cyrilzakka/clinical-trials huggingface dataset:
Clinical Characteristics and Discharge Assessment of Patients From Palliative Care

The number of people having chronic diseases and the demand for palliative care has increased. The factors that have an impact on length of stay and discharge of patient who were admitted to palliative care center will be investigated.

Adult patients admitted to the Diskapi Yildirim Beyazit Teaching and Research Hospitals Palliative Care Unit between August 2018 and September 2020 and discharged to their home will be retrospectively evaluated.

Patient's age, gender, diagnosis, conditions/comorbidities, Karnofsky Performance Scale, discharge status (death, intensive care unit or at home), gastrostomy status, presence of tracheostomy and/or mechanical ventilation, nutritional status (total parenteral nutrition or enteral nutrition), pressure ulcers, the lowest and highest recorded hemoglobin concentration, white blood cell count and serum sodium concentration and the education level of the patient and the caregiver will be recorded. Patients will be grouped according to length of stay (LOS) as Group 1: discharged in equal or less than 21 days or Group 2: Prolonged discharged in longer than 21 days and analysed accordingly

Eligibility Criteria:
Inclusion Criteria:

• Adult patients admitted to the palliative care unit

Exclusion Criteria:

• Patients not consenting to participate the study
Safety and Efficacy Study of NH004 Films for Relief of Sialorrhea Symptoms in Parkinson's Disease Patients

The primary goal of the study is to evaluate the safety and potential efficacy of intra-oral dissolvable NH004 films to improve the short-term symptoms of sialorrhea (drooling) in Parkinson's disease (PD) patients.

NH004 contains the anticholinergic agent tropicamide and is delivered in a convenient product form (intra-oral dissolvable thin films) designed for the management of sialorrhea. This study is a double blind, placebo-controlled, crossover study of the safety and potential efficacy of three doses of of NH004 films for the short-term relief of the symptoms of sialorrhea in Parkinson's disease patients.

A total of up to 36 Parkinson's disease patients will be enrolled in the study in two Phases. Phase A will include 12 patients and Phase B up to 24 patients. There will be an interim analysis after conclusion of Phase A. In both phases patients will be randomized into one of four groups. Each group will have a distinctive sequence for receiving intra-oral dissolvable films of 0.3 mg, 1 mg, 3 mg of NH004, or placebo during four visits.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with idiopathic Parkinson's disease, according to the United Kingdom Brain Bank criteria.
2. Patients complaining of drooling, with a score of at least 3 in the FLENI Sialorrhea scale.
3. Patient is between 50 and 80 years of age, inclusive.
4. Male or non-pregnant female. Females of child-bearing potential will be required to have undergone a pregnancy test with negative results prior to entry to the study and agree to use contraceptive measures for the duration of the study.
5. Patients must have used the same medication and dose for PD for the last month. No changes in the medication for PD are expected during the study.
6. Patients who can reasonable be expected to be on "on-state" for the duration of the testing procedures.
7. Patients who have a stable response to levodopa for PD.

Exclusion Criteria:

1. Pregnant women or women who may become pregnant.
2. Patients with a diagnosis of depression, schizophrenia or with obvious symptoms of these diseases.
3. Patients with Mini-Mental State Examination (MMSE) score equal to or lower than 26.
4. Patients who are receiving the following drugs: tricyclic antidepressants, Monoamine Oxidase Inhibitors (MAOI's), neuroleptics (antipsychotics), or anticholinergics.
5. Patients who have taken any of the drugs mentioned in exclusion criteria number 4 within the last week.
6. Patients with hypersensitivity to atropine or other anticholinergic drugs.
7. Patients who have experienced adverse effects as a result of taking anticholinergic drugs.
8. Patients taking hypnotic or other sleep inducing drugs.
9. Patients with severe urinary or gastrointestinal symptoms.
10. Patients with significant dental/oral pathology.
11. Patients with severe dysautonomia.
Myelofibrosis and Essential Thrombocythemia Observational Study (MOST)

The purpose of this prospective, longitudinal, noninterventional study is to describe clinical characteristics, evolution of disease burden, and treatment patterns in patients with select subcategories of essential thrombocythemia (ET) or myelofibrosis (MF).


