cyrilzakka/clinical-trials huggingface dataset:
Effects of Aromatherapy on Anxiety and Pain During Dental Treatment in Adults

Dental anxiety is a common problem in dental care. The aim of this protocol is to evaluate the effect of orange and tea essential oil for the control of anxiety and pain in adults during dental treatments.


Eligibility Criteria:
Inclusion Criteria:

* Patients who need dental treatment, such as resin filling, root canal treatment, periodontal initial treatment, tooth extraction, etc.
* Be able to understand the purpose of the study and volunteer to take part in the study.
* Be able to complete all assessments and follow-up during the study.

Exclusion Criteria:

* Patients who are allergic to the ingredients of the essential oils used in the experiment or to the materials used in the dental treatment.
* Patients who underwent only an oral examination.
* Patients with severe heart disease, hypertension, respiratory disease, or other systemic conditions that were not eligible for trial participation.
* Pregnant or lactating women.
* People with depressive symptoms, anxiety disorders or other mental illnesses that affect their mood state.
* People who are using sedative or analgesic drugs.
* Recent or current users of essential oil.
* Any circumstances considered by the investigator to be inappropriate for participation in this study.
Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS

TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %.

TIPS has been used for 20 years, as a means of reducing portal pressure in patients with cirrhosis and portal hypertension related complications. TIPS proved more effective than alternative treatments in controlling or preventing variceal bleeding and refractory ascites. The main drawback of the TIPS procedure is progressive overt hepatic encephalopathy (OHE). Three risk factors for post-TIPS OHE have been identified: age over 65 years, history of previous episodes of OHE, and Child-Pugh score equal to or over 10. However, the incidence of post-TIPS OHE in patients fulfilling these criteria remains close to 35 %. Furthermore, the pathogenesis of HE in general but also in patients treated by TIPS is still not well understood. Therefore, there is a real challenge in discovering new molecular mechanisms involved in pathogenesis of OHE as well as new treatment to better prevent the risk of OHE in patients treated by TIPS. Observational and experimental studies suggest a microbiota's role in the mechanism of OHE and recently a non absorbable antibiotic has proven to reduce the risk of recurrence of OHE. However, the effect of this drug for the prevention of a first episode of OHE in patients treated by TIPS is not known. In addition, the mechanisms of the beneficial effect of rifaximin remain poorly understood.

Eligibility Criteria:
Inclusion Criteria:

* cirrhosis with TIPS for ascit treatment or hydrothorax
* prevention digestive bleeding follow up portal hypertension -
* signed consent

Exclusion Criteria:

* hepatocellular carcinoma out of Milan criteria or palliative phase cancer
* Child Pugh score \> 12
* TIPS indicated for other indication than bellow
* encephalopathy signs : asterixis or confusion
* Hypersensibility to rifaximin, or derivated of rifamycin
* Patients treated by same class antibacterial
* pregnant woman
* Patient with hepatic transplant
The Impact of a Transitional Care Management Programme on the Migration Stress of Family Members of Patients

This study investigated the impact of the establishment and application of the "health care-family-environment" linkage mechanism on the level of migration stress, coping styles and care satisfaction of families of patients transferred from the EICU, in order to provide a reference for improving the physical and psychological health of families and to promote the role of family members in the social support of patients transferred out of this category.


Eligibility Criteria:
Inclusion Criteria:

1. Family members of trauma patients scheduled to be transferred from the EICU to a general unit within 24h;
2. Family members of patients aged ≥ 18 years;
3. Family members who are responsible for the main care tasks and medical decisions of the patient during hospitalisation;
4. Family members of patients with clear language and good communication skills;
5. Families of patients who volunteered to participate in this study.

