cyrilzakka/clinical-trials huggingface dataset:
Trastuzumab, Pyrotinib Combined With Dalpiciclib and Endocrine Therapy for HR +/HER2 + Advanced Breast Cancer

This study investigates the efficacy and safety of trastuzumab, pyrotinib combined with dalpiciclib and endocrine therapy for patients with advanced HR+/HER2+ brest cancer, providing more possible effective regimens for the survival benefit of these patients in clinical practice.

This study is a single-arm, open-label, multicenter, phase II clinical study. Subjects were eligible for screening and entered the trial period after enrollment and received treatment with pyrotinib（320mg/day), trastuzumab(8 mg→6mg/every 3 week), dalpiciclib(125mg once daily for 3 weeks, followed by 1 week off in each 4-week cycle), endocrine therapy until disease progression, or intolerable toxicity, or withdrawal of informed consent, or discontinuation of medication at the investigator 's discretion. On-study imaging assessments were performed according to RECIST 1.1 criteria and the site assessment was final.

Eligibility Criteria:
Inclusion Criteria:

1. Female breast cancer patients of any menopausal status aged 18-75 years.
2. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2.
3. Female breast cancer patients with HER2-positive HR-positive of recurrence or metastasis and are not suitable for surgical resection or radiation therapy with the purpose of cure.
4. ER and/or PR +: defined as positively stained tumor cells representing ≥ 10% of all tumor cells (confirmed by investigator review at the site) and HER2 +: defined as IHC 3 + or IHC 2 + and FISH +/CISH +.
5. measurable lesions by RECIST 1.1 criteria.
6. Patients' previous treatment should meet: a) prior systemic (neo) adjuvant therapy is allowed but not required, and if received, the disease-free interval (DFI) must be \> 24 months (DFI is defined as the time from surgery to the first recurrence); b) ≤ 1 line of systemic therapy for the tumor (including anti-HER2 targeted therapy, endocrine therapy and chemotherapy) is received at the metastatic stage;
7. Stable patients with brain metastases are allowed.
8. life expectancy ≥ 12 weeks.
9. adequate organ and bone marrow function.
10. adequate cardiac reserve, left ventricular ejection fraction (LVEF) ≥ 45% on echocardiogram.

Exclusion Criteria:

1. patients who are not suitable for endocrine therapy as judged by the investigator. Including symptomatic, advanced patients with disseminated visceral disease who are at short-term risk of life-threatening complications (including patients with uncontrolled large exudates \[pleural, pericardial, abdominal\], pulmonary lymphangitis and more than 50% hepatic involvement).
2. previous treatment with CDK4/6 inhibitors.
3. previous treatment with TKI.
4. visceral crisis.
5. Major surgery, chemotherapy, radiation therapy, any investigational agent, or other anticancer therapy within 2 weeks before entering the study.
6. Have been diagnosed with any other malignancy within 3 years before entering the study, except for curatively treated non-melanoma skin cancer, basal cell or squamous cell skin cancer, or cervical carcinoma in situ.
FAZA PETMRI Gastro-Oesophageal Study

This is a single arm, pilot study of PET/MRI scan with radiotracer 18F-Fluoroazomycin Arabinoside (FAZA) before and after standard of care platinum-based chemotherapy for patients with metastasized Gastro-Oesophageal Cancer.

Gastroesophageal cancer (GEC) accounted for 2,3000 deaths in Canada in 2017 and majority of the patients present or develop metastatic disease following diagnosis. These patients are treated with platinum-based chemotherapy. There is currently no biomarker that can be used to predict the therapy responses. Additionally, patients that do not respond to the chemotherapy often deteriorate rapidly and are unable to receive second line therapy. Intratumoral hypoxia (low oxygen concentration) is a signature feature of aggressive and resistant tumour phenotype. Accurately predicting hypoxia in solid tumours offers an innovative and rational pradigm for predicting therapy responses. PET/MRI is an imaging technique combining the Positron Emission Tomography (PET) scan with Magnetic Resonance Imaging (MRI) scan. A radiotracer called 18F-Fluoroazomycin Arabinoside (FAZA) is used as a type of "dye" in the PET/MRI scan.

The primary goal of the study is to validate FAZA PET/MRI as a biomarker of hyupoxia in setting of gastro-oesophageal carcinoma. Patients with GEC will undergo FAZA PET/MRI scan before and after the standard of care chemotherapy. This would be correlated with clinical outcome in patients with metastatic GEC that have different responses to chemotherapy. Ultimately, we hope that the use FAZA PET/MRI in the study can help select the most effective treatment method for advanced GEC to extend life and improve quality of life while minimizing toxicity and healthcare costs.

