cyrilzakka/clinical-trials huggingface dataset:
Intervention in Spirituality at the End of Life. The Kibo Protocol

This work aims to study the benefits that the therapeutic interview Kibo in palliative care patients can have for spirituality.

A parallel randomized controlled trial of two groups was performed. Information was collected on 60 palliative care patients during the moments before and after the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. To be 18 or more years of age.
2. Being in advanced or terminal disease phase (following World Health Organization criteria).
3. To have preserved cognitive capacity.
4. To have signed the informed consent.

Exclusion Criteria:

a) Estimated time of survival: Patients with a life expectancy of two weeks or less will not be intervened.
Patient-Reported Outcomes in PHiladelphia-nEgative Cytogenetic mYeloproliferative Neoplasms (PROPHECY).

This study will ultimately aim at developing a GIMEMA platform for collecting HRQoL and symptom burden information on Italian patients with Philadelphia chromosome negative MPN. The main objective of the protocol is to improve our understanding of the impact of the disease and various treatments on patients-wellbeing, symptom burden and daily functioning.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Polycythemia Vera (PV), Essential Thrombocythemia (ET) and Primary Myelofibrosis (pre-PMF, overt-PMF) and post-ET/post-PV Myelofibrosis (MF), (i.e. Philadelphia chromosome negative myeloproliferative neoplasm (MPN)) according to 2016 WHO classification.
* Known IPSS/IPSET/DIPSS risk score category at time of initial diagnosis of PV, ET and PMF, respectively.
* Initial diagnosis of MPN within one year before date of registration.
* Having a full baseline PRO Evaluation completed.
* Adult patients (≥ 18 years old).
* Written informed consent provided.

Exclusion Criteria:

* Having any kind of psychiatric disorder or major cognitive dysfunction problems hampering a self-reported evaluation.
* Not able to read and understand local language (i.e. Italian).
Drug Interaction Study of Isavuconazole and Oral Contraceptive Containing Ethinyl Estradiol and Norethindrone

The purpose of this study is to assess the effect of multiple doses of isavuconazole on the pharmacokinetics (PK) of a single dose of contraceptive in healthy post-menopausal women.


Eligibility Criteria:
Inclusion Criteria:

* The subject has a body weight of at least 45 kg and has a body mass index (BMI) of 18 to 32 kg/m2, inclusive
* Results for aspartate aminotransferase (AST), alanine aminotransferase (ALT), and total bilirubim must not be above upper limit of normal range
* The subject must be postmenopausal, defined as at least 2 years since the last regular menstrual cycle and have follicle stimulating hormone (FSH) \> 30 IU/L

Exclusion Criteria:

* The subject has had treatment with hormone replacement therapy within 3 months prior to Day -1
* The subject has a history of adverse events with taking oral contraceptives or hormone replacement therapy
* The subject has a history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative at a young age due to possible or probable cardiac causes)
* The subject has a positive result for hepatitis C antibodies or hepatitis B surface antigen at Screening or is known to be positive for human immunodeficiency virus (HIV)
* The subject has a known or suspected allergy to any of the components of the trial products or the azole class of compounds, or a history of multiple and/or severe allergies to drugs or foods (as judged by the investigator), or a history of severe anaphylactic reactions
* The subject is a smoker (any use of tobacco or nicotine containing products) within 6 months prior to Screening
* The subject has had treatment with prescription drugs or complementary and alternative medicines within 14 days prior to Day -1, or over-the-counter medications within 1 week prior to Day -1, with the exception of acetaminophen up to 2 g/day
* The subject has a recent history (within the last 2 years) of drug or alcohol abuse, as defined by the investigator, or a positive drug and/or alcohol screen
Genicular Nerve Block Versus Its Combination With Infiltration Between Popliteal Artery and Capsule of Posterior Knee

Comparison of the analgesic and physical recovery effect of genicular nerve block (GNB) alone and (GNB + infiltration between popliteal artery and posterior capsule of the knee (IPACK) in patients undergoing total knee replacement

Comparison of preemptive analgesia of (GNB) with (GNB+ IPACK) on postoperative pain control and recovery of knee physical activity in patient undergoing total knee replacement.

Eligibility Criteria:
Inclusion criteria:

* Adult patients aged between 21 to 60 years
* undergoing primary unilateral elective total knee arthroplasty under spinal anesthesia
* Having informed consents
* patients with physical status ASA I \& II
* both genders
* body mass index less than 40 kg/m2.