Exclusion Criteria:

1. Family members of patients temporarily transferred out of the EICU or temporarily discharged from trauma
2. Families of patients who voluntarily request termination of treatment;
3. Family members of patients with cognitive impairment, speech impairment or mental abnormalities.
Clinical Study on the Combined Administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine

This clinical study aims to evaluate the mutual influence of combined administration of 15-Valent Pneumococcal Conjugate Vaccine and Diphtheria, Tetanus, Pertussis Vaccine in the target population


Eligibility Criteria:
Inclusion Criteria:

* Infants aged 3 months (90-119 days old), full-term (37-42 weeks pregnant), with a birth weight of ≥ 2.5kg;
* The legal guardian provides informed consent and signs the informed consent form;
* The legal guardian agrees to comply with the requirements of the clinical research protocol, is willing to accept a follow-up of 10 months, and has the ability to use thermometers, scales, and fill out diary cards; 4) Have not received pneumococcal vaccine or pertussis vaccine, and have no history of receiving other live vaccines in the past 14 days or non live vaccines in the past 7 days; 5) Underarm temperature ≤ 37.0 ℃.

Exclusion Criteria:

* A history of invasive diseases caused by Streptococcus pneumoniae that has been confirmed through cultivation;
* Known to be allergic to any component of the experimental vaccine, especially those allergic to diphtheria toxoid, or those who previously have a fever of 39.5 ℃ or above after receiving vaccine;
* History or family history of seizures, epilepsy, encephalopathy, and mental illness;
* Infants born with abnormal labor processes (difficult labor, instrumental delivery) or with a history of asphyxia or neurological organ damage;
* A history of confirmed thrombocytopenia or other coagulation disorders may result in contraindications for subcutaneous injection;
* Injecting human normal immunoglobulin after birth;
* Known or suspected immunological dysfunction, receiving immunosuppressive therapy (radiation therapy, chemotherapy, corticosteroids, antimetabolites, cytotoxic drugs), such as continuous treatment with systemic corticosteroids (prednisone or similar drugs) for ≥ 14 days, human immunodeficiency virus (HIV) infection, etc;
* Having congenital malformations, severe malnutrition, developmental disorders, and genetic defects (such as favism);
* Currently suffering from serious chronic diseases, infectious diseases, active infections, liver diseases, kidney diseases, cardiovascular diseases, and malignant tumors;
* Severe asthma;
* Systemic rash, skin ringworm, skin suppuration or blisters;
* Currently or planning to participate in clinical trials of other drugs in the near future; Researchers believe that any situation that may affect the evaluation of the study.
Sorafenib in First-line Treatment of Advanced B Child Hepatocellular Carcinoma

The purpose of this study is to to compare the addition of sorafenib (800 mg/day)to best supportive care with best supportive care alone in terms of survival in patients with hepatocellular carcinoma (HCC) with impaired liver function (Child B).

Hepatocellular carcinoma (HCC) is the third cause of death for cancer in the world with an increasing incidence. No systemic therapy has proven effective in patients with advanced HCC until 2007, when results of the SHARP trial were presented. In this trial, the orally active multi-kinase inhibitor sorafenib (800 mg/day) significantly prolonged survival compared with placebo in patients with advanced HCC and good liver function (Child A). The same authors concluded that the effect of the drug in the population of patients with more impaired liver function should be further studied.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of hepatic cell carcinoma (HCC) according to the AASLD- EASL criteria
* Age \>18 years
* Advanced stage of disease defined as HCC not eligible for locoregional treatments (ab initio or following progression after such treatments)
* Liver function classified as Child-Pugh class B
* ECOG performance status \< or = 2
* Life expectancy of at least 2 months
* Adequate contraception for fertile male and female patients
* Signed informed consent

Exclusion Criteria:

* Prior exposure to sorafenib or antiangiogenesis drugs
* Concomitant diseases that contraindicate the use of sorafenib
* Gastro-intestinal bleeding in the previous 30 days
* Altered renal function(creatinine \> 1.5 x ULN), or haematological function (platelet count \< 60 x 10\^9/L, hemoglobin \< 9 g/dl)
* Serious active infections (\> grade 2 CTCAE version 3.0)
* Congestive heart failure, history of congestive heart failure, unstable angina pectoris, myocardial infarct or significant valvular heart disease or uncontrolled heart arrhythmia
* Patients who are unable or unwilling to participate in the study
* Pregnant or lactating females
* Hepatic encephalopathy of any grade
Desensitization and Cognitive Therapy in General Anxiety.

