cyrilzakka/clinical-trials huggingface dataset:
Idarubicin Based Combined Modality Therapy in Primary CNS Lymphoma

Idarubicin combined with high dose methotrexate and moderate dose radiotherapy will achieve similar survival outcomes but with reduced neurotoxicity compared to regimens using methotrexate with high dose radiotherapy.

Combined modality therapy in PCNSL has improved survival outcomes but at the cost of unacceptable rates of neurotoxicity when high dose radiotherapy is used. Idarubicin has activity in systemic lymphomas and crosses the blood brain barrier and may add to the efficacy of methotrexate. By combining these 2 drugs with moderate dose radiotherapy survival outcomes should be optimal but with lower rates of neurotoxicity.

Comparison: TROG has previously performed a phase 2 study using methotrexate with high dose radiotherapy and this will allow comparison of survival and neurotoxicity rates.

Eligibility Criteria:
Inclusion Criteria:

* Histologically proven primary CNS lymphoma.
* Absence of disease outside the CNS.
* ECOG performance status 0-3
* Negative HIV status.
* Peripheral blood counts with granulocytes \>1.5 x 109L and platelets \> 100 x 109L. Serum creatinine \<150mmol/L. Serum bilirubin \<1.5 times and AST \<2 times upper limit of normal.
* Age \>18 and \<=70 years.
* Patients must give written informed consent.
* Corticosteroids prior to histological diagnosis are allowed.

Exclusion Criteria:

* Previous history of malignancy (other than non-melanomatous skin carcinoma, or carcinoma in situ of cervix completely excised).
* Patients who are pregnant or lactating.
* NYHA (New York State Heart Association classification) cardiac failure grade 3
* Macroscopic spinal thecal or spinal cord disease.
Pharmacodynamic Effects, Safety and Tolerability of Cilobradine, to Healthy Male and Female Volunteers, With an Intra-individual Comparison to Moxifloxacin in a Subset of Volunteers

Incidence of visual phenomena, heart rate at rest, safety (with particular emphasis on QT analysis of ECGs), and pharmacokinetic parameters


Eligibility Criteria:
Inclusion Criteria:

1. Healthy males and females according to the following criteria:

   Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead Electrocardiogram (ECG), clinical laboratory tests

   1.1 No finding deviating from normal and of clinical relevance

   1.2 No evidence of a clinically relevant concomitant disease
2. Age ≥21 and Age ≤55 years
3. BMI ≥18.5 and BMI \< 30 kg/m2 (Body Mass Index)
4. Resting Heart rate (HR) (after 10 min. in the supine position) of equal or more than 60 bpm
5. Females: post-menopausal or those who have had a hysterectomy (plus a negative pregnancy test)
6. Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

1. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, ophthalmological, or hormonal disorders
2. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
3. History of relevant orthostatic hypotension, fainting spells or blackouts
4. Chronic or relevant acute infections
5. History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
6. Intake of drugs with a long half-life (\>24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
7. Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
8. Participation in another trial with an investigational drug within two months prior to administration or during the trial
9. Smoker (more than 10 cigarettes or 3 cigars or 3 pipes/day)
10. Inability to refrain from smoking on trial days
11. Alcohol abuse
12. Drug abuse
13. Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
14. Excessive physical activities (within one week prior to administration or during the trial)
15. Any laboratory value outside the reference range that is of clinical relevance.

    Exclusion criteria specific for this study:
16. Subjects at increased risk for development of cardiac arrhythmia (e.g. family history of long QT syndrome or sudden cardiac death)
8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis

The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding in patients with Child A cirrhosis

For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Eligibility Criteria:
Inclusion Criteria:

Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh A -

Exclusion Criteria:

The presence of gastric varices Non-cirrhotic portal hypertension Portal vein thrombosis The history of hepatic encephalopathy Total bilirubin ≥51.3 umol/L Previous treatment of TIPS or surgery Proven malignancy including hepatocellular carcinoma Contraindications to TIPS、EVL or propranolol End-stage renal disease under renal replacement therapy; Cardiorespiratory failure Pregnancy or patients not giving informed consent for endoscopic procedure

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Expert Learning in Musculoskeletal Ultrasound

Musculoskeletal ultrasound (MSUS) is a complex procedure and requires lifelong theoretical and practical training to ensure continued professional development.

