cyrilzakka/clinical-trials huggingface dataset:
A Research Study Looking at How Oral Semaglutide Works in People With Type 2 Diabetes in Germany, as Part of Local Clinical Practice

The purpose of the study is to collect information on how Rybelsus® works in people with type 2 diabetes and to see if Rybelsus® can lower their blood sugar levels. Participants will get Rybelsus® as prescribed to them by the study doctor. The study will last for about 34-44 weeks. Participants will be asked to complete questionnaires about how they take their Rybelsus® tablets. Participants will complete the questionnaires during their normally scheduled visit with the study doctor.


Eligibility Criteria:
Inclusion Criteria:

* Signed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* Diagnosed with type 2 diabetes mellitus.
* The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
* Male or female, age above or equal to 18 years at the time of signing informed consent.
* Available HbA1c value less than or equal to (≤) 90 days prior to the 'Informed Consent and Treatment Initiation visit' (V1) or HbA1c measurement taken in relation with the 'Informed Consent and Treatment Initiation visit' (V1) if in line with local clinical practice.
* Treatment naïve to injectable glucose-lowering drug(s). An exception is short-term insulin treatment for acute illness for a total of less than (\<) 14 days.

Exclusion Criteria:

* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Treatment with any investigational drug within 30 days prior to enrolment into the study.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
HMPL-813 in Treating Patients With Glioblastoma

This is an open-label study, to evaluated epitinib, which is a selective epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), to treat glioblastoma patients with EGFR gene amplification. As epitinib could cross blood-brain barrier (BBB), inhibition of EGFR may provide a novel mechanism in treating glioblastoma.

Epitinib could cross BBB and show its efficacy in brain metastasis tumors. Patients with histologically confirmed glioblastoma; standard treatment failed or no standard treatment as well as EGFR gene amplication are eligible. Patients will receive epitinib 120mg or 160mg epitinib daily. Epitinib is orally administered qd until patients reach intolerance or progression of disease. Tumor assessment takes place every 4 weeks. Simon two stage design was used, estimated making sample size of 35 cases.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed glioblastoma
2. Standard treatment failed or no standard treatment
3. EGFR gene amplification
4. Clearly measurable lesions (according to Response Assessment in Neuro-Oncolog (RANO))
5. Age ≥ 18
6. Eastern Cooperative Oncology Group (ECOG) score ≤2

Exclusion Criteria:

1. Use of Antiepileptic drugs were used\] within 2 weeks before enrollment
2. Immunotherapy, anti-angiogenesis or EGFR TKI and its downstream pathway signaling molecules and other targeted drugs within 4 weeks before enrollment; temozolomide chemotherapy, cranial radiotherapy or other systemic anti-tumor therapy within 3 weeks before enrollment
3. Previous toxic effects of anticancer therapy have not yet been recovered (defined as not restored to 0 or 1 level, except alopecia) or have not been fully recovered from previous surgery
4. Uncontrolled active infections such as acute pneumonia, Hepatitis B Virus (HBV) and so on
5. Eye disease or dry eye syndrome history
6. Positive pregnancy tested result
A Guided Internet Intervention for Women Treated for Gynecological Cancer

Gynecological cancers are the sixth most common cancer forms and the number of survivors is increasing as a consequence of more efficient treatment and longer life span. As part of regulary care after cancer treatment the women have five years of follow-up with the primary focus on recurrence, aiming to increase survival. However, several studies have shown that there is no evidence for this assumption on increased survival (ref). There are now suggested alternative perspectives in the follow up period targeting late effects, health-related quality of life (QoL) and patient satisfaction with care.The main aim of the current study is to test the feasibility and acceptability of an internet-based psychosocial intervention for women treated with curative intent gynecological cancer. Another aim is to test the perceived effect on gynecological cancer survivors health-related self-care and QoL.