The study subjects' clinical management will not be changed based on the PET-MR scan within the trial.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patients with de novo or secondary metastasized gastro-oesophagesal cancer (adenocarcinoma)
* Glomerular Filtration rate\> 45 ml/min
* No allergy to contrast agents

Exclusion Criteria:

* Contraindication for MR as per current institutional guidelines
* Inability to lie supine for at least 30 minutes
* Any patient who is pregnant or breastfeeding
* Any patient unable or unwilling to provide informed consent
* Patients who are allergic to ethanol as the FAZA preparation contains ethanol
Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

The purpose of this study is to determine whether patients with metastatic breast cancer treated with margetuximab plus chemotherapy have longer progression free survival (PFS) and overall survival (OS) than patients treated with trastuzumab plus chemotherapy.

A non-randomized sub-study cohort of approximately 88 patients will be enrolled to evaluate the safety of a reduced margetuximab infusion rate in patients receiving margetuximab either as monotherapy or in combination with chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.
* Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
* Prior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
* Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
* Life expectancy ≥ 12 weeks
* Acceptable laboratory parameters
* Women of childbearing potential must have negative pregnancy test performed within 14 days of randomization and on the first day of treatment. All subjects must agree to use an effective form of contraception for the duration of study treatment and for 7 months after the last dose of study drug.

Infusion sub-study prior therapy requirements: Same as above, except:

* Must have received 4 or more prior lines or therapy in the metastatic setting
* Must have received prior trastuzumab, pertuzumab, and T-DM1

Exclusion Criteria:

* Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis must have a CT or MRI performed within 4 weeks prior to randomization to specifically exclude the presence of radiographically-detected brain metastases
* History of uncontrolled seizures within 6 months of randomization
* History of prior allogeneic bone marrow, stem-cell, or solid organ transplantation
* History of clinically significant cardiovascular disease
* Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use to maintain adequate oxygenation
* Any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the physician's choice of chemotherapy
Proprioceptive Exercises on Joint Pain and QoL Among Geriatric Patients With Knee Osteoarthritis

Knee osteoarthritis, the disease of knee joint pain caused by joint degeneration, it is the commonest joint disease and had a negative effect on geriatric patients' quality of life (QoL). Proprioceptive exercise and isometric exercise have been recommended as suitable for reducing joint pain and improvement of quality of life in the geriatric patients.

Knee osteoarthritis (OA), known as degenerative joint disease of the knee. It is most common in the geriatric and is typically the result of wear and tear and progressive loss of articular cartilage. It happens when cartilage in knee joint breaks down. When this happens, the bones in knee joint rub together, causing friction that makes knees hurt, become stiff or swell. Knee OA is a painful condition and causes exhaustion in affected patients. Patients with this illness often complain of pain, decreased muscle strength, and joint instability. In addition, increased pain in knee OA patients also progressively worsen their quality-of-life. Proprioceptive activity in patients with knee OA gets limited or reduced and leads to reduced activities of daily living (ADLs). Joint proprioception is the ability of an individual to sense the joint position and movement. It encompasses the joint motion and joint position so proprioceptive exercises are being used for the strengthening of muscles around the knee joint. Thus, proprioceptive exercises are recommended exercise which significantly improved pain in knee OA patients which as results lead to improve quality of life. Quadriceps strengthening has been an important component of exercise program of knee osteoarthritis. This is because quadriceps weakness is the most presented finding among people with knee osteoarthritis. An isometric exercise is a form of exercise involving the static contraction of a muscle without any visible movement in the angle of the joint which lead to reduce joint pain and improving QoL in geriatric patients with knee osteoarthritis. The study sample (70) geriatric patients received proprioceptive exercises only, while the control group (70) geriatric patients received routine exercise (Isometric exercise) only.

Eligibility Criteria:
Inclusion criteria:

* Geriatric patients aged 60 years and above diagnosed with knee OA.
* Male and female geriatric patients.
* Alert and able to communicate.
* Mild and moderate knee OA (based on X-rays)

Exclusion criteria:

* Patients with advanced knee OA.
* Patients with end stage organ failure.
* Patients with cognitive impairment who will not be able to take active part in the study.
* Patients with neurological impairment or physical disability that interfere with their participation in the study.
* Patients with uncontrolled medical conditions.
Effects of Acute Grape Seed Extract Supplementation on Muscle Metaboreflex in Healthy Young Individuals

The aim of this study was to determine whether grape seed extract (GSE) supplementation could reduce the blood pressure (BP) in response to static exercise and post exercise muscular ischemia (PEMI) in normotensive young adults. In 12 healthy subjects (7 male and 5 female, 24.6±3.4 yr), we compared acute effect of both GSE (600 mg) and placebo (PL: 600 mg) on changes from rest in systolic BP (SBP), diastolic BP (DBP), mean arterial pressure (MAP), heart rate (HR), stroke volume (SV), cardiac output (CO), and total peripheral resistance (TPR) during static exercise (SE) and PEMI. Subjects completed 2 min of SE at 30% of maximal voluntary contraction (MVC) followed by 2 min of PEMI.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers (SBP \< 120 mmHg, DBP \< 80 mmHg)