Eligibility Criteria:
Inclusion Criteria:

* MF cohort: Diagnosis of MF and low-risk using DIPSS risk categorization OR intermediate-1 risk by DIPSS by reason of age alone.
* ET cohort: Diagnosis of ET and age ≥ 60 years OR history of thromboembolic events OR currently receiving ET-directed therapy (eg, hydroxyurea, anagrelide, interferon, busulfan, ruxolitinib, etc).
* Willing and able to provide written informed consent.
* Willing and able to complete patient assessment questionnaires either alone or with minimal assistance from a caregiver and/or trained site personnel.
* Under the supervision of a physician for the current care of MF or ET.

Exclusion Criteria:

* Individuals who are participating in blinded investigational drug studies.
* Individuals who are participating in Incyte investigational/interventional drug trials (company- or investigator-sponsored studies) until they have completed the 30-day end of study visit.
* Life expectancy ≤ 6 months.
* Diagnosis of secondary acute myeloid leukemia, myelodysplastic syndrome, chronic myelogenous leukemia, or secondary thrombocytosis.
Heart Failure With Normal Ejection Fraction (HFNEF) in Hemodialysed Patients: Beneficial Effect of Ivabradine

Heart failure with normal ejection fraction is often under diagnosed and certainly under treated in hemodialyzed patients. Because of the benefit of reducing heart rate, ivabradine, a pure heart-rate lowering agent without effects on blood pressure, is of potential therapeutic utility.


Eligibility Criteria:
Inclusion Criteria:

* hemodialyzed patients
* signs and symptoms of heart failure with normal ejection fraction
* sinus rhythm

Exclusion Criteria:

* atrial fibrillation/atrial flutter
* valvular heart disease
* unstable angina
* hospitalization for heart failure prior 3 months
Effects of Cervical Stabilization Exercise in Violinists With Chronic Neck Pain

The purpose of this study is to examine the influence of a 6-week cervical stabilization exercise program in university violin players with chronic nonspecific neck pain.


Eligibility Criteria:
Inclusion Criteria:

* duration of playing the instrument longer than 5 years
* practicing the violin more than 5 hours/week
* constant neck pain for more than 3 months or at least 2 pain episodes in the last 3 months

Exclusion Criteria:

* previous surgery in the neck and shoulder regions
* current participation in a structured exercises program
* current treatment for neck and shoulder pain
* red flags suggesting of cancer, infection, vascular insufficiency, and etc. during history taking
* neurological symptoms of the upper extremities during screening tests (e.g. Spurling test and upper limb tension tests)
Art Therapy Pain Management Adolescents Pediatric ED

This project is studying adolescents between the ages of 12 to 18 years that come to the emergency department and are in pain. We want to find out how well art therapy is able to decrease the pain they are experiencing. Art therapy will involve making art and working with an art therapist to find new ways of expressing thoughts and feelings through art making.

In adolescents presenting to the emergency department with a painful condition, our aims are as follows:

Aim #1: To determine the degree that art therapy intervention reduces pain and anxiety.

Aim #2: To determine the degree that art therapy reduces pain and anxiety 1 hour after the intervention.

Aim #3: To explore the qualitative experience of patients undergoing art therapy intervention.

Pain is one of the most common reasons for patients to visit the emergency department (ED), and can be treated using both complementary and pharmacological strategies. However, children are often undertreated for pain which results in not only short term problems, but long term consequences such as trauma and stress-induced disorders; health care avoidance as adults; increased pain sensitivity; and decreased response to future analgesia. There have been variable efforts made to improve the ED management of pain in children, but adolescents are frequently overlooked. A review of the literature revealed that art therapy for pain management in adolescents is understudied. The majority of studies describe the effects of art therapy on the emotional well-being in surgical and oncology populations in adults and children. The studies that did evaluate the effectiveness of art therapy for pain management in children focused primarily on surgical and medical oncology populations with children aged 2-14 years. Of these studies, none evaluated adolescents in the ED, which is a high volume and high stress environment that confers a distinct experience for patients compared to other medical settings. Evaluation of art therapy interventions using quantitative self-report measures with strong validity in children and further delineation of the patient experience related to art therapy is necessary. Advanced evaluation of aforementioned interventions would expand the evidence base needed to describe effectiveness of these interventions and support greater implementation and dissemination. These are the gaps in knowledge that the investigators aim to fill with the proposed study.

