cyrilzakka/clinical-trials huggingface dataset:
A Study of Abemaciclib in Participants With Cancer That is Advanced or Has Spread to Another Part(s) of the Body

This study is known as a "drug interaction study" and is being done to see how abemaciclib may affect the blood levels of a drug mixture of commonly used drugs (caffeine, warfarin, dextromethorphan, and midazolam) when taken in combination with abemaciclib. Each participant will complete screening and four study periods in a fixed sequence, with the option to continue to receive abemaciclib in a safety extension phase. All participants will complete a safety follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Have histological or cytological evidence of a diagnosis of cancer that is advanced and/or metastatic
* Have adequate organ function
* Have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale
* Have discontinued all previous therapies for cancer (including chemotherapy, radiotherapy, immunotherapy, cancer-related hormone therapy, and investigational therapy) for at least 21 days for myelosuppressive agents or 14 days for nonmyelosuppressive agents prior to receiving study drug and have recovered from the acute effects of therapy(treatment related toxicity resolved to baseline), except for residual alopecia

Exclusion Criteria:

* Require treatment with inducers or inhibitors of cytochrome P450 (CYP)1A2, CYP2C9, CYP2D6, and CYP3A within 14 days before the first dose of study drug through the end of Period 2
* History or presence of significant bleeding disorders
* Have known active uncontrolled or symptomatic CNS metastases
* Have a primary liver tumor
* Have lymphoma or leukemia
Optimization of the Patient Care Pathway in Immuno-oncology

This study compares the care pathway of melanoma patients treated by immunotherapy in two ambulatory care structures. The aim is to measure if a care structure specialized in immuno-oncology could rationalize the care of patients.

This protocol will be based on two different follow-up during the treatment period:

* dedicated and coordinated e-follow-up (IUCT-O in Toulouse)
* standard follow-up (University Hospital Center in Bordeaux)

Patients will be followed from the first cycle of immunotherapy until 3 months after the initiation treatment.


Eligibility Criteria:
Inclusion Criteria:

1. Patient with advanced (unresectable melanoma (stage III)) or metastatic (stage IV) melanoma and starting an Immune Checkpoint Inhibitor treatment (Monotherapy or Combination Therapy)
2. Patient starting first cycle of Immune Checkpoint Inhibitor treatment in an ambulatory care structure
3. Treatment which can be delayed for 7 days or more
4. Age \> or = 18 years old
5. Patient with a phone and/or computer equipment
6. Patient affiliated to the french social security system
7. Patient must provide written informed consent prior to any study-specific procedure or assessment

Exclusion Criteria:

1. Patient with diagnosis other than advanced melanoma
2. Patient who must receive a treatment other than Immune Checkpoint Inhibitor
3. Treatment administered during a conventional hospital stay (period of more than 24 hours)
4. Patient with no caregiver
5. Pregnant or breastfeeding women
6. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure
7. Patient protected by law
Determination of Health Care Needs of Elderly Individuals According to the Omaha Classification System and Investigation of the Effects of Implemented Nursing Interventions on Healthy Lifestyle Behaviors and Quality of Life

As in the whole world, there is an increase in the elderly population in the TRNC. However, no systematic care is provided for the registration and follow-up of elderly individuals. In this study, it is aimed to determine the health care needs of the elderly with a systematic method with the Omaha Classification System (OSS), which is used in the home care system in the world and in Turkey, and to examine the effectiveness of the nursing interventions applied according to the health care needs of the elderly people. With this method, it is thought that the continuity of monitoring and monitoring the health care needs of elderly individuals with a systematic approach will be ensured.

As in the whole world, there is an increase in the elderly population in the TRNC. However, no systematic care is provided for the registration and follow-up of elderly individuals. In this study, it is aimed to determine the health care needs of the elderly with a systematic method with the Omaha Classification System (OSS), which is used in the home care system in the world and in Turkey, and to examine the effectiveness of the nursing interventions applied according to the health care needs of the elderly people. With this method, it is thought that the continuity of monitoring and monitoring the health care needs of elderly individuals with a systematic approach will be ensured.

