cyrilzakka/clinical-trials huggingface dataset:
Study to Justify Steroid Use in Preterm Neonates to Prevent Bronchopulmonary Dysplasia

Most preterm babies require supplemental oxygen for a variable period of time, up to several weeks or months after birth. The aim of oxygen therapy is to achieve adequate oxygen supply to the tissues without causing oxygen toxicity and oxidative stress. The current routine monitoring relies on oxygen saturation by pulse oximetry without identifying the underlying pathology, as lung parenchyma and pulmonary vascular disease can be contributed in pathophysiology at variable degrees.

Steroids usage for prevention of Bronchopulmonary dysplasia also has been shown to have adverse neurodevelopmental outcome. Available data are conflicting and inconclusive; clinicians must use their own clinical judgment to balance the adverse effects of Bronchopulmonary dysplasia with the potential adverse effects of treatments for each individual patient. Very low birth weight infants who remain on mechanical ventilation after 1 to 2 weeks of age are at very high risk of developing Bronchopulmonary dysplasia.

When considering corticosteroid therapy for such an infant, clinicians might conclude that the risks of a short course of glucocorticoid therapy to prevent Bronchopulmonary dysplasia are warranted.

This is a prospective study. 30 Preterm infants admitted to neonatal intensive care units of Maadi, Ghamra military hospitals, and Ain Shams University hospitals, will be prospectively enrolled within 24 hours after birth. Daily evaluation of oxygen histograms with measurement of the cumulative time of oxygen saturations below 80%, (risk of hypoxemia and potential tissue hypoxia), and arterial oxygen saturations Sao2 above 95% (potential risk of hyperoxia and increased oxidative stress). Evaluation window will be on a weekly basis as long as the infant is on oxygen support and by applying oxygen tolerance test. The treating clinical team will be blinded to all results of Oxygen tolerance test.

Eligibility Criteria:
All preterm neonates admitted to the neonatal intensive care unit will be considered eligible for inclusion. Fully informed written consent from parents of all eligible infants will be sought prior to enrollment. Infants with major congenital abnormalities, cardiac lesions other than Patent ductus arteriosus, and lung hypoplasia will be excluded from this study.

Inclusion criteria:

* \< 36 week gestation pre-terms, not having major congenital anomalies

Exclusion criteria:

* Congenital heart disease
* Major congenital abnormalities
Assess Efficacy and Safety of the Dopamine Agonist Pramipexole Versus Levodopa / Benserazide (Madopar® DR) in Patients With Restless Legs Syndrome

The primary objective of this study is to determine that pramipexole (Sifrol) 0.25 mg to 0.75 mg daily is not inferior to levodopa 100 mg to 300 mg (in combination with benserazide 25mg to 75mg = Madopar DR) daily in the treatment of patients with idiopathic restless legs syndrome fulfilling the International Diagnostic Criteria. The efficacy parameters include an objective measure of the leg movements during the time spent in bed, and a quantitative clinical assessment of the severity of RLS, in the form of the RLS-score. In addition, the efficacy evaluations aim at comparing the impact of pramipexole and levodopa on outcome measures such as quality of life and sleep.


Eligibility Criteria:
Inclusion criteria:

* Patients diagnosed with idiopathic restless legs syndrome fulfilling the International Diagnostic Criteria 1 .
* Male or female patients, aged 25 to 85 years.
* Patients presenting RLS symptoms almost every day, as judged by the investigator and with more than 5 PLM/h during bedtime in each of three screening actigraphy nights.
* Patients must have given written informed consent in accordance with ICH-GCP and local legislation prior to participation in the study.

Exclusion criteria:

* Patients with significant diseases other than restless legs syndrome will be excluded. A significant disease is defined as a disease that, which in the opinion of the investigator may put the patient at a risk because of the participation in the study, that may influence the result of the study or the patient's ability to participate or that is expected to relevantly reduce life expectancy.
* Patients with known hypersensitivity or contraindications to pramipexole, levodopa or benserazide or any other substances present in the study medications.
* Patients with iron-deficiency
* Patients with disabilities or other incapacities that preclude regular attendance at clinic for the study visits, and patients on a shift-work-schedule or who are otherwise unable to follow a regular sleep-wake cycle.
* Patients who have been previously treated with pramipexole or levodopa.
* Pregnant or nursing women or women of childbearing age who are at risk of pregnancy and are not willing to use adequate contraceptive methods (hormonal contraception or intrauterine devices) during the study period.
Hemodynamic Monitoring to Prevent Adverse Events foLlowing cardiOgenic Shock Trial

