cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of Compound Methyl Salicylate Liniment for Topical Pain: a Multicenter Real-World Study in China

The purpose of this phase Ⅳ clinical trial was to evaluate the safety and efficacy of compound methyl salicylate liniment (Ammeltz) in a real-life environment in China. This multicenter clinical trial was conducted at 22 hospitals/centers in China between May 2014 and March 2015.

The primary aim of the trial was to evaluate the safety of Ammeltz in a real-life environment. The secondary monitoring objective was to evaluate the efficacy of Ammeltz in the treatment of soft tissue injury pain in a real-life environment.

In principle, according to the guide for drug monitoring in production enterprises in China, the number of patients included in the statistical analysis of key drug monitoring should not be less than 3000 in order to provide ample information about the trial drug. Therefore, the sample size of this study was chosen to be 3600 cases, considering the dropout rate of the subjects.

The investigators collected demographic data, vital signs, current medical history (type of soft tissue damage), and allergy history of the eligible patients on the day of Ammeltz prescription. At the same time, a doctor conducted the physical examination and evaluated the visual analog scale (VAS) score of each patient. On the seventh day of the drug administration (one course of the treatment lasts seven days), the investigator asked each patient by telephone about the actual use of the study drug, whether adverse events occurred, and about the self-assessment pain VAS score. On the 37th day of the treatment, the patients were interviewed again by telephone to inquire about the occurrence of adverse events .

The inclusion criteria for the patients were as follows: 1) age 3-75 years, male or female sex; 2) soft tissue pain caused by shoulder and neck pain, back pain, muscle pain, sprain, strain, contusion, muscle swelling and pain, and arthritis; local symptoms included pain, swelling, bruising, or tenderness; 3) signed informed consent and willing to participate in the study.

Patients were excluded if they met the following criteria: 1) allergy to any of the ingredients in this drug; 2) pregnant women, lactating women, and infants aged 0-3 years; 3) the affected area in the eye or mucous membranes, eczema, macules, wounds, and damaged skin; 4) patients without indications for the use of this drug.

Eligibility Criteria:
The inclusion criteria for the patients were as follows: 1) age 3-75 years, male or female sex; 2) soft tissue pain caused by shoulder and neck pain, back pain, muscle pain, sprain, strain, contusion, muscle swelling and pain, and arthritis; local symptoms included pain, swelling, bruising, or tenderness; 3) signed informed consent and willing to participate in the study.

Patients were excluded if they met the following criteria: 1) allergy to any of the ingredients in this drug; 2) pregnant women, lactating women, and infants aged 0-3 years; 3) the affected area in the eye or mucous membranes, eczema, macules, wounds, and damaged skin; 4) patients without indications for the use of this drug.
A Study for the Risky Decision-making Deficits Among Methamphetamine Dependence Individuals and Treatment

The risky decision-making deficits is the core feature of the methamphetamine (MA) dependence. Our previous research found that MA dependents have network abnormalities such as decision-making and rewarding. The feedback-related negativity amplitude in the prefrontal central area of MA users becomes smaller and blunted after a loss. Moreover, the neural modulation over the prefrontal cortex showed potent to decrease the craving, and the functional connectivity between frontal cortex and subparietal lobules increases. It suggests that there is a correlation between the decision-making network and the reward network of MA addicts, but there is no real-time observation of the dynamic changes of these brain network activities, so it is difficult to correct the interaction mechanism.

In order to clarify the dynamic brain network mechanism of the risky decision-making deficits among MA dependents, firstly, based on magneto-encephalography source information reconstruction methods, firstly, based on magneto-encephalography source information reconstruction methods, the investigators will observe the sequence and interaction among decision-making network, rewarding network, and emotion network. Besides, the investigators clarify that the trans-cranial current stimulation over prefrontal cortex could improve the speed and intensity of the key network interactions among MA dependents, which could improve risky decision-making and craving. The successful implementation of the study is expected to provide important clues for elucidating the pathological mechanism of risky decision-making deficits in MA dependents and providing a theoretical basis for the treatment of addiction.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of severe MA defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5); Normal hearing and vision, or within normal range after correction;

Exclusion Criteria:

Clinical diagnosis of substance use disorder other than an MA or nicotine use disorder defined in the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5) in the past 5 years; Suffering from diseases that affect cognitive function (such as cerebrovascular diseases) ; Schizophrenia, bipolar disorder, depression or other Axis I disorder of DSM-V criteria; any contraindication for fMRI scanning.
INSIGHTS ICD Registry

The purpose of the Registry is to collect data on how Implantable Cardioverter Defibrillator (ICD) therapies and medications are being used by physicians to treat ventricular arrhythmias in order to better understand how to improve the clinical care of patients and effectiveness of ICD therapies.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age or older.
* Patients or legal guardians who are willing and able to sign a Permission for Access to and Use of Health Information in a Registry Form and, if required by an Institution's IRB, an Informed Consent.
* New or replacement implants of Medtronic market released single, dual or triple chamber ICDs including: GEM VR, GEM DR, GEM III AT, Marquis VR, Marquis DR, Maximo DR, Maximo VR, InSync ICD, InSync Marquis ICD and InSync II Marquis ICD.

