cyrilzakka/clinical-trials huggingface dataset:
PD-1 Antibody SHR-1210 Combined With Apatinib of First-line Treatment of Advanced Acral Melanoma

the investigators launched this exploratory study to evaluate the objective response rate (ORR) of SHR-1210 combined with apatinib mesylate in the first-line treatment of patients with advanced acral melanoma.


Eligibility Criteria:
Inclusion Criteria:

1. age:18-75 years, male or female.
2. Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV).
3. Has not received any systematic anti-tumor drug treatment.
4. Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
5. ECOG 0-1.
6. Adequate organ function.
7. Life expectancy of greater than 12 weeks.
8. Patient has given written informed consent.

Exclusion Criteria:

1. Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy.
2. Known history of hypersensitivity to macromolecular protein preparation or any components of the SHR- 1210 formulation.
3. Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ);
4. Subjects with any active autoimmune disease or history of autoimmune disease
5. Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention;
6. Active infection or an unexplained fever \> 38.5°C during screening or before the first scheduled day of dosing (subjects with tumor fever may be enrolled at the discretion of the investigator);
7. Received a live vaccine within 4 weeks of the first dose of study medication.
8. Pregnancy or breast feeding.
9. Decision of unsuitableness by principal investigator or physician-in charge.
Potential Acceptance of COVID-19 Vaccines in Healthcare Workers in Egypt

The COVID-19 pandemic is expected to remain as a public health threat and economic burden all over the world. The available proposed vaccines are still lacking large randomized controlled trials testing its efficacy and safety. Thus, the acceptance of vaccination between citizens as well as healthcare workers is not guaranteed. As the vaccine is starting to be distributed the acceptance of healthcare givers should be measured as they are usually the front line facing the problem and they have a responsibility to explain the need of immunization to the rest of population.

Strategies to enhance the acceptance and trust of the available vaccines may be needed.


Eligibility Criteria:
Inclusion Criteria: Healthcare workers

-

Exclusion Criteria:

* None healthcare workers
Tamoxifen-RAD001 Versus Tamoxifen Alone in Patients With Anti-aromatase Resistant Breast Metastatic Cancer

Tamoxifen is a classical treatment for breast metastatic cancer after 3rd generation anti-aromatase hormonotherapy in adjuvant or in metastatic line. The Tamoxifen efficacy is lowered by the hormonoresistance mechanisms due to the primary use of the anti-aromatases. The Pi3K-AKT-mTor pathway is frequently associated to the hormonoresistance mechanisms. This study is aimed to check if the inhibition of this signal transduction pathway by a synthetic mTor inhibitor (Everolimus) could improve the efficacy of the Tamoxifen.


Eligibility Criteria:
Inclusion Criteria:

* Menopausal female patient aged \> 18 years
* Histologically proven breast adenocarcinoma
* ER and/or PR positive receptors and HER2 negative
* previously received first or second line of hormonotherapy for metastatic disease
* previously treated with anti-aromatase in adjuvant and/or in metastatic line
* presence of one or several mesurable or evaluable metastatic lesion(s)
* presence of at least one target lesion not previously irradiated
* ECOG Performance status \< 2
* adequate biological values
* patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion Criteria:

* patient with only local metastatic disease that can be treted by surgery
* uncotrolled brain metastases, pulmonary carcinomatosal lymphangitis, hepatic metastases
* Previous treatment by Tamoxifen unless in adjuvant and terminated more than a year before metastatic relapse
* Patient with a tumor surexpressing HER2 that should be treated by trastuzumab
* Patient that need an immediate local antalgic radiotherapy
* Thrombo-embolism disease
* serious concomitant pathology or uncontrolled that is susceptible to compromise the participation in the study
* history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin) and cancers cured for at least for 5 years
* patient with an history of significant cardiovascular impairment (congestive heart failure\> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia)
* patient with any medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude her from participating in this study
* patient with a known allergy to one or several of the study compounds
* patients who may not be regularly available due to geographical, social or family reasons
* history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product
* deficiencies of the upper intestinal tract, malabsorption syndrome
* patient who is pregnant, breast-feeding or using inadequate contraception
* Treatment with experimental drugs (mTor inhibitor or tyrosin kinase inhibitor)
* Patient treated with molecules that interfer with isoenzyme CYP3A
This is a Randomized Study of Early Involvement of Palliative Care Along Side Standard Treatment Versus Standard Treatment Alone in Newly Diagnosed Patients With Advanced or Metastatic Soft Tissue Sarcoma (SARQUALITY)