This study will test the feasibility and safety of adding interpersonal and emotional processing techniques to standard cognitive behavioral therapy for generalized anxiety disorder.

Generalized anxiety disorder (GAD) is characterized by chronic worry that interrupts normal functioning. Some research has shown cognitive behavioral therapy (CBT) as an effective treatment for GAD, but only half of people treated with CBT for GAD experience treatment benefits long-term. Standard CBT for GAD may lose effectiveness over time because it does not address interpersonal and emotional processing problems. This study will determine the safety and feasibility of training therapists to deliver a version of CBT with additional therapeutic techniques for addressing interpersonal interactions and emotional processing.

Participation in this study will include 14 weekly, 2-hour, individual therapy sessions. During the first hour of each session, all participants will receive standard CBT for GAD. Participants will be randomly assigned to receive one of two therapies during the second hour: training in interpersonal and emotional processing techniques or listening therapy. Participants taking medications will be required to maintain a fixed dosage and keep a daily dairy of medication use, starting 2 weeks before study entry and lasting throughout treatment.

In-depth study assessments will take place at baseline and after completing the 15 weeks of therapy. Assessments will include clinical interviews, self-report questionnaires, and a physiological measurement session. Questions will pertain to anxiety symptoms, self-perceptions, emotional experience, and perceptions of the world. The physiological measurement session will involve recording bodily reactions, including brain waves, heart rate, eye movement, and breathing, while performing simple perceptual tasks. Brief psychological assessments will also follow each hour-long portion of each therapy session. Follow-up assessments conducted 6, 12, and 24 months after completing treatment will involve interviews and questionnaires as well as recording a week's worth of medication diaries.

Eligibility Criteria:
Inclusion Criteria:

* Principal diagnosis of generalized anxiety disorder (GAD), as defined by the DSM-IV and agreed on by two diagnostic interviewers

Exclusion Criteria:

* Concurrent psychosocial therapy or past adequate dosage of CBT
* Medical contributions to anxiety
* Current substance abuse, psychosis, or organic brain syndrome
Preservation of Beta-cell Function in Type 2 Diabetes Mellitus

The study evaluates the rate beta-cell function decline in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.

This is a 72 months long randomized clinical trial longitudinally evaluating beta-cell function, as well as glycemic control and inflammatory markers in newly diagnosed type 2 diabetic patients on two different treatment regimens: insulin and metformin versus glyburide, metformin and pioglitazone.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus diagnosed within the prior 2 months
* HbA1c \> 7% at the time of inclusion
* willing to perform intensive diabetes management
* able to comply with treatment and follow-up regimen

Exclusion Criteria:

* HbA1c \> 8% at time of randomization
* creatinine \> 1.5 mg/dl
* liver function tests \> 3 times the upper limit of normal
* severe anemia
* severe proliferative retinopathy
* NYHA class III or IV heart failure
* active CAD or recent (within 6 months) MI
* pregnant, willing to get pregnant, or not willing to practice any contraceptive method
* non-english speaking
* active heavy alcohol or illicit drug users (within past 6 months)
* history of lactic acidosis
Suspected Cases of Carbon Monoxide Poisoning in the ED

The purpose of this study is to collect non-invasive observational data in suspected or known carbon monoxide poisoning.


Eligibility Criteria:
Inclusion Criteria:

* Known or suspected carbon monoxide poisoning

Exclusion Criteria:

* Less than 18 years of age
Sublingual Administration of PPI

Compare 24-hour intragastric pH and therapeutic effectiveness of proton pump inhibitor (PPI) among different administration methods: per oral (PO), intravenous (IV), and sublingual (SL).

Intragastric pH and therapeutic effectiveness of PPI was compared among patients given PPI with different administration methods. 24 hour intragastric pH catheter was inserted in stomach of patients with peptic ulcer an hour prior to PPI administration in order to observe the initial change in pH. Three groups of patients were given PPI through per oral, intravenous, and sublingual administration methods. The hypothesis of this study is that sublingual administration will be faster than oral or IV administration in PPI dosing with respect to intragastric pH change and re-bleeding rate.