Currently, the teaching approach for experts in MSUS is theoretical preparation first and then hands-on training, the "Tell-Then-Do" approach. The existing literature on optimizing training for experts is sparse, and it is unknown if the training intervention Discovery Learning could be a more effective teaching method for this group of learners.


Eligibility Criteria:
Inclusion Criteria:

* Experts in MSUS, defined as physicians who have performed more than 1000 MSUS examinations

Exclusion Criteria:

* Physicians who have not performed 1000 MSUS examinations.
Hemodynamic and Respiratory Effects of Esophageal Dilation in Children

The aim of this study compares hemodynamic and respiratory changes and complications in children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only control.

Esophageal strictures in children may develop as a secondary to a surgically repaired esophageal atresia (anastomatic strictures) or as a result of chemical injury after caustic ingestion. Emerging strictures are dilated with balloon catheter at regular intervals.

The possibility of various complications depending on the level of the stenosis during the dilation of esophagus. During Esophageal dilation may be pressed into airways and/or vascular structure.

Eligibility Criteria:
Inclusion Criteria:

* endoscopy for esaphageal dilatation and control
* ASA I-III
* 0-16 year old

Exclusion Criteria:

* ASA IV
* endoscopy for removing foreing body
rTMS for Depressive, Positive and Negative Symptoms, and Physiological Indices of Schizophrenia Patients

Around 40% of schizophrenia patients present depressive symptoms, which are associated with elevated suicide and violence risk and poor prognosis and quality of life. Recent meta-analysis showed the effect size of antidepressants for depressive symptoms of schizophrenia patients was as low as 0.25, so new therapeutic approach is warranted.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive, anesthesia-free brain stimulation therapy for treatment refractory depression. Currently, rTMS is classified as high-frequency stimulation (\>5Hz, usually 10Hz or 20Hz) and low-frequency inhibition (usually 1Hz). Intermittent theta burst stimulation (iTBS) is a new variant of rTMS, with stimulation frequency as high as 50Hz. Compared with high-frequency rTMS, iTBS has similar therapeutic effect and shorter stimulation duration. Up to now, studies exploring treatment effect of rTMS or iTBS for schizophrenia patients mainly focused on negative symptoms rather than depressive symptoms. Therefore, this study aims to explore treatment effect of rTMS or iTBS of depressive symptoms, negative symptoms, cognitive function and physiological indices for schizophrenia patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 20 years
* Able to give informed consent
* Diagnosed with schizophrenia or schizoaffective disorder according to DSM-5
* Has a score ≥ 7 on Calgary depression scale for schizophrenia
* The principal psychotropic agents are not changed within one month of the first session of rTMS

Exclusion Criteria:

* DSM-5 defined substance use disorder (excluding tobacco) in the past 3 months
* Have clinically relevant cognitive impairment (e.g., delirium, intellectual disability or MMSE \< 15)
* With electronic and/or magnetic implants (e.g. pacemaker, implantable cardioverter defibrillator \[ICD\], cerebral shunts, cochlear implant, etc.)
* With metallic or mechanic fragments (e.g., screws, plates, stents, clips, etc.)
* Pregnant, or has a pregnancy plan within 3 months
* With any known or history of neurological conditions including cerebral vascular accidents, epilepsy (or epileptiform waves detected by EEG prior to the first session of rTMS), brain tumor or space occupying lesion
* Received rTMS or iTBS treatment within 3 months
* Has a clinically significant abnormality on the screening examination that might affect safety, study participation, or confound interpretation of study results
Swedish Multicenter Trial of Outpatient Prevention of Leg Clots

Lower limb immobilization is associated with high risk of complications, i.e. venous thromboembolism (VTE) and failed healing. Pharmacoprophylaxis of VTE is in leg-immobilized patients, however, low- or non-effective and associated with adverse events. Thus, there is a need for novel treatments.

