cyrilzakka/clinical-trials huggingface dataset:
Smoking Pattern and Influencing Factors in Hospitalized Patients

This study examines the smoking patterns and determinants of inpatients who smoke, develops tailored smoking cessation interventions based on their individual needs, and aims to enhance the effectiveness of quitting and lower the likelihood of relapse.

Smoking is a major risk factor for many chronic and acute diseases, and quitting smoking can bring significant health benefits. However, many smokers find it hard to quit or relapse after quitting. This study aims to explore the smoking behavior and influencing factors of inpatients who smoke. The survey will collect data on the demographic, clinical, psychological, and behavioral aspects of the participants, as well as their smoking history, nicotine dependence, withdrawal symptoms, confidence and motivation to quit, and perceived barriers and facilitators to quitting.

Eligibility Criteria:
Inclusion Criteria:

1. aged 18 and above;
2. smoke at least 1 cigarette daily;
3. willing to participate in this study

Exclusion Criteria:

1. Smokers who have mental illness or cognitive impairment;
2. Unable to complete the questionnaire survey
Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments

The purpose of this study is to assess the retinal redetachment rates with 1000 centistoke versus 5000 centistoke silicone oil tamponade for repair of complex retinal detachments.

As part of retinal detachment surgery, the eye is typically filled with a gas bubble or silicone oil bubble. This bubble acts like a balloon inside the eye and helps to keep the retina pushed back against the eye wall so it can heal in its proper place. Gas bubbles spontaneously dissolve over a few weeks whereas silicone oil remains in the eye until removed with another surgery. When retinal detachments are associated with significant scar tissue on the retinal surface, silicone oil is often used since it can remain filling the eyeball for as long as necessary to help the retina to heal properly in place. Currently, two different types of silicone oil (1000 centistoke and 5000 centistoke) are commercially available and have been approved for use in the eye by the Food and Drug Administration. The goal of the study is to compare the outcomes using these two different types of silicone oil.

The retinal detachment will be repaired in a standard fashion. There will be no difference between the way retinal detachments are repaired in this study compared to those not in this study. Patients will be randomly assigned (like a flip of a coin) to receive one of the types of silicone oil. Both types of oil have very similar characteristics. The primary difference is that one type is thicker (more viscous) than the other, analogous to honey in comparison with maple syrup.

Eligibility Criteria:
Inclusion Criteria:

* Presence of rhegmatogenous retinal detachment or tractional retinal detachment due to grade C or worse proliferative vitreoretinopathy or proliferative diabetic retinopathy.
* Judgment by the investigator that silicone oil tamponade is surgically indicated for appropriate repair of the complex retinal detachment.
* Visual acuity of light perception or better.
* Ability to provide written informed consent and comply with study assessments for the full duration of the study.

Exclusion Criteria:

* Inability to re-attach the retina at the time of surgery.
* Prior trabeculectomy or tube shunt surgery.
* Corneal opacity which limits visualization of the trabecular meshwork.
Comparing Tai Chi Training to a Low-Stress Physical Activity to Enhance Sleep in Older Adults

The purpose of this study is to examine the effects of Tai Chi, in comparison to conventional exercise, on the quality of sleep among sedentary older adults.

Elderly individuals often suffer from sleep disturbances. Chronic sleep problems can cause significant medical, psychological, and social disruptions. Although many sleep-related studies exist, few studies have focused on improving quality of sleep. Tai Chi, an exercise that incorporates meditation and breathing with whole body movements, may improve the quality of sleep and health status of elderly individuals.

