cyrilzakka/clinical-trials huggingface dataset:
Subretinal Macugen® for Neovascular Age-Related Macular Degeneration

The purpose of this study is to assess the efficacy of pegaptanib (Macugen®) for neovascular (exudative) age-related macular degeneration (AMD) when the first dose is administered to the submacular space instead of vitreous body in cases when previous state-of-the-art treatment for the AMD was deemed ineffective.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 50 years and older with neovascular AMD proven by FA
* Patients who at baseline
* Have a BCVA letter score in the study eye between 20/40 to 20/320 using an ETDRS chart measured at 4 meters or Snellen equivalent
* Have a CNV lesion of any type in the study eye with the following characteristics as determined by fluorescein angiography:
* Evidence that CNV extends under the geometric center of the foveal avascular zone.
* Previous state-of-the-art therapy for the disease is deemed ineffective with following characteristics are given:
* Loss of visual acuity (2 or more Snellen lines) in the previous 3 months defined as either OR
* ≥10% increase in the lesion diameter as assessed by fluorescein angiography in the previous 3 months
* Ability of subject to understand character and individual consequences of clinical trial.
* Signed and dated informed consent of the subject must be available before start of any specific trial procedures.
* Women with childbearing potential practicing a medically accepted contraception (negative pregnancy test result, serum or urine at trial entry).

Exclusion Criteria:

* Subjects presenting with any of the following criteria will not be included in the trial:

  * Have a relevant ocular disease which may be associated with increased intraocular VEGF levels (namely uveitis, neovascular glaucoma, diabetic retinopathy, diabetic maculopathy, ocular ischemic syndrome, retinal vessel occlusion)
  * Had previous vitrectomy surgery for whatsoever reason
  * Are not pseudophakic
  * Have a \>50% area of scarring of the whole CNV lesion size as seen in FA
  * Arterial hypertension refractory to medical treatment
  * Pregnancy and lactation.
  * History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product.
  * Participation in other clinical trials during the present clinical trial or within the last 3 months.
  * Medical or psychological condition that would not permit completion of the trial or signing of informed consent.
  * Suspected or present ocular or periocular infection
Comparison of SE-TAP, M-TAPA, and Rectus Sheath Block in Abdominal Surgeries

The aim of this randomised controlled study is to compare the effects of three different fascial plane block \[subcostal exterior semilunaris transverses abdominis plane (SE-TAP) block, modified thoracoabdominal nerves block through perichondrial approach (M-TAPA), and rectus sheath block (RSB)\] on postoperative pain levels and opioid consumption in patients undergoing major abdominal surgeries with midline incision.

In last decade,ultrasound guided truncal fascial plane blocks such as transverses abdominis plane (TAP) block and rectus sheath block (RSB) have become popular as a part of postoperative multimodal analgesia for abdominal surgeries as the techniques are simple and the target sites are easily identify. Furthermore, the number of newly defined block techniques is daily increasing like M-TAPA and SE-TAP block.

The rectus sheath block (RSB) is an old technique that suite midline incisions and provides analgesia for somatic pain. The local anesthetic is injected into the space between the posterior wall of the rectus abdominis muscle and its sheath, to block the anterior branches of the thoracoabdominal nerves. It has been suggested that both anterior and lateral branches of the T5-T12 thoracoabdominal nerves are blockade in M-TAPA and SE-TAP blocks. So, they may provide better analgesia and quality of recovery for major abdominal surgeries due to presence of drains. However, the extent of the local anaesthetic diffusion and the dermatomal levels are not clear, and there is no randomised clinical trial about these new techniques, to our knowledge.

