cyrilzakka/clinical-trials huggingface dataset:
Favipiravir Combined With Tocilizumab in the Treatment of Corona Virus Disease 2019

The purpose of this study is to evaluate the efficacy and safety of favipiravir combined with tocilizumab in the treatment of corona virus disease 2019.

In clinical institutions that enroll patients with corona virus disease 2019, three arms, multi-center, randomized and controlled methods are adopted. Patients are divided into three groups, favipiravir combined with tocilizumab group, favipiravir group and tocilizumab group. 150 patients are expected to be enrolled and the cases are allocated according to the ratio of 3( favipiravir combined with tocilizumab group): 1(favipiravir group): 1(tocilizumab group).

Eligibility Criteria:
Inclusion Criteria:

1. Clinically diagnosed with Corona Virus Disease 2019
2. Increased interleukin-6
3. Sign the informed consent
4. Subjects who can take medicine orally
5. Agree to collect clinical samples
6. Female subjects of childbearing age are not pregnant and agree to take effective contraception within 7 days of the last oral medication to ensure that they are not pregnant within 3-6 months
7. Male patients agree to effective contraception within 7 days of last oral medication.

Exclusion Criteria:

1. Cases of severe vomiting that make it difficult to take the drug orally
2. Allergic to Favipiravir or tocilizumab
3. Pregnant and lactating women
4. Subjects received specific antiviral drugs such as lopinavir / ritonavir, ribavirin, arbidol, chloroquine phosphate, hydroxychloroquine, and monoclonal antibodies within one week before admission.
5. Cases of respiratory failure and requiring mechanical ventilation
6. Cases of shock
7. Combined organ failure requires ICU monitoring and treatment
8. Predicted clinically that there is no hope of survival, or cases of deep coma that do not respond to supportive treatment measures within three hours of admission
9. Alanine aminotransferase / Aspartate aminotransferase\> 5 times of upper limit of normal
10. Neutrophils \<0.5 × 10\^9 / L, platelets less than 50 × 10\^9 / L
11. Clear diagnosis of rheumatoid immunity, malignant tumors and other related diseases
12. Long-term oral anti-rejection drugs or immunomodulatory drugs
13. Allergic reactions to tocilizumab or any excipients
14. Patients with active hepatitis, tuberculosis, and definite bacterial and fungal infections
15. Organ transplant patients
16. Patients with mental disorders
Effects of IMT on Respiratory, Diaphragmatic and Balance Functions, Exercise Capacity and QOL in People After Stroke

This is a randomized controlled trial. This current RCT study will be a continuing project based on the optimal IMT intensity identified from our ongoing study. This ongoing study (registered on ClinicalTrials.gov with the registration number NCT06267768) aims to explore the optimal IMT intensity for the recruitment of diaphragm muscles in people after a stroke. Based on this intensity, the aim of this RCT is to explore the effects of a 4-week protocol of IMT on respiratory function, balance control, exercise capacity, and quality of life in people after a stroke.


Eligibility Criteria:
Inclusion Criteria:

* aged between 40 and 80 years;
* breathing spontaneously;
* clinically diagnosed with ischemic and/or haemorrhagic stroke;
* stroke duration from onset between 1 and 12 months;
* no history of thoracic or abdominal surgery within the last 6 months;
* able to understand and follow verbal instructions;
* no facial palsy, or mild facial palsy without limitation of labial occlusion;
* capable of maintaining a resting sitting posture without feet support for at least 30 seconds;
* no cognitive impairment, as indicated by a Montreal Cognitive Assessment (MoCA) score of ≥ 26;
* able to independently walk at least 10 meters with or without an assistive device.

