cyrilzakka/clinical-trials huggingface dataset:
" Application of Art Therapy in Oncology: Evaluation of the Symptomatic of Patients Suffering From a Cancerous Disease"

The purpose of this study is to evaluate the impact of art-therapeutic management on a patient with cancer, during chemotherapy treatment, on the reduction of physical or psychological symptoms.

Art therapy is a non-drug approach that can help some patients cope with the consequences of cancer beyond the care provided.

The common psychosocial difficulties experienced by cancer patients are pain, fatigue, depression, anxiety, drowsiness. In sum, the well-being and quality of life of the patient throughout the illness.

The main objective is to evaluate the impact of art therapy, as a supportive care, on improving the well-being felt after a session of cancer treatments (chemotherapy, immunotherapy, ...), during 6 sessions( around 24 days between 2 sessions) , at patients with a cancer pathology using two questionnaires, one on the evaluation of symptoms (ESAS), the other on the quality of life (FACT-G).

Patients will be randomized into the following groups:

* Group 1: Art therapy as supportive care in 6 consecutive sessions of cancer treatments with or without additional supportive care
* Group 2: 6 consecutive sessions of cancer treatments with or without additional supportive care.

Symptom assessment with the Edmonton Symptom Assessment System (ESAS) is done before and after each treatment session for each patient.

The FACT-G questionnaire on the quality of life at the beginning and the end of the care for the two groups (group benefiting from the art-therapy and group not benefiting from the art-therapy) and a questionnaire on the contribution of art therapy, at the end of care, for the participants of the art-therapy group.

Eligibility Criteria:
Inclusion Criteria:

* aged over 18
* patient cared for on Onco-hematology day with a cancerous pathology
* consent of the patient
* patient affiliated to social Security

Exclusion Criteria:

* patient minor
* patient under legal protection
* patient with too much impairment of vital and / or cognitive functions to participate and understand the study
* patient whose predictable management is less than the follow-up period (6 sessions),
* patient who has already participated in an art therapy session during their lifetime
T-DM1 Combined With CDK4/6 Inhibitor Ribociclib

To explore the efficacy and safety of T-DM1 combined with CDK4/6 inhibitor Ribociclib in the treatment of HER2-positive advanced breast cancer.

This is a multicenter, single-arm,Phase II clinical trial to explore the efficacy and safety of Trastuzumab Emtansine (T-DM1) combined with CDK4/6 inhibitor Ribociclib in the treatment of unresectable locally advanced or metastatic HER2-positive breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 at the time of signing the informed consent.
* Patient's ability to follow the study protocol as determined by the investigator.
* A representative tumor tissue sample is required to confirm a HER2-positive diagnosis.

HER2 expression status and ER expression status of invasive cancer lesions were determined based on previous pathological sections or current pre-treatment biopsy materials, and the HER2 IHC assay was locally confirmed to be consistent with 3+, or IHC assay with 2+, and further FISH detection was positive before study enrollment.

* At least one evaluable lesion was detected by CT or MRI (see protocol for additional details).
* For metastatic or recurrent breast cancer, there is currently no opportunity for surgical radical resection.
* Metastatic or recurrent breast cancer that has received at least first-line rescue therapy in the past must have been treated with trastuzumab and taxanes.
* The Physical status (ECOG) score of the Eastern Tumor Collaboration group was 0 or 1.
* Sufficient haematology and organ function to meet the definition of laboratory test results, which must be provided within 14 days before the start of study therapy.
* Fertile women should remain abstinent (no heterosexual intercourse) or use contraceptive methods.

Exclusion Criteria:

* Past treatment with other antibody-drug conjugate (ADC) drugs or anti-tumor therapy with CDK4/6 inhibitors.
* Past treatment with other anti-HER2 drugs other than trastuzumab, pertuzumab and tyrosine kinase inhibitors (TKI).
* Advanced breast cancer with central nervous system metastasis.
* Patients who have developed other malignancies in the 5 years prior to screening, except adequately treated cervical cancer in situ, non-melanoma skin cancer, localized prostate cancer, ductal carcinoma in situ, or stage I uterine cancer.
* Severe dysfunction of vital organs prior to enrollment (see protocol details).
* Received an investigational drug within 28 days prior to initiation of study therapy.
* Known hypersensitivity or hypersensitivity to CDK4/6 inhibitors.
* The results of the serum pregnancy test were positive.
Testosterone & Tamoxifen Trial

This is a concise single arm, feasibility study, which will be executed in the University Medical Center Groningen, The Netherlands. Male patients with metastatic BC (n=6) are eligible for this study after at least 1 line of conventional endocrine therapy.