Eligibility Criteria:
Inclusion Criteria:

* Patients with peptic ulcer disease
* Age: 20-75 years old
* Patients who submitted informed consent

Exclusion Criteria:

* Peptic ulcer disease with spurting and oozing
* Shock, hypotension, pregnancy
* Gastrointestinal malignancy
Evolution of the Therapeutic Care in Ovarian Cancer From 2011

The ESME Ovarian Cancer database is a multi-center real life database using a retrospective data collection process in 18 French Comprehensive Cancer Center (FCCC) over 20 sites). This database compiles data from existing data available from patient's electronic medical records (EMR).

This database compiles data from existing data available from patient's electronic medical records (EMR) and integrates data from non-structured ans structured sources.

The database includes data related to patient demographics, tumor characteristics (diagnosis, histology, relapses, metastatic disease, etc.), treatments (dates, INN, route of administration, treatment protocols, reason for termination, etc.), and clinical events. Data is collected at each participating site by technicians who are specifically trained for the project using an electronic data collection (eDC) tool.

Data imported into the final database are controlled, recoded, and harmonized before import according to the data management plan. All coding procedures are predefined by the data manager. There is no transmission of individual data; all data are centralized within each center using a shared anonymous format. All data is exclusively obtained retrospectively; no attempts are made to recover non available data from the patient's medical record by contacting healthcare providers or patients.

ESME OC database aims to be a clinical and therapeutic database centralizing existing and available data from different sources used in the participating hospitals. Data do not contain any personal data on patients. In compliance with the authorization delivered by the French Data Protection agency to Unicancer, only aggregated statistical reports and publication are released.

Eligibility Criteria:
Inclusion criteria :

* 18 years old female
* Female who received surgery, chemotherapy, targeted therapy, immunotherapy, radiation therapy, diagnostic procedure, other specific therapeutic procedure) for ovarian cancer in a French Comprehensive Cancer Center.

Exclusion criteria : None
Study of Pharmacokinetics and Metabolism on [(14)C]ADC189

This study is designed to determined the metabolism, excretion, and substance balance of almonertinib of ADC189. The pharmacokinetic characteristics and safety profile of ADC189 was investigated following a single oral dose (45 mg/100 µCi) in healthy Chinese male participants.

This study adopted a single-center, open, non-randomized, single-dose design. Six to eight healthy Chinese male subjects were planned to be enrolled, and the final aim is to collect all required samples and data from at least 6 subjects.

After each subject take a single oral dose of 45 mg (about 100 μCi) \[14C\]ADC189 on Day 1, whole blood, plasma, urine and feces samples were collected at specified time points during the study. The total radioactivity was measured to calculate the ratio of total radioactivity of whole blood to total radioactivity of plasma, pharmacokinetic parameters, recovery rate and excretion pathway data of total radioactivity in whole blood and plasma. Meanwhile, the radioactive metabolite spectrum and structural identification of main metabolites in plasma, urine and feces were performed to obtain the pathway and characteristics of main metabolic elimination of ADC189 in human body, as well as circulating metabolites ≥10% of total radioactivity exposure in plasma.

Eligibility Criteria:
Inclusion Criteria:

* 1. healthy Chinese male subjects within 18 to 45 years old inclusive;
* 2. body weight over 50 Kg, and within a BMI range of 19.0 to 26.0 kg/m2 inclusive;
* 3. has no sperm donation plan, no family planning and voluntarily adopts strict contraceptive methods during the study period and within six months after the completion of the trial;
* 4. able to comprehend and willing to sign an Informed Consent Form (ICF).