Thus, it will be ensured that nursing interventions for the health care needs of elderly individuals are planned and implemented, and the nursing interventions applied for the field of health behaviors they live will be planned. In line with the data to be obtained as a result of the research, it is aimed to establish a system that will provide an opportunity to provide quality nursing care aimed at improving the health of the elderly, which is an important area of public health nurses in the TRNC.

Eligibility Criteria:
Inclusion Criteria:

* 65 years old self care

Exclusion Criteria:

* comminication barrier mentally handicapped
Positioning and the Spontaneous Breathing Test in Neonates

The spontaneous breathing test (SBT) is routinely performed on all intubated patients in the NICU who are potential candidates for extubation from mechanical ventilatory support. For all parents who consent, the routine SBT will be performed on all infants. In addition to the routine SBT the following will occur:

1. work of breathing indices: obtained non-invasively through respiratory inductive plethysmography (RIP).
2. Performing the SBT in the prone position, in addition to the routine position (supine).


Eligibility Criteria:
Inclusion Criteria:

* Infants who qualify for SBT as part of their normal care

Exclusion Criteria:

* Previous history of abdominal or chest surgery (i.e. chest tube, PDA ligation, surgical NEC)
* Congenital malformation of the chest of abdomen
* Neuromuscular disorder
* Current medications affecting neuromuscular tone (ex morphine)
* Unable to be positioned either prone or supine as determined by the attending neonatologist.
A Real-world Study on the Treatment of Non-small Cell Lung Cancer With Leptomeningeal Metastasis in China

This is a retrospective and prospective study planned to include NSCLC patients with Leptomeningeal metastasis (LM) and treated with antitumor therapy after 2018, from multiple centers such as the First Affiliated Hospital of Guangzhou Medical University, Guangdong Sanjiu Brain Hospital, etc., aiming to establish a database related to the treatment strategies of LM patients, and to evaluate the efficacy (eg. Overall Survival/Time to Failure) and safety of different treatment strategies of LM patients, etc., as well as the significance of concomitant testing in LM patients.

retrospective and prospective study

Eligibility Criteria:
Inclusion Criteria:

* non-small cell lung cancer patients with Leptomeningeal metastases diagnosed after January 2018;
* Patients who underwent antitumor therapy after diagnosis of LM.

Exclusion Criteria:

* Patients with small cell lung cancer components;
* complicated with tumors other than non-small cell lung cancer.
Correlation of Different Signs for Assessment of Dry Eye Syndrome

Dry eye syndrome (DES) is a highly prevalent ocular condition inducing an inflammatory response of the ocular surface. Common symptoms include ocular discomfort, visual impairment and instability of the tear film with potential damage to the ocular surface.

The rationale of the present study is to compare signs as assessed with new methods such as measurement of tear film thickness, tear film osmolarity and scattering of the tear film with well established methods for assessment of the severity of DES (Break up time, staining of the cornea with fluorescein). Additionally, impression cytology and determination of tear cytokines/chemokines will be performed to obtain information about inflammatory processes on the ocular surface.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged over 18 years
* History of dry eye syndrome for at least 3 months
* At least 2 symptoms of dry eye syndrome (foreign body sensation, burning, photophobia, blurred vision, pain, itching) and/or tear break up time \< 10 seconds
* Normal ophthalmic findings except dry eye syndrome

Exclusion Criteria:

* Participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Presence or history of a severe medical condition that will interfere with the study aim as judged by the clinical investigator
* Wearing of contact lenses
* Intake of dietary supplements in the 3 months preceding the study
* Glaucoma
* Treatment with corticosteroids in the 4 weeks preceding the study
* Topical treatment with any ophthalmic drug in the 4 weeks preceding the study except topical lubricants
* Ocular infection or clinically significant inflammation
* Ocular surgery in the 3 months preceding the study
* Sjögren's syndrome
* Stevens-Johnson syndrome
* Pregnancy, planned pregnancy or lactating
Real-world Health Outcomes in Canadian Patients Using Semaglutide

Glucagon-like peptide-1 receptor agonists (GLP-1 RA) are an injectable, non-insulin therapy for patients with type 2 diabetes (T2D). Semaglutide (Ozempic®) is the newest GLP-1 RA to become available in Canada in 2018, and is administered subcutaneously once-weekly. In clinical trials, semaglutide has been superior to placebo and other antihyperglycemic agents in HbA1c reduction and body weight loss. However, there is little real-world evidence available on the effectiveness of semaglutide in real-world clinical practice.

