cyrilzakka/clinical-trials huggingface dataset:
Intravenous Erythromycin Before Endoscopy in Patients With Variceal Bleeding: A Randomized, Double-Blind Trial

Objectives:

Blood in stomach \& oesophagus in patients with variceal bleeding often obscures the endoscopic view \& makes endoscopic intervention difficult to perform. Erythromycin, a motilin agonist induces gastric emptying. The aim of this study was to assess the effect of Erythromycin on endoscopic visibility and its outcome.

Methods:

Adult patients with liver cirrhosis or stigmata of chronic liver disease presenting with hematemesis and or melena within previous 12 hours were randomized in a double blind trial to receive either 125 mg erythromycin or placebo 30 minutes before endoscopy. The primary end points were endoscopic visibility assessed by objective scoring system \& mean endoscopy duration. Secondary end points were need for repeat endoscopy and blood transfusions within 24 hours of first endoscopy , endoscopy related complications and length of hospital stay.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients with liver cirrhosis or stigmata of chronic liver disease presenting with hematemesis and or melena within previous 12 hours with
* Age \>18 years
* Informed consent
* Hemodynamically stable patient at the time of endoscopy after resuscitation.

Exclusion Criteria:

* Known allergy to erythromycin
* Prior gastric lavage on admission
* Current use of antiarrhythmic drugs
* Prior gastric surgery
* Previous history of cardiac arrhythmias
* Concomitant use of antihistaminic drugs with possible drug interactions with erythromycin
* Prior use of other prokinetic agents
* Pregnancy or lactation
Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.

investigators hypothesize that T2 \* vein abnormalities are frequent and are specific to the migraine aura.

The diagnosis of migraine aura is now based solely on clinical criteria and the assertion of the diagnosis on these clinical criteria alone proves difficult in the acute phase. Added to this difficulty, the symptomatology of a migraine aura can sometimes be similar to that of a stroke, so a diagnosis can be poorly established, resulting in poor patient care. The possibility of making the positive diagnosis of migraine aura on a routine MRI sequence, T2 \*, would be an important advance for the management of these patients

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 55 years
* Admitted to the Neuro-Vascular Intensive Care Unit for Acute Focused Neurological Symptoms and MRI

  * less than 4 hours 30 minutes after onset of symptoms if symptoms persist during admission
  * less than two hours after the disappearance of symptoms if the patient arrives asymptomatic
* Affiliated to a social protection scheme.
* Having given their informed consent

Exclusion Criteria:

* Patients with neurological signs pointing to vertebrobasilar localization (vertigo, diplopia) or with a disorder of consciousness
* Presence of recent explanatory abnormalities on the MRI to make a diagnosis compatible with the initial neurological symptomatology (visible stroke in diffusion, cerebral hemorrhage, tumor, arteriovenous malformations).
* Potential strong cause of stroke known or discovered at the arrival of the patient, in particular stenosis of a cervical or intracranial artery upstream of the cerebral zone may correspond to the symptoms and emboligenic heart disease type atrial fibrillation.
* Pregnant women - Patients with a contraindication for MRI.
* Patients benefiting from a system of legal protection (tutelage,
Prediction of Risk Factors for Adverse Events After Head and Neck Vascular Recanalization Surgery Based on Machine Learning Models

Prediction of risk factors for adverse events after head and neck vascular recanalization surgery based on machine learning models


Eligibility Criteria:
Inclusion Criteria:

* All enrolled patients were diagnosed with clear head and neck artery stenosis and a risk event after head and neck revascularization;
* Location of lesion: origin of internal carotid artery, bifurcation of internal and external carotid arteries;
* Patients with symptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, and with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 50% found on angiography;
* Asymptomatic head and neck artery stenosis and risk events after head and neck revascularization, with a degree of stenosis ≥ 70% on non-invasive examination or stenosis ≥ 60% found on angiography;
* Asymptomatic head and neck artery stenosis and dangerous events after head and neck blood flow reconstruction, with a non-invasive examination of stenosis degree less than 70%, but angiography or other examinations indicate that the stenosis lesion is in an unstable state;
* Symptomatic head and neck artery stenosis and risk events after head and neck revascularization, non-invasive examination of head and neck artery stenosis and risk events after head and neck revascularization are 50% to 69%;
* Sign the project informed consent form