The study's objectives and research questions Research questions

1. How did the participants use the program?

   1. What are the barriers and facilitators concerning technologies of the internet-based self -management intervention?
   2. Number of logins
   3. How much time did the participants spend on the program (per login )
   4. Number of modules completed, number of home-work and mindfulness assignment completed
   5. Type of errors made ...
2. What is the participants' perceived credibility of the program?
3. How do the participants experience the guided psychosocial digital intervention?

   1. How do participants experience the cancer trajectory, their every-day lives and health-related QoL post-treatment gynaecological cancer (before the intervention)?
   2. How do the participants experience the internet-based intervention regarding content, the home-work assignments, and the mindfulness assignments, the active participation?
   3. How do the participants experience the telephone-contact and follow-ups with the nurse once a week?
   4. Which factors do they describe as important for their satisfaction and dissatisfaction
4. How is the perceived effect on the gynecological cancer survivors' competence, QoL, self-care and coping?

It is hypothesized that an internet-based psycho-social intervention will support women in developing self-competence and self-care which could be measured as increased QOL and secondarily affect the impact of cancer, distress, anxiety, depression, self-esteem, and self-reported ability to monitor and respond to symptoms of recurrence.

Eligibility Criteria:
Inclusion Criteria

* have had gyneocological cancer
* maximum 1 year after gynecological cancer

Exclusion Criteria:

* severe medical or psychiatric condition
* relapse of gynecological cancer
A Study to Assess the Efficacy and Safety of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week Period in Subjects With Moderate to Very Severe COPD (Sophos)

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study with PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID.

This is a Phase III randomized, double-blind, parallel group, multi-center, 52-week COPD exacerbation and lung function study. Subjects will undergo a 1- to 4-week Screening Period. Subjects who successfully complete the Screening Period will be randomized to one of the following three treatment groups: PT009 320/9.6 μg, PT009 160/9.6 μg and PT005 9.6 μg, all administered BID. Following randomization, subjects will enter the Treatment Period and undergo additional treatment visits over 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Give their signed written informed consent to participate
2. At least 40 years of age and no older than 80 years of age
3. COPD patients who are symptomatic
4. Must be receiving one or more inhaled bronchodilators as maintenance therapy
5. Must have a documented history of COPD exacerbations

Exclusion Criteria:

1. Current diagnosis of asthma
2. COPD due to α1-Antitrypsin Deficiency
3. Known active tuberculosis, lung cancer, cystic fibrosis, and significant bronchiectasis, Pulmonary resection or Lung Volume Reduction Surgery during the past 6 months.
4. Long-term-oxygen therapy (≥ 15 hours a day).
Placebo Effects on Blood Pressure Induced by Expectancy Manipulation

The objective of the present study was to examine the effects of a single placebo intervention on blood pressure and to investigate autonomic and psychological mediating mechanisms.


Eligibility Criteria:
Inclusion Criteria:

* informed consent

Exclusion Criteria:

* not meeting inclusion criteria
* hypotension or hypertension
* treated or untreated hypertension or hypotension
* Severe systemic disorders (tumors, tbc, diabetes, asthma etc)
* diseases that influence the cardiovascular or gastrointestinal system
* intake of drugs affecting blood pressure and/or autonomic nervous system
* pregnancy and lactation phase
* body mass index \>= 32
* cardiovascular risk factors (diabetes, smoking)
* drug or alcohol abuse
* insufficient compliance
* participation in another trial within the last three months
Post Marketing Surveillance of Alesion® in Japanese Paediatric Patients With Allergic Rhinitis, Eczema/Dermatitis, Urticaria and Pruritus

Study to investigate the safety and efficacy of Alesion® Dry Syrup under the proper use in daily clinical practice in Japanese paediatric patients with allergic rhinitis, eczema/dermatitis, urticaria and pruritus


Eligibility Criteria:
Inclusion Criteria:

* All the patients who:

  * haven't treatment experience of epinastine product;
  * have at least one out of following diseases. allergic rhinitis, eczema, dermatitis, pruritus, urticaria