The goal of this study is to learn whether early referral to palliative care improves quality of life for patients with advanced sarcoma.

Participants enrolled in this study will complete quality of life questionnaires before starting their treatment, and every 6 weeks for 24 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Signed written and voluntary informed consent.
* Have histologically documented advanced sarcoma, either locally advanced not amenable to curative treatment, or metastatic.
* Age ≥ 18 years.
* Have not received any previous systemic treatment with palliative intent for advanced sarcoma.
* Performance status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance scale.
* Life expectancy \> 6 months.
* Willing/able to complete questionnaires.

Exclusion Criteria:

* Clinical evidence of cognitive impairment that would preclude the ability to provide informed consent and complete questionnaires, at investigator´s discretion.
* Patient in need of urgent home support services or symptom management through a palliative care team.
* Patient is being actively followed by a palliative care physician.
* Active psychiatric disorder or drug abuse.
* Insufficient English literacy to complete questionnaires.
Fluoxetine for the Modification of Colorectal Tumor Immune Cells Before Surgery in Patients With Colorectal Cancer

This phase I trial tests whether fluoxetine (prozac) works to modify the tumor immune cells before surgery in patients with colorectal cancer. Fluoxetine is a commonly used selective serotonin reuptake inhibitor (SSRI) prescribed for major depressive disorder and generalized anxiety. Giving fluoxetine may modify the immune cell composition in the tumor and its microenvironment and may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread in patients with colorectal cancer.

PRIMARY OBJECTIVE:

I. To evaluate alterations in tumor immune cell composition and activity under SSRI treatment.

OUTLINE:

Patients receive fluoxetine orally (PO) once daily (QD) for 10 days prior to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age at visit 1
* Previously untreated cytologically or histologically confirmed colorectal adenocarcinoma that will not need neoadjuvant therapy
* Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
* World Health Organization (WHO) Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Absolute neutrophil count (ANC) ≥ 1.5x10\^9/L
* Platelets ≥ 100x10\^9/L
* Hemoglobin ≥ 9 g/dL
* Serum creatinine (sCr) ≤ 1.5 x upper limit of normal (ULN)
* Creatinine clearance (Ccr) ≥ 40 mL/min (as calculated by Modified Cockcroft-Gault formula)
* Serum total bilirubin ≤ 1.5 x ULN
* Aspartate aminotransferase (AST)(serum glutamic-oxaloacetic transaminase \[SGOT\]) / alanine aminotransferase (ALT)(serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x ULN
* Baseline corrected QT (QTc) within normal limits per the Bazett formula. Any electrocardiogram (EKG) done prior to consent is acceptable for baseline QTc monitoring.

  * Normal QTc ranges from 350-450 ms for adult men and from 360-460 ms for adult women

Exclusion Criteria:

* Presence of a condition or abnormality that in the opinion of the investigator would compromise the safety of the participant or the quality of the data
* A diagnosis of metastatic colorectal adenocarcinoma
* Individuals who have received neoadjuvant chemotherapy prior to the planned colon cancer resection
* Individuals with absolute or relative contraindications to fluoxetine

  * Baseline prolonged QTc
  * Concurrently taking tamoxifen, pimozide, or thioridazine
* Individuals using other SSRIs, serotonin and norepinephrine reuptake inhibitors (SNRIs), monoamine oxidase inhibitors (MAOIs), lithium or other antidepressants at time of initial biopsy
* Currently active second primary malignancy or history of malignancy less than 5 years prior to the time of study eligibility (Patients with history of skin cancers excluding melanoma will be eligible for participation)
Study of SIM0500 Alone in Participants With Relapsed or Refractory Multiple Myeloma