Patients and Methods: This is a prospective, randomised, double-blind clinical study; carry out on 120 patients schedule for elective major abdominal surgery with midline incision. While the fascia is closed, 1 g paracetamol and 1 mg/kg tramadol will be administered routinely to all patients for postoperative multimodal analgesia. At the end of surgery, patients will be randomly allocated into three groups (40 patients each); bilateral SE-TAP block in Group S, bilateral RSB in Group R, and bilateral M-TAPA block in Group M will be performed under ultrasound guidance. Patient controlled analgesia with intravenous morphine will be started at the recovery room. Postoperative pain levels, opioid consumption, and quality of recovery will be questioned and recorded at the first postoperative day.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiology physical classification I-III
* Scheduled for elective laparotomy with a midline incision

Exclusion Criteria:

* Not agree to participate in the study
* Have mental status disorders
* Inability to communicate
* Known bleeding and/or coagulation disorders
* Infection at injection site
* Chronic opioid intake
Burden and Medical Care of Sarcoma in Germany

The main objective of the study is to assess the treatment situation of sarcoma patients in Germany and to investigate their potential influence on Quality of Life (and other Patient Reported Outcomes) of the affected persons. Impaired quality of life domains and factors associated with it are to be identified.

To this end, a national network of sarcoma treatment specialists and a structure for patient recruitment will be established. This care network is intended to reflect the current situation of the treatment of sarcoma patients in Germany.


Eligibility Criteria:
Inclusion Criteria:

* patients with sarcoma diagnosis according to International Classification of Diseases for Oncology (ICD-O) and World Health Organisation (WHO) classification

Exclusion Criteria:

* not mentally able to fill out questionaires
* not able to till out questionaires in German
Efficacy of Cannabinoids in Amyotrophic Lateral Sclerosis or Motor Neurone Disease

This is a randomised, double-blind, placebo controlled study on a cannabis-based medicine extract (MediCabilis CBD Oil), in patients with Amyotrophic Lateral Sclerosis or Motor Neurone Disease. Participants will be randomised in a 1:1 ratio to receive MediCabilis CBD Oil or placebo oil. The treatment duration is 6 months with one-month safety follow up. Participants will be checked every month either face to face or via telephone and will be assessed to collect data for study objectives such as ALSFRS-R, Forced Vital Capacity, pain and spasticity score, and quality of life. Thirty (30) participants will be randomised.


Eligibility Criteria:
Inclusion Criteria:

1. Affected by ALS/MND, either of definite or probable according to the El Escorial revised criteria
2. Can provide written informed consent
3. Able and willing to comply with all study requirement
4. Male or female, ages 25-80 years old
5. Onset of first symptom within the last 2 years
6. Forced Vital Capacity (FVC) of at least 60% on baseline

Exclusion Criteria:

1. Participants who are bedridden
2. Have used or taken cannabis or cannabinoid-based medications within 30 days of study entry
3. History of any psychiatric disorder other than depression associated with their underlying condition including immediate family history of schizophrenia
4. Heavy consumption of alcohol or use of illicit drug
5. Hypersensitivity to cannabinoids or any of the excipients
6. Any of the following: eGFR \<30 mL/min/1.73m2, ejection fraction \<35%, or ASL and ALT \>5 X ULN
7. Unwillingness of a female participant of child bearing potential, or their partner, to use effective contraception during the study and 30 days thereafter
8. Pregnant, lactating mother or female participant planning pregnancy during the course of the study and for 30 days thereafter
9. Received any investigational drug or medical device within 30 days prior randomisation
10. Any other significant disease or disorder which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study
11. Inability to cooperate with the study procedures
12. Unwilling to stop driving vehicle or operating dangerous machinery whilst on study drug.
13. Close affiliation with the study team, e.g. close relative of the investigator
The Nutrition Care in Canadian Hospitals Study; 2010-2013.

The Nutrition Care In Canadian Hospitals study, conducted by the Canadian Malnutrition Task Force had the primary purpose of determining the prevalence of malnutrition in Canadian acute care hospitals. Secondary objectives were to determine the independent association of malnutrition with patient centred outcomes (e.g. length of stay) and describe the nutrition care processes for malnourished and well nourished patients.

Data from 18 community and academic hospitals was collected from a convenience sample of 1022 medical or surgical patients. This prospective cohort study followed patients throughout their admission to 30-day post discharge. Measures included nutrition indicators, nutrition care processes and health outcomes.