Exclusion Criteria:

* Patients with poor overall condition and intolerance to general anesthesia;
* Patients with mental illness or severe mental illness;
* Severe respiratory system diseases;
* Pregnant and lactating women;
* Participating in another clinical study;
* Patients with advanced tumors or those who are expected to die within one year;
Phase II Trial of Dose-dense Paclitaxel and Cisplatin as Neo-adjuvant Chemotherapy for Operable Stage II and IIA NSCLC

A single arm, open-label phase II is appropriate to evaluate the efficacy and safety of dose - dense combination of paclitaxel with cisplatin supported by pegfilgrastim for neo-adjuvant chemotherapy in this patient population.

This is an open-label, single-arm Phase II study of dose-dense regimen with paclitaxel and cisplatin supported by pegfilgrastim as neo-adjuvant chemotherapy in patients with operable stage II, IIA NSCLC.

Paclitaxel will be administered via intravenous infusion over approximately 3 hours at dose of 175mg/m2 on Day 1 of each 14-day cycle. Cisplatin 75mg/m2 will be given via intravenous infusion on day 1 (after paclitaxel) according to institutional guidelines.

Pegfilgrastim (Neulasta) fixed dose of 6mg (0.6mL of a 10mg/mL solution) as a single subcutaneous injection on Day 2 of each study cycle.

All drugs will be given in 2-weekly cycle. Three cycles of pre-operative chemotherapy are planned.

Eligibility Criteria:
Inclusion Criteria:

* histologic or cytologic diagnosis of NSCLC
* Presence of clinical Stage IIA,IIB or IIA disease
* tumor amenable to curative surgical resection
* Patients with clinically measurable lesions will be enrolled in this study.
* No prior tumor therapy
* Performance status of 0-1 on ECOG Scale
* Patients compliance and geographic proximity that allow adequate follow-up.
* Medical fitness of patient, including respiratory function, adequate for radical NSCLC surgery.

Exclusion Criteria:

* Presence of clinical Stage IIIA disease, according to the revision by Mountain CF of American Joint Committee on Cancer.
* Treatment within the last 30 days with any investigational drug.
* Cocurrent administration of any other tumor therapy, including radiotherapy, cytotoxic chemotherapy, immunotherapy, molecular target therapy.
* Active infection that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
* pregnancy/breast feeding
* Serious concomitant disorders that would compromise the safety of the patient or compromise the patients ability to complete the study, at the discretion of the investigator.
* poorly controlled diabetes mellitus
* Second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* History of significant neurological or mental disorder, including seizures or dementia.
Impact of Surgical Mask, FFP2 Mask and FFP3 Mask (With and Without Exhalation Valve) on Exercise Tolerance and Blood Gas Parameters of Patients With Known Lung Disease and Long-term Oxygen Therapy

The aim of the study is to find out how blood gas parameters change under the use of surgical mask, FFP2 masks and FFP3 masks (with and without exhalation valve) in patients with known lung disease and long-term oxygen therapy.

In particular, the question arises whether patients become hypoxemic or hypercapnic by using a mask. Or whether wearing a mask increases oxygen saturation by its reservoir function.