This is an open-label, multicenter phase 1 clinical trial to evaluate the safety and tolerability, efficacy, and pharmacokinetics of SIM0500 in adult participants with Relapsed or Refractory Multiple Myeloma(RRMM). The trial is consisted of two parts, Part 1 (dose escalation) and Part 2 (dose optimization). In both parts, SIM0500 will be administered until disease progression, intolerable toxicity, withdraw of consent or end of trial.


Eligibility Criteria:
Inclusion Criteria:

1. Voluntary participation and signature of informed consent form.
2. ≥18 years of age.
3. Have documented diagnosis of relapsed or refractory multiple myeloma according to Criteria for Response to Multiple Myeloma Treatment(IMWG)diagnostic criteria who have failed all established standard of care.
4. Life expectancy ≥12 weeks.
5. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
6. Adequate hematologic, hepatic, and renal function.

Exclusion Criteria:

1. Toxicities from previous anticancer therapies should have resolved to baseline levels or to Grade 1 or less except for alopecia or peripheral neuropathy.
2. Active hepatitis B (HBsAg positive and HBV DNA ≥ 1×104 copies/mL or ≥ 2,000 international unit \[IU\]/mL) or hepatitis C (HCV antibody positive and HCV RNA ≥ ULN) infection; participant with HBsAg positive or detective HBV-DNA at screening should receive antiviral treatment as per local practice during the trial.
3. Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS).
4. Participant is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial.
5. Active known or suspected autoimmune disease. Participants with vitiligo, residual hypothyroidism only requiring hormone replacement, psoriasis not requiring systemic treatment or conditions not expected to recur in the absence of an external trigger, type 1 diabetes mellitus (blood glucose can be controlled by insulin therapy) can be included.
6. Current or previous other malignancy within 3 years of study entry, except basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the prostate, cervix or breast.
7. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.
8. Participants with known active infection within 14 days prior to the first SIM0500.
Development of Problem-solving Skills Among Female Adolescents by Application of Social Cognitive Theory in Parent-Child Relationship

Adolescence is the most important period of growth for humans. The conflict and disagreement which exists within family relationships will affect the children behaviors. Family relationships are the cause of many problems in adolescents, to develop a training program on problem-solving skills for adolescent girls to change their relationship with their parents.


Eligibility Criteria:
Inclusion Criteria:

* female secondary schools
* healthy body,
* not having a psychiatric disorder

Exclusion Criteria:

* psychiatric disorder
* not being volunteer to participate in the present study.
A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension

This study assessed the blood pressure effect, safety and tolerability of LCI699 compared to placebo and eplerenone in participants with resistant hypertension.


Eligibility Criteria:
Inclusion criteria:

* Diagnosis of hypertension with mean sitting systolic blood pressure (MSSBP) ≥140 millimeters of mercury (mmHg) and \<180 mmHg
* Stable on a three-drug regimen (including a diuretic) for at least 4 weeks for the treatment of resistant hypertension
* Male and female participants 18 to 75 years of age

Exclusion criteria:

* Recent history of myocardial infarction (MI), heart failure, unstable angina, coronary artery bypass graft, percutaneous coronary intervention, hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack
* Clinically significant electrocardiography (ECG) findings related to cardiac conduction defects
* Type 1 diabetes or uncontrolled type 2 diabetes (haemoglobin A1c \[HbA1c\] \>9%)
* Malignancies within the last 5 years (excluding basal cell skin cancer)

Other protocol-defined inclusion/exclusion criteria may apply.
Remifentanil Requirement for Acceptable Intubating Condition

Ketamine and opioid are known to improve the intubating condition, respectively. Combination of ketamine and opioid potentiate analgesic effect and give hemodynamic stability in complementary manner. Therefore, the combination use of ketamine and remifentanil could be useful for acceptable intubating condition in the general anesthesia without the use of neuromuscular blocking agent. Generally, induction dose of ketamine ranges between 1 and 2 mg. There was no report about the optimal dose of remifentanil with 1 or 2 mg ketamine induction dose for intubation without neuromuscular blocking agent. The investigators focus on remifentanil dose using Dixon's up and down method.