Eligibility Criteria:
Inclusion Criteria:

* 12 to 18 years of age, inclusive
* Painful condition with self-reported pain score of \>3/10

Exclusion Criteria:

* Critical illness as per attending physician
* Any neurological or developmental condition that precludes engagement in art therapy or ability to use a self-reported measure of pain
* Chronic disease associated with pain (e.g. sickle cell disease, fibromyalgia)
* Medical condition necessitating multiple painful procedures (e.g. malignancy, organ transplant)
* Does not speak English
Neuromonitoring of Hepatic Encephalopathy

Neuromonitoring of critically ill patients in the intensive care unit (ICU) is challenging. Clinical scoring systems produce insufficient information with deeply sedated patients, and disturbances of normal hemostasis limit the use of invasive intra-cranial pressure measurements. EEG based monitoring algorithms have been introduced into the operation theater and general anaesthesia, but these algorithms cannot be used in the intensive care setting without modifications. EEG is also susceptible to electrical disturbances, such as those created by patient movement.

The study is conducted in Finland, in the intensive care unit of the Surgical Hospital of Helsinki. The total number of patients in this study is 20, and it is a part of a larger neuromonitoring study with a total of 110 patients. The patients are divided into four subgroups, as follows: 1. patients admitted to ICU with acute liver failure, 2. patients admitted to the postoperative cardio-thoracic ICU after cardiac surgery with perioperative total heart arrest, 3. patients admitted to the ICU because of status epilepticus and finally 4. patients in critical condition, admitted to the ICU after any surgery. This study concentrates on the first group of patients with acute liver failure.

Clinical care of patients is not altered. When arriving into the ICU EEG-monitoring will added to routine monitoring. To evaluate the neurological status the following tests are performed: clinical test, blood tests and transcranial doppler ultrasound. The Entropy of EEG is measured along with the raw EEG signal.

The recruiting of study patients was begun in December 2005 and the final study patients were recruited in December 2011. GE Healthcare Finland supplies the entropy monitoring devices and pays the salary of the research nurses who collect the study data. Clinical investigators will not receive funding from any commercial company. All patients (or their next of kin) included have given their written informed consent for inclusion in the study.

The aim of this study is to find new factors and new non-invasive techniques, which correlate with the neurological state and outcome of patients suffering critical illness.


Eligibility Criteria:
Inclusion Criteria:

* age 18 or over
* acute liver failure, referred to the ICU of the Surgical Hospital

Exclusion Criteria:

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Minimally Invasive Open Excisional Hemorrhoidectomy Compared to Conventional Open Excisional Hemorrhoidectomy: a Clinical Trial

This study aims to demonstrate that open excisional hemorrhoidectomy (OEH), when performed using a minimally invasive approach, results in less postoperative pain and comparable outcomes to conventional OEH.

At our hospital, the investigators have developed a new approach to hemorrhoid surgery by modifying the traditional open excisional hemorrhoidectomy. This new method incorporates an image-amplifying device and utilizes microsurgery tools. Preliminary results have shown significant improvement in patients' immediate postoperative pain, with efficacy comparable to conventional methods one year after treatment.

We propose conducting a clinical trial to confirm these initial findings. The study will include two gropus: one undergoing conventional open excisional hemorrhoidectomy (OEH) and the other receiving minimally invasive open excisional hemorrhoidectomy (miOEH). Patients will be randomly assigned to one of these two groups.

The primary outcome of interest will be the level of postoperative pain assessed 10 days after surgery. The secondary outcomes will evaluate the effectiveness of the technique one year post-surgery, measured by the Hemorrhoidal Disease Symptom Score(HDSS) and the Short Health Scale in Hemorrhoidal Disease (SHSHD).

Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years.
* Hemorrhoids grade III.
* Surgical indication for hemorrhoidal disease.