Participants will be randomly assigned to either a Tai Chi group or a conventional exercise control group. Participants in each group will exercise for 60 minutes, 3 times per week, for 6 months. Assessment of sleep quality and health status will be done at study start, 3 months, 6 months, at the end of the study, and at a 3-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Sedentary, as defined by a lack of regular exercise during the previous 6 months
* Healthy to the degree that participation in exercise testing and an exercise program would not exacerbate any existing disease condition
* Physician's clearance for participation
* Willingness to adhere to the conditions of the study

Exclusion Criteria:

* Sleep medication or other psychotropic medication during the study
* Current sleep disorder treatment
* Significant cognitive impairment as indicated by a score of 3 on the Pfeiffer Mental Status Questionnaire
* More than 7 alcoholic beverages per week or use of alcohol close to bedtime
* Smoking more than 10 cigarettes per day
* Score of 5 or higher in the Pittsburgh Sleep Quality Index questionnaire
* Score of 3 or higher on 2 out of 3 sleep items drawn from the Sleep Questionnaire and Assessment of Wakefulness
Study to Compare How the Body Changes the Blood Level of Darifenacin Tablet Form vs. the Modified Release Liquid Form in Healthy Subjects

This purpose of this study is to compare the how the body changes the blood level of a single dose of darifenacin when given as 7.5 mg modified release tablet and the modified release liquid suspension (1.5 mg/ml) under fasted and fed conditions in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, male or female subjects age 18 to 50 years of age (inclusive)
* In good health
* Female subjects either surgically sterilized at least 6 months prior to study participation or post-menopausal (no regular menstrual bleeding for at least 2 years)
* Body mass index within the range of 18.5 to 29.9 kg/m2 and weigh at least 45 kg

Exclusion Criteria:

* Smokers
* History of
* Urinary retention, narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment, severe ulcerative colitis, toxic megacolon
* Symptomatic hiatus hernia, erosive or symptomatic gastroesophageal reflux disease/heartburn (\>2 days in a week), severe constipation, gastrointestinal obstructive disorders, and gastric retention.
* Clinically significant cardiac abnormalities, fainting, low blood pressure upon standing, irregular heartbeats
* Acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease)
* Clinically significant drug allergy or history of atopic allergy (asthma, urticaria, eczematous dermatitis)
* Known hypersensitivity or severe adverse event to darifenacin or similar drugs
* Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardize participation in the study
* Immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result
* Positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
* Drug or alcohol abuse within the 6 months prior to dosing
* Use of prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing. Paracetamol is acceptable.
* Participation in any clinical investigation within 4 weeks prior to dosing
* Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing.
* Significant illness within 2 weeks prior to dosing.

Other protocol-defined inclusion/exclusion criteria may apply.
Magnetic Resonance With Gadoxetic Acid for the Diagnosis of Hepatocellular Carcinoma in Patients With Liver Cirrhosis. Evaluation of Its Impact for the Non-invasive Diagnosis

This is a study to evaluate the primovist as a new contrast agent useful to diagnostic of hepatocellular carcinoma

The investigators plan to define the imaging patterns of hepatocellular carcinoma in cirrhotic patients when studied with gadoxetic acid magnetic resonance imaging including the dynamic phase and the hepatobiliary phase at 10 and 20 minutes after contrast injection and to evaluate the usefulness of liver magnetic resonance imaging with gadoxetic acid in the differentiation between benign and malignant nodules in the cirrhotic liver. To determine the diagnosis and clinical significance of the infracentimetric additional nodules detected in the hepatobiliary phase

Eligibility Criteria:
Inclusion Criteria:

* more than 18 years old
* patient with diagnosis of liver cirrhosis Child Pugh A-B
* Patients without previous hepatocellular carcinoma in whom ultrasound detects a suspicious hepatic lesion; solitary solid and well-defined nodule between 10 and 20mm
* patients in whom diagnosis of hepatocellular carcinoma is a clinical need prior to treatment indication
* patient that agree to participate signing informed consent form

Exclusion Criteria:

* Patients with poor liver function who would have undergone transplantation even without hepatocellular carcinoma diagnosis (Child-Pugh C)
* patients with previous diagnosis of hepatocellular carcinoma
* patients with significant comorbidities that could prevent the optimum therapeutic decision in case of positive diagnosis of hepatocellular carcinoma
* patients with severe clotting alterations that contraindicate the fine-needle biopsy -Patients with chronic kidney disease or glomerular filtration rate \< 30 ml/min
* patients with contraindications to perform magnetic resonance imaging (pacemaker, claustrophobia...)
* Known hypersensitivity to study drugs or excipients
* pregnancy or breastfeeding
A Study Of Sertraline Compared With Paroxetine In The Treatment Of Panic Disorder

To evaluate the efficacy and safety of sertraline compared to paroxetine in patients with panic disorder.