This study aims to demonstrate in leg immobilized patients who have suffered an ankle fracture (1000 patients) or an Achilles tendon rupture (400 patients) that adjuvant intermittent pneumatic compression (IPC) therapy, which targets impaired vascular flow, compared to treatment-as-usual with plaster cast, reduces VTE incidence and improves healing.

The proposed intervention, intermittent pneumatic compression (IPC) is an evidence-based prevention for VTE in hospitalized patients and used in daily practice. IPC is, however, not currently used on outpatients and it is currently unknown if it reduces the risk of VTE during long term leg-immobilization. Plaster cast and orthosis treatments are currently used in daily practice on Achilles tendon ruptures and ankle fractures. At present there is no consensus about using VTE prophylaxis in leg-immobilized patients. Since pharmacoprophylaxis has shown low- or no VTE preventive effects in leg-immobilization, is not recommended by some guidelines.

Furthermore, since all patients will undergo clinical examinations and have DVT-screening performed with compression Doppler ultrasound (CDU) removal of leg immobilization this will comprise an extra security for the included patients to detect a VTE. If a VTE is detected clinical guidelines will be followed by initiating chemical VTE-treatment.

Eligibility Criteria:
Inclusion Criteria:

* Acute unilateral Achilles tendon rupture or isolated Ankle Fracture
* Treatment starts within 10 days in a hospital setting

Exclusion Criteria:

* Inability or refusal to give informed consent for participation in the study
* Inability to comply with the study instructions
* Known kidney disorder
* Heart failure with pitting oedema
* Presence of known malignancy
* Current bleeding disorder
* Pregnancy
* Planned follow-up at another hospital
* Pilon fracture
Intercostal Cryoanalgesia for Acute Pain After VATS Lung Resection

Intercostal cryoanalgesia is a technique that allows extensive and prolonged analgesia of the hemithorax. The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute thoracic pain after VATS lung resection surgery.

VATS lung resection is associated with a high incidence of moderate to severe acute thoracic pain. In the postoperative period, optimal analgesia may facilitate recovery, lead to higher patient satisfaction, and lower postoperative complications.

Regional analgesia techniques are usually recommended for VATS, and the paravertebral block is often used. However, the duration of the paravertebral block is short (6 to 24 hours), and prolongation of the effect requires the placement of a paravertebral catheter and local anesthetic infusion into the paravertebral space. At our institution, patients with VATS lung resections are often discharged home 24-48 hours after surgery.

Intercostal cryoanalgesia has an onset of about 12 hours, which coincides with the weaning of the single-injection paravertebral block. Analgesia is usually prolonged over several weeks, does not require catheter placement, and is not associated with hemodynamic side effects. These characteristics may allow rapid recovery and safe home discharge after VATS lung resection.

The aim of this study is to demonstrate the efficacy of intercostal cryoanalgesia as an adjunct to a single-injection paravertebral block for the management of acute thoracic pain after VATS lung resection surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for elective anatomical pulmonary resection (anatomical segmentectomy, lobectomy or bilobectomy) by VATS for lung cancer
* American Society of Anesthesiologists (ASA) score 1-3

Exclusion Criteria:

* Contraindication to the paravertebral block (coagulopathy, discontinuous paravertebral space, impossible thoracoscopic visualization of the paravertebral space)
* Contraindication to intercostal cryoanalgesia (cold urticaria, cryoglobulinemia)
* Epidural analgesia preferred (high risk of thoracotomy, marginal lung function)
* Surgical criteria (conversion to thoracotomy, non anatomical wedge resection)
* Known allergy to acetaminophen, celecoxib, sulfa or both hydromorphone and morphine
* Preoperative thoracic or shoulder pain on the operated side
* History of thoracic surgery on the operated site
* Regular use of opioids or medication with effects against neuropathic pain (tricyclics, gabapentinoids, duloxetine, venlafaxine)
* Inability to understand pain scales or to communicate clearly despite adequate teaching
* Contraindication to non-steroidal anti-inflammatory drugs (renal filtration rate \< 60 mL/min, active gastric ulcer)
* Pregnancy
* Patient refusal to participate
A Study of Terlipressin in Patients With Hepatorenal Syndrome Type 1

This is an open-label, multi-center study, investigating the efficacy and safety of terlipressin in Japanese patients with hepatorenal syndrome type 1.