Exclusion Criteria:

* cardiovascular and/or pulmonary disease,
* musculoskeletal disorders
* medications that prevent the safe completion of the exercise protocol
National Tunisian Registry of Percutaneous Coronary Intervention

The National Tunisian Registry of Percutaneous Coronary Intervention is an observational, prospective and multicenter study aiming to assess coronary intervention strategies in tunisian departments of cardiology. Cardiologists from both sectors (public and private) are participating in the study, with 37 investigational centers. Data will be captured electronically by DACIMA Clinical Suite, according to FDA 21 CFR part 11 (Food and Drug Administration 21 Code of Federal Regulations part 11), HIPAA (Health Insurance Portability and Accountability Act) \& ICH (International Conference on Harmonisation) requirements.


Eligibility Criteria:
Inclusion Criteria:

* Tunisian patient needing PCI (Percutaneous Coronary Intervention) at the enrollment period
* Informed and signed consent

Exclusion Criteria:

* Withdrawn consent
Comparison of Dendritic Cells Versus Montanide as Adjuvants in a Melanoma Vaccine

In this study, a melanoma vaccine (5 melanoma peptides) is given with either Montanide or dendritic cells as adjuvants. This randomized trial will establish the safety of both vaccines and compare the 2 vaccine adjuvants in their efficacy to induce immune responses.

In this study, we will examine whether DCs pulsed with candidate melanoma-specific peptides and KLH can boost CTL responses to melanoma antigens in melanoma patients who are clinically free of disease but at high risk for recurrence. This vaccine will be compared to direct injection of the same peptides with KLH and Montanide as adjuvant.

Eligibility Criteria:
Inclusion Criteria:

* Resected stage IIB, IIC, or stage III melanoma.
* Fully recovered from surgery
* Human leukocyte antigen (HLA) A\*0201 positive.
* Age \>18 years.
* Karnofsky performance status: \>80% and normal labs.

Exclusion Criteria:

* Prior chemotherapy.
* Known chronic infection with HIV, hepatitis B or C.
* Patients with known autoimmune disease \[e.g. systemic lupus erythematosus (SLE), rheumatoid arthritis (RA)\]. Patients with vitiligo are not excluded.
* Pregnant women.
* Patients with known allergy to gentamicin, tobramycin, streptomycin and amikacin (risk of cross-reaction between aminoglycosides).
* Patients who have known retinal or choroidal eye disease.
* Patients previously treated with one of the peptides used in this trial, melanoma protein vaccine, melanoma whole cell vaccines, or with Montanide are not eligible.
* Allergy to shellfish.
Minimal Occlusive Pressure With Cuffed ETTs: The Effect of 3 Different Sizes of cETT on Intracuff Pressure in Children

Based on standard and historical practice, the predictive size of the endotracheal tube (ETT) to be used in children has been based on various formulas. However, no study has clearly compared these formulas to determine the optimal size of cuffed ETTs. Furthermore, they were developed when using a polyvinylchloride cuff and not the thinner polyurethane cuff which is in common clinical use today. Hence, the purpose of this current study is to evaluate which of the currently available formulas most closely predicts the appropriate size of cuffed ETT to be used based not only on the fit within the trachea, but more importantly the intracuff pressure after the cuff is inflated to seal the airway.


Eligibility Criteria:
Inclusion Criteria:

* Children who are less than 8 years of age and are scheduled for surgical procedures requiring endotracheal intubation with a cuffed ETT.

Exclusion Criteria:

* Children with airway anomalies or other factors that may impact tracheal size will be excluded from the study.
the Thickness of the Muscles and Pain in Impingement Syndrome

Pain intensity will be measured with visual analog scale. Sonographic severity grade of shoulder impingement syndrome, serratus anterior muscle, upper trapezius and middle trapezius will be measured with USG in patients diagnosed with impingement and meeting the criteria and healthy volunteers.

Patients diagnosed with impingement and meeting the criteria will be included, while the healthy group will consist of hospital staff who do not have shoulder pain and who are not diagnosed with a shoulder-related disease. Pain intensity will be measured with VAS (visual analog scale), the sonographic severity grade of shoulder impingement syndrome, the serratus anterior muscle, the upper trapezius and the middle trapezius will be measured with USG.