Eligibility Criteria:
Inclusion Criteria:

* Patient who meets diagnosis of Panic Disorder (with or without Agoraphobia) according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV).
* Patients must have experienced at least 4 panic attacks within 4 weeks before screening.
* At baseline patients with Panic Disorder of total score of 18 or higher on the Panic and Agoraphobia scale (clinician rated version).

Exclusion Criteria:

* Patients who concurrently have bipolar disorder, schizophrenia, delusional disorder, epilepsy, Major Depression Disorder (MDD), Obsessive Compulsive Disorder (OCD), Seasonal Affective Disorder (SAD) or General Anxiety Disorder (GAD) according to the DSM-IV criteria.
* Patients who concurrently have depression/depressive state, anxiety disorder and generalized anxiety disorder may be included in the study if the primary diagnosis is identified to be panic disorder
* Patients with the total score of at least 18 on the Hamilton Depression Rating Scale (HAM-D) (Items 1 to 17) at the start of Screening (Visit 1)
* Patients who require concomitant drug therapy with psychotropic agents (including benzodiazepines) and monoamine oxidase inhibitor during the period of the study.
Marine n-3 Polyunsaturated Fatty Acids in Pre- and Postmenopausal Women

The study is a randomised placebo controlled double-blinded clinical trial where a group of healthy pre- and postmenopausal women is randomised to the intake of fish oil capsules or placebo oil capsules for 12 weeks. Anthropometric measurements(weight, height,blood pressure) blood samples and adipose tissue biopsies will be taken in order to illustrate the effect of marine n-3 PUFAs (fish oil) on the concentration of circulating female hormones and to investigate what impact menopause might have on the ability to incorporate marine n-3 PUFAs into tissues.


Eligibility Criteria:
Inclusion Criteria:

* age 18-70 years old
* healthy or well-treated chronic disease

Exclusion Criteria:

* hormone treatment
* foreseen compliance problem
* fish oil consumers
Treatment of Periodontitis by Conventional 4 Weekly Sections or Within 24 Hours

Periodontitis is a form of gum disease that affects many people in the world. Its traditional protocol of treatment includes oral hygiene instruction and dental scaling to remove debris, dental plaque and tartar in 4 weekly sections. There is an additional time-reduced option also usually cheaper. In this last one, all above described procedures are performed within 24 hours. However, up to now comparative effectiveness between these both types of treatment is not well understood. For, example it is not clear if patients treated in the shorter-time experienced more pain. Therefore, the present study used several parameters to clarify whether beneficial differences between these therapeutic protocols exist or not. In addition, aspects that could help clinicians' and patient's decisions such as experience of pain and anxiety related to dental treatment were also investigated. After receiving verbal and written explanations and signed the informed consent form 150 individuals (n=15/group) having the most common type of periodontitis in adults were randomly allocated to be treated in 4 weekly sections or within 24 hours. Oral hygiene instructions and dental debridement were performed alone or in conjunction with antimicrobial agents: a mouth rinse containing chlorhexidine or systemic azithromycin antibiotic tablets. The parameters measured at baseline, 3, 6 and 9 months after treatment were: indicators of inflammation, amount of oral debris and malodor; quantification of bacteria in plaque samples collected with paper points from teeth and tongue; amount of produced saliva and self-reported questionnaires to collect information about oral condition, daily activities, pain and anxiety related to dental treatment.