Eligibility Criteria:
Inclusion Criteria:

* ASA I-II
* Undergoing general anesthesia with endotracheal tube

Exclusion Criteria:

* Anticipated difficult airway
* Patient with upper respiratory infection within 14 days
* Asthma
Tablet-based Cognitive Behavioral Intervention for Older Adults With Arthritis Fatigue

The purpose of this project is to pilot test a long-term effect of Tab-G (tablet-based cognitive behavioral group education intervention). The investigators will evaluate the effect of Tab-G, relative to usual care group, on (a) daily steps, (b) fatigue level, (c) self-efficacy and (d) quality of life.

Tab-G participants will receive 4 weekly CBT-based group education focusing on shared goal setting and mutual reinforcement in a group with 5 members. The outcomes will be measured baseline, week 4 (intervention completion) and week 8 (follow-up). The investigators hypothesize that older adults receiving Tab-G will have greater improvements on outcomes compared to those receiving usual care at week 4, the intervention completion and at week 8 follow-up.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosis of osteoarthritis or rheumatoid arthritis;
2. presence of greater than minimal fatigue scoring ≥13 (T-score\>55) on the Patient Reported Outcomes Measurement Information System (PROMIS) Short Form (SF) v1.0-Fatigue 6a; and
3. having Wi-Fi at home

Exclusion Criteria:

1. currently engaging in regular exercise;
2. non-ambulatory or presence of a condition that would limit the ability to walk (e.g., foot deformity, lower extremity joint surgery in past 6 months, stroke, severe chronic obstructive pulmonary disease, etc.); and
3. delirium, dementia, or any conditions indicating deteriorating cognitive status as determined by the Mini-Cog.
Vitamin D Deficiency and Effect of Its Supplementation on Interstitial Lung Diseases(ILD).

This study evaluates serum level of Vitamin D in Interstitial Lung Diseases in patients with Interstitial Lung Diseases other than connective tissue diseases associated-Interstitial Lung Diseases and effects of its supplementation.

All patients will receive the standard regimen of treatment (corticosteroids and immunosuppressive drugs)and will be randomly assigned to either Group 1:who will receive Vitamin D supplementation (Interventional group)or Group 2:who will not receive Vitamin D supplementation(Control group).

Pulmonary fibrosis was due to chronic inflammation and disordered wound healing in response to damage induced by a variety of agents such as viral infection and radiotherapy or environmental toxins.it is characterized by accumulation of myofibroblasts and excessive deposition of the extracellular matrix.Epithelial cells undergoes epithelial mesenchymal transition (EMT).

Supplementation with vitamin D or its analogs suppresses lung fibrosis via triggering anti-fibrotic effect through attenuation of transforming growth factor beta (TGF-B).vitamin D can reduce TGF-B expression and attenuate TGF-B induced epithelial mesenchymal transition in lung fibroblast and epithelial cells.

Eligibility Criteria:
Inclusion Criteria:

patients who will be diagnosed as interstitial lung disease by multidisciplinary approach based on clinical, functional, radiological and pathological diagnosis when needed.