Exclusion Criteria:

* Alesion® Dry Syrup is contraindicated for the patients with history of hypersensitivity to any ingredients of Alesion® Dry Syrup in package insert. However, it was unknown whether a patient was hypersensitive to the ingredients of the product in almost cases. And this survey was drug utilization study to observe actual use in any patients. Therefore exclusion criteria are not set in the protocol
Stepwise Positive End Expiratory Pressure Elevation For Lung Recruitment in Acute Respiratory Distress Syndrome (ARDS)

Acute respiratory distress syndrome is a severe lung disease caused by a variety of direct and indirect issues. It is characterized by inflammation of the lung parenchyma leading to impaired gas exchange and persistent hypoxemia. This condition is often fatal, usually requiring mechanical ventilation. Recruitment maneuver aimed to enhance the effect of mechanical ventilation.The objective of this study was to compare safety and efficacy of two lung recruitment maneuvers.

In patients with acute respiratory distress syndrome (ARDS), protective lung strategy and positive end expiratory pressure (PEEP) therapy should be started as early as possible to avoid lung damage by high pressures, volumes and fraction of inspired oxygen (FiO2). Recruitment is a strategy aiming at re-expanding the collapsed lung tissue and then maintaining an adequate level of PEEP to prevent subsequent de-recruitment. The objective of this study was to compare safety and efficacy of two lung recruitment maneuvers (RM): stepwise PEEP elevation with determination of the alveolar collapsing pressure versus sustained lung inflation in ARDS patients

Eligibility Criteria:
Inclusion Criteria:

* ARDS
* lung injury score more than 2.5
* on mechanical ventilation

Exclusion Criteria:

* hemodynamic instability
* left heart failure
* pneumothorax
* COPD
* restrictive lung disease
A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia

The purpose of this study was to compare the subthalamic nucleus(STN) with the globus pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically refractory dystonia.

In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN and Gpi of 40 patients with dystonia.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is aged 18 to 75 years old, male or female.
2. Diagnosed with cervical dystonia by a movement disorders neurologist.
3. Has cervical dystonia alone, not generalized or multifocal.
4. Has had adequate trials of medical therapy.

Exclusion Criteria:

1. Cognitive impairment.
2. Abnormalities on pre-operative magnetic resonance imaging (MRI).
3. Medical conditions precluding general anaesthetic or surgery.
4. Unstable psychiatric disease.
5. Previous brain lesions to treat cervical dystonia.
6. Attended some other trials within three month.
Type 2 Diabetes Post Exercise Arterial Stiffness

The overall aim of this research proposal is to determine the impact of GLP1 agonists on post-exercise arterial stiffness. Therefore, the investigators will examine the cardiovascular responses to exercise in individuals with Type 2 Diabetes mellitus (T2DM) taking these medications during and following a graded maximal exercise test.

Type 2 diabetes mellitus (T2DM) is a significant public health concern associated with increased cardiovascular morbidity and mortality. Notably, individuals with T2DM often exhibit increased arterial stiffness, a key indicator of cardiovascular risk. Pharmacological interventions such as GLP1 agonists have emerged as crucial treatments for T2DM, offering glycemic control and potential cardiovascular benefits, including improvements in blood pressure and arterial stiffness. However, while the effects of GLP1 agonists on glycemic control and blood pressure regulation have been explored, their impact on arterial stiffness, specifically in response to exercise, remains largely unexplored in individuals with T2DM. Arterial stiffness is a critical marker of cardiovascular health, and its reduction is associated with decreased cardiovascular risk which include lowered blood pressure. Therefore, the overall aim of this research is to investigate whether GLP1 agonists attenuate arterial stiffness post exercise and reduce peak exercise blood pressure in individuals with T2DM.

Eligibility Criteria:
Inclusion Criteria:

Individuals diagnosed with type 2 diabetes mellitus (T2DM).