Eligibility Criteria:
Inclusion Criteria:

* 18-65 years
* Cognitive ability to understand test instructions
* Symptom duration longer than 1 month
* At least two positive Neer, Hawkins and painful arch tests

for healty volunteers

* 18-65 years
* cognitive ability to understand test instructions
* negative impingment test

Exclusion Criteria:

* Fibromyalgia
* cervical radiculopathy
* those who have received injections or physical therapy in the last month
* Those with a disorder that may affect shoulder joint range of motion and muscle mass (previous fracture, surgery, subluxation)
* BMI over 35
* inflammatory disease
Do Terpenes Play a Role in the Stress-reducing Effects of a Forest Bathing Intervention?

This pilot study evaluates the role terpenes play in the stress-reducing effects of a forest bathing intervention. Participants will participate in two interventions in random order: 1) terpene exposure and 2) no terpene exposure.

The investigators will use an individual-level crossover design in which each session is conducted independently and on different days. Participants will be outfitted with a powered air purifying respirator (PAPR) to selectively modulate exposure to a natural suite of forest-derived volatile organic compounds (VOCs) while present in forest environments. Each participant will undergo two forest bathing sessions, one in which VOCs are not filtered (treatment condition), and one in which they are filtered (control condition). Sessions will be separated by a washout period of at least 8 days for each participant, and order will be counterbalanced. The investigators will estimate the average effect of treatment over 40 distinct treatment days against 40 distinct control/filtered days. The power and sample size calculations (N = 40) were determined using previous nature exposure studies of similar cross-over design. The study is adequately powered assuming the conventional targets of α = 0.05 and β = 0.80 with a 10% anticipated dropout rate, and including temperature, wind, and light variability during treatment days.

The specific aim of this project is to 1) assess whether VOC inhalation regulates increases in the high frequency (HF) (ms2) component of heart rate variability (HRV) as the primary outcome (with decreases in blood pressure, heart rate, self-reported stress, and levels of inflammatory cytokines in serum included as secondary outcomes); and 1a) assess the degree of association of absorbed dose of six forest-derived VOCs (i.e., α-pinene, β-pinene, β-myrcene, Δ-3-carene, limonene, β- carophyllene) in serum with these outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Non-smoker
* Physically capable of walking for approximately 15-20 min from the study vehicle to the clinic and experimental locations.

Exclusion Criteria:

* Pregnancy
* Current or prior diagnosis of neurologic, hypertensive, psychiatric, respiratory disorder, or anosmia/hyposmia
* Some types of medication.
* Olfactory sensitivity threshold (assessed via UPSIT® test kit (Sensonics International, Haddon Heights, NJ)

At enrollment, participants will complete a baseline survey on demographics, personality traits, and regular nature contact and perceptions. Study staff will also use the clinically-validated UPSIT® test kit (Sensonics International, Haddon Heights, NJ) to evaluate olfactory sensitivity and identify/exclude participants with undiagnosed smell loss.

Study staff will work with participants to schedule their forest bathing sessions and review instructions on how to prepare (e.g., by avoiding alcohol, marijuana, and certain foods, drinks, and household cleaning products with high terpene concentrations 24 hrs before their session).
Postoperative Conformal Radiotherapy for Stage II-III B Type Thymoma

The purpose of this study is to determine whether postoperative conformal radiotherapy are effective in the treatment of Masaoka stage II-III B type thymoma.

The role of postoperative radiotherapy in thymoma is controversial. Some retrospective studies were for the radiotherapy, but others were against. However, more inherent biases existed in these trials. Resection, Masaoka stage and pathology were widely accepted as the prognostic factors for thymoma. Furthermore, the frequency of local failure after radical resection was still high in Masaoka stage II-III B type thymoma. With the conformal technique appearing, conformal radiotherapy can escalate the dose without increasing the risk of normal tissue toxicities.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-75, Zubrod-ECOG-WHO 0-2, the interval of surgery to radiotherapy \< 2months, Masaoka stage II-III and WHO B type thymoma

Exclusion Criteria:

* No second primary tumor, no serious comorbidity, no neoadjuvant anticancer treatment, no adjuvant chemotherapy.
Dermacyd Delicata Pocket BR - Photo Evaluation

The purpose of this study is to prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Delicata Pocket BR.


Eligibility Criteria:
Inclusion Criteria:

* Phototype Skin II and III
* Integral skin test in the region

Exclusion Criteria:

* Lactation or gestation;
* Use of Antiinflammatory and/or immunosuppression drugs 15 days before the selection
* Diseases which can cause immunity decrease, such as HIV, diabetes
* Use of drug photosensitizer
* History of sensitivity or irritation for topic products
* Active cutaneous disease which can change the study results
* History or photodermatosis active
* Family or personal antecedent of cutaneous photoinduced neoplasias
* Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium
* Intense solar exposure in the study area
* Use of new drugs or cosmetics during the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.