Eligibility Criteria:
Inclusion Criteria:

* Known lung disease and
* LTOT
* informed consent

Exclusion Criteria:

* Severe disease with contraindication for stress testing (e.g. myocardial infarction, acute pulmonary embolism, acute heart failure)
* Acute exacerbation of lung disease
Cerebrovascular Reactivity in Obstructive Sleep Apnea (OSA) Subjects

Obstructive sleep apnea (OSA) is a prevalent sleep breathing disorder in the general population in which recurrent collapse of the upper airway occurs during sleep. OSA is more prevalent in subjects with stroke and is associated with a 3 fold increased risk of stroke. This makes it a serious public health problem. Approximately 50% of subjects with OSA are asymptomatic and are often only detected following investigation for the cause of heart disease or a stroke. In subjects who are treated for OSA many are intolerant or poorly compliant with treatment. Therefore, the identification of those subjects with OSA most at risk of adverse consequences such as stroke is important, so that treatment compliance can be improved.

Therfore, the investigators want to determine if compared to subjects without OSA, subjects with OSA have evidence of increased stroke risk by assessment of changes in cerebral blood flow (cerebrovascular reactivity) as measured on Doppler ultrasound of the middle cerebral artery (TCD) and blood oxygen level-dependent magnetic resonance imaging of patterns of cerebral blood flow (BOLD MRI) to two stimuli. These stimuli include increased carbon dioxide concentrations (causes increased cerebral blood flow) and reduced oxygen concentrations (causing decreased cerebral blood flow). In order to deliver these stimuli the investigators will use a special machine (RespiractTM) which allows for the precise control of carbon dioxide and oxygen concentrations in the lungs and blood. The precise control of carbon dioxide and oxygen in conjunction with BOLD MRI has enabled the production of detailed maps of the brain that identify areas of healthy and abnormal blood supply.

OSA is associated with increased risk of cardiovascular and cerebrovascular disease compared to the general population. The mechanism for the increased stroke risk in OSA is unknown. However, the constellation of adverse pathophysiological consequences, including intermittent hypoxia and carbon-dioxide retention as a result of OSA may be detrimental to CVR and predispose the brain to ischemia. Previous studies in OSA subjects have measured CVR only using TCD. Therefore, our study will examine CVR by two methods (TCD and BOLD-MRI) with reliable and reproducible hypercapnia and independent control of oxygen saturation (RespiractTM). Patterns seen on CVR may eventually allow the identification of OSA patients who will be at greatest risk for stroke and will therefore, require aggressive risk reduction and/or treatment irrespective of symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Subjects referred for sleep studies

Exclusion Criteria:

* Known cardiac, neurological or major liver or kidney disease -
* Cardioverter/defibrillator metal heart valve or pacemaker
* Vascular stent implanted within 6 weeks
* Severe claustrophobia
* Pregnancy
* Shrapnel or history of ophthalmic foreign body
* Resting oxygen saturation on room air \< 95%
* Insulin-dependent diabetes
* Obstructive or restrictive lung disease such that subject is unable to walk up 2 flights of stairs
* Major depression.
Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)

Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to Eculizumab due to complement C5 polymorphisms.

Coversin, a small protein complement C5 inhibitor which prevents the cleavage of C5 by C5 convertase into C5a and C5b, will be used in an open label, non-comparative clinical trial in patients with PNH and proven resistance to eculizumab due to C5 polymorphisms. Patients will be treated with Coversin by daily subcutaneous injection for 6 months in order to determine the safety and efficacy of the drug in these circumstances. If satisfactory control of the PNH is achieved, and at the discretion of the Principal Investigator (PI), patients will have the option of remaining on Coversin and being entered into the long term follow-up study for 2 years.

Please note, 'Coversin' is used throughout, but Nomacopan is the official name/INN.

Please note, the end points were assessed for 6 months, but the adverse events were measured over the 2 year period.

