cyrilzakka/clinical-trials huggingface dataset:
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer

The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer. Participants must have hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) breast cancer and must live in India. For each participant, the study could last up to eight months and may include up to eight visits to the study center.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer
* Have locoregionally recurrent disease not amenable to resection or radiation therapy with curative intent or metastatic disease
* Have postmenopausal status
* Have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have adequate organ function
* Have discontinued previous cytotoxic therapies, biological agents, investigational agents, and radiotherapy
* Are able to swallow oral formulation

Exclusion Criteria:

* Have visceral crisis, lymphangitic spread, or leptomeningeal carcinomatosis.
* Have clinical evidence or history of central nervous system metastasis.
* Have received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, everolimus, or any cyclin-dependent kinase (CDK) 4 \& 6 inhibitor.
* Have received recent (within 28 days prior to study intervention) live vaccination (for example, yellow fever). Seasonal flu vaccinations that do not contain a live virus are permitted.
* Have a personal history of presyncope or syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
* Have inflammatory breast cancer or a history of any other cancer (except nonmelanoma skin cancer or carcinoma in-situ of the cervix), unless in complete remission with no therapy for a minimum of 3 years.
* Have received an autologous or allogeneic stem-cell transplant
* Have clinically relevant active bacterial or fungal infection, or detectable viral infection (for example, human immunodeficiency virus or viral hepatitis). Screening is not required for enrolment.
* Are pregnant or breastfeeding.
Safety & Tolerability Study That Compares Restylane to Restylane With Lidocaine While Correcting Wrinkles in the Nasolabial Folds

Safety \& tolerability study that compares Restylane to Restylane with Lidocaine (Restylane-L) while correcting wrinkles in the area around your nose.

A Randomized, Double-Blind Study Comparing Safety and Tolerability of Restylane® With and Without Addition of 0.3% Lidocaine HCL During Correction of Nasolabial Folds

Eligibility Criteria:
Inclusion Criteria:

* Subjects seeking augmentation therapy for correction of bilateral NLFs
* Same WSRS score at both NLFs (either both Moderate \[3\] or both Severe \[4\])
* Subjects willing to give written informed consent to participate in the study
* Women of childbearing potential willing to use an acceptable form of birth control during the study period

Exclusion Criteria:

* Active or chronic skin disease, inflammation or related conditions, near or on the NLFs
* Subjects who had undergone procedures based on active dermal response e.g., laser or chemical peeling procedures) within 6 months prior to study entry
* Use of any facial tissue augmenting therapy with non-permanent filler or aesthetic facial surgical therapy within 9 months prior to study entry
* Permanent implant placed in the NLF area
Turkish Validity and Reliability Study of Pediatric Anesthesia Satisfaction Scale

Strategies to increase patient satisfaction have a positive effect on clinical care. Therefore, evaluation of emotional and psychological satisfaction and satisfaction can increase the quality of anesthetic care. The number of satisfaction evaluation studies, especially for pediatric patients who have undergone surgery, is very few, and the validity and reliability of the existing satisfaction scoring systems in the Turkish population has not yet been established. As a result of this study, it will be possible to use a Turkish validity and reliability scale that can evaluate the satisfaction levels of pediatric patients and parents after anesthesia, which is planned to be developed, to be used in the studies of improving health services, increasing the quality of the hospital, and using it in scientific studies by researchers and academicians in Türkiye.The aim of this study is to conduct a Turkish validity and reliability study by examining the reliability, validity, acceptability and reproducibility of a pediatric patient and parent satisfaction questionnaire previously validated in English.

The research data will be realized by the face-to-face filling of the Turkish version of the pediatric anesthesia satisfaction scale, which has been published in the literature, by the child and their parents.

The Turkish version of the scale in question will be asked to fill out the questionnaire within the first hour of being transferred from the operating room to the pediatric surgery service after the surgery/surgical procedure for all parents who have been operated by Yozgat Bozok University Research and Practice Hospital Pediatric Surgery. The delivery of the questionnaire and its face-to-face filling process will be carried out by an anesthesiologist (specialist or specialist student) different from the relevant anesthesiologist, who is responsible for the outpatient evaluation of the patient and the anesthesia management in the peroperative period, so that the respondent is not affected by any embarrassment, intentional reasons, etc.


Eligibility Criteria:
Inclusion Criteria:

1. Speaking Turkish of the child patient and the parent
2. Absence of any known psychiatric disease
3. Agreeing to participate in the study (patients and parents with cognitive development who can give consent)

Exclusion Criteria:

1. Having any known psychiatric disease of the child patient or parent
2. Having a history of drug use that will affect the cognitive functions of the child patient or parent
3. Parent's refusal to participate in the study (patients and parents with cognitive development who can give consent)
4. Child patient or parent does not know Turkish
Lenalidomide and Sintilimab for Relapsed/Refractory NK/T-cell Lymphoma

The purpose of this study is to evaluate the efficacy and safety of Sintilimab in combination with lenalidomide in the treatment of Relapsed/Refractory NK/T-cell lymphoma patients who failed pegaspargase-based regimens.