Exclusion Criteria:

* Patients enrolled in a device study which effects programming and or treatment.
A Personalized and Interactive Web-based Health Care Innovation to Advance the Quality of Care

This study evaluates the clinical efficacy and cost-effectiveness of the ACQUIRE-ICD care innovation as add-on to usual care as compared to usual care alone in patients with an implantable cardioverter defibrillator.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a first-time ICD or CRT-D
* ≥18 years of age

Exclusion Criteria:

* Subcutaneous ICD
* Upgrade from a pacemaker to ICD or CRT
* History of psychiatric illness other than affective/anxiety disorders
* Cognitive impairments (e.g. dementia)
* Left ventricular assist device (LVAD) or upcoming LVAD implant
* Under evaluation or on the waiting list for heart transplantation
* No e-mail address
* Inability to manage or cope with computer technology
* Insufficient knowledge of the Danish language
* Participation in other randomized controlled trials unless of a technical nature
* Irresponsible to ask patient to participate according to GCP
Influence of Different Light Dose on the Adverse Effect of Swallowing for Esophageal Carcinoma

The purpose of this experiment is to study the alleviating effects and side effects of different laser irradiation doses on esophageal stricture of esophageal cancer in order to find the appropriate dose of light.

Background: Photodynamic therapy (PDT) is one of the effective means for the control of esophageal stenosis in advanced esophageal cancer, among which the dose intensity of laser irradiation is one of the factors affecting the efficacy. This study aims to pursue the appropriate dose of light.

Aim: To compare the efficacy and safety of two groups of different laser irradiation doses for advanced esophageal cancer and esophageal stricture.

Methods: Fifty-seven patients were recruited for this study and randomly divided into two groups: single irradiation group and reirradiation group.Single irradiation group: 46-48h irradiation after photosensitizer injection: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Double irradiation group: 46-48h, 72h after photosensitizer injection, divided into two irradiation times: power density: 200mW·cm-2, irradiation time: 900s, volume density: 180 J·cm-2;Power density: 200mW·cm-2, irradiation time: 300s, volume density: 60 J·cm-2.

Primary endpoints: ORR rates at 1 and 3 months, the quality of life

Eligibility Criteria:
Inclusion Criteria:

* esophagus cancer
* 18-80 years old
* grade 3-4 dysphagia （Stoller classification）
* Non-eradicative second-line treatment

Exclusion Criteria:

* Ulcerative tumor
* Esophageal stenosis caused by radiotherapy
* Survival is less than 3 months
* Patients known to be allergic to photosensitizers
Analysis of P-Selectin Expression on Platelets of Blood From Lung Cancer Patients

Purpose:

Selectins are vascular cell adhesion molecules involved in adhesive interactions of leukocytes and platelets and endothelium within the blood circulation.

Plasma soluble P selectin (sP-selectin), is a one of member of selectin family, an adhesion molecule and component of the membrane of the platelet alpha granulate has been proposed as a one marker of platelet activation. In this study we evaluate of expression of P selectin on platelets of blood between serum samples from lung cancer and healthy individuals.

Material and Methods:

The investigators enrolled patients with lung cancer which divided on 3 group: 1- 23 patients with operating tumor; 2-ten patients with advanced and metastatic disease who received palliative RT (RT - radiotherapy); 3-five patients with advanced inoperable disease, who received radical RT or RT + CT (CT- chemotherapy).

In 1 group the specimens of blood we collected before surgery and 1-2 month after. In 2 group - before palliative treatment and in group 3 before radical treatment and one month after completion treatment. To compare to serum specimens from patients with lung cancer was obtained plasma from healthy volunteers.

Serum separation and Raman spectroscopy analysis:

A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. The Raman spectra (RS) of the solid residues from serum samples were measurement by placing 10µl of serum from the aliquots onto an aluminium substrate and allowed to dry for at least 30 min. The Raman system (Renishaw inVia Microscope integrated with Leica microscope) was calibrated with a silicon standard using the Raman peak at 520 cm-1. Multiple scans were conducted on the solid residue by moving the substrate on an X - Y stage. The wavelength of excitation was 785 nm and the laser beam was focused on the surface of the sample with a 50x objective. The radius on the beam was 3.0 µm and the laser power irradiation over the sample was 5mW. Each spectrum was taken with an exposure of 30s, 10 accumulation and collected in the region from 400 to 1540 cm-1.