Eligibility Criteria:
Inclusion Criteria:

* Patients with known Paroxysmal Nocturnal Haemoglobinuria (PNH)
* LDH \>=1.5 Upper Limit of Normal (ULN)
* Resistance to Eculizumab proven by both a recognised C5 polymorphism on genetic screening and complement inhibition on CH50 ELISA of \<100% at concentrations of Eculizumab in excess of 50 μg/mL
* Willing to self-inject Coversin daily or to receive daily subcutaneous injections by a home nurse or in a doctor's office or hospital clinic
* Males or females taking adequate contraceptive precautions if of childbearing potential, 18 - 80 years of age
* Body weight ≥50kg and ≤ 100kg
* The patient has provided written informed consent.
* Willing to avoid prohibited medications for duration of study
* Must agree to take appropriate prophylactic precautions against Neisseria infection.
* Must be counselled regarding the possible reproductive risks of using Coversin and be advised to use an adequate method of contraception pending further data on reproductive toxicology.

Exclusion Criteria:

* Body weight \<50kg or\>100kg
* Pregnancy (females)
* Failure to satisfy the PI of fitness to participate for any other reason
* Known allergy to ticks or severe reaction to arthropod venom (e.g., bee or wasp venom)
A Study To Learn About the Safety Medicine (Called Mylotarg) In People With Acute Myeloid Leukemia

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Mylotarg) for the potential treatment of acute myeloid leukemia (AML). AML is a disease that affects the body's white blood cells. This study is seeking participants in Korea who:

* Are 18 years of age or older
* Are adults and newly diagnosed with AML
* Currently receive Mylotarg for AML treatment in a hospital
* Are capable of a personally signed and dated informed consent document indicating that the participant (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Participant's health will be closely monitored for any unwanted reactions during Mylotarg treatment. Disease progression will also be monitored. This will help determine if Mylotarg is safe to use and its effect on AML treatment.

This is a prospective, single-arm, open-label, non-interventional, multi-centre, PMS to evaluate safety and effectiveness of Mylotarg® in patients with newly-diagnosed CD33-positive AML. As this is a Non-Interventional Study (NIS) all treatment and monitoring of the patients will be at the discretion of the investigator as part of routine practice. The study can be performed in Korean health care centers where Mylotarg® is prescribed to treat AML after obtaining informed consent from the patients as whole case enrollment method.

This study is conducted to determine any problems or questions associated in regard to the following clauses under general clinical practice after marketing Mylotarg®, in accordance with the "Re-examination Guideline of New Drugs, Etc.":

1. Serious Adverse Event (SAE)/Adverse Drug Reaction (ADR)
2. Unexpected Adverse Event (AE)/Adverse Drug Reaction (ADR) that has not been reflected in the approved drug label.
3. Known Adverse Drug Reaction (ADR)
4. Non-Serious Adverse Drug Reaction (Non-SADR)
5. Other safety and effectiveness information

Eligibility Criteria:
Inclusion Criteria:

* Adult Patients newly diagnosed as CD33-positive AML who have been treated\* or are being treated\* or determined to be treated with Mylotarg® by the investigator's medical decision under routine clinical practice (\*patients that have been treated or are being treated with Mylotarg® will be eligible for inclusion during the whole case enrollment period, 2 years after approval date)
* Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Patients to whom Mylotarg® is contraindicated as per the local labeling (Patients with a history of hypersensitivity including anaphylaxis to the active substance in Mylotarg® or to any of its components or to any of the excipient.)
* Any patients (or a legally acceptable representative) who does not agree that Pfizer and companies working with Pfizer use his/her information
A Phase I Study of TAS-102 in Patients With Advanced Solid Tumors With Hepatic Impairment

Study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors and varying degrees of hepatic impairment.

This is a Phase 1, open-label study to evaluate the safety, tolerability, and pharmacokinetics of TAS-102 in patients with advanced solid tumors with varying degrees of hepatic impairment. The study is conducted in 2 parts: the Pharmacokinetic Part (Cycle 1) and the Extension Part (Cycles 2 and beyond). Patients may continue to receive treatment with TAS-102 during the study extension part only after completion of the Pharmacokinetic Part.