Eligibility Criteria:
Inclusion Criteria:

1. Male
2. A history of proven ER+ (\>10% of cells), AR+ (\>10% of cells), and HER2- metastatic BC
3. Tumor progression after at least one line of conventional endocrine therapy (tamoxifen, AI, fulvestrant, CDK4/6, ±LHRH analogue).
4. Age ≥ 18 years
5. Adequate hematological, renal and liver function as follows:

   * Absolute neutrophil count \> 1.5 x 109/L
   * Platelet count \>100 x 109/L
   * White blood cell count \>3 x 109/L
   * AST and ALT \<2.5 or \<5.0 in case of liver metastases x upper limit of normal (ULN)
   * Creatinine clearance \>50mL/min
   * Prothrombin time, partial thromboplastin time and INR \<1.5 x ULN
6. Written informed consent

Exclusion Criteria:

1. History of prostate, testicular or liver cancer
2. Patients already using testosterone supplements
3. Patients using medication with anti-androgenic effects (e.g. spironolactone)
4. Elevated PSA (\>4μg/L) or severe urinary tract problems (as defined with a Prostate Symptom Score \>19). Patients with known BRCA mutation and PSA \>3 μg/L will be referred to the urologist for prostate cancer screening, and can participate if they have no signs of prostate cancer.
5. Hematocrit \>50%
6. Patients with uncontrolled hypertension, diabetes mellitus or other significant cardiovascular morbidity.
7. Patients with recent history of coronary artery disease or trombo-embolic events within 6 months prior to screening
8. Severe concurrent disease, infection, co morbid condition that, in the judgment of the investigator would make the patient inappropriate for enrollment
9. Visceral crisis and/or rapid progression necessitating chemotherapy
10. Previous allergic reaction to androgen agonists
11. Contra-indication for PET imaging
12. Tamoxifen or fulvestrant treatment \<5 weeks prior to FES-PET.
Enzalutamide and Hormone Therapy Before, During, and After Radiation for High Risk Localized Prostate Cancer

The study is being done to find out whether combining two FDA approved drugs along with radiation therapy for the treatment of high risk localized prostate cancer is safe and well tolerated.

* this pilot study will assess the safety and tolerability of combining enzalutamide with an gonadotropin-releasing hormone agonist (GnRH) and external beam radiation
* Correlative imaging and tissue biopsy analysis will be performed to assess the radiographic response to enzalutamide plus gonadotropin-releasing hormone agonist (GnRH) therapy as well as intratumoral androgen signaling

Eligibility Criteria:
Inclusion Criteria:

* histologically proven adenocarcinoma of the prostate within 6 months of screening
* Eastern Cooperative Oncology Group(ECOG) score 0-2
* adequate organ and and blood marrow function
* must be a candidate for long-term androgen deprivation in combination with external beam radiation for the treatment of high risk prostate cancer
* patient must permit a targeted prostate biopsy at the time of study initiation or at the beginning of radiation treatment
* men who are sexually active with female partners of child-bearing potential mush agree to use adequate contraception

Exclusion Criteria:

* prior treatment with agents known to have endocrine effects on prostate cancer
* treatment with corticosteroids within 4 weeks of enrollment
* treatment with androgens within 6 months of enrollment
* may not be receiving any other investigational agents
* Prostate specific antigen greater than 160ng/dL
* history of malignancy( other than non-melanoma skin cancer) within 5 years
* uncontrolled intercurrent illness
* cardiovascular event within 6 months of enrollment
* seizure or seizure disorder history
* contraindications to MRI- pacemakers, clips, etc
Effects of Exercise During Gestation on Maternal and Foetal Health

The main objective of this project is to assess the effects of a novel and supervised exercise intervention in overweight pregnant and their newborn.