* Age between 18 and 60 years old.
* Currently receiving treatment with a glucagon-like peptide 1 (GLP1) agonist for the management of T2DM for a minimum duration of six months.
* For control group no current use of a glucagon-like peptide 1 (GLP1) agonist for the management of type 2 diabetes mellitus (T2DM).
* HbA1c levels between 6.5-8%
* Body Mass Index (BMI) within the range of 25 to 40 kg/m2.

Exclusion Criteria:

* Coronary heart disease.
* Pulmonary disease (e.g. asthma, chronic obstructive pulmonary disease)
* Neurological disorders (e.g. Alzheimer's disease, dementia)
* Congestive heart failure.
* Peripheral vascular disease.
* Liver failure.
* Kidney failure.
* Alcohol abuse.
* Drug abuse.
* Smoking.
* Hypertension (defined as Systolic Blood Pressure ≥ 140 mmHg or Diastolic Blood Pressure ≥ 90 mmHg)
* Insulin therapy for the management of T2DM
* Severe obesity (defined as Body Mass Index \>40 kg/m2);
* Pregnancy
* Non-English speaking individuals
Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation

Electronic cigarettes have shown promise but have yet to proven effective for smoking cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers who are trying to quit smoking compared with a standard therapy, the nicotine inhaler. The investigators hypothesize that electronic cigarettes will be comparable to the nicotine inhaler in terms of smoking cessation.

Cigarette smoking remains the leading cause of preventable death and disease worldwide.

The purpose of this trial is to evaluate the effectiveness of electronic cigarettes for smoking cessation compared to a similar nicotine replacement therapy, the nicotine inhaler.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 year old
* Meet DSM-IV criteria for nicotine dependence
* Seeking treatment for smoking cessation
* Smoking at least 15 cigarettes per day
* Capable of giving informed consent and complying with study procedures

Exclusion Criteria:

* Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder
* Current DSM-IV criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non- pharmacological intervention over the course of the study
* Currently receiving any treatment for nicotine dependence, including nicotine replacement therapy
* Pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men
* Unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous
* Current DSM-IV diagnosis of substance dependence, other than nicotine
* Use of cannabis or alcohol on more than 20 days in the past 30 days
* Risk for suicide
Evaluation of Soluble ST2 in Patients Receiving Primary PCI With ST-elevation Myocardial Infarction

ST-elevation myocardial infarction (STEMI) is an urgent symptom associated with sudden myocardial ischemia and ST segment elevated in ECG. Primary percutaneous coronary intervention (PCI) re-open infarct artery efficiently for STEMI patients. However, patients are readmitted shortly after the primary PCI for several unfavorable clinical outcomes including thrombosis in stent, recurrence of myocardial infarction, stroke, and heart failure. This study is intended to test the predictive ability of a new biomarker soluble ST2 (sST2) in peripheral blood. Previous studies have shown that elevated sST2 is highly associated with unfavorable clinical outcomes of patients with ischemia heart diseases and heart failure. This study will further investigate the ability of sST2 to predict unfavorable outcomes for STEMI patients after primary PCI.


Eligibility Criteria:
Inclusion Criteria:

* Patients with first onset STEMI receive primary PCI according to 2013 ACCF/AHA guideline for management of STEMI

Exclusion Criteria:

* Patients with previous stroke, pneumonia, cirrhosis, autoimmune diseases or severe infection are excluded from this study.
Does Emergence Time Relate With Emergence Agitation in Pediatric Patients?

Emergence agitation (EA) is one of the unpleasant symptoms after general anesthesia. The patient can be irritable, uncooperate, cry, moan and combative behaviors. Sometimes the patient may need to be thrashed to prevent physical harm. The mechanism of EA is still unknown. EA is usually self limiting within 45 to 60 minutes after wake up from anesthesia. The incidence of EA is much higher in pediatric group when compared with adult. In some centre the incidence of EA can be up to 67 % depends on anesthesia technique, race, and child's temperament. Kain et al, reported that the patient who had marked EA tended to have post operative maladaptive behaviors. These maladaptive behaviors such as insomnia, eating disturbance, aggressive behavior and even developmental regression can be happen until one year after anesthesia.