Eligibility Criteria:
Inclusion

1. Has provided written informed consent
2. Has advanced solid tumors (excluding breast cancer)
3. Has normal hepatic function, mild, moderate, or severe hepatic impairment
4. ECOG performance status of ≤2
5. Is able to take medications orally
6. Has adequate organ function
7. Women of childbearing potential must have a negative pregnancy test and must agree to adequate birth control if conception is possible. Males must agree to adequate birth control.

Exclusion

1. Certain serious illnesses or medical condition(s)
2. Has had certain other recent treatment e.g. major surgery, anticancer therapy, extended field radiation, received investigational agent, shunt in the liver within the specified time frames prior to study drug administration
3. Has received TAS-102
4. Has unresolved toxicity of greater than or equal to CTCAE Grade 2 attributed to any prior therapies
5. Is a pregnant or lactating female
Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)

Use of PTH (1-84) a recombinant hormone in 25 µg or 50 µg doses for the treatment of adults with hypoparathyroidism. The use of PTH (1-84) should result in a decrease of calcium and vitamin D supplements.

Patients with a history of Hypoparathyroidism will be randomized to receive study drug for 8 weeks, which will be injected daily in either thigh. During that time they will be monitored for safety (specifically calcium levels in blood or urine). In addition, the patients' intake of Vitamin D and Calcium will be measured.

Eligibility Criteria:
Main Inclusion Criteria:

1. Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study
2. With regard to female patients: women who are postmenopausal or willing to use two medically acceptable methods of contraception for the duration of the study with pregnancy testing conducted at every scheduled office visit
3. Total serum calcium ≤ ULN based on local laboratory results prior to randomization
4. Serum 25(OH) vitamin D ≤ 1.5 times the ULN within approximately 8 weeks prior to randomization

Main Exclusion Criteria:

1. Any disease or condition that, in the opinion of the investigator, has a high probability of precluding the patient from completing the study or being able to appropriately comply with study requirements
2. Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of participation in the REPLACE trial
3. Chronic (ie, ≥ 1 month exposure) use of systemic corticosteroids, oral bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride
4. Pregnant or lactating women
5. Any condition that would, in the investigator's opinion in consultation with the sponsor, preclude the safe use of PTH
6. Use of any experimental drug other than NPSP558 within 3 months of baseline.
Comparison of Two Methods of Patellar Resurfacing in Total Knee Arthroplasty

The aim of this prospective, randomized study was to compare the clinical and radiological results of "free-hand" technique and "resection guide" technique for preparing patella during total knee arthroplasty.

With improved surgical techniques and implant designs, patella resurfacing has been favored by increasing surgeons. When performing the resection, several principles such as restoring the original patellar thickness, avoiding over or under resection must be complied in order to achieve satisfactory outcomes.This study was conducted to compared the outcomes of two commonly adopted methods for performing patellar resection in total knee arthroplasty. One hundred patients with osteoarthritis were recruited in the clinical trial using Nexgen Legacy Posterior Stabilized-Flex prosthesis. Patients were randomized to receive "free-hand" technique and "resection guide" technique when performing patellar resection in total knee arthroplasty. Patients were evaluated preoperatively and at follow-up visits conducted at twelve months, at twenty-four months. Clinical outcome was assessed and compared with use of the visual analogue pain scale (VAS), range of motion, Knee Society Score (KSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 (SF-36). Patellar alignment was assessed before surgery and at each follow-up by measuring the patellar tilt (PT) and lateral patellar displacement (PD). Prosthetic position and leg alignment were also compared between the two groups.

Eligibility Criteria:
Inclusion Criteria:

diagnosis of primary osteoarthritis of the knee, with Ahlbäck grade of ≥2 (symptoms persisting after conservative treatment for at least 3 months) knees with \<20° varus or \<15° valgus deformity patellar thickness is more than 21mm

Exclusion Criteria:

restricted motion (flexion contracture of \>25°) patella alta (Insall-Salvati ratio of \<0.6) history of previous knee surgery