Pegaspargase is the backbone of treatment for NK/T-cell lymphoma (ENKTCL), and patients with ENKTCL who failed pegaspargase-based regimens have extremely poor survival outcomes. Previous study has confirmed the efficacy of anti-PD-1 antibodies (including pembrolizumab or sintilimab). Constitutive activation of NF-kB pathway has been demonstrated to be involved in the development of ENKTCL and plays critical role in therapy resistance. Lenalidomide, an immuno-modulatory drug, has been found to inhibit NF-kB pathway, and synergize with anti-PD-1 antibody in the treatment of multiple myeloma. Thus, we hypothesize that the combination of lenalidomide and sintilimab will further deepen the remission status and benefit patients who failed pegaspargase-based regimens.

Eligibility Criteria:
Inclusion Criteria:

* Histopathology and immunohistochemistry confirmed diagnosis of NK/T-cell lymphoma according to WHO 2016 criteria.
* Previously treated with pegaspargase-based regimens (refractory or relapsed after initial remission).
* PET/CT or CT/MRI with at least one objectively evaluable lesion.
* General status ECOG score 0-3 points.
* The laboratory test within 1 week before enrollment meets the following conditions:

Blood routine: Hb\>80g/L, PLT\>50×10（9）/L. Liver function: ALT, AST, TBIL ≤ 2 times the upper limit of normal. Renal function: Cr is normal. Coagulation : plasma fibrinogen ≥ 1.0g / L. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.

* Sign the informed consent form.
* Voluntary compliance with research protocols, follow-up plans, laboratory and auxiliary examinations.

Exclusion Criteria:

* Patients with a history of pancreatitis.
* Active infection requires ICU treatment.
* Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are not excluded.
* Serious complications such as fulminant DIC.
* Significant organ dysfunction: such as respiratory failure, NYHA classification ≥ 2 chronic congestive heart failure, decompensation Hepatic or renal insufficiency, high blood pressure and diabetes that cannot be controlled despite active treatment, and cerebral vascular thrombosis or hemorrhagic time within the past 6 months.
* Pregnant and lactating women.
* Had a history of autoimmune diseases, and disease was active in the last 6 months, and was still taking oral immunosuppression in the past three months.
* Those who were known to be allergic to drugs in the study regimen.
* Patients with other tumors who require surgery or chemotherapy within 6 months.
* Other experimental drugs are being used.
The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers

The purpose of this study is to study the effects of 8 weeks of treatment with mirtazapine on alcohol consumption in alcohol high consuming men. This study is a randomized, double-blind placebo controlled clinical trial with parallel group design(N=59).


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years of age
* male sex
* alcohol high consumption
* signed informed consent

Exclusion Criteria:

* psychiatric disorders (except nicotine and alcohol dependence)
* severe somatic disorders
* inadequate knowledge of the Swedish language
Jointly Managing JIA Online: An Internet-based Psycho-educational Game for Children With JIA and Their Parents

Arthritis in children is a long-term illness and it can make a child's life very difficult. In children 8-11 years old, the child and their family work together to deal with the problems that arthritis can cause. Learning to cope with and manage the problems that come with arthritis can stop it from getting worse. It is important to create programs that teach children and families how to cope with and manage arthritis. This study will develop and test an online game that helps children learn how to better manage their arthritis. The goal of these studies is to test: (1) how easy to use and acceptable the online game is; and (2) if children who play the game feel less pain, have fewer limitations, and a better quality of life compared to children who do not play the game.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 8 and ≤ 11 years of age
2. Diagnosed with JIA (minimum 3 months) using International League of Associations for Rheumatology classification criteria96
3. Active disease
4. Child and primary parent/caregiver are able to speak and read English or French
5. Participants are willing and able to complete online measures

Exclusion Criteria:

1. Cognitive impairments (as assessed by reviewing medical chart and consultation with the patient's rheumatologist)
2. Major co-morbid illnesses (e.g., medical \[inflammatory bowel disease, cancer, diabetes\] or psychiatric \[depression, anxiety\]) which may impact their ability to understand and use the game or complete outcome assessments (as determined by their rheumatologist).
3. Children currently participating in other Cognitive Behavioural Therapy (CBT) interventions
4. Usability testing participants
The Effects of a Music Intervention on Stress, Anxiety and Academic Performance on Nursing Students

This study is examining the effect of listening to music on personal variables such as stress, anxiety, and academic performance. Previous research has shown that listening to music can help in reducing the effects of anxiety and stress.