To better understand the effectiveness of semaglutide on clinical outcomes in a real-world setting, this retrospective cohort study will use the Canadian LMC Diabetes Registry to examine the effects of semaglutide on glycemic control, body weight, and other clinical outcomes in patients with T2D who initiate once-weekly semaglutide as part of usual clinical care in a diabetes specialist practice group in Canada.


Eligibility Criteria:
Inclusion Criteria:

* First prescription for semaglutide between Feb 1 2018 and Feb 1 2019
* Age ≥ 18 years at medication index date
* Clinical diagnosis of type 2 diabetes for greater than six months
* ≥ one HbA1c measurement at baseline and at follow-up
* ≥ one follow-up visit post index date
* Informed consent for medical data to be used for research purposes

Exclusion Criteria:

* Clinical diagnosis of type 1 diabetes
* Recent eGFR \<40 ml/min/1.73m2
* Documented history of bariatric surgery
Comparison of Non-invasive Vs. Invasive Hemodynamic Measurements

Comparison of a non-invasive method of measuring central venous pressure to the conventional modality of invasive central venous pressure.

The conventional method used to measure central venous pressure has limitations since it is an invasive procedure that requires a central venous catheter. To overcome this challenge, a new technology to assess CVP non-invasively using an oscillometric method is being developed. It is called enclosed zone central venous pressure (ezCVP). A comparison study of ezCVP and CVP is needed to determine accuracy and reproducibility.

Eligibility Criteria:
Inclusion Criteria:

1. Adult age over 18 years.
2. Arm circumference is 23 cm to 55 cm
3. Subject will have an existing central venous catheter during their ICU stay
4. Subject or legally authorized representative (LAR) is able to understand the risks and potential benefits of participating in the study and is willing to provide written informed consent
5. Subject or LAR is willing and able to comply with protocol procedures

Exclusion Criteria:

1. Finger and/or upper arm anatomical anomaly or disease that may interfere with attaching a pulse oximeter sensor and/or blood pressure cuff.
2. Pregnant (self-reported)
3. Upper extremity deep venous thrombosis currently being treated
4. Severe skin disease involving the upper arm(s)
5. Study investigator may exclude patients based on clinical judgement
Clinicopathologic Characteristics, Progression, and Prognostic Analysis of IPNB

The main aim of this observational study is to understand the clinicopathological and prognostic information of IPNB, a rare tumor. The participants have already received treatment during their previous routine medical management and took part in follow - up. We will look into their survival information after previous medical visits and treatment.


Eligibility Criteria:
Inclusion Criteria:

* IPNB with or without malignant transformation was confirmed by pathological examination

Exclusion Criteria:

* missing other essential clinical data
* coexisting malignant tumors of other digestive system organs
Lurasidone HCl A Phase 3 Study of Patients With Acute Schizophrenia

Lurasidone HCl is a compound developed for the treatment of schizophrenia. This clinical study is designed to test the hypothesis that lurasidone is more efficacious than placebo. The study will also evaluate the safety and tolerability of lurasidone as compared to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent and aged between 18 and 75 years of age.
* Meets DSM-IV criteria for a primary diagnosis of schizophrenia.
* Not pregnant, if of reproductive potential agrees to remain abstinent or use adequate and reliable contraception for duration of study.
* Able and agrees to remain off prior antipsychotic medication for the duration of study.
* Good physical health on the basis of medical history, physical examination, and laboratory screening.
* Willing and able to comply with the protocol, including the inpatient requirements and outpatient visits.