Eligibility Criteria:
Inclusion Criteria:

* acute care admission, medical or surgical unit; English or French language;anticipated to stay in hospital for 2 or more days; consent to study entry;

Exclusion Criteria: other hospital units; palliative patients; unable to complete informed consent due to language barrier or no proxy available; dementia

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MSC-EVs in Acute/ Acute-on-Chronic Liver Failure After Liver Transplantation

Acute liver failure (ALF) refers to a potentially reversible disorder that was the result of severe liver injury, with an onset of encephalopathy within 8 weeks of symptom appearance and in the absence of pre-existing liver disease. Acute-on-chronic liver failure refers to a liver failure syndrome in which some patients with chronic liver disease with relatively stable liver function suffer from acute liver decompensation and liver failure due to the effects of various acute injury factors. Liver transplantation is the only curative treatment for this type of end-stage liver disease. The potential of MSCs to repair or regenerate damaged tissue and suppress immune responses makes them promising in the treatment of liver diseases, especially in the field of liver transplantation. Many studies have shown that MSC-based therapies can reduce the symptoms of liver disease due to their paracrine effects. Therefore, compared to the cells they derive from, mesenchymal stem cells-derived extracellular vesicles (MSC-EV) are gradually gaining attention for their enhanced safety, as they do not replicate or cause microvascular embolism, and can be easily stored without losing their properties. It represents a novel and effective cell-free therapeutic agent as alternative to cell-based therapies for liver diseases, and liver failure was also concerned. This study was designed to evaluate the safety and tolerability of MSC-EV in acute-on-chronic liver failure after liver transplantation.

In the MSC-EV group (experimental group), 15 patients will receive a single injection of MSC-EV after their first liver transplantation. In the non-MSC-EV group (control group), 15 patients will not receive MSC-EV therapy after their first liver transplantation.

The outcome of the experimental group will be compared with that of similar control patients undergoing liver transplantation but who will not receive MSC-EV. Both of the two groups will receive standard immunosuppressive therapy( a regimen based on tacrolimus (TAC), mycophenolate mofetyl (MMF) and steroids). Patients participated in the experimental cohort will be infused with a single dose of 10 E10 MSC-EV particles per 100ml, at an appropriate time during the first 1-5 days after transplantation.

Eligibility Criteria:
Inclusion Criteria:

* aged 18-70 years;
* Acute on chronic liver failure-which is characterized by acute hepatic insult manifesting as jaundice (serum total bilirubin \[TBil\] ≥ 10×ULN umol/L) and coagulopathy (international normalized ratio \[INR\] ≥ 1.5 or prothrombin activity \< 40%), complicated within 4 weeks by ascites and/or encephalopathy as determined by physical examination, in patients with previously diagnosed or undiagnosed chronic liver disease; Requiring liver transplantation due to acute on chronic liver failure;
* Obtain the patients' consent after informing patients of the purpose and method of the clinical trial;

Exclusion Criteria:

* Past history of malignant disease
* Active uncontrolled infection;
* Combined transplantation
* EBV-negative;
* HIV or HCV positive;
* Retransplantation;
Expanded Access to Entrectinib for Cancers With NTRK1/2/3, ROS1, or ALK Gene Fusions

Expanded access to entrectinib will be given to patients with cancers harboring NTRK1/2/3, ROS1, or ALK gene fusions who do not qualify for participation in, or who are otherwise unable to access, an ongoing clinical trial for entrectinib.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of advanced cancer with an NTRK1, NTRK2, NTRK3, ROS1, or ALK gene fusion
* Unable to participate in an ongoing entrectinib (RXDX-101) clinical trial
* Willing and able to provide written, signed informed consent
* Medically suitable for treatment with entrectinib (RXDX-101)

Exclusion Criteria:

* Currently enrolled in an ongoing clinical study with any other investigational agent
Pharmacokinetic Study in Cerebral Spinal Fluid After a Single Dose of AVI-4020

During a clinical study of people with severe West Nile virus infections, it was determined that the drug AVI-4020 crossed the blood-brain barrier. This study will assess the amount of drug that goes across the blood-brain barrier and the drug levels measured in both the blood and urine.

