cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of Hetrombopag in Non-severe Aplastic Anemia

This is a prospective one arm study to explore the efficacy and safety of Hetrombopag in non-severe aplastic anemia. Patients meeting the inclusion and exclusion criteria would be recruited. Treatment of Hetrombopag would be started with 5mg/day. The dosage would be increased by 2.5mg/day every 2 weeks if the platelet count remains less than 20×10e9/L and reduced if the platelet count reaches over than 150×10e9/L. The maximum dosage is 15mg/day. All patients would receive treatment for at least 6 months except that the platelet \<20×10e9/L at the dosage of 15mg/day for 4 weeks or the platelet ≥200×10e9/L at the dosage of 5mg/week for 2 weeks. The hematological response rate and safety will be recorded and compared at D15, 1month, 1.5month, 2month, 3month, 4month, 5month, 6month, 8month, 10month and 1year.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed to be non-severe aplastic anemia
2. Patients with platelet count \< 30×109/L and have at least one of the followings: ①absolute neutrophil count \< 1.5×109/L, ②platelet count \< 50×109/L, ③ hemoglobin level \< 100g/L
3. Patients have no response or relapsed following at least one treatment course in a period time of \> 6 months of immunosuppression containing CsA or CsA+anti-thymocyte globulin (ATG);
4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
5. Patients able to understand and comply with protocol requirements and instructions and have signed and dated informed consent.

Exclusion Criteria:

1. Congenital aplastic anemia;
2. Presence of chromosomal aberration;
3. Evidence of a clonal hematologic bone marrow disorder (MDS, AML) on cytogenetics;
4. Presence with PNH clone ≥50%;
5. Patients received HSCT before;
6. Uncontrolled infection or bleeding with standard treatment;
7. Allergic to Hetrombopag or accessories;
8. HIV, HCV or HBV active infection or liver cirrhosis or portal hypertension;
9. Patient with QTcF (Fridericia's QT correction formula) at screening \<450 msec, or\<480 msec with bundle branch block, as determined via the mean of a triplicate ECG and assessed at site, unstable angina pectoris, uncontrolled hypertension(\>180/100mmHg)，pulmonary artery hypertension;
10. Have any concomitant malignancies within 5 years expect for local basal cell carcinoma of the skin;
11. Past history of thromboembolic event, heart attack or stroke (including anti-phospholipid antibody syndrome) and current use of anticoagulants;
12. Pregnant or nursing (lactating) woman;
13. Have attended other clinical trials within 3 months;
Endoresection of the Tumor Scar or Transpupillary Thermotherapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)

Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation


Eligibility Criteria:
Inclusion Criteria:

* Tumor of 7 mm of thickness or more
* Patients treated by proton beam therapy
* Patients aged at least 18 years
* Patients clearly informed of the study, having received the letter of information and signed the consent

Exclusion Criteria:

* Massive extrascleral extension posterior to the equator
* Patients with metastasis at diagnosis.
* Patients with glaucoma before the radiation therapy
* Patients with opaque media preventing transpupillary thermotherapy
* Patients for whom follow up will be difficult due to geographical, social or psychological reasons
Effects of MSCs Derived Pleiotropic Factors on Wound Healing in Endonasal Surgeries

Nasal trauma, deviated nasal septum, sinusitis, nasal polyps and other nasal benign diseases are common clinical diseases and require endoscopic sinus surgery. The proper application of the surgical procedure as well as ensuring high quality of wound healing, is also important to achieve successful results in endoscopic sinus surgery. If good quality wound healing cannot be achieved in the surgical field,synechiae and anatomic defects can occur that may require revision surgeries.