Exclusion criteria

* patients with Peripheral vascular disease
* patients with history of allergy to local anesthesia or opioid analgesia,
* those on anti-platelet, anticoagulant or B blocker drugs
* Patients with acute decompensated heart failure
* Patients with hypertension
* Patients with heart block
* Patients with coronary disease
* Patients with bronchial asthma
* Patients with bleeding disorders
* Patients with compromised renal or hepatic function
* pregnant female.
Treatment With Immunological Checkpoint Inhibitors of HIV-infected Subjects With Cancer

It has been reported that peripheral and lymph node resident Cluster of Differentiation 4 (CD4)+ T cells expressing Programmed cell death protein 1 (PD-1) contribute to Human Immunodeficiency Virus (HIV) persistence during Antiretroviral Therapy (ART). In HIV-infected individuals, PD-1 expression on CD4+ T cells correlates with HIV disease progression, and loss of HIV-specific CD4+ T cell function can be reversed in vitro by PD-1 blockade. There are only a limited number of case reports describing the evolution of HIV-infected patients with concurrent oncological disease treated with immunological checkpoint inhibitors. However, this case provides very limited information on the effect of pembrolizumab on the HIV reservoir. Here, the investigators aim at describing changes in the HIV reservoir and in the HIV-specific immunity in HIV-infected patients on ART who receive immunological checkpoint inhibitors for the treatment of cancer, especially for metastatic melanoma.

Long-lived latently infected resting CD4+ T cells are the main reason why current antiretroviral therapy (ART) is unable to cure HIV infection. Recent work has suggested that the expression of immune checkpoint markers, such as the programmed death-1 (PD1) or the cytotoxic T-lymphocyte antigen 4 (CTL-4), may play a role in viral persistence on ART via either suppression of virus transcription and/or reduced HIV-specific T cell activity, but the in vivo role of immune checkpoint markers in HIV persistence on ART is not clear.

Immunological checkpoint inhibitors are humanized monoclonal Immunoglobulin G (IgG) antibodies directed against several cell surface receptors, including PD-1 that inhibits binding of PD-1, expressed on activated T cells to its ligands PD-L1, overexpressed on certain cancer cells, and PD-L2, which is primarily expressed on antigen presenting cells. Activated PD-1 negatively regulates T-cell activation and plays a key role in tumor evasion from host immunity antigen presenting cells. Immunological checkpoint inhibitors can also target CTL-4, which is constitutively expressed in Treg cells but only upregulated in conventional T cells after activation, a phenomenon which is particularly notable in cancers. These drugs are used to treat oncology diseases, including metastatic melanoma, and have been associated with multiple changes in immune function thought to enhance antitumor T cell function.

This exploratory study will include HIV-infected subjects with advanced melanoma or other oncological conditions in which the use of immunological checkpoint inhibitors is clinically indicated. The study is conceptually observational as the patients will be in regular clinical treatment with immunological checkpoint inhibitors for oncological conditions.

Eligibility Criteria:
Inclusion Criteria:

* HIV-infected subjects with advanced melanoma or other oncological conditions in which the use of immunological checkpoint inhibitors is clinically indicated

Exclusion Criteria:

* None
Vitamin D Homeostasis in Sarcoidosis

This study evaluates the relationship between vitamin-D status and severity of sarcoidosis, and the effects of vitamin-D repletion in vitamin-D insufficient patients with sarcoidosis. Half the patients with sarcoidosis who are vitamin-D insufficient will receive standard vitamin-D supplementation via standard regimen while the other half will receive a placebo. Sarcoidosis patients who are vitamin-D sufficient will also act as controls.

Sarcoidosis is a multi-system inflammatory disease characterized by T-helper lymphocyte hyperactivity leading to granulomatous inflammation. The granuloma cells autonomously convert 25-hydroxy-vitamin-D (25OHD) to the active metabolite 1,25-dihydroxy-vitamin-D (1,25OH2D) independent of normal feedback control but dependent on substrate (25OHD) concentration.

Circulating 1,25OH2D exerts both anti-inflammatory and mineral metabolic actions. Deficiency of 25OHD limits substrate-dependent 1,25OH2D synthesis, diminishes anti-antigenic innate immunity and augments pro-inflammatory adaptive immunity. Thus, low vitamin-D stores could aggravate sarcoid inflammation while repletion of vitamin-D stores could mitigate inflammation in sarcoidosis.

Eligibility Criteria:
Inclusion Criteria:

* Stable medical condition defined as no hospitalization or emergency room visit in the previous 3 months
* No evidence of active pulmonary or systemic infection
* No other active inflammatory disease,
* No active malignancy.
* Normal serum ionized calcium level

Exclusion Criteria:

* Hospitalization or emergency room visit in the previous 3 months
* Evidence of active pulmonary or systemic infection
* Evidence of active other inflammatory disease
* Evidence of active malignancy
* Elevated serum ionized calcium level
Ultrasound Guided Psoas Compartment Block vs Suprainguinal Fascia Iliaca Compartment Block

The aim of this study was to compare the intraoperative and the postoperative analgesic effect of psoas compartment block (PCB) and supra-inguinal fascia iliaca compartment block (SFIB) in pediatric patients undergoing developmental dysplasia of the hip

All subjects after entering operation room will be connected to standard monitor electrocardiograph, non-invasive blood pressure, heart rate, oxygen saturation.

