cyrilzakka/clinical-trials huggingface dataset:
A Study of Reslizumab in Patients 12 Years of Age and Older With Severe Eosinophilic Asthma

This is a multicenter, open-label (OL) extension study to obtain additional long-term safety data for subcutaneous (sc) administration of reslizumab treatment administered at a fixed dose of 110 mg in patients 12 years of age and older with severe eosinophilic asthma who completed the treatment period of a placebo-controlled Phase 3 trial of sc reslizumab. The study consists of a screening/baseline visit followed by a 36-week OL treatment period and a 15-week follow-up period.


Eligibility Criteria:
Inclusion Criteria:

• Patient with eosinophilic asthma who completed the treatment period of a double-blind, placebo controlled sc reslizumab study (Study C38072-AS-30025 or C38072-AS-30027)

\~\~ Additional criteria apply, please contact the investigator for more information

Exclusion Criteria:

* Patient has received any reslizumab administration in any previous clinical trial other than Studies C38072-AS-30025 and C38072-AS-30027.
* The patient has any clinically significant, uncontrolled medical condition
* The patient has another confounding underlying lung disorder
* The patient has a known/diagnosed hypereosinophilic syndrome.
* The patient has a diagnosis of malignancy within 5 years of the screening visit, except for treated and cured non-melanoma skin cancers.
* The patient is a pregnant or lactating woman
* The patient is a current smoker (ie, has smoked within the last 6 months before screening) or has a smoking history ≥10 pack-years.
* The patient is currently using any systemic immunosuppressive or immunomodulatory agents other than OCS
* The patient has a history of allergic reaction or hypersensitivity to any component of the study drug.
* The patient has a history of an immunodeficiency disorder including human immunodeficiency virus (HIV).

  * Additional criteria apply, please contact the investigator for more information
The Evaluation of Therapeutic Efficacy on the Integrated Group Psychotherapy for Patients With Schizophrenia

Although the patients with schizophrenia can be treated with new generation of antipsychotics medication, additional approaches are necessary to improve schizophrenics' cognitive functions, interpersonal relationships as well as social adjustment. When some of patients return to community, they expose to practical pressure that contribute to worsen and relapse of disease. That further damages patient's cognitive functions. Integrated Psychological Therapy(IPT) on treating schizophrenia has dramatic improvement in recent years; it has formed structured treatment gradually on relieving illusion, hallucination as well as negative symptoms. This study aims at conducting 12-week structured IPT group therapy. The intended subjects are patients, met with DSM-Ⅳ-TR diagnosis of schizophrenia, from community, outpatient and inpatient service. The overall treatments are designed to provide 1-2 hours weekly group therapy which focuses on relieving illusions, hallucination, and negative symptoms. Patients' cognitive functions, ability of emotional adjustment and interpersonal relationship would be evaluated in pre-test and post-test to indicate whether the significant difference exists. There is a controlled group, in which patients who still receive treatment as usual (TAU). The study also compares the evaluation results between IPT group and TAU group, hoping to develop the therapeutic framework for Taiwan people with schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* schizophrenia,
* can concentrate in group for 30 minutes.

Exclusion Criteria:

* substance abuse (alcohol, illegal medication),
* self harm history.
Hemothorax Caused by Posterior Correction Surgery for Spinal Deformity

Owing to the development of instruments and surgical techniques, the number of spinal deformity correction surgeries has increased significantly. The incidence of hemothorax due to posterior correction surgery for spinal deformity is reported to be as low as 0.1%, and the vast majority of these cases were treated through observation without additional intervention. However, if hemothorax that occurs is missed, it can result in increased mortality and morbidity. Furthermore, there is a paucity of data on management of hemothorax caused by posterior correction surgery. The aim of this retrospective study is to evaluate our cases of hemothorax after posterior correction surgery for spinal deformity.

We retrospectively reviewed medical records of all pediatric patients who underwent posterior correction surgery from 2016 to 2021.

Eligibility Criteria:
Inclusion Criteria:

* Children who underwent posterior correction surgery for spinal deformities (age range 1-18 years)

Exclusion Criteria:

-
A Phase III Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma

The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.

Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a，TxNxM1a （according to AJCC2002）

Scheme:

Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (N0 or N1), then randomized to 2 arms at 1:1 ratio.

Arm Cisplatin:

Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.

Arm Paclitaxel:

Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy for 2 cycles.

Eligibility Criteria:
Inclusion Criteria:

* Joined the study voluntarily and signed informed consent form;
* Age 18-75
* Both genders
* Esophageal squamous cell carcinoma confirmed by pathology
* Local advanced esophageal squamous cell carcinoma (T2N0M0-TxNxM1a, AJCC 2002)
* No radiotherapy, chemotherapy or other treatments prior to enrollment
* PS ECOG 0-2
* Life expectancy of more than 3 months
* Hemoglobin（Hb）≥9 g/dL
* WBC≥3x109/L, Neutrophils (ANC )≥1.5x109/L
* platelet count (Pt) ≥100x 109/L
* Hepatic function: ALAT and ASAT \< 2.5 x ULN, TBIL\<1.5 x ULN
* Renal function: creatinine \< 1.5 x ULN
* No immuno-deficiency
* Use of an effective contraceptive for adults to prevent pregnancy.

Exclusion Criteria:

* Complete esophageal obstruction
* Deep esophageal ulcer
* Esophageal perforation
* Haematemesis
* After surgery, exploratory thoracotomy, radiotherapy, chemotherapy, or targeting therapy
* Other malignant tumors, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived with no evidence disease for over 3 years
* Participation in other interventional clinical trials within 30 days
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
* Drug addiction
* Alcoholism or AIDS
* Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
* Patient who has metastasis such as lung, liver metastasis
Nesiritide Therapy to Preserve Function of the Left Ventricle After Myocardial Infarction

The purpose of this study is to determine the efficacy of intravenous human beta natriuretic peptide (BNP, Nesiritide) as compared to placebo to prevent adverse post acute myocardial infarction left ventricular remodeling.

Post acute myocardial infarction (AMI) left ventricular (LV) remodeling begins within hours of the acute event with permanent consequences. Previous studies have demonstrated that LV remodeling is one of the major determinants of long-term survival post AMI. Recent studies have reported that the cardiac natriuretic peptides, atrial natriuretic peptide (ANP) and BNP have direct anti-fibrotic and anti-proliferative effects on the myocardium. More importantly, it has been reported that in the acute phase of AMI, the secretion of the cardiac natriuretic peptides may be insufficient relative to the chronic phase. Therefore, augmentation of the cardiac natriuretic peptide system, such as by exogenous administration of exogenous peptide may prevent post AMI LV remodeling because of the cardioprotective effects. The objective of this study is to to determine the efficacy of IV human BNP (Nesiritide) as compared to placebo to prevent adverse post AMI LV remodeling. This is a randomized double blinded placebo controlled study to determine efficacy of 72 hours of IV BNP at 0.006µg/Kg/min as compared to placebo in patients with anterior ST-elevation myocardial infarction and successful revascularization. The study population will include 60 patients admitted to the Cardiac Care Unit with a first anterior AMI and successful reperfusion therapy (TIMI grade 3 flow) within 24 hours of onset of chest pain documented by coronary angiography.

Eligibility Criteria:
Inclusion criteria:

* Patients with acute ST elevation myocardial infarction with \> or = 2 mm ST elevation in one or any combination of anterior leads, with successful revascularization (TIMI grade 3 flow) of the lesion within 24 hours of symptoms and consented within 24 hours of procedure.

Exclusion criteria:

* Cardiogenic shock or hypotension, Systolic BP\< 90 mmHg or overt Congestive Heart Failure (CHF)
* Previous history of MI (Myocardial Infarction)
* Previous ECG suggesting previous MI
* Known Ejection Fraction (EF) \< 30%
* Atrial fibrillation
* Previously known significant valvular disease (Grade III, IV), cardiomyopathy and congenital heart disease.
* Hemoglobin \<10 mg/dL
* Pregnant women/nursing mothers
* Participants still menstruating and have not been surgically sterilized must have a negative pregnancy test prior to participating in this study.
* Unable to undergo cardiac MRI (Magnetic Resonance Imaging).
* Contraindications to MRI include pacemaker or defibrillator, pregnant women, atrial fibrillation or other arrhythmia, cerebral aneurysm clips or severe claustrophobia.
Impact of 18F-FES PET on the Therapeutic Treatment of Patients With Metastatic Breast Cancer

This is a multi-center study in France to evaluate the impact of ESTROTEP PET/CT results on the therapeutic management of patients with metastatic breast cancer (MBC).