Students will be divided and randomized into two recording groups: 1.) Music Intervention Group, 2.) Non-Music Control Group. The music intervention group will receive a 15-minute music intervention and variables such as heart rate, blood pressure, anxiety, and academic performance will be measured. The non-music control group will not receive the intervention; however, the same variables will be measured.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Enrolled at UT Health San Antonio School of Nursing clinical course
* First semester undergraduate nursing student

Exclusion Criteria:

* Under 18 years
* Second, third or fourth semester undergraduate nursing student
Abg in Blunt Chest Trauma

This study aims to determine the value of ABG measurments in patients with blunt chest trauma and its role in prognosis of different outcomes and the results would aid the emergency physicians to speed up the management and reduce the cost of diagnosis


Eligibility Criteria:
Inclusion Criteria:

- all patient with polytrauma or blunt trauma to chest and thoraco-abdominal area from both genders are included in the study

Exclusion Criteria:

* shocked patients whom were intubated ,patients that had pulmonary disease or heart diseases ,penetrating chest injury ,pregnant female ,patients who do not want to participate in the study
Group Psychodrama for Skin Picking

This study aims to evaluate the effectiveness of psychodrama group therapy (PGT) compared with supportive group therapy (SGT) for excoriation disorder (ED). Patients will be randomly allocated for either PGT or SGT. The Skin Picking Scale Revised (SPS-R) will be the primary outcome and emotional regulation measured by the Difficulties in Emotion Regulation Scale (DERS) will be evaluated as a potential intermediator. The Clinical Global Impression Scale (CGI); Beck Depression Scale (BDI); Beck Anxiety Scale (BAI), and the Social Adjustment Scale (EAS) will assess secondary outcomes.

Excoriation disorder (ED) is a diagnostic characterized by recurrent picking at one´s own skin, resulting in skin lesions, despite repeated attempts to stop the behavior that causes clinically significant distress or impairment in important areas of functioning. The skin picking behavior is better accounted by physiological effects of a substance or better explained by symptoms of another mental disorder.

Objective: This study aims to evaluate the effectiveness of psychodrama group therapy (PGT) compared with supportive group therapy (SGT).

Justification: The scientific studies on treatment for ED are scarce and all associated with behavioral therapy methods, which do not adequately consider underlying factors of ED, such as emotional dysregulation. There are also not reports of group treatment for ED.

Method: patients who meet criteria for ED according to DSM-5 will be selected . Patients in need of treatment for psychiatric comorbidities (such as anxiety and depression) will wait at least 4 weeks until pharmacological prescription is stable. The subjects will be randomly allocated to either PGT or SGT. The Skin Picking Scale Revised (SPS-R) will be the primary outcome and emotional regulation measured by the Difficulties in Emotion Regulation Scale (DERS) will be evaluated as a potential intermediator. The Clinical Global Impression Scale (CGI); Beck Depression Scale (BDI); Beck Anxiety Scale (BAI), and the Social Adjustment Scale (EAS) will assess secondary outcomes.

Hypotheses:

1. The PGT is more effective than SGT for the ED patient regarding the reduction of skin excoriation behavior.
2. PGT is more effective than SGT for the ED patient regarding the improvement of the symptoms of anxiety, depression and trichotillomania (when present).
3. The therapeutic effects of PGT is intermediated by emotional regulation.

Eligibility Criteria:
Inclusion Criteria:

* Skin Picking diagnosis

Exclusion Criteria:

* Illiteracy
* Other acute psychiatric diagnosis in need of inpatient treatment
* Mental retardation
* Prader-Willi syndrome or other medical condition causing recurrent excoriation behavior or intense itching
Safety and Tolerability Study of the Taris Placebo System

The aim of this protocol is to evaluate the tolerability of the Taris placebo system for the development program and to provide key safety and tolerability data for the Taris platform.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers, 18 to 55 years of age
* Body weight \>100 lbs and BMI (body mass index) within the range 18-30 kg/m2
* A score of less than 11 on the pelvic pain/urgency-frequency scale (PUF)

Exclusion Criteria:

* Presence of any bladder or urethra anatomical feature that, in the opinion of the investigator, might prevent the safe placement, indwelling use, or removal of the TARIS placebo system
* History of significant urogenital surgery (any type of bladder suspension, prolapse repair, incontinence procedure, or vaginal hysterectomy)
* History of kidney stone formation
* Chronic or recurring bacterial or viral infections of the urogenital system
A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects

This is a study to determine the safety and pharmacokinetics of CDX-0159 administered subcutaneously in healthy subjects.

CDX-0159 is a humanized monoclonal antibody that binds to a protein called KIT that is expressed on mast cells.