Pilot Prospective Randomized Unblinded Pragmatic Trial of Pulmonary Artery Hemodynamic Monitoring Following Hospitalization for Cardiogenic Shock


Eligibility Criteria:
Inclusion Criteria:

1. Subject or legal representative has signed Informed Consent Form (ICF) and the patient has the capacity to participate in the study and complete the study questionnaires, in the estimation of the study investigator.
2. Age ≥ 18 years
3. NYHA Class III with dyspnea upon mild physical activity, regardless of left ventricular ejection fraction (LVEF).
4. Survive to discharge during a current hospital admission with cardiogenic shock (CS) as defined by clinical criteria previously used in cardiogenic shock trials: systolic blood pressure \< 90 mmHg for \> 30 minutes or requiring infusion of catecholamines to maintain the systolic blood pressure above 90 mmHg, with evidence of end-organ dysfunction such as pulmonary edema or impaired end-organ perfusion including altered mentation, oliguria with urine output \< 30 mL/h, or serum lactate \> 2 mmol/L (5). Hemodynamic criteria include cardiac index ≤ 1.8 L/min/m2 without vasoactive pharmacologic agents, or cardiac index ≤ 2.2 L/min/m2 and pulmonary artery occlusion pressure ≥ 15 mmHg with vasoactive agents.
5. Patients must have internet and phone access (to allow communication of the implanted device with the researchers).

Exclusion Criteria:

1. Technical obstacles which pose an inordinately high procedural risk, in the judgment of the investigator.
2. Treatment with ongoing mechanical circulatory support (MCS) such as a durable left ventricular assist device (LVAD) or recipient of a heart transplantation for the treatment of cardiogenic shock during the index hospitalization for CS.
3. If of childbearing potential with a positive pregnancy test.
4. Transition to hospice care.
5. Intolerance to or inability to adhere to antiplatelet therapy for 1 year after device implantation.
6. Presence of an active, uncontrolled infection.
7. Any condition other than heart failure that could limit survival to less than 6 months
8. Discharge to facility other than acute rehabilitation or to the ambulatory setting.
9. No access to internet or phone.
Efficacy and Safety of Rasagiline in Prodromal Parkinson's Disease

To investigate whether a year of rasagiline may reduce the progression from idiopathic REM sleep behavior disorder (RBD) to Parkinson's disease (PD).


Eligibility Criteria:
Inclusion Criteria:

* PSG confirmed RBD with subtle motor symptoms (4≤MDS-UPDRS-III≤10 at baseline)
* no clinical diagnosis of Parkinson's disease or dementia at baseline
* age 30-75
* no concomitant or previous use of any other anti-parkinson medications
* provide written informed consent

Exclusion Criteria:

* diagnosed with secondary parkinsonism (eg., drug-induced, vascular, psychogenic)
* secondary RBD (eg., drug-induced, immune-mediated)
* nervous system comorbidities (eg., stroke, epilepsy, encephalitis)
* severe psychiatric comorbidities
* allergic to rasagiline
* severe systemic diseases (eg., end-stage kidney disease, liver failure)
Effect of Lifestyle Intervention on Mobilization of Fat Storage and Iron Deposition in Obesity

The goal of this clinical trial is to learn if calorie-restricted balanced diet could uniquely influence various fat storage pools and iron deposition and explore the relationships between fat or iron deposition loss in specific locations and glucose metabolism. The main questions it aims to answer are:

After lifestyle intervention, which part of the body shows the fastest fat mobilization? Which part shows the slowest fat mobilization? Which area's fat mobilization is most related to the alleviation of glucose metabolism? Is there a relationship between the fat deposition in organs and the iron deposition in organs?

Researchers will compare the liver fat, pancreatic fat, visceral fat, subscutaneous fat, liver and pancrease iron depositon after lifestyle intervention using self pre-and post-control .

Participants will:

Receive the lifestyle intervention in outpatient. Visit the clinic once after 6 months for checkups and tests. Keep a diary of their diet.

Fat mobilization status is assessed using magnetic resonance, while the relief of glucose metabolism is determined based on the results of the OGTT before and after life style intervention.