Three mg/kg of propofol, 0.2 μg/kg of fentanyl and 0.1 mg/kg midazolam will be used for sedation. Oxygen at the concentration of 100% will be administrated under the mask in all patients after satisfactory sedation, tracheal intubation will be performed after intravenous anesthesia with administration of 3 mg/kg of propofol, 0.6 μg/kg of fentanyl and 0.9 mg/kg of rocurium. After intubation 2-3% of sevoflurane and 0.2-0.3 mcg/kg/min of fentanyl will be used to maintain anesthesia guided by PSI and hemodynamic monitoring.

The two groups will receive nerve block with local anesthetics. In the SFIB group, the patients will receive ultrasound-guided SFIB, while the patients in the PCB group will receive PCB under the guidance of ultrasound.

Local anesthetic 0.25% Ropivacaine will be used at 1 ml/kg for SFIB and PCB. (the dose of local anesthetic for SFIB or PCB was not more than 35ml). All blocks will be performed by the same experienced anesthesiologist.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing undergo acetabuloplasty
* Anesthesiologists (ASA) physical status of I to II

Exclusion Criteria:

* Known allergy to local anesthetic
* Infection at the block site.
Anti-TNF-alpha Trough Level Measurements in Inflammatory Bowel Disease

Drug serum concentrations will be measured at several time-points for inflammatory disease patients treated with anti-TNF agents. The purpose is to determine which patients that will clinically benefit from either discontinue treatment, adjusting the dose, switch to another anti-TNF agent or a different class of medication.

Crohn´s disease and ulcerative colitis are diseases where the proinflammatory cytokine Tumor Necrosis Factor-alpha (TNF) plays an important role. Anti-TNF agents are used in the treatment. However, some patients do not respond and response rates declines over time. The cause may be immunogenicity against the agent itself, the agent´s failure to neutralize TNF or another biological pathway leading to inflammation. Anti-TNF agents have been administrated as fixed doses at certain frequencies and this may not be optimal for all patients, but recent studies have indicated a correlation between efficacy and serum drug concentration levels (trough levels). Our preliminary data suggest that trough levels early in the treatment course may be predictive of later trough levels. By multiple measurements, this will be assessed. The study will also investigate biological markers in serum and blood cells which may be predictable for trough levels. Finally, we will compare different methods to measure serum drug concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Inflammatory bowel disease
* Treated with anti-TNF drug
* Follow-up at specialized gastroenterologist in Norway
* Age 18 or over

Exclusion Criteria:

* Patients refusing to participate by not giving their informed consent
A Study of Donafenib Monotherapy in Advanced Oesophageal Cancer

This open-label, one-center, noncomparative, two-stages phase 1B trial assessed the tyrosine kinase inhibitor donafenib tosylate tablets(400 mg/d,200mg bid) in patients with advanced, inoperable oesophageal cancer progressing after chemotherapy .

The primary endpoint is the safety.The secondary endpoints are tumor response and progression-free survival.

This open-label, noncomparative, two-part phase 1B trial recruited patients with advanced, inoperable oesophageal cancer. The primary objectives were to assess the safety for donafenib tosylate tablets .The secondary objectives were to estimate tumor response, progression-free survival, duration of response, and disease control rate (response plus stable disease); to evaluate changes in quality of life(QoL); This study is 2-stages designing. The investigators plan to enroll 19 patients in the first stage study. The investigators will start the secondary stage study if the disease control rate \>=8/19.

Eligibility Criteria:
Inclusion Criteria:

* All patients provided written, informed consent.
* Have histologically confirmed advanced oesophageal squamous-cell carcinoma, or type I/II Siewert junctional tumours.
* Have received up to two previous chemotherapy regimens( Platinum containing regimens \& Paclitaxel / docetaxel containing regimens).
* Have an Eastern Cooperative Oncology Group Performance status of 0-1.
* Have ability to swallow tablets.
* no contraindications to sorafenib or donafenib.
* Have either measurable or evaluable lesion on CT.

Exclusion Criteria:

* Patients with brain metastases.
* Patients receiving cytotoxic chemotherapy, immunotherapy or hormonal therapy, radiotherapy to site of measurable or evaluable disease within the previous 4 weeks.
* Patients had evidence of clinically active interstitial lung disease or abnormal blood results by predefined criteria (serum bilirubin \>1.5 times upper limit of reference range, aspartate or alanine aminotransferase\>2.5 times the upper limit of normal if no demonstrable liver disease) .
Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily from mental health disorders, such as anxiety disorders and depression. Cognitive behavior therapy (CBT) has been shown to be an effective treatment of these disorders. Despite the strong evidence for CBT there is a lack of evidence-based psychological treatment in primary care. For various reasons, the progress of research has not affected clinical practice. For successful implementation of CBT in primary care cost-effective therapies, access to therapists with proper training and supervision, evidence-based manuals and management that support the implementation is needed.

Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All patients are first treated with self-help CBT (N = 400). Patients that do not improve after treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based on published studies 2/3 is expected to be improved after self-help and therefore do not undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to individual CBT (N = 67) or continued self-help treatment (N = 67).


Eligibility Criteria:
Inclusion Criteria:

* Have an anxiety disorder diagnosis (obsessive compulsive disorder, social phobia, panic disorder, generalized anxiety disorder), or/and major depression, or/and maladaptive stress reaction, or/and primary insomnia Clinician severity rating scale 2-6

Exclusion Criteria:

* A higher score than 6 on the Clinician severity rating scale
EGFR-TKI Resistance Profile in Chinese Patients With Advanced EGFRm+ NSCLC

A Prospective Multi-center Study to Investigate the EGFR-TKI Resistance Profile in Chinese Patients with Advanced EGFRm+ NSCLC

Patients with EGFR mutation and presented secondary resistance to prior first-generation EGFR-TKI should have received biopsy of at least on progressed lesions and are able to provide tissues for pathological examination and NGS testing.All enrolled patients will be followed up to clinical outcome (treatments, tumor response, survival, etc).

Eligibility Criteria:
Inclusion Criteria:

* Provision of informed consent prior to any study specific procedures.
* Male or female patients aged 18 years and older.
* Histological confirmation of stage IIIB/IV NSCLC.
* Documented EGFR mutation positive .
* WHO Performance Status 0, 1 or 2

Exclusion Criteria:

* Any other significant clinical disorder or laboratory finding that made it undesirable for the patient to participate in the study.
* Previous (within 6 months) or current treatment with AZD9291.
Pharmacokinetic Study of Ondansetron Administered as IR (Zofran) and MR (EUR1025)

The objective of the study is to assess blood levels of ondansetron (EUR1025 24 mg) dose and Zofran 8 mg dose after single and multiple doses are given when taken with a meal and taken on an empty stomach.

The objective of this study is to evaluate the pharmacokinetics (PK) of ondansetron administered as a novel modified-release formulation (EUR1025 24 mg) as well as the immediate-release formulation (Zofran 8 mg) after single and multiple oral dose administration under fasting and fed conditions based on the requirements of the respective indications. The safety profile of each treatment will also be assessed by recording the nature, severity, frequency, duration and relation to the treatment of any adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Male and female volunteers
* Non- or ex-smokers
* At least 21 years of age but not older than 55 years
* Body mass index targeted to be at least 18.5 and less than 30 kg/m2.
* Acceptable lab tests
* Normal 12 lead ECG
* Negative human chorionic gonadotropin (hCG) for females.

Exclusion Criteria:

* No known hypersensitivity to Ondansetron or any related products
* No presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption
* No presence of significant heart disease or disorder discovered on screening ECG
* Not pregnant
* No alcohol or drug abuse history
* No use of any enzyme-modifying drugs, including strong inhibitors of cytochrome P450 (CYP)
* No previous Investigational Product (in another clinical trial) or donated 50 ml or more of blood in the previous 28 days before day 1 of this study
Cross-Cultural Adaptation and Psychometric Validation of the Turkish Version of Atroshi-Lyrén 6-item Symptoms Scale

This study aims to develop Turkish version of the Atroshi-Lyrén 6-item symptoms scale (A-L scale) and to perform validity and reliability evaluations.


Eligibility Criteria:
Inclusion Criteria:

* Aged between 18-65 years old,
* Had symptoms of numbness, tingling, weakness and pain in the hands for at least 1 month,
* Assessed through provocation tests and physical examination to match the median nerve distribution.

Exclusion Criteria:

* Not willing to participate in the study,
* Clinical or electrophysiological signs of proximal nerve compression,
* Diabetes or other metabolic disease,
* Rheumatoid arthritis or other general inflammatory diseases.
Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound

Transabdominal ultrasound guidance is the golden standard for embryo transfers. Transvaginal ultrasound guidance was proposed recently to provide better visualization and reduce patient discomfort as embryo transfer can be performed with an empty bladder in this case. The purpose of this study is to determine whether there are any differences between transvaginal and transabdominal ultrasound-guided embryo transfer in terms of ease of use, patient satisfaction, and treatment outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing oocyte donation treatment with transfer of 2 embryos on day 3

Exclusion Criteria:

* Submucous or \>3 cm intramural fibroids
* Turner syndrome
* Black recipients