Mesenchymal stem cells play an active role in the treatment of many diseases. it primarily exerts therapeutic effects through paracrine. In this study, the effect of mesenchymal stem cell-derived multipotent factors on mucosal repair after nasal surgery was evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. 18 to 60 years old;
2. The clinical diagnosis is nasal trauma, nasal septum deviation, sinusitis, and nasal polyps requiring endoscopic surgery;
3. The patient's physical and mental state is stable, and he can return to the hospital regularly for follow-up examinations and cooperate to complete the experiment;

Exclusion Criteria:

1. Younger than 18 or older than 60;
2. Clinical diagnosis of nasal malignancies, or uncontrolled severe infectious diseases;
3. Past medical history of mental illness, malignant tumor, nose surgery;
4. People with serious underlying diseases (hypertension, diabetes, rheumatism, asthma) require long-term medication;
5. Long-term smoking, more than 5 cigarettes per day;
6. Work or daily life environment is exposed to large amounts of dust and chemical raw materials;
Glivec in Pediatric Chronic Myeloid Leukemia (CML)

It is a phase 4 study, not randomised and multicentric. Within 2 months after the diagnosis, the patients daily receive imatinib by oral way during at least 1 year (260mg/m² once a day), i.e. until the cytogenetic analysis.

Beyond 1 year of treatment, if a haematological relapse or a loss of the cytogenetic response is observed, the nature of the treatment suggested to the patient is left with the appreciation of the investigator.

Later on, discontinuation of imatinib is discussed if a molecular remission (negative RT-PCR) is obtained and maintained for at least 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Old \< 18 years, male or female.
* Chronic myeloid leukaemia confirmed on the cytogenetic level by the presence of the translocation t(9; 22) (q34; q11) or by the presence of transcript BCR-ABL in the event of absence of description of the translocation t(9; 22) (q34; q11).
* Chronic phase of a chronic myeloid leukaemia
* Absence of extra-medullary disease (except for a hepatomegaly and/or of a splenomegaly).
* Absence of any former treatment of chronic myeloid leukaemia except for hydroxyurea.
* Stop of hydroxyurea at least week before the beginning of the imatinib mesylate.
* Diagnosis of chronic myeloid leukaemia in chronic phase recent (less than 2 months).
* Score of Lansky ≥ 60.
* Effective contraception among patients in age to procreate.
* Written voluntary informed consent of the two parents or the legal guardian.

Exclusion Criteria:

* Patients with grade 3 / 4 cardiac disease.
* Pathology cardiac, pulmonary, hepatic, renal or neurological of grade \> 2 (WHO).
* Participation in a clinical trial in the 28 days preceding the beginning by the treatment.
* Impossible Follow-up during at least 2 years, patient not compliant.
* Expectant mother or nursing.
Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis:A Comparative Study

The study will be conducted to investigate the efficacy of posterior nasal neurectomy in control of recurrence and improvment of allergic symptoms in patients with allergic rhinitis combined with nasal polyposis

Allergic rhinitis patients with nasal polyposis will go through FESS combined with posterior nasal neurectomy to detect recurrence rate

Eligibility Criteria:
Inclusion Criteria:

* all cases presented to ENT department Assuit University with allergic rhinosinusitis with nasal polyposis

Exclusion Criteria:

* refusing enrollment into the study. Pregnant women Refusing surgery Containdication to surgery Patients with aspirin syndrome
Comparison of Catheterized and Clean Catch Urine Specimens for Protein/Creatinine Ratio in Preeclampsia Evaluation

The purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

Preeclampsia is the new onset of hypertension and proteinuria after twenty weeks of gestation in pregnant women. The gold standard for evaluation of proteinuria in the diagnosis of preeclampsia is a twenty-four hour urine collection. However, single-specimen protein/creatinine ratios have been used to detect preeclampsia without the delay and inconvenience that a twenty-four hour urine collection would entail. At our institution, women are routinely catheterized for urine collection of protein/creatinine ratios because of concerns that vaginal contaminants would falsely elevate protein measurement in urine. However, no studies have specifically evaluated whether catheterized urine specimens correlate to clean catch urine specimens in protein estimation. Thus, the purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant hypertensive patients between the ages of 14 - 50 of any gestational age greater than 20 weeks undergoing evaluation for preeclampsia