Exclusion criteria:

* acute myocardial infarction or acute heart failure;
* acute pain in any part of the body;
* with respiratory illness or positive clinical signs of impaired respiratory function, such as shortness of breath, hypoxemia, chronic cough, or sputum retention;
* with chronic cardiovascular dysfunction;
* Trunk Impairment Scale (TIS) score ≥ 20;
* presence of a nasal feeding tube, tracheal tube, or any condition that prevents the measurement or implementation of the study procedure.
Shear Wave Elastography in Differentiating Acute or Chronic Kidney Disease

Chronic kidney disease is a common global public health issue and its prevalence increased year by year. Early diagnosis and intervention can prevent further complications and comorbidities of long-term dialysis, cardiovascular events and mortality as well as improve the patients' life quality. To differentiate acute from chronic kidney disease was crucial especially in the setting of crowded and high-risk emergency department. To diagnose acute or chronic kidney disease, physicians usually use blood sample test combined with image studies such as conventional sonography, CT and MRI. However, there was lots of limited factors. The patients may have no previous visit records, poor renal function to receive contrast medium, or critical clinical condition to undergo time-wasting exam. Although the conventional renal sonography is accessible and inexpensive, the judgement is subjective and provide little clinical information. Recent researches of shear wave elastography in evaluating renal parenchymal stiffness showed some correlation with nephropathy. In our study, aiming to facilitating clinical implication, the investigators will use swear-wave elastography combined with conventional renal sonography to benefit patients in diagnosis of acute or chronic kidney disease.

This is a case-control study. The investigators obtained data from participants who were older than 20 years old and received renal sonography examination in the emergency department of National Taiwan University Hospital. The investigators examined the participants' kidneys by recording the kidney size, cortical thickness, possible lesions and elasticity by shear-wave elastography. These data combined with the participants' medical history and renal function revealed by blood examination will be analyzed. This study was designed to determine the correlation between renal cortical elasticity and chronic kidney disease.

Eligibility Criteria:
Inclusion Criteria:

* The patients older than 20 years old who needed to receive renal sonography in emergency department of National Taiwan University Hospital.

Exclusion Criteria:

* The patients who didn't obtain agreement.
* The patients who can't cooperate or follow the directions
Taste Reward Processing in Pediatric Obesity

The study aims to provide a better understanding of the neural influence of eating behavior in the development of childhood obesity. Children ages 4-8 will be recruited to examine fMRI brain response to pictures that signal delivery of a chocolate milkshake and to the taste itself. The brain response will be compared to body mass index percentile scores for each child to help us determine whether brain differences present in adolescents and adults with obesity are present in young children.


Eligibility Criteria:
Inclusion Criteria:

* ages 4-8
* parent available to complete surveys in English

Exclusion Criteria:

* no presence of metal in body
* no claustrophobia
* no psychiatric or neurological condition that will affect brain function
Chemotherapy Combined With Radiotherapy Versus Radiotherapy Alone for Solitary Plasmacytoma

Solitary plasmacytoma (SP) is characterized by a localized mass of clonal plasma cells with no or minimal bone marrow plasmacytosis. It can present either as EMP or SBP. Radiotherapy is the first-line treatment with high response rate. However, 65-84% SBP patients and 25-35% EMP patients progress at 10 years. We aimed to investigate whether adjuvant bortezomib based chemotherapy with radiotherapy could prolong event-free survival in treatment-naive SP patients compared to that with radiotherapy alone.


Eligibility Criteria:
Inclusion Criteria:

* treatment-naïve SP.

Exclusion Criteria:

* Not appropriate for radiotherapy.
* ECOG \> 2.
* Co-morbidity of uncontrolled infection.
* Co-morbidity of other active malignancy.
* Patients in pregnancy or lactation.
* Prior or concurrent pulmonary embolism.
* Patients not able to tolerate thrombosis prophylaxis, bortezomib, lenalidomide or dexamethasone.
* Seropositive for human immunodeficiency virus, seropositive for hepatitis C, or HBV-DNA \> 1000 copies/mL.
* Myocardial infarction, NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled arrhythmias within 6 months prior to enrollment.
* Grade 2 or higher neuropathy according to National Cancer Institute Common Terminology Criteria for Adverse Events.
* Neutrophil \<1×10E9/L，hemoglobin \< 8g/dL，or platelet \< 75×10E9/L.
* Severely compromised hepatic or renal function: ALT or AST \> 3 × ULN, total bilirubin \> 1.5 × ULN，or eGFR \< 40mL/min.
Role of CT Angiography With Three-dimensional Reconstruction of Mesenteric Vessels in Planning and Performing of Laparoscopic Colorectal Resections