Methods/Design: The present study is a Randomized Controlled Trial. Sixty overweight pregnant interested in participate in the intervention program will be randomly assigned to either exercise (3 sessions/week), or to usual care (control) group (30 pregnant per group). The primary outcome measures are maternal weight gain, and maternal and neonatal glycaemic profile. Secondary outcomes measure are: i) body composition; ii) dietary patterns; iii) physical fitness; iv) objectively measured physical activity and sedentary behaviour; v) sleep quality; vi) mental health, quality of life and positive health; vii) haematology and biochemical analysis; viii) oxidative stress; ix) pro- and anti-inflammatory markers; x) bone health biomarkers; xi) adiposity-related proteins expression. The data will be analysed on an intention-to-treat basis and per protocol.


Eligibility Criteria:
Inclusion criteria:

* Overweight pregnant woman with a normal pregnancy course.
* Answer "no" to all questions on the PARmed-X for pregnancy\*.
* To be able to walk without assistance.
* To be able to read and write enough.
* Informed consent: To be capable and willing to provide consent. \*In addition, specific inclusion criteria for data analysis are: gestational age at delivery of 37-42 weeks with single foetus, spontaneous vaginal delivery or instrumental vaginal and caesarean without maternofoetal pathology (or other indication that does not involve maternofoetal risk, such as disproportion, failed induction, no foetal progression or non-cephalic presentation), newborn with appropriate weight, Apgar score\>7 in the 1st and 5th minute of life, cord blood pH (normal\>7.20) and normal monitoring results.

Exclusion criteria:

* Acute or terminal illness.
* Malnutrition.
* Inability to conduct tests for assessing physical fitness or exercise during pregnancy.
* Underweight, normal-weight or obesity.
* Pregnancy risk factors (such as hypertension, type 2 diabetes, etc.).
* Multiple pregnancies.
* Chromosopathy or foetal malformations.
* Uterine growth restriction.
* Foetal death.
* Upper or lower extremity fracture in the past 3 months.
* Presence of neuromuscular disease or drugs affecting neuromuscular function
* Be registered in other exercise program
* Perform more than 300 minutes of at least moderate physical activity per week
* Unwillingness to either complete the study requirements or to be randomised into control or intervention group.
Effects of Essential Amino Acid Intake on Net Protein Synthesis in Weight-losing Non-small Cell Lung Cancer Patients

Weight loss commonly occurs in lung cancer patients, negatively influencing their quality of life, treatment response and survival. Gains in lean body mass are difficult to achieve in cancer unless specific metabolic abnormalities are targeted. It is our hypothesis that a nutritional supplement containing a high amount of essential amino acids will target the metabolic alterations of cancer patients. Preliminary research performed in our laboratory in elderly supports this hypothesis. We hypothesize that intake of an essential amino acid nutritional supplement will positively influence protein synthesis rate in advanced non-small cell lung cancer (NSCLC) patients. Furthermore, insight in the underlying mechanism of the higher anabolic response of the essential amino acid supplement will be examined. This information will potentially enable us to formulate a supplement that is more effective than normal food intake, and that will reduce the need for muscle protein breakdown.

In this study, we will test the following hypothesis: A high-leucine essential amino acid mixture stimulates whole body protein synthesis (and in this way protein anabolism) to a larger extent than a regular balanced mixture of total (essential and non-essential) amino acids in NSCLC patients with and without recent weight loss. The principal endpoint will be the extent of stimulation of protein synthesis rate as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism. This project will provide important clinical information, based on novel fundamental basic knowledge on the process and the specific underlying mechanisms of muscle wasting in patients with NSCLC, and the role of EAA as a potential anabolic substrate. In this way, it will provide preliminary data for the development of nutritional strategies that will prevent or even stop this process of ongoing muscle loss in NSCLC.