Each patient will be screened to determine whether the patient meets all the inclusion criteria and none of the exclusion criteria.

After inclusion, a standardized pre ESTROTEP PET/CT questionnaire will be completed by the investigators to evaluate the initial management plan. Patient will perform the ESTROTEP PET/CT examination at visit 2. A standardized post ESTROTEP PET/CT questionnaire will then be completed by the investigators.

Patients will be followed for 12 months to evaluate their clinical status and standard of care investigations.


Eligibility Criteria:
Inclusion Criteria:

1. Female aged at least 18 years old at the time of enrolment
2. Oestrogen-receptor positive primary breast cancer in IHC (ER ≥10%)
3. HER2-negative primary breast cancer (0, 1+, 2+ FISH negative)
4. Metastatic stage with at least one lesion identifiable on the conventional work-up other than a liver lesion
5. Patient relapsing under first-line treatment combining a CDK4/6inhibitor and hormone therapy
6. Patient having undergone an FDG PET/CT during follow-up of first-line treatment for metastatic tumour revealing the relapse or undergoing a baseline FDG PET/CT seeking the relapse during 2nd line staging (according to the recommendations of the Guide to Correct Use (GBU) for medical imaging tests). A period of 2 to 28 days will be respected between the 2 PET/CT scans (FDG/FES).
7. ECOG 0, 1 or 2
8. Life expectancy of at least 12 months
9. Patient registered with a Social Security scheme
10. Patient having signed an informed consent form
11. Patient able to follow the study procedures and fill in the quality of life questionnaires

Exclusion Criteria:

1. Isolated hepatic metastases (taking into account the high physiological hepatic uptake of FES)
2. Patients as first-line treatment for metastatic cancer or aftersecond-line treatment for metastatic cancer
3. Person presenting a known allergy to one of the components of EstroTep
4. Patients having been treated with a CDK4/6 inhibitor in combination with an SERM or SERD as first-line metastatic therapy
5. atients suffering from severe or known chronic liver or renal failure
6. Patient following a low-sodium diet or having alcohol consumption levels incompatible with the administration of EstroTep, according to the investigator's opinion
7. Woman of childbearing age with no effective means of contraception according to the investigator's opinion
8. Severe intercurrent disease or comorbidity assessed at risk
9. Persons referred to in articles L. 1121-5 to L. 1121-8 and L11222 of the French Public Health Code
Efficacy of Tinkering Activities in Individuals With Subjective Cognitive Decline

Given that preventing and delaying the onset of dementia is a crucial public health policy issues worldwide, it is essential to develop effective interventions and implement early interventions before the onset of dementia. Subjective Cognitive Decline (SCD) is considered the earliest manifestation of dementia and individuals with SCD may have a higher risk for future cognitive decline and dementia. Despite performing normally on objective cognitive tests, individuals with SCD have been found to exhibit worse performance on some cognitive domains, including executive functions, compared to those without SCD. Executive Functions (EFs) refer to a set of cognitive processes that include working memory, inhibition, cognitive flexibility, planning, problem solving and reasoning, enabling individuals to achieve goals by controlling and regulating thoughts and behaviors. EFs are important for our daily functioning and their decline can negatively impact an individual's quality of life. However, to our knowledge, there is limited research on maintaining or improving EFs in individuals with SCD. Tinkering Activity (TA) is a hands-on cognitive activity that emphasizes process of problem-solving, active engagement and open-ended exploration, which challenges EFs. In addition, previous research has shown the benefits of TA for community-dwelling older adults.