Eligibility Criteria:
Inclusion Criteria:

* confirmed lung cancer
* WHO 0-2
* 6 month after chemotherapy in palliative patients

Exclusion Criteria:

* double cancer
* another cancer
* chemotherapy in radical patients
* prior external beam radiation in an interview with the patient
Three Debriefing Methods in Virtual Patient Simulation

In simulation-based training, the debriefing session is considered a cornerstone of learning. Therefore, this study aims to compare two different methods of debriefing sessions.


Eligibility Criteria:
Inclusion Criteria:

* Being 4th grade nursing student at a nursing faculty

Exclusion Criteria:

* Not having participated in simulation before and not having practiced with a virtual patient.
To Evaluate the Impact of Treatment Interruption on Re-initiation of Bifeprunox

The purpose of this study is to investigate a safe treatment interruption interval(s) for re-initiation of bifeprunox at a therapeutic dose. The study duration is approximately 7 to 10 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Schizophrenia or Schizoaffective disorder
* 18-55 years

Exclusion Criteria:

* Subjects who are acutely psychotic
* Subjects with current Axis I primary psychiatric diagnosis other than schizophrenia
* Subjects at significant risk of suicide
* Subjects with a seizure disorder
The Effect of Web-Based Mindful Breastfeeding Program During Pregnancy on Postpartum Breastfeeding

The aim of this study is to evaluate the effectiveness of a web-based mindful breastfeeding program in pregnancy to increase awareness, breastfeeding adaptation and breastfeeding self-efficacy in postpartum breastfeeding. The Mindful breastfeeding program intervention will be compared to the group receiving basic breastfeeding education. The main hypothesis is that pregnant women included in the mindful breastfeeding program have higher postpartum breastfeeding awareness, breastfeeding adaptation and breastfeeding self-efficacy.

The aim of this study is to evaluate the effectiveness of a web-based mindful breastfeeding program in pregnancy to increase awareness, breastfeeding adaptation and breastfeeding self-efficacy in postpartum breastfeeding.

There will be two groups in the study:

The web-based "Mindful Breastfeeding Program" (mindfulness-based breastfeeding program) consisting of 8 sessions in total, 2 sessions per week for 4 weeks, will be applied to the pregnant women who make up the intervention group. During the research, a QR code supported website will be established in order to support the awareness practices of the participants at home. While doing mindfulness practices at home, participants will be able to benefit from the short training videos on the website or the audio recordings prepared by the researcher with his own voice.

Only one session online breastfeeding training will be given to the control group and the training brochure for this training will be delivered to the participants via whatsapp.

A total of 40 pregnant women, 20 in the intervention group and 20 in the control group, will form the sample of the study. The main hypothesis is that the postpartum breastfeeding awareness, breastfeeding adaptation and breastfeeding self-efficacy of pregnant women included in the mindful breastfeeding program is higher than the pregnant women who participated in the single-session basic breastfeeding training.

Statistical analysis of the data obtained from the research will be made using SPSS (Statistical Packet for Social Science) for Windows 25.0 program.

Eligibility Criteria:
Inclusion Criteria for Research

* Able to communicate in Turkish,
* Being literate,
* Over 18 years old,
* Having primigravida,
* Conceiving naturally,
* Gestational week between 28-32 weeks,
* Having a single baby (no multiple pregnancy),
* Intention to breastfeed their baby after birth,
* The mother and her baby do not have any health problems,
* Having a smart phone and wireless internet,
* All pregnant women who score below 5 points in the depression sub-dimension, below 4 points in the anxiety sub-dimension, and below 8 points in the stress sub-dimension according to DASS-21 will be included in the sample.

Exclusion Criteria

* If the participant states that he/she wants to withdraw from the research,
* Not attending at least two training sessions,
* Premature birth (before 37 weeks of pregnancy),
* Not breastfeeding the baby after birth,
* Not participating in the post-test,
* Failure to complete the follow-up period for any reason.
Effect of Probenecid on Pexidartinib Pharmacokinetics

The primary objective of this trial is to assess the effect of probenecid on the pharmacokinetics (PK) of single-dose pexidartinib in healthy subjects.

Secondary objectives are to assess the safety and tolerability of pexidartinib alone and in combination with probenecid.

Participants will be confined to the clinic for approximately 32 days. Blood samples will be collected for PK analysis of pexidartinib and metabolites at predose and up to 312 hours (h) post dose.