The objective of this study is to find out how much and how fast this drug crosses this barrier.

AVI-4020 was designed to interfere with West Nile virus translation, and has been shown to cross the blood-brain barrier in both normal and inflamed meninges in a clinical study in patients with severe West Nile virus disease.

At issue, is whether this observation is limited to AVI-4020 PMO drug, or is observed with other PMO drugs. This study is one of three to assess the specific ability of PMO drugs to cross the blood-brain barrier, using similar dosing, and PK assessment time points. In order to rigorously assess the pharmacokinetics, this study is being performed in healthy volunteers at a single point in time.

The ability of other PMO drugs to cross the blood-brain barrier will set the stage for future studies that exploit this product characteristic.

Eligibility Criteria:
Inclusion Criteria:

* Adult males 18 years to 64 years of age;
* Good general health (as evidenced by no chronic conditions, normal physical exam, vital signs within normal limits; laboratory evaluations within normal range)
* Signed and dated written informed consent form; and
* Willing to participate in all study activities and all requirements, including effective contraception (viz., a double-barrier method) during the 7-day study surveillance period.

Exclusion Criteria:

* Hematology, serum chemistry (exclusive of electrolytes), and urinalysis laboratory test values \>2 times upper limits of normal or anemia (hemoglobulin \<11 g/dL), leukopenia (total white blood count \<3,000/µL or total neutrophils \<1,500/ µL) or thrombocytopenia (platelets \<100,000/µL). Electrolytes and coagulation values exceeding normal ranges are to be excluded.
* Body Mass Index (BMI) \>35.
* Calculated creatinine clearance (by the Cockroft and Gault Formula) \<70 mL/min, based on age and gender.
* Positive HIV-1 or HIV-2 serology.
* Positive HCV serology and/or positive plasma HCV-RNA status.
* Positive Hepatitis B status.
* Solid or hematopoetic organ transplant recipient.
* Active illness or recent illness within 30 days of the first dose of study drug.
* History of any of the following: brain injury, neoplasm, chronic or migraine headaches, cancer, meningitis or hydrocephalus.
* Usage of any prescribed, over-the-counter or illicit drug(s) within 30 days of study drug administration. Use of herbal remedies and/or supplements at the discretion of the Investigator.
* Unwilling to practice effective contraception during the study period.
* Participation in any clinical interventional trial within the previous 6 months.
* Positive drug urine screen.
Dexmedetomidine and Subarachnoid Haemorrhage

The purpose of this study is to investigate how dexmedetomidine affects static and dynamic autoregulation, intracranial pressure (ICP) and cerebral oxygenation in aneurysmal subarachnoid haemorrhage (SAH) patients.

Dexmedetomidine is a selective α2-agonist which induces sedation, anxiolysis and analgesia without respiratory depression. These effects, as well as neuroprotective properties in experimental studies would be ideal in neuroanaesthesia and in neurocritical care. Poor grade SAH patients are treated in intensive care units (ICU). These patients are sedated often with propofol. However, to assess the patient's neurology, the propofol sedation must be stopped and the wakening of the patient may take time. Dexmedetomidine would be more advantageous, allowing wakening during the infusion. However, the effects of dexmedetomidine on cerebral autoregulation are unknown in SAH patients.

15 SAH patients requiring sedation, mechanical ventilation and ICP monitoring will be rolled in to the study.

Eligibility Criteria:
Inclusion Criteria:

* Aneurysmal SAH
* Aneurysm treated with coil(s) or clip(s)
* Age 18-80 years
* Written informed consent from the next of kin

Exclusion Criteria:

* Pregnancy
* Nursing woman
* Sick sinus syndrome
* Carotid stenosis
* Heart rate less than 50 beats / minute
* Mean arterial pressure less than 50 mmHg
Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya

This effectiveness-implementation hybrid-3 study evaluates dissemination, implementation, and effectiveness of myPlanKenya. myPlanKenya will be disseminated through formal and informal sectors. This clinical trial portion of the study enrolls women at risk for intimate partner violence (IPV) who are referred to myPlanKenya by disseminators (i.e. "end-users").