Exclusion Criteria:

* Patients who have other diseases affecting Vitamin D levels like chronic liver diseases, chronic kidney diseases and malignancy.
* patients who will be unable to do pulmonary functions or 6-minutes walk test.
* patients with ischemic heart diseases and congestive heart failure.
* patients with connective tissue-associated interstitial lung diseases.
* interstitial lung diseases exacerbation.
Efficacy and Safety of Relaxin for the Treatment of Acute Heart Failure

Different doses of relaxin will be compared to placebo to determine efficacy and safety for the treatment of patients hospitalized with acute heart failure

This is an international, randomized, double-blind, placebo-controlled, Phase II/III trial of intravenous recombinant relaxin for the treatment of signs and symptoms in patients hospitalized for acute decompensated heart failure. The Phase II pilot study has completed; the Phase III main portion of the trial is ongoing.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized for acute heart failure
* Dyspnea at rest or with minimal exertion
* Pulmonary congestion
* Able to provide informed consent
* Systolic blood pressure \> 125 mmHg
* Impaired renal function defined as an eGFR of 30-75 mL/min/1.73m2

Exclusion Criteria:

* Use of other IV therapies for acute heart failure
* Fever or sepsis
* Recent major neurologic event
* Recent major surgery
* Recent acute coronary syndrome
* Other recent investigational drug use
Effectiveness of Three Executive Function Interventions on Direct and Far Transfer in Chilean School Children

Executive functions (EF) are a set of effortful cognitive processes that allow children to control their thoughts, emotions, behaviors, update information in their memory and be mentally flexible. The literature shows that the development of EF is essential for school success, in addition to being an important predictor of quality of life in adulthood. As a result, numerous interventions have sought to stimulate EF development through different programs and formats, typically reporting moderate effectiveness in improving core EF components. However, evidence for effects on untrained, domain-specific areas, such as academic performance, is less consistent. One explanation for these mixed findings may lie in the heterogeneity of interventions and participant characteristics; particularly regarding the modality of the intervention (e.g., using digital media versus traditional media) and children's stage of development. Although the current literature suggests these factors moderate intervention efficacy, there is a lack of randomized controlled trials that compare these variables within a single design. To address this gap, a randomized controlled study has been proposed, aimed at examining an EF intervention delivered in one of three modalities-traditional (paper-and-pencil), digital (computer-based), and mixed-in low-income, urban Chilean school children at two developmental stages (5-6 years and 9-10 years). Each program will target core EF components and measure both efficacy in EF improvement and outcomes in literacy and math skills. By contrasting these intervention modalities across distinct age groups, this study seeks to identify whether developmental level and format have moderating effects on EF improvement and academic performance. Our findings will contribute to ongoing debates about the best practices for EF stimulation, potentially informing evidence-based interventions that can be scaled or adapted for children at different developmental stages and in under-resourced settings. In doing so, this research seeks to clarify how, when, and for whom EF interventions yield lasting benefits beyond immediate cognitive skills.


Eligibility Criteria:
Inclusion Criteria:

* Schools must be classified by the Chilean government as being public elementary schools located in an urban setting, with a proportion of vulnerability of at least 70% or greater (index for socioeconomic status). Schools also must contain at least one kindergarten class.
* For participants, the children must be regularly attending either kindergarten, or the fourth or fifth grade.

Exclusion Criteria:

* Schools that are considered rural, private or subsidized are not eligible. Additionally, schools that have a vulnerability index of less than 70% are not eligible.
* For participants, children with an intellectual disability, or are unable to understand and speak Spanish, will be excluded from the data analysis.
Polymorphonuclear Cells' Sensitivity to Aggregatibacter Actinomycetemcomitans Bacteria in Patients With Aggressive Periodontitis

aggressive periodontitis is an inflammatory disease which damage the teeth supporting structures mostly in young patients. and has genetic basis.

a specific bacteria: Aggregatibacter actinomycetemcomitans (Aa) is associated with this disease, and found to damage leukocytes by using a specific leukotoxin.

in the research the investigators are aiming to find molecular and immunological basis to aggressive periodontitis.


Eligibility Criteria:
Inclusion Criteria:

* patients in periodontal department
* healthy
* diagnosed with chronic/aggressive periodontal disease
* interested in participating the research

Exclusion Criteria:

* diagnosed with diabetes, heart disease, immunosuppression, thrombocytopenia, clotting enzyme deficiency.
* using alcohol, or drugs
* pregnancy