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* have a BMI greater than 28.0 kg/m2
* exhibit abdominal obesity, defined as a waist circumference of at least 90 cm for men and 85 cm for women
* willing to undergo a 6-month lifestyle intervention

Exclusion Criteria:

* a prior history of pancreatic diseases;
* combination of drug-induced hepatitis, autoimmune hepatitis, and viral hepatitis;
* with a definitive diagnosis of diabetes who have already started medication treatment;
* severe complications from type 2 diabetes or other significant diseases;
* usage of drugs affecting body weight, insulin sensitivity, or metabolic-associated fatty liver disease in the past three months (such as insulin, glucocorticoids, thiazolidinediones, metformin, SGLT-2 inhibitors, or GLP-1 receptor agonists);
* with malignant tumors;
* acute or chronic infection;
* hemochromatosis;
* alcohol dependence, defined as ethanol intake exceeding 140 g/week for men and 70 g/week for women.
Surgical Trial to Evaluate the Impact of a Lymphoscintigraphy Prior to Sentinel Node Biopsy in Early Breast Cancer

Sentinel node biopsy is a well established tool for axillary staging in early breast cancer. So far the impact of a preoperative lymph node scintigraphy is unclear. This study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective randomized multicenter study design.

Sentinel node biopsy is a well established tool for axillary staging in early breast cancer. So far the impact of a preoperative lymph node scintigraphy is unclear. Several studies indicate sentinel node biopsy to be a reliable method irrespective of prior lymph node scintigraphy, but data from prospective randomized trials are not available.

Although a preoperative lymph node scintigraphy is not explicitly demanded in current S3 guidelines in Germany its performance is a common practice.

If a preoperative lymphoscintigraphy could be safely omitted, possible benefits are a facilitation of the preoperative workflow as well as cost reduction for health care systems.

This study aims to clarify whether a preoperative lymphoscintigraphy is of additional benefit in a prospective randomized study design. In the two study arms sentinel node biopsy is performed either with or without knowledge of the preoperative lymphoscintigraphy findings. Primary end point is the average number of histologically detected sentinel lymph nodes per patient in both treatment arms.

Eligibility Criteria:
Inclusion Criteria:

* invasive mamma carcinoma as verified by core cut biopsy
* extensive ductal carcinoma in situ as verified by core cut biopsy (at least 5 cm or at least 2,5 cm and G3 grading)
* clinical stage tumor T1-T3
* no signs of axillary lymph node metastasis on clinical examination including ultrasound examination
* no signs of distant metastatic disease
* male/ female patient in the age not less than 18 years
* Karnofsky performance status at least 70% or Eastern Cooperative Oncology Group (ECOG) score not higher than 1
* written patient informed consent

Exclusion Criteria:

* suspect axillary lymph nodes on clinical/ultrasound examination
* positive fine-needle biopsy of axillary lymph nodes
* sentinel lymph node biopsy to be performed after neoadjuvant chemotherapy
* recurrence of a mamma carcinoma
* prior extensive surgery of breast or axilla
* inflammatory or extramammary breast cancer
* pregnancy
* contraindication to the radionuclide
* inability to understand the studies purpose
* inability to receive surgery
* no written patient informed consent
The No-Tie Technique Using the Harmonic Scalpel in Total Thyroidectomy With Central Neck Dissection: A Prospective Randomized Study

To investigate the safety and efficacy of the no-tie technique using the harmonic scalpel (HS) in terms of the operating time and complications in total thyroidectomy with central neck dissection (CND). Recently, the HS has been used as an alternative to conventional hand-tied ligation for hemostasis in thyroid surgery, which is a time-consuming procedure. Very limited data have been published on evidence of its safety in total thyroidectomy accompanied by CND without supplementary hand-tied ligation.


Eligibility Criteria:
Inclusion Criteria:

* patients with total thyroidectomy plus central neck dissection
* if primary tumor size was more than 1 cm in papillary thyroid cancer
* there was any evidence of lymph node enlargement in paratracheal lymph node group preoperatively or intraoperatively
* patients who underwent minimal resection of the surrounding soft tissues, including the sternothyroid or sternohyoid muscle, for extracapsular extension of thyroid cancer

Exclusion Criteria:

* patients who required lateral compartment neck dissection or mediastinal dissection for preexisting lymph node metastasis
* patients had clinical or laboratory indicators of coagulation disorders
* patients with preexisiting vocal cord palsy, fixation of the tumor to the recurrent laryngeal nerve requiring trnasection of the nerve
* patients with massive extracapsular extension to the surrounding soft tissues.
Pemetrexed as the First Treatment in Advanced or Metastatic Breast Cancer

The purposes of this study are to determine whether pemetrexed can help patients with metastatic (cancer that has spread to other parts of the body) breast cancer, to determine any side effects that may be associated with the drug, to determine how much pemetrexed should be given to patients, and to collect DNA for future research regarding metastatic breast cancer. The collection of DNA is optional to the patient.