Exclusion Criteria:

* Ruptured membranes
* Any vaginal bleeding or spotting
* Pre-existing urinary tract infections or patients who are found to have a concurrent urinary tract infection upon culture of urine
* Patients who have previously been enrolled in the study
Greater Occipital Nerve Block Versus Metoclopramide

We are comparing a type of nerve block called greater occipital nerve block versus standard therapy among patients who present to an emergency department for acute migraine. This is a randomized, double-blind, double dummy study. The greater occipital nerve block will be performed bilaterally with bupivacaine 0.5%. Standard therapy is metoclopramide 10mg IV.


Eligibility Criteria:
Inclusion Criteria:

Eligible patients are adults who present with an acute moderate or severe headache meeting migraine headache criteria, as defined by the International Classification of Headache Disorders-3β (1.1, migraine without aura). Patients who meet criteria for Probable Migraine without Aura (1.5.1) will also be included, provided they have had at least one similar attack previously.

Exclusion Criteria:

Patients will be excluded if informed consent cannot be obtained, if there is concern for a secondary cause of headache, if the maximum documented temperature is greater than 100.3 degrees, for a new objective neurologic abnormality, skull defect, suspected infection overlying injection site, known bleeding disorder, ongoing use of anti-platelet agents including P2Y12 platelet inhibitors (clopidogrel, prasugrel, ticagrelor), heparins, warfarin, or 10a inhibitors (rivaroxaban, apixaban, edoxaban, fondaparinux), prior treatment with a greater occipital nerve block, allergy to the investigational medications, pheochromocytoma, seizure disorder, Parkinson's disease, use of MAO inhibitors, and use of anti-rejection transplant medications.
Biomarkers in Blood and Tissue Samples From Patients With Epstein-Barr Virus-Positive Hodgkin Lymphoma

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research trial studies biomarkers in blood and tissue samples from patients with Epstein-Barr virus positive Hodgkin lymphoma.

OBJECTIVES:

* Evaluate germline DNA from patients with Epstein-Barr virus positive (EBV+) and Hodgkin lymphoma (HL) for inducible T-cell kinase (ITK) mutations.
* Examine the effects of ITK mutations on expression of the ITK protein.
* Determine whether ITK mutations correlate with specific clinical or histopathological features of HL.

OUTLINE: Archived blood and tumor tissue samples are analyzed for germline DNA expression and inducible T-cell kinase (ITK) mutations by PCR, IHC, flow cytometry, and western blotting, and EBV-encoded RNA (EBER) using in situ hybridization. Each patient's data, such as date, sex, age, tumor stage and histology at diagnosis, treatment received, response to treatment, development of recurrent disease, date of last follow-up, and outcomes are also collected.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of Hodgkin lymphoma (HL) meeting the following criteria:

  * Epstein-Barr virus-positive (EBV+) HL as assessed by positive EBV serology, elevated levels of EBV genome in the blood or tumor tissue following quantitative polymerase chain reaction (PCR) and/or evidence of EBV positivity of pathology samples (EBER+ or LMP+) and, when possible, mixed cellular histology
  * Young age (\< 10 years) at diagnosis
  * Presence of hemophagocytic lymphohistiocytosis (HLH)

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Clinical Study of Chemoradiation Followed by VIPD in Nasal Natural Killer (NK)/T-cell Lymphoma

Nasal NK/T-cell lymphoma is a peculiar clinico-pathologic subtype of non-Hodgkin's lymphoma (NHL). Although most patients present with stage I/II, only 30-60% of the patients remain disease-free. The efficacy of the conventional anthracycline-based chemotherapy (cyclophosphamide, doxorubicin, vincristine, prednisone \[CHOPP\]) has been unsatisfactory.