Exclusion Criteria:

* Considered by the investigator to be at imminent risk of suicide or injury to self, others or property.
* Any chronic organic disease of the CNS (other than schizophrenia).
* Used investigational compound within 30 days.
* Clinically significant or history of alcohol abuse/alcoholism or drug abuse/dependence within the last 6 months
A Comparison of Patients on AVAMYS ® Versus NASONEX (A Trade Mark of Schering Corporation) and FLIXONASE ® on Key Health Outcome Measures

Previous publications have indicated that Allergic Rhinitis (AR) patients suffering from both ocular and nasal symptoms have a greater burden of illness and lower quality of life than patients suffering from nasal symptoms alone. Fluticasone furoate (FF) acts against both nasal and ocular symptoms. The purpose of this study was to evaluate the differences in symptom control (both perceptually and objectively) and resource use for patients with current seasonal AR.

* Allergic rhinitis (AR) is a common inflammatory condition of the upper respiratory tract, nasal cavity and eyes affecting up to 20% of the population in the United States and Europe. The bothersome nature of AR symptoms can severely affect daily activities including ability to work and examination performance and impact on quality of life (QoL) and psychosocial well being.
* This study assesses the impact of Fluticasone furoate (FF) on the QoL of seasonal allergic rhinitis (SAR) patients, including the number of symptom-free days (SFD) and quality of life over the last 4 weeks, and compares this with other inhaled nasal steroids (INS): mometasone furate (MF) and fluticasone proprionate (FP).
* Selected physicians provide information including a range of demographic, symptom and treatment details for a number of their SAR patients. The patient themselves are then invited to provide details about their SAR including symptoms, the impact of AR upon their lifestyles, attitudes to treatment and completion of Health Related Quality of Life (HRQoL) instruments.

Eligibility Criteria:
Patient Inclusion Criteria:

* Current Seasonal Allergic Rhinitis sufferer (based on physician judgement)
* Currently receiving prescribed INS treatment (no other treatment restrictions apply)
* Have consumed at least one full prescription on the specified INS treatment
* No comorbid Asthma or COPD diagnosis
* Informed Consent

Exclusion Criteria:

* None specified
The Effect of Two Different Types of Forces on Possible Root Resorption in Relation to Dentin Phosphoprotein Levels

External root resorption is a common unfavourable sequel of orthodontic treatment. Although diagnosis of root resorption is usually done by radiographs; they are technique sensitive. Dentine phosphoprotein, a non-collagenous protein, is suggested to be released into the gingival crevicular fluid during active root resorption, serving as a good diagnostic tool. Also, the manner of force application is a modifiable factor suggested to affect root resorption.

Early detection of teeth at risk of severe resorption is crucial.At present, using radiographs is common but detecting only resorption after 60-70% of the mineralized tissue is already lost. Moreover, they only provide two-dimensional information, identifying apical change primarily. Also, radiographs cannot indicate if the process of root resorption is still active for monitoring its progress and additional radiation exposure to the patient will be needed. Therefore, a safer, more reliable alternative method to clinically diagnose early stages of root resorption is needed and may include detecting biomarkers in gingival crevicular fluid. Furthermore, the relationship between the manner of orthodontic force application and orthodontically induced root resorption is under study. It has been suggested that pausing orthodontic forces during treatment may reduce the amount of root resorption, likely due to cementum repair during the inactive period. This is important specifically in individuals who are biologically and genetically prone to root resorption. The aim of the study is to compare the extent of root resorption between controlled continuous and intermittent orthodontic forces using levels of dentin phosphoprotein in gingival crevicular fluid.

Eligibility Criteria:
Inclusion Criteria:

* Malocclusion that requires extraction of first maxillary premolars on both sides.
* No previous reported or observed dental treatment to the teeth to be extracted.
* No previous reported or observed trauma to the teeth to be extracted.
* No previous reported or observed orthodontic treatment involving the teeth to be extracted.
* Free of any systemic disease affecting the dentition.