Therefore, the goal of this clinical tri is to examine the efficacy of TA based cognitive intervention in enhancing EFs in individuals with SCD. This study will be a one-group pretest-posttest design. Twelve to fifteen individuals with SCD will be recruited from the communities. All participants will receive 12 intervention sessions, each lasting 2 hours, with two sessions per week for 6 weeks. All participants will be assessed before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥50 years
* Can communicate in Mandarin and is literate in Chinese
* No impairment in basic activities of daily living(BADL) or Barthel Index score of 100
* Score \>23 on the Taiwanese version of the Montreal Cognitive Assessment(MoCA-T)
* Willing and able to participate fully in the intervention
* Individuals with Subjective Cognitive Decline, screened from the communities:

  1. Experience subjective cognitive difficulties: answered "yes" to any questions in part I of the Subjective Cognitive Decline Scale(SCDS).
  2. Display normal performance in the Color Trails Test and Word Lists Test of the Wechsler Memory Scale-3rd Edition(after adjustment of age, gender and education, scoring on average above -1.5 standard deviations)

Exclusion Criteria:

* Diagnosed with Mild Cognitive Impairment(MCI) or Dementia
* Cognitive changes due to psychiatric or neurological disorders, substance abuse, and those with unstable conditions and symptomatic disturbances, or a score of ≥ 29 on the Beck Depression Inventory II (BDI-II)
* Unable to participate due to physical illnesses
* Severe impairment in visual and auditory abilities
* Participated in other cognitive training while engaged in this study
Human Versus Analogue Insulin for Youth With Type 1 Diabetes in Low-Resource Settings

The primary objective of this trial is to determine whether insulin glargine reduces the risk of serious hypoglycemia or improves Time in Range at 6 months when compared against standard of care human insulin (e.g. NPH or premixed 70/30) among youth living with type 1 diabetes (T1D) in low resource settings.

Long-acting insulin analogues have become a de-facto standard of care for patients with T1D living in high-income countries. Unfortunately, insulin analogues remain unavailable or unaffordable for much of the global population. In both 2017 and 2019, applications to add long-acting insulin analogues to the WHO's Model List of Essential Medicines (EML) were rejected due to insufficient evidence of superiority and an unfavorable cost-effectiveness profile when compared against older, less expensive, human insulins (e.g., NPH insulin and premixed 70/30 insulin). In 2021, long-acting insulin analogues were added to the EML but the decision remains controversial since the WHO concluded that "magnitude of clinical benefit of long-acting insulin analogues over human insulin for most clinical outcomes was small." Moreover, studies that compare long-acting insulin analogues versus human insulins conducted in high-income settings may not generalize to children and young adults living with T1D in very low-resource settings.

To address this unmet need, Pitt has partnered with Brigham and Women's Hospital, The London School of Hygiene and Tropical Medicine, the Clinton Health Access Initiative and Life For a Child to conduct a randomized controlled trial comparing insulin glargine, a long-acting analogue insulin, against intermediate human insulin among 400 children and young adults living with T1D in a lower resource setting.

Eligibility Criteria:
Inclusion Criteria:

1. Children and young adults (age 7-25)
2. Have a clinical diagnosis of type 1 diabetes (T1D)

Exclusion Criteria:

1. Prior use of any insulin analogue
2. Patients (or parents for children \<18 years old) who refuse to or cannot provide informed consent
3. Who are currently pregnant or plan to become pregnant over the next year
4. Who have previously used a continuous glucose monitor (CGM) for glucose monitoring
5. Who were first diagnosed with T1D less than 12 months ago
6. Who is diagnosed with severe malnutrition
Prognosis of Geriatric Patients 1 Year After Hospitalization for COVID-19

Old patients hospitalized in Acute Geriatric Units are characterize by advanced age, frailty, high number of comorbidities, cognitive impairment and loss of functional autonomy. Although, intra-hospital mortality in geriatric population (out of COVID) is low (6%) the long-term prognosis is often worse (30 to 60% of loss of autonomy and 30% of one-year mortality among hospital survivors).