Eligibility Criteria:
Inclusion Criteria:

1. Recently diagnosed with Stage III (unresectable) or Stage IV lung cancer (only for the NSCLC group)
2. Ability to sign informed consent
3. Age 40 years and older

Exclusion Criteria:

1. Previous anti-cancer therapy (e.g. radiotherapy, chemotherapy) or surgery less than 4 weeks prior to the experiment.
2. Presence of fever within the last 3 days
3. Established diagnosis of Diabetes Mellitus
4. BMI \> 35 kg/m2
5. Untreated metabolic diseases including hepatic or renal disorder
6. Presence of acute illness or metabolically unstable chronic illness
7. Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
8. Diagnosis of moderate to severe chronic airflow limitation, defined as measured forced expiratory volume in one second (FEV1) ≤ 70% of referen¬ce FEV1 (only for the healthy control group)
9. Use of supplements enriched with amino acids
10. Any other condition according to the PI or study physicians would interfere with proper conduct of the study / safety of the patient
11. Failure to give informed consent
The Degree of Knowledge and Attitude of Egyptian Physicians Regarding Emergency Treatment of Traumatic Dental Injuries

This study intends to evaluate physicians' fundamental knowledge and attitude regarding the management of TDIs in Egypt. A convenience sample of physicians will be enrolled in this cross-sectional study, and they will be asked to complete a validated questionnaire. The questionnaire includes demographic questions, two case scenarios involving crown fractures and the avulsion of permanent teeth, and self-evaluation questions.

Several epidemiological studies continue to show significant levels of dental trauma in many countries. In industrialized countries, about one in five children experience a traumatic dental injury (TDI) to permanent teeth before leaving school.

Primary care providers (e.g., family physicians, pediatricians, emergency medicine physicians and nurses) can play an important role in offering primary care following dentofacial trauma, especially for rural populations with limited access to dentists.

Several global studies indicate that physicians and even pediatricians lacked the emergency management knowledge to deal with traumatic dental injuries (TDIs). Emphasizing the fact that medical students are not well educated or trained to manage TDIs.

To the best of our knowledge, no study has been conducted in Egypt to investigate physicians' knowledge and attitudes addressing traumatic dental injury.

Eligibility Criteria:
Inclusion Criteria:

Physicians who accept to participate.

Exclusion Criteria:

Physicians who refuse to participate.
Effect of Statins on the Radial Intima-media Thickness After Transradial Angioplasty

The first event of the atherosclerotic plaque formation is the accumulation of the low density lipoprotein-cholesterol (LDL-cholesterol) in to the intima of the arterial wall. After accumulation of the LDL-cholesterol, the oxidation of the LDL-cholesterol particles and recruitment of monocytes to the intima and media are the next steps. The thickening of intima-media thickness (IMT) is resulted from these initial events. The IMT can be easily measured by high-resolution ultrasonography in various arteries including carotid, brachial and radial arteries. The increased carotid IMT can be used as a non-invasive independent parameter indicating increased cardiovascular mortality. Some investigators reported increased radial IMT is associated with increased early failure of the radiocephalic arteriovenous fistula in the hemodialysis patients. Moreover, radial IMT is increased in patients underwent radial artery intervention because of denudation injury of the radial artery. Recently, the use of statin can halt the progression of the carotid IMT progression. However, it is unknown that the use of statin can prevent the progression of radial IMT after the transradial coronary intervention. The investigators want to evaluate the effect of statins on the progression of the radial IMT after the transradial intervention.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing coronary intervention via the radial artery

Exclusion Criteria:

* Contraindication to statins
* Left ventricular ejection fraction less than 30%
* Recent history of hematologic disease or leukocyte count \<3000/mm3 and/or platelet \<100 000/mm3
* Hepatic dysfunction with AST or ALT \>3 times the upper normal reference limit
* History of renal dysfunction or a serum creatinine level \>2.0 mg/dL
* Serious noncardiac comorbid disease with a life expectancy \<1 year
* Inability to follow the protocol
Micromanaging Human Sleep Physiology to Treat Sleep Apnea and Other Disorders

This study will examine whether a combination of breathing training during wake and targeted reactivation of the training during sleep can induce breathing changes during sleep and subsequent cognitive benefits during wake.

Participants with obstructive sleep apnea (who have not yet been treated for sleep apnea) will be recruited. Participants will engage in breath training for one week in their own homes and to record their sleep at home using commercially available mobile devices and subsequently have their sleep monitored for one night of polysomnography recordings plus targeted reactivation in a laboratory setting.