The study will evaluate the safety, pharmacokinetics, and pharmacodynamics of CDX-0159 administered subcutaneously in healthy subjects.

Eligibility Criteria:
Key Inclusion Criteria:

* An informed consent signed and dated by the subject.
* Healthy volunteer aged 18-55.
* In generally good health and without significant medical conditions based on physical exam, ECG, and laboratory test results.
* Body mass index (BMI) ≥ 18.5 kg/m2 to ≤ 35 kg/m2
* No medication other than mild analgesics, vitamins and mineral supplements or, oral contraceptives.
* Both males and females of child bearing potential must agree to use a medically accepted contraceptive regimen during study and up to 150 days afterwards.
* Not a current smoker, vaper, or regular user of any nicotine or cannabinoid containing products
* Willing to follow all study rules

Key Exclusion Criteria:

* Women who are pregnant or nursing
* History of anaphylaxis or systemic reactions to food or other triggers
* Autoimmune disorders requiring more than topical medication
* Vaccination with live vaccines within 4 months prior to screening visit (subjects must agree to avoid live vaccination during the study and 4 months after).
* Positive urine test for alcohol and drugs of abuse.

Other Protocol defined inclusion and exclusion criteria could apply.
Stress, Anxiety and Type A Personality and Analgesics

Patients scheduled for elective cardiac surgery are preoperative evaluated using different personality type, stress and anxiety tests.

Patient are randomized to receive the investigators' standard moderate dose sufentanil (bolus 1microgram/kg and propofol 0.03 mg/kg/min) or low dose sufentanil (bolus 0.5 microgram/kg and propofol 0.06 mg/kg/min).

Patients randomized and the type of induction informed to the anaesthetist 30 minutes before surgery.

Patients are monitored before induction of anesthesia. Propofol is started on the randomized infusion rate. Sufentanil bolus are given according to randomization. BIS level is followed. Time to reach BIS \< 50 is monitored. BIS after 30, 60 and 90 minutes are registered. Lowest BIS during surgery are registered. Total amounts of sufentanil and propofol recorded.

Eligibility Criteria:
Inclusion Criteria:

* All elective cardiac surgery patients

Exclusion Criteria:

* Patients requiring special attention or monitoring during induction
* Patients with expected longer postoperative ventilation time
* Patients allergic to sufentanil and or propofol
* Participation in other projects
* Pregnancy
Mechanism Exploration of Anti-HER-2 Small-molecule Tyrosine Kinase Inhibitor-related Diarrhea and Establishment of Prevention and Treatment Model(Measure)

Small-molecule tyrosine kinase inhibitors (TKI) that target HER2 are routinely used to treat patients with HER2 (+) breast cancer. The main adverse reactions included diarrhea, nausea, and rash, among which diarrhea had the highest incidence. It can reduce the quality of life and medication compliance of patients, and further affect the efficacy of TKI anti-tumor therapy. Therefore, the investigators conducted this study to establish a risk assessment model before TKI treatment, in order to screen out the high-risk population and influencing factors of TKI-associated diarrhea, and planned to carry out corresponding animal experiments to verify the relationship between various mechanisms and the main mechanism in TKI-associated diarrhea and to explore the corresponding treatment methods.


Eligibility Criteria:
Inclusion Criteria:

* Plan to take pyrrolidine or naratinib for ≥ 28 days;
* HER2 positive female patients with breast cancer aged ≥ 18 years and ≤ 65 years;
* Patients with the following treatment schemes: 1. Pirotinib/naratinib monotherapy 2. Pirotinib/naratinib combined endocrine therapy; 4. The ECOG score is 0-1;
* Life expectancy ≥ 6 months;
* Patients who followed diet intervention after enrollment;
* Volunteer to join the study, sign the informed consent form, have good compliance and are willing to cooperate with follow-up.

Exclusion Criteria:

* People who may be allergic to pyrrolidine, naratinib or excipients;
* There are many factors that affect the absorption of oral drugs, such as inability to swallow, nausea and vomiting;
* Patients with biliary obstruction;
* Participate in other clinical trials related to diarrhea;
* Pregnant and lactating women, women with fertility and positive baseline pregnancy test, or women of childbearing age who are unwilling to take effective contraceptive measures during the whole trial period;
* According to the judgment of the investigator, there are concomitant diseases (including but not limited to severe hypertension and severe diabetes beyond drug control) that seriously endanger the patient's safety or affect the patient's completion of the study;
* Have taken other drugs that may cause diarrhea adverse reactions within 3 weeks before enrollment;
* There are drugs with high probability of causing diarrhea adverse reactions in patients' combined medication;
* Any other situation in which the researcher believes that the patient is not suitable to participate in this study.