Exclusion Criteria:

* Acute hemorrhoidal disease.
* Previous hemorrhoidal surgery.
* Concomitant anal fissure.
* Concomitant anal fistulae.
* Concomitant rectal prolapse.
* Concomitant inflamatory bowel disease or anal cancer.
* Language impairment.
Ex Vivo Cultured Bone Marrow Derived Allogenic MSCs in AMI

This clinical trial aims to find out the safety and efficacy of adult mesenchymal stem cells in patients with myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Patients with STEMI aged between 20 and 70 years, either males or females with non-child bearing potential, after 2 days of successful PCI.
* Patient has global left ventricular systolic dysfunction with an ejection fraction of \<50% and \>30%.
* ECG with sign of acute anterior MI with ST-elevation ≥ 2 mm in at least 2 of the following leads I, AVL, V1-V6, or ECG with sign of acute inferoposterior MI with ST-elevation ≥1 mm on all of the following leads- II, III, V5-V6 or STelevation ≥ 2 mm in at least 2 of the leads.
* The target lesion located in the proximal section of the left anterior descending, left circumflex or right coronary artery.
* Patient with acute myocardial infarction within 10 days prior to IP administration.
* Normal liver and renal function.
* Able to understand study information provided to him.
* Able to give voluntary written consent.

Exclusion Criteria:

* History of acute/chronic inflammatory condition or severe aortic stenosis or insufficiency; severe mitral stenosis or severe mitral insufficiency.
* Severe co-morbidity associated with a reduction in life expectancy of less than 1 year.
* Advanced renal dysfunction and creatinine ≥ 2mg%.
* Advanced hepatic dysfunction.
* Have clinically serious and/or unstable intercurrent infection, medical illnesses or conditions that are uncontrolled or whose control, in the opinion of the Investigator, may be jeopardized by participation in this study or by the complications of this therapy
A Study to Assess Change in Patient Experience in Adult Participants With Chronic Lymphocytic Leukemia (CLL) Receiving Oral Venetoclax Tablets + Intravenous Rituximab or Bruton's Tyrosine Kinase Inhibitors Tablets in the United Kingdom

Chronic lymphocytic leukemia (CLL), a form of Non-Hodgkin's Lymphoma, is the most common type of leukemia in adults, affecting approximately 3,800 people in the UK each year. This study will evaluate the patient experience of CLL in adult participants who are prescribed venetoclax+rituximab or Bruton's tyrosine kinase inhibitors in the United Kingdom (UK).

Venetoclax+rituximab is a drug approved to treat CLL. Study participants will receive venetoclax+rituximab as prescribed by their study doctor in accordance with approved local label. Adult participants prescribed venetoclax+rituximab or Bruton's tyrosine kinase inhibitors will be enrolled. Around 140 participants will be enrolled in the study in approximately 10 sites in the UK.

Participants will receive venetoclax tablets to be taken by mouth and rituximab intravenous (IV) injection according to the approved local label.

There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Has a confirmed diagnosis of chronic lymphocytic leukemia (CLL) (as defined by 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute Working Group (IWCLL NCI-WG) Guidelines).
* Has relapsed/refractory (R/R) disease having received only 1 prior line of treatment, which must have been a chemotherapy or chemoimmunotherapy treatment.
* Has treatment experience with venetoclax+rituximab (Ven+R) or bruton's tyrosine kinase inhibitor (BTKi)s that meets the criteria for inclusion described in the protocol, for which recruitment targets have not yet been met.

Exclusion Criteria:

* Previously treated with a BTKi, a BCL-2 inhibitor or other investigational agents.
* Has any other medical condition or disorder that, in the opinion of the site investigator or study director, could compromise participant's ability to give written informed consent and/or prevent or interfere with his or her ability to comply with study procedures and provide meaningful information about his or her CLL experience.
A Study of HY004 Treatment in Adult Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia (r/r B-ALL)

This is a multi-center, phase I/II trial to evaluate the safety and efficacy of HY004 treatment in Adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-cell ALL).

This trial is a multi-center, open label, single-arm, phase I/II trial to evaluate the safety and efficacy of HY004 treatment in Adult (aged 18\~65 years old) patients with r/r B-cell ALL.