Eligibility Criteria:
Inclusion Criteria:

- Patients who were diagnosed with HRS type 1 according to the diagnostic criteria of HRS and whose serum creatinine value (SCr) doubled at 2.5 mg/dL or greater within 2 weeks or whose 24h creatinine clearance (Ccr) decreased by half at less than 20 mL/min.

Patients should meet all the following 5 criteria:

\[Modified International Ascites Club's Diagnostic criteria of HRS\]

1. Chronic or acute liver disease with advanced hepatic failure and portal hypertension.
2. Low glomerular filtration rate (SCr \>1.5 mg/dL or 24h Ccr \<40 mL/min)
3. Absence of shock, ongoing bacterial infection, current or recent (within 2 weeks) treatment with nephrotoxic drug
4. No sustained improvement in renal function (decrease in SCr to 1.5 mg/dL or less or increase in 24h Ccr to 40 mL/min or more) following diuretic withdrawal and expansion of plasma volume with 1,500 mL/24h of isotonic saline for 24 to 48h.
5. Protein urea \<500 mg/dL, and no ultrasonographic evidence of obstructive uropathy or parenchymal renal disease

   * Age; 20 to 79 years

Exclusion Criteria:

* Cr value ≥5 mg/dL
* Child-Pugh Score ≥14
* Fulminant hepatitis
* Septic shock
* Hepatocellular carcinoma that does not meet the Milan Criteria
* Acute renal failure caused by contrast medium
* Chronic renal failure
* Bradycardia (heart rate \<50/min)
* Hyponatraemia (serum Na \<120 mEq/L)
* Ischemic heart diseases (angina pectoris, myocardial infarction), heart failure or clinically relevant arrhythmia
* Poor-controlled hypertension
* Arteriosclerosis obliterans or peripheral vascular disorder
* Cerebrovascular disorder
* Respiratory diseases such as chronic obstructive pulmonary disease
* Pregnant or possibly pregnant women and patients who or whose partner desire -pregnancy during the study period
* Patients considered by the investigator or sub-investigator as unsuitable to participate in the study
Comparison of Blood Loss in Laparoscopic vs Open Pancreaticoduodenectomy in Patients With Periampullary Carcinoma

the study is designed to compare the blood loss between laparoscopic vs open pancreaticoduodenectomy in a randomized clinical trial

the study will assess the difference in the amount of blood loss in Lap vs Open WPD. the amount of blood loss will be calculated on the basis of a formula which takes pre operative and post operative hematocrit, PCV and blood volume into consideration.

Eligibility Criteria:
Inclusion Criteria:

1. Patients of both the sex aged between \>18 years.
2. Patients with a diagnosis of resectable periampullary carcinoma on imaging.
3. Patients with ASA grade 1 or 2

Exclusion Criteria:

* 1) Patients found to have unresectable disease on radiological investigation. 2) Patients with ASA grade 3 or above
Acute Anterior or Posterior Cerebral Artery Occlusion Recanalization Therapy and Relationships With Clinical Outcome (ACAPULCO)

Nearly 3% of patients with ischaemic stroke (IS) have an isolated occlusion of the anterior or posterior cerebral artery in the acute phase of the disease. In those patients, intravenous thrombolysis (IT) is indicated for 4.5 hours after symptoms onset. Due to a lack of data, mechanical thrombectomy (MT) is not considered as a gold standard to treat IS alone or in addition with IT. Therefore, observational studies are needed to understand the clinical evolution of patients with IS treated with IT and/or MT. The ACAPULCO retrospective observational study aims to highlight potential benefits of MT in those patients to improve their management and to propose targeted therapies in the future.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 and \< 96
* Clinical signs consistent with acute ischemic stroke
* Patients who presented within 6 hours of stroke symptoms onset
* Isolated occlusion of the anterior or the posterior artery