The aim of this study is to evaluate if the prior knowledge of the individual mesenteric vascular anatomy of patients represents an advantage in performing laparoscopic colorectal resections. The investigators want demonstrate that the three-dimensional reconstruction of colonic vascular anatomy, acquired with a CT angiography, may lead to a more effective and less extensive dissection and to a fewer intraoperative and postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* need of colorectal resection
* absence of preoperative CT scan

Exclusion Criteria:

* contraindications to laparoscopy
* ASA IV
* BMI \> 40 Kg/m2
* need of non standard colonic resection
A Study of Crenolanib With Fludarabine and Cytarabine in Pediatric Patients With Relapsed/Refractory FLT3-Mutated Acute Myeloid Leukemia

This is a phase II, multicenter, single-arm study to assess the safety and feasibility of combining crenolanib with fludarabine and cytarabine chemotherapy in pediatric patients with relapsed/refractory FLT3-mutated AML. Patients will receive up to two courses of salvage chemotherapy with fludarabine, cytarabine, and crenolanib. Response will be assessed between day 29-43 of each course.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 1 years and ≤ 21 years
2. Confirmed diagnosis of AML according to World Health Organization (WHO) 2016 classification
3. Definitive evidence of a FLT3-ITD and/or FLT3-TKD (D835/I836) mutation at the time of enrollment
4. Patients must have histologically or molecularly confirmed relapsed or refractory AML
5. Karnofsky or Lansky performance score ≥ 50. Use Karnofsky for patients \> 16 years old and Lansky for patients ≤ 16 years of age.
6. Adequate renal function, defined as:

   * Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m2 or
   * Normal serum creatinine based on age/gender
7. Adequate liver function, defined as:

   * Serum total bilirubin ≤ 1.5x ULN for age,
   * Serum aspartate aminotransferase (AST) ≤ 3.0x ULN for age, and
   * Serum alanine aminotransferase (ALT) ≤ 3.0x ULN for age.

Exclusion Criteria:

1. Patients with any of the following current or previous diagnoses:

   * Acute promyelocytic leukemia (APL)
   * Down syndrome
   * DNA fragility or bone marrow failure syndromes (such as Fanconi anemia, Bloom syndrome, Kostmann syndrome, or Shwachman syndrome)
   * AML secondary to prior MDS/MPN, including chronic myelomonocytic leukemia and juvenile myelomonocytic leukemia
   * Blastic plasmacytoid dendritic cell neoplasm
   * Acute leukemia of ambiguous lineage
   * B-lymphoblastic leukemia/lymphoma
   * T-lymphoblastic leukemia/lymphoma, including early T-cell precursor lymphoblastic leukemia (ETP-ALL)
2. Patients who are refractory to first line (induction and re-induction) and a second line (1st salvage) treatment for AML.
3. Patients who have received more than 1 prior allogeneic HSCT
4. Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection of which they exhibit ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
5. Patients will be excluded if there is a plan to administer non-protocol chemotherapy, radiation therapy, or immunotherapy during the study period.
6. Known severe liver disease (e.g. cirrhosis, non-alcoholic steatohepatitis, sclerosing cholangitis or hyperbilirubinemia)
7. Known, active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV)
8. Currently receiving prophylactic treatment of hepatitis B with anti-viral therapy
9. Known infection with human immunodeficiency virus (HIV)
Study of Tremelimumab Alone or Combined With Olaparib for Patients With Persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma)

This study will be looking at what dose of tremelimumab and olaparib is safe and effective in patients with persistent EOC (Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma).