Eligibility Criteria:
Inclusion Criteria:

* Must have been diagnosed with either advanced or metastatic breast cancer.
* Chemotherapy has not been given for advanced or metastatic breast cancer.
* The diagnosis of advanced or metastatic breast cancer was made at least 12 months after chemotherapy was given after breast surgery.
* Able to carry out work of a light nature (for example, light housework, office work).
* Must be at least 18 years old.

Exclusion Criteria:

* Have received prior bone marrow or peripheral stem cell transplantation.
* Have received prior chemotherapy for metastatic breast cancer.
* Are currently pregnant or breast-feeding.
* Have an active infection that your doctor decides will affect your safety.
* Are unable to take folic acid or vitamin B12.
Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)

Primary objectives :

* To investigate the safety and the tolerability of ATO by IV infusions to patients with SLE,
* To determine the maximum tolerated dose of ATO.

Secondary objectives :

* Evaluation of the clinical and biological response of the SLE to ATO,
* Time of relapse in case of positive response,
* Determination of the efficacy,
* Pharmacokinetic study of ATO.


Eligibility Criteria:
Inclusion Criteria:

* Systemic Lupus meeting the ACR (American College of Rheumatology) criteria, progressive either SLEDAI activity score ≥ 4, despite a corticosteroid therapy ≥ 10 mg / d associated with hydroxychloroquine (in the absence of contraindication or intolerance) and / or an immunosuppressive treatment at a stable dose,
* Insured,
* Availability for hospitalization required by the protocol (conventional and daily hospitalizations).

Exclusion Criteria:

* Inability to give their signed informed consent form,
* Performans status \> 2
* QTcorrected space before treatment \> 0.45 seconds
* Hemoglobin less than 11g/dL
* Neutrophils rate below 1 200 / mm3
* Platelets rate below 100 Giga / mm3
* Previous history of arrhythmia or heart rhythm disorder or other rhythm trouble by referring cardiologist
* Heart disorder (progressive pericarditis, valvular disease, ...) according to cardiologist
* Family previous history of arrhythmias
* Taking drugs that potentially prolong the QT
* Hypersensitivity to the active substance of Trisenox® or any of the excipients
* Serum potassium ≤ 4 milliequivalent / L
* Magnesemia ≤ 1,8 mg / dl
* Increase corticosteroids beyond 20 mg / day within 15 days before inclusion
* Immunosuppressive treatments, thalidomide introduced within the last 3 months
* Biotherapy (rituximab, belimumab, ...) introduced within 6 months prior to inclusion
* Pregnancy or lactation
* For women of childbearing age, men and their partner : unless effective contraception for the duration of participation in the study that is 7 months
* Creatinine clearance \<50 ml / min,
* Hepatocellular insufficiency (TP \<50%), and / or AST (aspartate aminotransferase) / ALT (alanine aminotransferase) / ALP (alkaline phosphatase) \> 2N
* HBsAg positive, DNA detectable HbS
* Infection with HIV, HBV (hepatitis B virus) or HCV (hepatitis C virus)
* Renal or progressive central neurological impairment with possible alternative therapeutic (to be discussed with the principal investigator and scientific board meeting)
* Peripheral neuropathy
* Unweaned alcoholism
* Minor
* Patients older than 65 years
* Patient having been professionally exposed to arsenic (cleaning electronic circuits for example)
* Guardianship patients
Feasibility of Real-time Ultrasound-guided Spinal Anesthesia Using Dynamic Needle Tip Positioning

Confirming the L4-L5 or L3-L4 vertebrae level with ultrasound in real time for adults who scheduled elective surgery under spinal anesthesia, and introduce the spinal needle into the subarachnoid space. The ultrasound probe continues to track needle tips in real time by sliding/tilting with short axis view. Check that the spinal needle reaches subarachnoid space, and that CSF is released through the needle hub, and administer the drug.

In this process, it is recorded by observing the success of the procedure, the time taken for each step, the number of needle position changes, NRS pain score of the subject, satisfaction with anesthesia, and its side effects.