Eligibility Criteria:
Inclusion Criteria:

* mild to moderate chronic periodontitis;
* at least 20 natural teeth;
* good general health

Exclusion Criteria:

* systemic diseases or other conditions that could influence the periodontal status;
* events of high blood pressure or diagnosed hypertension;
* alcohol abuse;
* orthodontic devices;
* extended prosthetic fixed devices, removable partial dentures or overhanging restorations;
* pregnancy or breast-feeding;
* history of sensitivity or suspected allergies following the use of oral hygiene products and/or the test antibiotic;
* the need for antibiotic prophylaxis;
* antibiotics and/or anti-inflammatory drug use in the three months prior to the beginning of the study;
* regular use of chemotherapeutic antiplaque/antigingivitis products;
* any furcation lesions;
* periodontal treatment performed within six months prior to study initiation;
* unwillingness to return for follow-up.
Cardiac Substructure Radiation Dose and Early Clinical Monitoring of Stage N2-3 Non-Small Cell Lung Cancer

Calculating which cardiac substructure accepting with the highest radiation dose by conventional radiotherapy, then to investigate the relationship between the changes of global longitudinal strain or cardiac magnetic resonance imaging and cardiac biomarkers and the certain cardiac substructure for stage N2-3 non-small cell lung cancer

All patients receive intensity-modulated radiotherapy (IMRT). The prescription dose of PTV is 60-70Gy，Troponin I, troponin T, hypersensitive troponin, brain natriuretic peptide and NT-proBNP are detected before radiotherapy, at the end of radiotherapy (day 15), at the end of radiotherapy and at 1 month after radiotherapy. Echocardiography was performed before radiotherapy, in the middle of radiotherapy (day 15) and at the end of radiotherapy to obtain global longitudinal strain value. Cardiac magnetic resonance imaging is used to measure the blood flow of the anterior descending coronary artery before and at the end of radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at TNM stage N2-N3 NSCLC confirmed by histopathology or cytology using IASLC International TNM staging standard (8th edition)
2. KPS score \>80; Aged 18 to 75 year-old
3. No contraindications to radiotherapy
4. No history of heart disease before treatment
5. Patients receiving intensity modulated radiation therapy (IMRT)
6. Patients receiving PTV at a prescription dose of 60-70Gy by IMRT
7. Patients receiving radiotherapy alone and concurrent chemoradiotherapy

Exclusion Criteria:

1. Patients with pleural effusion
2. Patients with serious medical illness or infection
3. Patients with acute myocardial infarction within 6 months
4. In patients with NYHA grade 3-4, baseline LVEF before radiotherapy is below 59%
5. Patients with congenital heart diseases, valvular diseases and arrhythmia
6. Patients with pericardial effusion
7. Patients receiving immunotherapy and drug targeted therapy
8. Patients with a history of anthracycline use
Donor Immune Cell Therapy for Acute Myeloid Leukemia

This study aims to introduce a new technology of donor NK cell infusion. NK cells defend against viruses and cancer cells in vivo whereas this effect declines in patiens with tumors. In this study, NK cells will be separated from donated peripheral blood or umbilical cord blood. Eligible NK cells will be infused to patients with Acute myeloid leukemia (AML). This new therapy will probably induce their sustained remission and reduce recurrences.

Primary end point:

To determine the rate of overall survival at 2 years of Interventional cohort

Secondary end point:

To determine the cumulative incidence of relapse at 2 years. To determine the rate of disease-free survival at 2 years. Describe the safety and toxicity of donor NK cell infusion.

Study Design:

This study is a phase I clinical trial. 15 eligible AML patients will be enrolled sequentially to receive detached NK cells product during induction or consolidation therapy. Refractory or relapsed patients and patients who achieved complete remission (CR) after induction therapy are included. They will receive anthracycline-based chemotherapy according to NCCN guidelines. At the same time, Cultured NK cells will be infused into patients after chemotherapy. Anti-allergic therapy and prophylaxis of graft versus host disease (GVHD) will be given before infusion. Treatment effect will be measured and adverse effect will be treated and documented after intervention.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have been diagnosed as acute myeloid leukemia in accordance with "Chinese Diagnosis and Treatment Guidelines of AML". Those who achieved CR after chemotherapy are mainly included. Refractory/relapsed AML can also be enrolled.
* Patients with normal heart function (ejection fraction ≥ 50%), normal liver function(ALT and AST ≤ 2.5 times the upper limit of normal value, bilirubin ≤ 2 times the upper limit of normal value) and normal renal function with blood creatinine ≤ 3.0 mg/dL (≤ 260 µmol /L) can be enrolled.
* Patients will be required to sign an informed consent.