The phase I part of the trial is to evaluate the safety, optimal dose of HY004, Pharmacokinetics/Pharmacodynamics(PK/PD)and preliminary efficacy in the treatment of Adult patients with r/r B-cell ALL. The phase II part of the trial is to evaluate the efficacy and safety of HY004 in in the treatment of Adult patients with r/r B-cell ALL. The study includes screening, pre-treatment (Cell Product manufacture \& lymphodepletion), HY004 infusion, safety and efficacy follow-up, and survival follow-up. All subjects who have received HY004 infusion will be followed for up to 2 years.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent prior to any study procedures (patient and/or parent or legal guardian);
2. Gender is not limited, and the age at the time of screening is ≥ 18 years old and ≤ 65 years old;
3. Relapsed or refractory acute lymphoblastic leukemia (ALL);
4. Documentation of CD19 and/orCD22 tumor expression demonstrated in bone marrow or peripheral blood within 3 months before screening;
5. Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening;
6. ECOG score 0-1 points;
7. Organ function requirements: All patients must have adequate renal and liver functions.

Exclusion Criteria:

1. Active Central Nervous System (CNS) involvement by malignancy;
2. Isolated extra-medullary disease relapse;
3. Patients with Burkitt's lymphoma/leukemia;
4. History of concomitant genetic syndrome;
5. Patients with acute graft-versus-host disease (GVHD) or moderate-tosevere chronic GVHD within 4 weeks before screening; Patients with a history of allogeneic hematopoietic stem cell transplantation within 12 weeks before single collection;
6. Active systemic autoimmune disease;
7. Known infection with human immunodeficiency virus (HIV) or chronic infection with hepatitis B virus (HbsAg positive) or hepatitis C virus (anti- HCV positive);
8. Patients with active infections at screening;
9. Patients who have used CAR-T cell therapy before screening;
10. Patients with an expected lifespan of less than 3 months.
Cytomegalovirus Infection After HSCT and PT-CY as GVHD Prophylaxis >> GVHD PROPHYLAXIS ERA

Multicentre, observational, retrospective study to analyze the differences in CMVi pattern and recurrences between two groups of allogeneic HSCT patients (haplo vs no haplo HSCT), with intervention both postransplant cyclophosphamide as GvHD prophylaxis, using a database with information from historical clinic data.

The overall aim of the study is to to analize CMVi after PTCy for GVHD prophylaxis, with a detailed description of CMVi and recurrences, direct and indirect consequences, in a HSCT population comparing two cohorts: haploidentical HSCT vs no haploidentical HSCT

Eligibility Criteria:
Inclusion Criteria:

1. Age \> 18 years.
2. Period of HSCT: January 1st 2013 to December 31th 2018.
3. GvHD prophylaxis: Post-transplantation Cyclophosphamide (50 mg/Kg on days +3 and +4 or +3 and +5) and calcineurine inhibitors as GvHD prophylaxis.
4. Conditioning chemotherapy regimen and source of stem cells: myeloablative or reduced intensity TBF (Thiotepa 5 mg/Kg D -7-6, Fludarabine 50 mg/m2 D -5-4-3, Busulfan 3,2 mg/Kg D -4-3-2) starting on D-7 followed by peripheral blood or bone marrow infusion on day 0.

Exclusion Criteria:

1. Cord blood HSCT.
2. Antilymphocytic or anti thymocytic thymoglobulin as GvHD prophylaxis.
3. Alentuzumab as GvHD prophylaxis.

3. Sirolimus as GvHD prophylaxis.

4. HIV positive, HVC, HVB active or latent at HSCT.

5. CMV prophylaxis with letermovir.

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The Effects of an Aromatic Botanical Extract on Respiratory Health.

This study is a randomized, double blind, placebo controlled, intervention study evaluating the effect of an aromatic botanical extract on overall respiratory health among otherwise healthy adults.

After being informed about the study and providing informed consent, patients with respiratory complaints will be randomized into a double blind placebo controlled trial of the botanical extract.

Eligibility Criteria:
Inclusion Criteria:

* age: 18-60 years
* currently experiencing respiratory symptoms
* otherwise healthy

Exclusion Criteria:

* underlying respiratory conditions
* pregnant, breastfeeding, or trying to conceive
* tobacco use in the home
* allergies to any of the ingredients