This trial aims to evaluate the effectiveness of myPlanKenya referral on resilience, health and safety among a cohort of women referred to myPlanKenya based on disclosure of IPV or assessed to have IPV related risks.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 16 or older
* Physical or sexual partner violence or relationship-based fears within the past six months; behaviorally assessed
* Living in Nairobi, Kenya with no plans to move in the next 12 months
* Access to a safe smart phone or computer (personal or shared), and comfort using it to access the myPlan Kenya app
* Literate in English or Swahili languages; confirmed by reading and completing a short passage by filling in several blanks with the appropriate words, selected from a drop-down menu.

Exclusion Criteria:

* Male
* Under age 16
* Have not experienced physical or sexual partner violence or relationship-based fears in past 6 months
* Lives outside of the study area or plans to move within the next 12 months
* Does not have access to a safe smart phone or computer, or is uncomfortable using it to access the myPlan Kenya app
* Illiterate in English or Swahili languages
Diagnostics for the Reperfusion Injury Following MI

The primary purpose of this study is to correlate new cardiac imaging modalities (2D, 3D echocardiography, contrast echocardiography, strain analysis and cardiac MRI) to biochemical parameters as the L-arginine-nitric oxide pathway and inflammatory cascades to characterize the reperfusion injury following myocardial infarction and thus providing a basis for further diagnostic and therapeutic approaches.

By reperfusion of ischemic myocardium further tissue damage occurs (ischemia / reperfusion injury). Various contributing mechanisms have been discussed in experimental studies, e.g. disturbances in coronary microcirculation and consecutive induction of inflammatory cascades involving formation of reactive oxygen species. The ischemia / reperfusion injury causes diastolic and regional as well as global systolic dysfunction. The time course of the reperfusion injury within the first hours after reperfusion and its effects on the global geometry of the left ventricle have not been investigated so far. In the present study a comprehensive morphological and functional characterisation of the ischemia / reperfusion injury in the acute phase is performed. New cardiac imaging modalities (2D, 3D echocardiography, contrast echocardiography, strain analysis and cardiac MRI)and biochemical parameters including the L-arginine-nitric oxide pathway and inflammatory cascades are applied. Hereby morphological and biochemical markers for the functional recovery of myocardial function should be identified.

Eligibility Criteria:
Inclusion Criteria:

* patients with acute ST elevation myocardial infarction and consecutive percutaneous coronary intervention of the infarct-related artery (first myocardial infarction and recurrent myocardial infarction, as long as infarct-related artery is occluded for the first time)
* written informed consent

or 30 patients with stable CAD (control group 1) or 30 healthy volunteers regarding cardiovascular diseases (control group 2)

Exclusion Criteria:

* minors
* incompetent persons
* pregnant and lactating
* moderate to severe renal insufficiency defined by an GFR \< 60 ml/kg/m2
* missing written consent
* other reasons complicating a clinical reevaluation and/or coronary angiography
Early Maladaptive Schemas in French Health Care Professionals With Burn Out

The purpose of this study is to compare the profiles and domains of maladaptive early schemas in care professionals with burnout symptoms with care professionals without burnout symptoms and with care non-professionals with burnout symptoms.

This is an ambispective, non-interventional, comparative, multicentre study in France.

Participants who are care professionals without burn out and care non-professionals with burn out will be matched in age (± 2 years) and gender to participants who are care professionals with burn out.

The study population will be made up of care professionals in a state of burn out, care professionals without a state of burn out, and care non-professionals in a state of burn out.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years ;
* State of burnout (at least one of the 3 dimensions of the Maslach Burnout Inventory) for care professionals and non-professionals in a state of burnout and absence of a state of burnout for the group of care professionals without a state of burnout;
* Membership of a social security scheme;
* Patient having been informed and having given his/her oral non-opposition.

Exclusion Criteria:

* Characterised psychiatric pathology pre-existing the burn out state for the burn out groups and characterised psychiatric pathology for the no burn out group;
* Participation in another clinical trial, or in a period of exclusion from another clinical trial;
* Participant under guardianship, curatorship or deprived of liberty.