Exclusion Criteria:

* 1. history or presence of an abnormal ECG;
* 2. participation in more than 1 other radiolabeled investigational study drug trial within 12 months prior to Check-in;
* 3. exposure to significant radiation within 12 months prior to Check-in;
* 4. participation in any other investigational study drug trial;
* 5. use of any prescription medications/products within 14 days prior to Check-in;
* 6. use of any drug that affects drug metabolism enzymes or transporters (P-gp and BCRP) in the 30 days prior to taking the study drug, as detailed in Appendix 5;
* 7. receipt of blood products within 1 month prior to Check-in.
Evaluation of the Standard Catheter-directed Thrombolysis Effectiveness in Intermediate-High-Risk Pulmonary Embolism Patients

A single-center, open-label, randomized comparative study of two treatment strategies in patients with intermediate-high-risk acute pulmonary embolism (PE). Patients will be randomized in a 1:1 ratio to standard anticoagulant therapy or standard catheter-directed thrombolysis (SСDT) with a low dose of alteplase, followed by evaluation of short- and long-term efficacy and safety in each group


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Computed tomography angiography (CTA) - verified proximal (pulmonary trunk and/or main and/or lobar branches of the pulmonary artery) PE and symptom onset \< 14 days prior
* Intermediate-high risk PE with a RV dysfunction (RV/LV diameter ratio \>1 on TTE or CTA) and an elevated biomarker (hs-troponin or NT-proBNP) level
* Signed informed consent

Exclusion Criteria:

* High-risk pulmonary embolism
* Thrombus in the heart chambers on TTE
* Absolute contraindications for the use of thrombolytic therapy: history of hemorrhagic stroke or stroke of unknown etiology; ischemic stroke or transient ischemic attack within the last 6 months; extensive bleeding currently or within the previous 6 months, hemorrhagic diathesis; diseases of the central nervous system (including neoplasms, aneurysm, surgery on the brain or spinal cord); intracranial (including subarachnoid) hemorrhage currently or in history, suspicion of hemorrhagic stroke; severe uncontrolled arterial hypertension; major surgery or major trauma within the previous 3 months, recent traumatic brain injury; labor during the previous 10 days; severe liver diseases, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis; bacterial endocarditis, pericarditis; acute pancreatitis; confirmed peptic ulcer of the stomach or duodenum within the last 3 months; arterial aneurysms, congenital anomalies of arteries/veins;
* Haemoglobin level \< 70 g/L, platelet count ≤ 100 x 109
* Allergic to alteplase or UFH or contrast allergy
* Pregnant or breastfeeding
* Clinically significant malignancies
The Relationship Between Isolated Head Trauma During Pregnancy and Preterm Birth

Pregnant patients who presented to the Emergency Department of Şanlıurfa Training and Research Hospital with isolated head trauma due between January 2018 and January 2024 were included in the study and followed up with until the time of pregnancy termination.

The criteria for inclusion in the study were as follows: all of the pregnant women over 18 years of age with isolated head trauma (closed blunt trauma) who were evaluated with neurosurgical consultation or computed tomography/magnetic resonance (CT/MRI) and whose birth records are available at our hospital.

The exclusion criteria included patients with previous premature birth, pregnancies in the first trimester, pregnancies with assisted reproductive techniques, multiple pregnancy, the threat of preterm labor or abortus imminens in the current pregnancy, maternal or fetal life-threatening situations that may cause termination of the pregnancy, cervical insufficiency, short cervix or history of conization, asymptomatic bacteriuria, periodontal disease, and smoking and substance use. Patients who had trauma to the other parts of the body or placental abruption were also excluded. Additionally, the study did not include those with missing hospital records regarding birth and pregnancy follow-up.

Eligibility Criteria:
Inclusion Criteria:

* All of the pregnant women over 18 years of age with isolated head trauma (closed blunt trauma) who were evaluated with neurosurgical consultation or computed tomography/magnetic resonance (CT/MRI) and whose birth records are available at our hospital.

Exclusion Criteria:

Patients with previous premature birth, Pregnancies in the first trimester, Pregnancies with assisted reproductive techniques, Multiple pregnancy, The threat of preterm labor or abortus imminens in the current pregnancy, Maternal or fetal life-threatening situations that may cause termination of the pregnancy, Cervical insufficiency, Short cervix or history of conization, Diagnosis of asymptomatic bacteriuria, Diagnosis of periodontal disease, Smoking and substance use. Patients who had trauma to the other parts of the body or placental abruption Missing hospital records regarding birth and pregnancy follow-up.

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