Exclusion Criteria:

* Administration of recanalization treatment before hospital admission
Partial Neuromuscular Blockade for Lung Protective Mechanical Ventilation

Controlled mechanical ventilation may lead to the development of diaphragm muscle atrophy, which is associated with weakness and adverse clinical outcome. Therefore, it seems reasonable to switch to partially supported ventilator modes as soon as possible. However, in patients with high respiratory drive, the application of partially supported modes may result in high lung distending pressures and diaphragm injury.

Recently, the investigators published a study that demonstrated that a low dose of neuromuscular blocking agents (NMBA) facilitates lung-protective ventilation and maintains diaphragm activity in intensive care unit (ICU) patients. That study was conducted in a small (N=10), selected group of patients and partial neuromuscular blockade was applied for only 2 hours (proof-of-concept study). Therefore, further research has to be done before this strategy can be applied in clinical practice.

The primary goal is to investigate the feasibility and safety of prolonged (24 hours) partial neuromuscular blockade in patients with high respiratory drive in partially supported mode. The secondary goals are to evaluate the effect of this strategy diaphragm function, lung injury, hemodynamics and systemic inflammation.


Eligibility Criteria:
Inclusion Criteria:

* high respiratory drive, defined as tidal volume \> 8ml/kg PBW on inspiratory support of 12 cmH2O.
* sedation level: richmond agitation-sedation scale (RASS) ≤ -3
* ventilated in pressure support mode

Exclusion Criteria:

* recent use of NMBA (\< 2 hrs)
* arterial pH \< 7.25
* hemodynamic instability, i.e. high dose vasopressors (\>0.5 μg/kg/min) or inotropes (dobutamine \>15 μg/kg/min or enoximone \>25 μg/kg/min)
* intracranial pressure \> 20 cmH2O
* past medical history of neuromuscular disorders
* known pregnancy
* known previous anaphylactic reaction to NMBA's.
Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy

The TQL block may prove a valuable method for treating postoperative pain following scopic removal of the gall bladder.

The trial will compare active TQL block versus placebo TQL block after said operation.

The hypothesis is that active TQL block significantly will reduce postoperative pain following scopic removal of the gall bladder compared with placebo TQL block.


Eligibility Criteria:
Inclusion Criteria:

* scheduled for elective laparoscopic cholecystectomy
* received oral and written information about the trial
* American Society of Anaethesiologists (ASA) classification 1-3
* NRS score \> 3 upon arrival at the PACU area

Exclusion Criteria:

* Cannot cooperate
* Does not speak or understand Danish
* Allergy towards drugs used in the trial
* Large daily consumption of opioids
* Known alcohol og medicin abuse
* Difficult or impossible by ultrasound to visualise the intended nerve/tissue structures necessary to perform block
* Pregnancy
Aspiration of Limited Number of Follicles to Prevent Severe Ovarian Hyperstimulation Syndrome

The purpose of this study is to evaluate the effect of single ovarian puncture to retrieve 7eggs only in prevention of severe ovarian hyperstimulation syndrome.

Thirty patients will be selected for this study grouped into two groups, each group contains fifteen patients.

Group 1 :study group ( retrieval of 7 eggs only). Group 2 :control group ( retrieval of all eggs). Study is held to compare between the two arms, the proportion of patients who will be prevented from the progression to severe OHSS after this interventional method.

Eligibility Criteria:
Inclusion Criteria:

1. More than 9 days of induction of ovulation.
2. Each ovary contains more than 20 follicles.
3. The majority of follicles are \>14mm in diameter.
4. Mild fluid in Douglas pouch.
5. The patient started to complain of considerable lower abdominal pains before the egg collection.

Exclusion Criteria:

1. Recurrent ICSI failure or bad obstetric history.
2. Any medical disorder affecting the fluid shift as: diabetes mellitus, autoimmune diseases, hepatic, renal or cardiac conditions.