From the previous study, reported that fast emergence was associated with a high incidence of agitation.

This prospective observation study is conducted to determine that emergence time has any effect on EA or not. The authors use process electroencephalogram (entropy) to monitor emergence time which defined as the time which state entropy level over sixty to eighty. Meanwhile, we will evaluate the emergence time by the conventional method which used the time from ceasing anesthesia to the time of eye opening by normal voice stimuli.

The primary outcome of this study is the correlation between emergence time (both from Process EEG and clinical presentation) and incidence of emergence agitation. Two secondary outcomes will be measured. Firstly, the correlation between emergence time and postoperative behavioral changes. Secondly, the relationship between entropy monitoring and clinical symptoms.


Eligibility Criteria:
Inclusion Criteria:

Pediatric patient aged between 3-12 years, ASA physical status I-II who is scheduled for inpatient elective surgery

Exclusion Criteria:

emergency surgery, neurosurgery, antiepileptic medication taken and having ICU admission planning.
Artificial inTelligence in eNdometriosis-related ovArian Cancer and Precision Surgery in eNdometriosis-related ovArian Cancer

Endometriosis (EMS) is a chronic, invaliding, inflammatory gynaecological condition affecting 10-15% of women in reproductive age. EMS is characterized by lesions of endometrial-like tissue outside the uterus involving pelvic peritoneum and ovaries. In addition, distant foci are sometimes observed. Unfortunately, the aetiology of the EMS is little known. Although non-malignant, EMS shares similar features with cancer, such as development of local and distant foci, resistance to apoptosis and invasion of other tissues with subsequent damage to the target organs. Moreover, patients with EMS (particularly ovarian EMS) showed high risk (about 3 to 10 times) of developing epithelial ovarian cancer (EOC). Epidemiologic, morphological and molecular studies reported endometrioma as the precursor of EOC, including clear cell (CCC) endometrioid carcinoma which are both called "EMS-related ovarian carcinoma (EROC)". To date, it remains unclear why benign EMS causes malignant transformation. This multi-step process, unlike high-grade serous carcinomas, offers the possibility to identify the carcinoma precursors enabling an early diagnosis and in the early stages of the disease.

EOC is the most lethal female gynecological cancer with 25% 5-year overall survival (OS), due to the lack of effective screening tools, and rapidly spreads over the entire peritoneal surface (carcinosis) thus involving all abdominal organs. Diagnosis and clinical staging of EOC is currently performed by qualitative image evaluation although the sensitivity/specificity is suboptimal. To date, diagnostic, staging, and prognostic factors are strongly correlated with subjective assessment training and clinician experience.

Genomic analysis based on Next Generation Sequencing (NGS) has revealed the presence of cancer-associated gene mutations in EMS. Moreover, the chronic inflammatory process of EMS involves many factors, such as hormones, cytokines, glycoproteins, and angiogenic factors, which are expected to become early EMS biomarkers.

A promising new branch of cancer research is the use of artificial intelligence (AI) to recognize new image patterns and texture and/or detecting novel biomarkers to improve the early identification of EROC patients. AI has never been used for EROC and we want to investigate whether these methods/techniques can support and even improve current diagnostics and risk assessment. AI will be used to construct a new 3D risk assessment model based on images and volume of interest


Eligibility Criteria:
Inclusion Criteria:

* age\>18
* Suspected diagnosis of epithelial ovarian cancer
* Patients eligible for surgery
* radiological imaging available
* informed consent

Exclusion Criteria:

* Patients with previous different malignancies
* Patients with previous chemotherapeutic treatment
* Patients with previous pelvic radiotherapeutic treatment