This clinical trial was initially intended to be a Phase 1/2 trial, but the trial never moved forward to Phase 2 prior to termination.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form
2. Age ≥ 18 years
3. Recurrent or persistent EOC (epithelial ovarian, fallopian tube or primary peritoneal carcinoma)
4. Have archival tissue or willingness to undergo a tumor biopsy
5. Have measurable disease
6. Have had one prior taxane-platinum-based chemotherapeutic regimen
7. Have had a treatment-free interval following platinum-based therapy of less than 12 months, have progressed during platinum-based therapy, or had persistent disease after a platinum-based regimen
8. Have received hormonal therapy
9. ECOG Performance Status of 0 to 1
10. Ability to take oral medications
11. HIV, HTLV-1, HBV, and HCV negative
12. Adequate organ and bone marrow function as defined by study-specified laboratory tests
13. Normal blood coagulation parameters
14. Life expectancy greater than 16 weeks
15. Must use acceptable form of birth control through the study and for 28 days after final dose of study drug
16. Willing and able to comply with study procedures

Exclusion Criteria:

1. Prior therapy with an anti-CTLA-4 antibody or PARP inhibitor
2. Active infection requiring antibiotics
3. Active autoimmune disease
4. Active and uncontrolled intercurrent illness
5. History of other cancers within the past 5 years
6. Systemically active steroid use
7. Receiving systemic chemotherapy or radiotherapy within 4 weeks prior to the first dose of study drug
8. Use of ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, telithromycin, clarithromycin and nelfinavir
9. Requirement for chronic parenteral hydration/nutrition
10. Vaccination with live attenuated vaccine within 1 month prior to first dose of study drug
11. Patients with untreated brain metastases, treated brain metastases that are not stable, leptomeningeal disease, or seizures uncontrolled with standard medical therapy
12. Patients with myelodysplastic syndrome/acute myeloid leukaemia
13. History of diverticulitis
14. History of bleeding disorder or diathesis.
15. Serious or nonhealing wound, ulcer, bone fracture, or osteonecrosis of the jaw
16. Major surgical procedure within 28 days of study enrollment, or anticipated while on study.
17. Pregnant or breast feeding woman
Management of Post-delivery Pain and Its Impact on Resumption of Sexuality

Study of management of pain and information given to women post-delivery and their impact of the resumption of sexuality.

Survey to be completed by women at 8 and 15 days and 1 or 3 months after delivery.


Eligibility Criteria:
Inclusion Criteria:

* Primiparous woman
* Age between 18 and 45 years old
* Delivery after 37 weeks of amenorrhea
* Speaking French
* Pregnancy, delivery and new-born examination without morphologic or biometric abnormalities, respiratory distress and no pathology discovered at neonatal screening on day 3
* Heterosexual woman with partner
* Signed consent
* Affiliate of national health insurance scheme

Exclusion Criteria:

* Multiple pregnancy,
* BMI \> 30
* Conjugopathie
* Known psychiatric history
* Medical history with gynecologic impact
* Surgery history with gynecologic impacts
* Hysterectomy post-delivery
* Protected by French law
Evaluation of Vulvar Lichen Sclerosus Treatment Using Adipose Tissue Associated With Autologous Platelet-rich Plasma.

LIQUENIA clinical trial is a phase II, controlled, prospective and unicentric study to assess vulvar lichen sclerosus (VLS) treatment using adipose tissue associated with autologous platelet-rich plasma (PRP) coming from the inner side of the patients' thighs, which aims to restore the structure and elasticity of the affected vulvar subunits, and to improve vulvar subunits lesions and symptoms, therefore, patients' quality of life from the early phases of the treatment.

Randomized, prospective and unicentric study, in which the investigators evaluate patients with vulvar lichen sclerosus who undergo surgical treatment consisting of two separate infiltrations by intra and subdermal injection in each half vulvar of autologous fatty tissue associated with autologous platelet-rich plasma, in order to:

Main objective:

To estimate the population parameters of the study variables, as well as their variability, to be able to determine the sample size and statistical power for a future clinical trial whose main objective will be to demonstrate the efficacy of this treatment regarding the increase in the vulvar elasticity in patients with vulvar lichen sclerosus.