Exclusion Criteria:

* Patients with severe infection or other malignant tumors.
* Women during pregnancy or lactation.
* Other patients deemed unsuitable by the investigator.
Confocal Laser Endomicroscopy in Pleural Malignancies

To date, the different biopsy methods, such as CT-guided pleural biopsy, mediastinal biopsy, endosonography and thoracoscopy have their limitations in diagnosing pleural malignancies, such as mesothelioma. Sampling errors frequently occur resulting in the common histological finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty for clinicians and patients. Confocal laser endomicroscopy (CLE) provides real-time imaging on a cellular level, however data of CLE in pleural malignancies are lacking.

Novel optical imaging techniques such as confocal laser endomicroscopy (CLE) have emerged in recent years as techniques that actually enable in vivo real-time microscopic analysis of malignancies of the GI-tract and lung cancer. Through recent advances the probe became small enough to fit through a biopsy needle and can be used during CT-guided and endosonographic guided biopsies (EUS-FNA). Patients with intra-thoracic malignancies often require invasive procedures such as bronchoscopy, thoracoscopy, mediastinoscopy, transthoracic needle aspiration or surgical exploration to obtain a diagnosis. Intra thoracic malignancies encompass lung cancers, thymomas and malignant pleural mesothelioma. These tumors often present with pleural thickening, unilateral pleural effusion, mediastinal enlargement or a peripheral located mass in the lungs. Tissue collection of the suspected pleural thickening is required to assess a diagnosis and differentiate between the tumor types, to classify and to stage in a proper manner. To date, the different biopsy methods, such as CT-guided pleural biopsy, mediastinal biopsy, endosonography and thoracoscopy have their limitations in diagnosing these malignancies. Sampling errors frequently occur resulting in the common histological finding of 'non-specific pleuritic/fibrosis', which presents a great uncertainty for clinicians and patients. Novel microscopic imaging techniques such as CLE are capable of real time imaging on a cellular level. Data of CLE in intra-thoracic malignancies are lacking.

Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* Supected intra-thoracic malignancies with pleural involvement and referred for a diagnostic procedure by thoracoscopy, CT guided biopsy or endosonography

Exclusion Criteria:

* Inability and willingness to provide informed consent
* Patients with known allergy for fluorescein or risk factors for an allergic reaction
* pregnancy or lactating women
Efficacy and Safety of VER-01 in the Treatment of Patients With Chronic Low Back Pain

The aim of the trial is to prove the efficacy and safety of VER-01 corresponding to 22.5 mg or 32.5 mg THC compared to placebo in patients with chronic low back pain (CLBP) for whom drug treatment is indicated and previous optimized treatments with non-opioid analgesics have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance.


Eligibility Criteria:
Inclusion Criteria:

* Chronic (≥ 6 months) pain in the lower back (between the 12th thoracic vertebra and lower gluteal folds). CLBP patients without a clear specific somatic cause, for which targeted therapy can have a positive effect on the course of the disease.
* Patients with indicated opioid drug treatment where previous optimized treatments with non-opioid analgesics (including combinations) have not led to sufficient pain relief or were unsuitable due to contraindications or intolerance

Exclusion Criteria:

* Any painful comorbidity which could, in the opinion of the investigator, interfere with the low back pain intensity assessment during the trial participation
* Pregnant or breastfeeding female patients
* Known history of previous or current severe psychiatric disorder as per DSM-5 (e.g., schizophrenia, bipolar disorder, severe anxiety disorder, psychotic disorder, post-traumatic stress disorder), or currently taking antipsychotic medication.
* Cardiovascular event or clinically significant cardiac dysfunction (e.g., congestive heart failure, myocardial ischemia, arrhythmias, poorly controlled high blood pressure, congenital long QT syndrome) within 12 months prior to Visit 1 or a cardiac disorder that, in the opinion of the investigator, would put the patient at risk of a clinically significant arrhythmia or myocardial infarction.