Eligibility Criteria:
Inclusion Criteria:

* Patients who scheduled for elective surgery under spinal anesthesia
* Age \>= 20

Exclusion Criteria:

* Patient refusal
* Coagulopathy (INR ≥1.2, anticoagulant therapy)
* Sepsis or local infection at the site of injection
* BMI \> 35
* Spine deformity
Application of Electrical Impedance Myography (EIM) as a Potential Biomarker of Idiopathic Inflammatory Myopathies

1. To assess changes in impedance parameters in Idiopathic Inflammatory Myopathies (IIMs).
2. To assess whether EIM parameters are reflective of disease severity, based on clinical outcome measures of IIMs.

1. To assess changes in impedance parameters in Idiopathic Inflammatory Myopathies (IIMs) There are structural and compositional changes in muscles, such as edema, adipose infiltration, and/or atrophy, in IIMs. Electrical impedance myography (EIM) is sensitive to such changes. EIM parameters will be different when compared to healthy controls in IIMs.
2. To assess whether EIM parameters are reflective of disease severity, based on clinical outcome measures of IIMs.

Clinical outcome measures reflect on disease severity which is an indirect measure of muscle involvement in IIMs. If EIM parameters correlate with clinical outcome measure, it would indirectly prove that EIM can reflect disease severity in IIMs

Eligibility Criteria:
Inclusion Criteria:

* duration of weakness \>12 months.
* ages 18 to 80 years old.
* serum CK level no greater than 15 times the upper limit of normal.
* quadriceps weakness \>hip flexor weakness and/or finger flexor weakness \>shoulder abduction weakness.
* one or more of the following pathological findings:
* endomysial inflammatory infiltrate.
* rimmed vacuoles.
* protein accumulation or 15-18 mm filaments.

DM/PM inclusion criteria:

* ages 18 to 80
* Symmetric proximal weakness
* Elevated CK
* EMG suggestive of myopathy with evidence of muscle membrane irritation
* Muscle biopsy suggestive of inflammatory myositis (degeneration, regeneration, necrosis, and interstitial mononuclear infiltrates)
* Typical skin rashes of DM (Heliotrope rash or Gottron sign)

Key inclusion criteria for the control group:

* no active neuromuscular disorders or known history of neuromuscular disorders.
* no sign or symptoms of muscle weakness.
* no family history of muscular dystrophies or ALS.
* ages 18 to 80

Exclusion Criteria:

* Patients with decompensated congestive heart failure
* Patients with chronic kidney disease on hemodialysis
* Patients with active cancer on chemotherapy or radiotherapy
* Patients with severe disease who are already wheel chair bound
PET/MR in the Staging and Efficacy Evaluation of Newly Diagnosed NK/T-cell Lymphoma

This study intends to evaluate the application value of Positron Emission Tomography/Magnetic Resonance (PET/MR) in the staging and efficacy evaluation of NK/T cell lymphoma, aiming to explore a more accurate system for predicting the prognosis of patients and guiding the treatment.

Nature Killer/T-cell Lymphoma (NKTCL) is a highly heterogeneous, aggressive lymphoma subtype with poor prognosis. Ninty percent of patients have lesions involving the nasal region, other extranodal organs include adrenal glands, gastrointestinal tract, skin and so on. Local tumor infiltration (bone, skin, paranasal sinus, etc) is a poor prognostic factor. Therefore, NK/T-cell lymphomas have high demands on the resolution of fine anatomical structures. PET/CT and nasopharyngeal contrast-enhanced MR are routine examination methods for diagnostic staging and efficacy evaluation, but the images cannot be fused, and the divided examinations bring inconvenience to patients.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed NK/T-cell lymphoma based on the WHO classification 2016
* Age from 14 to 70 years-old
* ECOG 0-2 score
* Patients with a life expectancy of at least 6 months
* Patient has not been treated before for NK/T cell lymphoma
* Commit to abide by the research procedures and cooperate with the implementation of the whole process of research
* Written informed consent

Exclusion Criteria:

- Subjects who meet any of the following criteria are not eligible for study entry

* Diagnosed aggressive NK cell leukemia
* Pregnant or lactating women
* Liver and kidney insufficiency
* Other PET/MR contraindications:

  1. Those with implanted functional electronic devices such as cardiac pacemakers
  2. Carotid aneurysm clipping and other implants are ferromagnetic materials
  3. Implanted perfusion devices such as insulin perfusion pumps
  4. Those who do not cooperate in examinations such as coma, mental illness, and critically ill patients
  5. Those who are claustrophobic
* Other concurrent and uncontrolled medical conditions that the investigator believes will affect the patient's participation in the study