Secondary Objectives:

1. To evaluate if there is a structural improvement in the vulva areas treated at month, 3 months, 6 months and 12 months after the first infiltration and at 3 and 9 months after the second infiltration.
2. To analysis the improvement of fibrosis and inflammation 6 months after the first infiltration and 3 months after the second infiltration.
3. To study if there is an improvement in symptoms at month, 3 months, 6 months, 12 months after the first infiltration and at 3 months and 9 months after the second infiltration.
4. To examine whether there is an improvement in the quality of patients life.
5. Subsequent use of clinical and pain assessment scale in this study and in another lichen sclerosus vulvar studies with a greater number of patients.
6. To evaluate the adverse events derived from the treatment during the first year after the first infiltration through its registration in the CRD.

Eligibility Criteria:
Inclusion Criteria:

* Adult women between 18 and 70 years old.
* Patients with clear clinical and/or histological diagnosis of vulvar lichen sclerosus (VLS).
* Moderate to severe affectation of the disease at genital level.
* Patients who have taken topical treatment for at least three months with 0.05% clobetasol propionate.
* Prior signed informed consent form.

Exclusion Criteria:

* Pregnant or lactating women.
* Alcoholic patients.
* Patients with malignant disease diagnosed in the last 5 years.
* Patients infected with HSV-II, HPV, HIV, HBV and HCV viruses.
* Injecting drug users.
* Patients with serious active infectious diseases.
* Patients with known allergy or intolerance to any of the aforementioned treatments.
* Patients with inflammatory diseases that may affect the vulvar area (Crohn's disease, ulcerative colitis, psoriasis, eczema).
* Patients with unrealistic expectations regarding the final benefits of the treatment.
Predicting Lung Injury From Transfusion in Patients With Liver Disease

A certain molecule floating in the blood may represent a risk of lung injury after a transfusion. We are determining whether detection of this molecule on a simple blood clotting test will predict the development of lung injury due to transfusion in bleeding patients with chronic liver disease.


Eligibility Criteria:
Inclusion criteria: Subjects will be eligible to participate in the study if they meet all of the following criteria:

1. Admit to an ICU due to gastrointestinal bleeding AND an INR \> 1.5
2. Patient has chronic liver disease defined as 1 or more of the three following diagnostic criteria:

   1. Previous diagnosis of chronic liver disease OR Imaging or biopsy diagnosis of cirrhosis
   2. Signs of portal hypertension (ascites, varices, hypersplenism)
   3. Laboratory evidence of synthetic dysfunction (INR\>1.5, Bilirubin\> 2.0, Albumin\< 2.5) AND ≥2 physical exam findings on admission associated with chronic liver disease (palmar erythema, spider angiomata, asterixis, caput medusa, gynecomastia)

Exclusion criteria: Subjects will be ineligible to participate in the study if they meet any of the following criteria

1. Patient under age 18 OR pregnant OR incarcerated
2. Patient meets criteria for acute respiratory distress syndrome (ARDS) (PaO2/FiO2\<165)
3. Patient admitted to ICU for re-bleed on same hospital admission OR has already received \>4 units of plasma.
4. History of inheritable or acquired clotting or bleeding disorder
5. Patient actively anticoagulated or has recently received (within 72h) vitamin K antagonists, direct thrombin inhibitors, heparins or Xa antagonists
The Hasselt APPendicitis Immunology and Environmental Cohort STudy

The Hasselt Appendicitis Immunology and Environmental Study (HAPPIEST) aims at characterizing factors that influence the development and severity of acute appendicitis. In a cohort of 300 patients and 300 controls, environmental factors as well as genetic make-up of the innate immune system, focusing mainly on pattern recognition, will be analyzed in order to gain insight in their relative importance in the pathology of appendicitis. Furthermore, populations of micro-organisms present in the gut of patients will be characterized, and the interaction between relevant micro-organisms and the innate immune system will be analyzed.


Eligibility Criteria:
Inclusion Criteria:

* Acute appendicitis
* Appendectomy within 7 days after onset of symptoms
* Signed informed consent

Exclusion Criteria:

* Appendectomy 7 days or more after onset of symptoms
* Participation in any clinical investigational drug study within 4 weeks of screening
* Severe, life-threatening disease with a life expectancy of less than 2 months.