Eligibility Criteria:
Inclusion Criteria:

* Is a healthy, nonsmoking person with a body mass index of 18 kg/m2 to 30 kg/m2 (inclusive) at Screening
* Is willing to be confined at the clinic for approximately 32 days
* Is surgically sterile or a naturally postmenopausal female and not lactating, or a male who agrees to use double barrier methods of contraception and avoid donating sperm from Check-in until 90 d after the final dose of pexidartinib

Exclusion Criteria:

* Has any history or condition, per protocol or in the opinion of the investigator, that might compromise the participant's safety, their ability to complete the trial, and or analysis of results
Multiple Ascending-Dose Study of EDP 322 in Healthy Adult Volunteers

This was a Phase I, single-center, randomized, double-blind, placebo-controlled, ascending multiple dose study to evaluate the safety, tolerability, and pharmacokinetics of orally administered EDP-322 in healthy adult volunteers.

Fifty-two subjects were enrolled into 6 cohorts. Six subjects of each cohort were randomized to received EDP-322 and 2 subjects of each cohort received placebo. Each cohort received the study drug once daily (QD) for 7 days under fed conditions. Multiple oral doses of EDP 322 ranging from 200 to 800 mg were safe and generally well tolerated by the healthy male and female subjects in this study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males or females between 18 and 45 years of age
* Females are eligible if documentation exists that they are surgically sterilized
* In good general health \[determined by medical history, physical examination, clinical laboratory tests, and without evidence of a clinically significant abnormality, in the opinion of the investigator and medical monitor.
* Subject has a resting 12-lead ECG at screening that shows no clinically significant abnormality and a Bazett-corrected QT interval less than 450 milliseconds.
* BMI between 18-32 kg/m2
* Subject read, understood, and signed the ICF

Exclusion Criteria:

* History of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, CNS, hematologic or metabolic disease, or has an immunologic, emotional, and/or psychiatric disturbance.
* History of gastric surgery, etc.
* Abnormality or clinical lab test results at Screening that is considered clinical significant by the investigator or the medical monitor.
* Gastroenteritis within 1 week before Day 1.
* Acute illness that could pose a threat or harm to the subject or interfere with laboratory test results or interpretation of study data.
* Donated blood within a 4 week period before Day 1.
* Positive for Hep B, C or HIV-1, HIV=2, or positive results at Screening for hepatitis B surface antigen (HBsAG), HCV antibody, or HIV-1 or HIV-2 antibodies
* Medication-related exclusions
A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy

This is an observational, retrospective, cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a reference population not exposed to Wegovy, so that participants and healthcare providers can make informed treatment decisions.


Eligibility Criteria:
Inclusion Criteria:

* Evidence of a pregnancy end event on a medical claim (example, live birth, stillbirth, or spontaneous abortion) during the pregnancy identification period (that is, 04 June 2021 - 17 February 2027).
* Aged 15-45 and female on the date of the last menstrual period (LMP).
* Continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of LMP through 42 days after the pregnancy end date.
* Among the pregnancies that meet the inclusion criteria, three main cohorts of interest and two sub cohorts will be identified (one Wegovy-exposed cohort and two comparison cohorts):
* Wegovy-exposed- for greater than or equal to 1 day of Wegovy exposure from estimated conception date (LMP +14) - 35 days to end of pregnancy.
* Other AOM-exposed- greater than or equal to1 day of phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone exposure, defined as the following:
* Benzphetamine, diethylpropion, orlistat, or phendimetrazine exposure from estimated conception date-1 day to end of pregnancy.
* Phentermine or bupropion/naltrexone exposure from estimated conception date- 5 days to end of pregnancy.
* Cohort with Overweight/Obesity-
* Greater than or equal to 1 diagnosis code for obesity or BMI greater than or equal to 30 kilogram per meter square (kg/m\^2) on a medical claim during the six month pre-pregnancy period.
* Greater than or equal to 1 diagnosis code for BMI greater than or equal to 27 kg/m\^2 or less than 30 kg/m\^2 on a medical claim and greater than or equal to 1 non-diagnostic medical claim for dyslipidemia, type 2 diabetes mellitus, or hypertension during the six month pre-pregnancy period.
* No exposure to Wegovy or other AOM during the defined exposure window in pregnancy.
* Among Wegovy-exposed and Other AOM-exposed pregnancies, the subset with first trimester exposures will be identified as those with greater than or equal to 1 days of exposure at \< less than 14 WGA.

Exclusion Criteria:

* Pregnancies exposed to other glucagon-like peptide-1 receptor agonist (GLP-1 RA) during the exposure identification window (estimated conception date - 35 days through pregnancy end date).
* Pregnancies with exposure to both Wegovy and other AOM during the exposure identification window (estimated conception date - 35 days through pregnancy end date).
* Pregnancies resulting in multiple infants will be excluded from the analysis of infant outcomes.