For geriatric patients with COVID19, intra-hospital mortality is higher than in younger Covid patients (1), but also higher than in geriatric patients outside the Covid context (30 vs 6% (2, 3)). Our hypothesis is that geriatric patients surviving hospitalization for COVID-19 have a worse vital and functional prognosis at 12 months than geriatric patients surviving hospitalization for another medical reason.

Old patients hospitalized in Acute Geriatric Units are characterize by advanced age (average 85 years), frailty, high number of comorbidities, cognitive impairment and loss of functional autonomy.These particular state leads to multiple decompensations and the reason for initial hospitalization is often only the "tip of the iceberg". Although, intra-hospital mortality in geriatric population (out of COVID) is low (6%) the long-term prognosis is often worse (30 to 60% of loss of autonomy and 30% of one-year mortality among hospital survivors).

For geriatric patients with COVID19, intra-hospital mortality is higher than in younger Covid patients (1), but also higher than in geriatric patients outside the Covid context (30 vs 6% (2, 3)). This excess mortality is all the more surprising as these patients seem to have fewer comorbidities than those usually hospitalized in acute geriatric units.

Our hypothesis is that geriatric patients surviving hospitalization for COVID-19 have a worse vital and functional prognosis at 12 months than geriatric patients surviving hospitalization for another medical reason.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=75 years
* Hospitalized for medical reason in acute geriatric unit
* Alive at hospital discharge

Exclusion Criteria:

* Patients hospitalized for surgical reason
* Patients under legal protection
* Patient refusal
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome

Expanded access to Stiripentol for patients with Dravet Syndrome.

This is a treatment plan, and therefore patients will be monitored according to clinical standard of care.

Eligibility Criteria:
Inclusion Criteria:

* 6 months and older
* Diagnosis of Dravet Syndrome with intractable seizures

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients
* Past history of psychoses in the form of episodes of delirium
* Impaired hepatic and/or renal function, defined as creatinine \>2 and/or transaminase \>4xULN
4D Cone Beam CT Reconstruction for Radiotherapy Via Motion Vector Optimization

To validate a new 4D Cone Beam CT (4DCBCT) reconstruction algorithm that was developed in our research group recently in terms of its geometry and intensity accuracy through real patient studies. Dose calculation found out in this study will not be used on the subject

Before patient studies, we will have conducted experimental studies on a lung phantom.

The purpose of this step is to comprehensively evaluate the system performance and gain confidence prior to its applications to real patient cases. We will operate the phantom to simulate motion patterns with different motion amplitude/frequency. 4DCBCT images will be reconstructed using our method and the conventional FDK algorithm. The validation will focus on two aspects: HU value accuracy and anatomy location accuracy.

Imaging dose in these scans will be also measured in phantom studies to make sure the radiation dose level is acceptable for patient studies. adiation dose level is acceptable for patient studies.

After testing the reconstruction algorithm on phantoms, we will move on to real patient cases. We will conduct patient studies on lung cancer patients treated under Image Guided Radiation Therapy (IGRT) at Department of Radiation Oncology, UT Southwestern Medical Center. CBCT projection data will be collected (4 gantry rotations, each within 1 minute) in only one treatment fraction. 4DCBCT images will be reconstructed from the current standard FDK algorithm using all the projection data, and from our system using data only in the first gantry rotation. Patient 4DCT image will also be used, which have been acquired during treatment planning stage per standard treatment protocol at UTSW.

The image quality of our 4DCBCT will be assessed in two aspects:

1) geometry accuracy, by comparing selected anatomical landmark locations with those in 4DCBCT reconstructed by the FDK algorithm. 2) HU accuracy, by comparing HU values in selected regions of interest (ROIs) with those in 4DCT.

The 4DCT images will be extracted from radiation therapy information system MOSAIQ.

The CBCT projection data will be exported from a computer that controls the image acquisition system

Eligibility Criteria:
Inclusion Criteria:

1. Patients that have been diagnosed with lung cancer, and are treated at Department of Radiation Oncology, UTSW.
2. Patients are greater than 18 years of age.
3. Patients understand a written informed consent document and are willing to sign the consent form.

Exclusion Criteria:

1. Women who are pregnant or trying to get pregnant
2. Children (under age of 18)