Exclusion Criteria:

* Past or present signs or symptoms of periodontal disease.
* Past or present signs or symptoms of bruxism.
Safety and Efficacy Study of Target Therapy Combined With Radiotherapy to Treat Senile Locally Advanced SCCHN

Radiotherapy alone is generally the only treatment in old patients with SCCHN. No evidence indicates combination with EGFR Target therapy can bring benefit for the patients. Senile Society is coming in China, the mean age in Beijing reaches 80 years old. A valuable treatment with efficacy and safety is needed for senile patient with SCCHN. The purpose of the study "Prospective, Randomized, Controlled, Phase II Multiple Centered Clinical Trial of Nimotuzumab Combined with Radiotherapy for Senile Locally Advanced SCCHN" was sponsored to evaluate the efficacy and safety for Nimotuzumab Combined with Radiotherapy in Senile SCCHN patients.

condition: Senile Locally Advanced SCCHN. Intervention: Drug:Nimotuzumab. Arm A: Radiotherapy+Nimotuzumab; Arm B: Radiotherapy alone. Phase: Phase 2

Eligibility Criteria:
Inclusion Criteria:

* Informed consent form
* Age 65-85，both genders
* HNSCC Confirmed by pathology
* Primary site of oral cavity, oropharynx, hypopharynx, larynx
* Stage Ⅲ/ⅣA,B
* Primary lesions can be measured
* Karnofsky's Performance Scale ≥60
* Life expectancy of more than 6 months
* Haemoglobin≥100g/L ,WBC ≥3.5×109/L, platelet count≥90×109/L
* Hepatic function: ALT、AST\< 1.5 x ULN, TBIL\< 1.5 x ULN
* Renal function: Creatinine \< 1.5 x ULN

Exclusion Criteria:

* Received other anti EGFR monoclonal antibody treatment
* Previous chemotherapy or radiotherapy
* Participation in other interventional clinical trials within 1 month
* Other malignant tumor (except of non-melanoma skin Cancer or carcinoma in situ of cervix)
* History of serious allergic or allergy
* History of Serious lung or heart disease
Nutritional Strategy for Blood Pressure Control in Patients With Hypertension (NUPRESS)

Adherence to a healthy dietary pattern is part of the self-care of patients with hypertension, and may contribute substantially to therapeutic target goals as well as to a better quality of life. However, not all nutritional recommendations aimed at these patients are easily applicable in clinical practice. The primary objective of the study is to evaluate the effectiveness of a nutritional strategy for blood pressure control in patients with hypertension users of a Public Health System after 6 months of follow-up. As secondary objectives, we will evaluate the impact of the proposed strategy on self-care and on the quality of life of the patients. In this multicenter open-label randomized trial, 408 patients ≥21 years old with hypertension, systolic blood pressure (SBP) ≥140mmHg at the moment of the screening and who have not received or received nutritional counseling for at least 06 months will be enrolled. Patients allocated to the control group will receive individualized dietary prescription according to the guidelines of the Brazilian Society of Cardiology. Nutritional counseling in the intervention group will be performed based on the quality of the diet, the Food Guide for the Brazilian Population and concepts of mindfulness and mindful eating; all dietary guidance will be based on feasible goals built together (patient and nutritionist), and no diet will be prescribed for intervention group. In both groups, patients will receive automatic monitors for residential self-monitoring blood pressure. On-site follow-up visits will be carried out at 30, 60, 90, and 180 days (final consultation). At 120 and 150 days, participants in the intervention group will receive motivational messages via e-mail or SMS (for these patients, consultation of 30 days will be a group meeting). Laboratory tests (lipid and glycemic profile, serum creatinine, serum sodium, urinary sodium, serum potassium, urinary potassium and albuminuria) will be performed at baseline and 180 days; anthropometric indexes and diastolic blood pressure (DBP) will be also evaluated.


Eligibility Criteria:
Inclusion Criteria: ≥21 years old with medical diagnosis of hypertension, systolic blood pressure (SBP) ≥140 mmHg at the moment of the screening and who have not received or received nutritional counseling for at least 06 months.

Exclusion Criteria:

* Diagnosis of resistant and/or secondary hypertension;
* Severe neuropathy;
* Chronic kidney disease;
* Active cancer or life expectancy \<6 months;
* Chemical dependence or use of antipsychotic drugs;
* Autoimmune disease or chronic use of steroids;
* Pregnancy and lactation;
* Acute coronary syndrome in the last 60 days;
* Severe or unstable heart failure;
* Wheelchair users;
* Extreme obesity (body mass index \[BMI\] ≥40kg / m²);
* Cognitive, neurological or psychiatric condition that prevents participation in the study;
* Participation in other clinical trials.