Eligibility Criteria:
Inclusion Criteria:

1. Right-handed, English-speaking adults, 18-60 years old who report normal hearing during sleep
2. Participants with suspected obstructive sleep apnea (OSA) (including those who have been diagnosed by a physician and those whose self-reported symptoms of OSA on the STOP-BANG questionnaire classify them as being "individuals with intermediate to high risk".
3. No report of any other sleep disorder besides OSA.
4. No report of any neurological or cardiometabolic diseases or disorders.
5. Not currently under active treatment for sleep apnea.
6. BMI ≤ 40.
Inetetamab Plus Chemotherapy ± PD-1/PD-L1 in HER2+ Advanced Biliary Cancer

To evaluate the efficacy and safety of inetetamab in combination with chemotherapy ± immunotherapy as a first-line treatment for HER2-positive advanced biliary tract cancer, providing theoretical evidence and practical guidance for further optimizing treatment regimens and improving therapeutic outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged ≥18 years;
* Histologically confirmed HER2-positive metastatic biliary tract cancer;
* ECOG performance status of 0 to 1;
* No prior treatment with anti-HER2 therapies;
* Patients have not received any systemic anticancer treatment in the recurrent/metastatic setting;
* Patients who have experienced disease recurrence more than 6 months after curative surgery; if adjuvant therapy (chemotherapy and/or radiotherapy) was received post-surgery, patients must have had recurrence more than 6 months after completion of adjuvant therapy;
* Presence of at least one measurable lesion;
* Adequate function of major organs as defined by the following criteria;
* Estimated survival of ≥3 months;
* Voluntary participation in this study, signing of the informed consent form, good compliance, and willingness to cooperate with follow-up.

Exclusion Criteria:

* Known allergy or contraindication to any component of the study drugs;
* Previous treatment with anti-HER2 therapies;
* Prior use of immunotherapy;
* Use of immunosuppressive agents within 14 days before the first dose, except:

Intranasal, inhaled, topical steroids, or local injections (e.g., intra-articular) Systemic corticosteroids ≤10 mg/day prednisone or equivalent Steroids for hypersensitivity reactions (e.g., premedication for CT scans)

* Known active central nervous system metastases or carcinomatous meningitis;
* Other malignancies within 5 years, excluding cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer;
* Major surgery or significant trauma within 4 weeks before randomization, or planned major surgery;
* Severe cardiac disease;
* Resting dyspnea due to tumor progression or comorbidities, or requiring supplemental oxygen;
* Neuropathy ≥ Grade I per NCI criteria;
* Active interstitial lung disease (ILD) or pulmonary disease requiring bronchodilators;
* History of immunodeficiency;
* Participation in another drug trial within 4 weeks before screening;
* Pregnant or breastfeeding women, or women of childbearing potential with a positive pregnancy test at screening; unwillingness to use effective contraception during and for 6 months after the study;
* Any serious concomitant illness or conditions that may interfere with the planned therapy or render participation unsuitable.
Tocilizumab Versus Baricitinib in Patients With Severe COVID-19

The aim of this study is to investigate whether baricitinib is non-inferior to tocilizumab in severe COVID-19.

Patients with COVID-19 will be assigned to one of the two arms on 1:1 ratio based on the time point that PaO2/FiO2\<200 will be observed. Patients aged 18 years or older with PaO2/FiO2 \<200 at any time during their hospitalization will be included in the analysis irrespective of values in inflammatory markers, such as CRP and ferritin. Exclusion criteria will be: age\<18 years, pregnancy, glomerular filtration rate\<30 and application of mechanical ventilation prior patients' transfer to our Hospital. Each patient or the patient's legally authorized representative provided written or witnessed oral informed consent.

Day 1 will be considered the first day that PaO2/FiO2\<200 will be identified. Treatment with either tocilizumab or baricitinib will start from day 1. Primary and secondary outcomes will be assessed in the days described below.

This study aims to investigate whether baricitinib is non-inferior to tocilizumab in patients with severe COVID-19. Two hundred fifty one (n=251) patients will be enrolled based on the following assumptions: 1) HR θ 1, 2) HR θο 1.5, 3) overall probability of event (primary end point) 0.6 (based on previous records of our hospital), 4) power 80%, 5) type I error α 5%.

Eligibility Criteria:
Inclusion Criteria:

- COVID-19, PaO2/FiO2\<200

Exclusion Criteria:

- Age\<18 years, Pregnancy, Glomerular filtration rate\<30, Application of mechanical ventilation prior patients' transfer to our Hospital