outcome. In this multicenter study the investigators are able to investigate a large cohort of patients undergoing implant based breast reconstruction using a TCPM.

Eligibility Criteria:
Inclusion Criteria:

* Indication for immediate or secondary implant based breast reconstruction

Exclusion Criteria:

* age \< 18 years