The optimal treatment of localized NK/T-cell lymphoma has not been defined yet. The optimal dose, sequence, and multi-modality treatment with involved field radiotherapy still need to be refined. This trial is to evaluate the efficacy of concurrent chemoradiotherapy with cisplatin followed by VIPD (etoposide, ifosfamide, cisplatin, dexamethasone) in localized NK/T-cell lymphoma patients.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed NK/T-cell lymphoma
* Localized (Ann Arbor stage I/II) disease
* At least one measurable lesion
* Age \> 18
* ECOG performance status 0 - 2
* Expected life span of at least 12 weeks
* Normal marrow function (hemoglobin ≥ 9.0 g/dL; absolute neutrophil count ≥ 1,500/mm3; platelet count ≥ 100,000/mm3)
* Normal liver function (total bilirubin \< 2x upper limit of normal \[ULN\], transaminase \< 3x ULN)
* Normal renal function (serum creatinine ≤ 1.5 mg/dL, creatinine clearance ≥ 50 mL/min)
* Written informed consent

Exclusion Criteria:

* Other malignancies except for treated non-melanoma skin cancers and cervical cancer in situ
* Serious medical illnesses (congestive heart failure, angina, respiratory failure, and renal failure)
* Acute or active infection requiring intravenous (IV) antibiotics
* Pregnant, lactating women
* Previous history of chemotherapy or radiotherapy
* Concomitant medication that may influence the study drugs
* Allergic reaction to study drugs
* Grade 2 or greater peripheral neuropathy
Effects of Different Revascularization StrateGies in Complex Coronary Artery DiseasE (EDGE)

Coronary heart disease is one of the most serious diseases that endanger people's health. Complex coronary artery disease is critical and has high mortality. Therefore, it is urgent to explore the best treatment method for complex coronary artery disease. Some previous studies have shown that patients with left main coronary artery disease with a SYNTAX score\> 32 points, and diabetic/non-diabetic three-vessel disease patients with coronary heart disease with a SYNTAX score \> 22 points, CABG is recommended for revascularization. However, with the continuous innovation of surgical technology and the rapid development of surgical instruments, the treatment of patients with complex coronary artery disease is increasing. Therefore, it is necessary to investigate the effects of different revascularization strategies on long-term prognosis in patients with complex coronary artery disease (SYNTAX score \> 22 points).


Eligibility Criteria:
Inclusion Criteria:

1. Male/female aged 18-80 years;
2. Having complex coronary artery disease (SYNTAX score \> 22 points) undergoing myocardial revascularization

Exclusion Criteria:

1. Cardiogenic shock or hemodynamic instability;
2. Undergoing other heart surgery at the same time;
3. Previous coronary artery bypass surgery;
4. History of cerebral hemorrhage;
5. Ischemic stroke in the past six months;
6. History of cancer;
7. Life expectancy no more than 12 months
Comparison of Lower Limb Endovascular Interventions With and Without the EndoNaut Workstation

To demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to procedures performed without EndoNaut.

Peripheral artery disease (PAD) is characterized by a narrowing of the size of arteries, which resulting in a loss of hemodynamic load. Endovascular (or percutaneous) procedures performed at the infrainguinal level (axefemoro-popliteal) are very common in affected patients. Therenva offers a complete and consistent lightweight navigation solution (EndoNaut®) based on artificial intelligence (AI) algorithms, and providing technology accessible to all operating rooms for PAD procedures. The aim of this study is to demonstrate that the use of EndoNaut for endovascular procedures on the femoropopliteal axis has a clinical impact for the patient (decrease in irradiation and the volume of contrast product) as well as for nursing staff (reduction in irradiation) compared to the procedures performed by EndoNaut.

Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral arterial disease of the lower limbs, all clinical stages, lesions of the femoro-popliteal stage and candidates for endovascular treatment of these lesions.
* Major patients
* Patients not opposed to their participation in the study

Exclusion Criteria:

- Patients requiring conventional surgical revascularization.
Chemotherapy Plus Reduced Radiotherapy in Intracranial Germinoma

The purpose of this study is to evaluate the outcome of intracranial germinoma treated with chemotherapy plus reduced radiotherapy.

Treatment outcome of intracranial germinoma is excellent with radiotherapy/chemotherapy. However, late sequelae are unavoidable especially with craniospinal irradiation, and various efforts have been done to reduce the dose and extent of radiotherapy. In this study, chemotherapy and further reduced dose of radiotherapy will be used to minimize the late sequelae in the patients with intracranial germinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with pathologically proven intracranial germinoma

Exclusion Criteria:

* Elevated serum/cerebrospinal fluid alpha-feto protein
* Patients with organ dysfunction as follows (creatinine elevation, ejection fraction, liver function test \> CTCAE grade 2)
Effect Analysis of Physical Therapy Based on Electronic Medical Record

WHO has reported the heavy disease burden of psychiatric disorders. Due to the unsatisfactory effect of pharmacotherapy, physical therapy has attracted extensive attention as a complementary therapy. However, few large sample real-world studies are exploring its efficacy. This study intends to explore the efficacy of physical therapy in different types of mental disorders, which is meaningful for the formulation of personalized treatment plans.


Eligibility Criteria:
Inclusion Criteria:

* age is not limited
* gender is not limited
* meets the diagnostic criteria of ICD-10 F20-F48 and its sub-categories
* has relevant HIS system data that can be utilized.
* have been treated with physical therapy

Exclusion Criteria:

* patients who did not meet the appeal diagnosis
* patients who met the above three diagnoses but had severe data loss (missing value ≥ estimated data value of 30%)
Prevention of Very Preterm Delivery by Testing for and Treatment of Bacterial Vaginosis

Background. Anomalies of the vaginal flora (bacterial vaginosis, BV) are associated with an increased risk of late abortions and preterm birth. Studies of antibiotic treatment of BV to reduce the risk of prematurity have not found a statistically significant diminution of risk (\<= 32 wks: OR=0.49 \[0.05-5.1\], \< 37 wks: OR=0.83 \[0.59-1.17\]).A partial explanation of these findings is that some of these treatment were administered vaginally, most often during the second or third trimester

Aim: To reduce the frequency of late abortions and very preterm birth by prescribing clindamycin vs placebo to patients diagnosed with BV before 13 weeks.

Patients diagnosed with BV before 13 weeks will be divided into two groups. They will be defined as at low risk when they have no history of spontaneous preterm delivery or late abortion. Women with such histories will be defined as at high risk.

Low risk patients will be asked to participate in a trial with 3 equal parallel groups, comparing two regimes of clindamycin (one or three 4-day treatments of clindamycin 300 mgx2/d) and placebo.

High-risk patients will be asked to participate in a trial with 2 parallel groups to assess the usefulness of repeating antibiotic treatment monthly by comparing the administration of one 4-day treatment of clindamycin (300 mgx2/d) to three 4-day treatments, one month apart.

Eligibility Criteria:
Inclusion Criteria:

* Nugent score \>= 7
* pregnant women \< 15 weeks (strictly)
* signed informed consent
* \>=18 old
* speaking and understanding French language

Exclusion Criteria:

* metrorrhagias during 7 days before
* birth anticipated in an other area
* clindamycin allergy
Trial of Extended Treatment With Liatermin (r-metHuGDNF) Administered by Continuous Intraputaminal (IPu)Infusion to Subjects With Idiopathic Parkinson's Disease Who Have Completed a Previous Trial of Liatermin

The purpose of this study is to determine long-term efficacy of continuous IPu liatermin infusion administered with concomitant standard anti-Parkinsonian therapy.


Eligibility Criteria:
Inclusion Criteria: - Completion of the 20020168 protocol