cyrilzakka/clinical-trials huggingface dataset:
Predictive Value of Serum and Tissue Molecular Markers and Imaging Features in the Invasiveness and Prognosis of Pituitary Neuroendocrine Tumors

As the clinical manifestations of pituitary neuroendocrine tumors vary greatly, 2.7-15% of them are resistant to conventional treatments such as surgery, drug therapy and radiotherapy, and often relapse or regrow in the early postoperative period, which is invasive and has a poor prognosis. Therefore, it is important to find imaging, histological or serum molecular markers for early prediction of the invasiveness and clinical prognosis of pituitary neuroendocrine tumors. The aim of this study is to observe the changes of biomarkers and imaging features in serum or tissues of pituitary neuroendocrine tumors during the course of disease and treatment, and to explore the biomarkers and imaging features that can predict the proliferation, progression and recurrence risk of pituitary neuroendocrine tumors after medical or surgical treatment.


Eligibility Criteria:
Inclusion Criteria:

Patients with pituitary neuroendocrine tumors: pituitary adenoma was diagnosed by clinical imaging, with or without pituitary hormone secretion function was confirmed by pituitary hormone detection.

Exclusion Criteria:

1. Previous pathological specimen suggested pituitary carcinoma.
2. always have received radiation and chemotherapy or immune and targeted therapy of the patients.
3. with known genetic syndrome can cause excessive secretion of hormones (such as Carney syndrome, McCune - Albright syndrome, multiple endocrine neoplasia type 1, acute interstitial pneumonia) patients.
4. there are ectopic neuroendocrine tumor patients.
5. within one month before the screening for major surgery, or within 3 months before screening for patients with sphenoid pituitary surgery.
6. crisis of gland function (the pituitary gland, thyroid crisis, adrenal crisis).
7. peripheral glands or other solid tumors in patients with severe disease or blood system.
8. serious organ damage such as heart, kidney, liver, etc.
9. with severe mental or nervous system disease.
10. serious high blood glucose or poorly controlled hypertension or emergency patients.
Drug Sensitivity of Hydrothorax and Ascite Organoids from Breast Cancer

Malignant hydrothorax and ascitic fluid in advanced breast cancer often arise from metastasis to the lungs, pleura, or liver. Patients with this condition experience rapid disease progression and multidrug resistance, facing limited treatment options. Clinical guidelines offer various therapies based on molecular subtypes; however, their effectiveness can be hindered by prior treatments, patient health, and tumor evolution. Current evaluations of treatment efficacy typically take two cycles, delaying the recognition of ineffective therapies and resulting in unnecessary side effects and costs. Organoid models present a promising solution, accurately replicating tumor structure and cellular diversity compared to traditional methods. These patient-derived models facilitate improved drug sensitivity testing, leading to more personalized treatment plans. In this study, 90 patients diagnosed with metastatic breast cancer accompanied by hydrothorax and ascitic fluid will be recruited. Patient-derived organoids will be used to assess the sensitivity of chemotherapy regimens, including Doxorubicin, Carboplatin, Cyclophosphamide, and Paclitaxel, along with targeted therapies such as Herceptin and Pertuzumab.

90 metastatic breast cancer patients with hydrothorax and ascitic fluid will be recruited. Baseline data, including medical history, ultrasound, and MRI records, will be collected both before and after two cycles of chemotherapy. Tumor samples from hydrothorax and ascitic fluid will be obtained and cultured to generate patient-derived organoids (PDOs). These PDOs will then be exposed to standard chemotherapeutic drugs used in breast cancer treatment. Organoid growth will be monitored post-treatment, and dose-response curves will be generated to assess drug sensitivity. To evaluate clinical outcomes, the RECIST criteria will be applied to measure tumor response in patients. Correlation analysis will be performed to determine the consistency between the treatment responses observed in the PDO models and the actual clinical outcomes of the patients.

Eligibility Criteria:
Inclusion Criteria:

1. Signed informed consent form and willingness to participate in the clinical study.
2. patients aged between 18 and 70 years old.
3. Confirmed metastatic breast cancer patients with hydrothorax and ascite fluid, which was verified to contain tumor cells by lab.
4. ECOG performance status score of 0-1.
5. No significant abnormalities in liver and kidney function (BIL \<1.5-fold upper limit of normal (ULN)；ALT\<2.5×ULN; AST\<2.5×ULN；Crea≤1×ULN).

Exclusion Criteria:

1.Patients not suitable for chemotherapy and target therapy
Comparison of Human Insulin Produced by the Current Process and the NN729 Process in Healthy Volunteers

This trial is conducted in Europe. The aim of this trial is to show that the product of the new production process has a similar pharmacological profile to the traditional process used for the current commercial product Actrapid®.


Eligibility Criteria:
Inclusion Criteria:

* Normal findings in medical history and physical examination unless the investigator considers any abnormality to be clinically irrelevant
* Fasting blood glucose below or equal to 6 mmol/L
* Body Mass Index (BMI) 22.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Participated in another clinical study with an investigational drug within the last 4 weeks
* Any condition requiring the regular use of any medication, including herbal remedies, over the counter medicines and vitamins. Occasional paracetamol is acceptable
* Known or suspected allergy to the trial product or related products
* Family history of type 1 diabetes
Identifying Patients in Risk of Post-operative Complications Using PACU Discharge Criteria

In the Postoperative Care Unit surgical patients are monitored closely to ensure safe condition before transfer to the ward. This study will aim to identify patients in risk of complications on the ward using the national postanesthesia care unit (PACU) discharge criteria, a modified Aldretes score. Secondary to identify patients in risk of micro events as detected by continuous monitoring of vital signs on the ward.

Patients undergoing esophageal resection and pancreaticoduodenectomy are at high risk of developing complications after surgery. Described patient groups are monitored for at least 24 hours in PACU before returning to the ward.

In Denmark physiological parameters are assessed in the PACU every hour until discharge using the DASAIM discharge criteria (A modified Aldrete score).

The PACU discharge score is calculated on parameters including sedation, respiratory rate, saturation, systolic blood pressure, puls, physical capability (if epidural or spinal anesthesia), pain in rest, nausea, diuresis and temperature. Each parameter is given a score between 0 and 3. 0 describes no problem and 3 describes a severe problem.

The investigators will investigate the predictive value of the PACU discharge criteria and interventions in the PACU setting, to identify patients at risk of developing postoperative complications. Secondary outcome is micro events on the ward. Patients vital signs are monitored continuously from PACU discharge until the 5th postoperative day. Micro events are defined as deviations of vital parameters from normal range.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery
* Pancreaticoduodenectomy (KJLC30)
* Transthoracic esophageal resection without interposition (KJCC10)

Exclusion Criteria:

* Patients not expected to be able to cooperate
* Patients not cognitive well (Mini Mental State Examination \< 24)
* Pacemaker
* Patients with allergies including band aid, plastic and silicone
Traditional Three-incision Esophagectomy Versus Minimally Invasive Thorascopic and Laparoscopic Esophagectomy

Esophageal carcinoma is an aggressive malignancy with poor prognosis. Surgical resection remains the most effective method for this malignant disease. VATS esophagectomy has become more and more popular in China and around the world. Although VATS esophagectomy has been proven to be effective in preventing respiratory complications, there is still no ample evidences to demonstrate that VATS esophagectomy is as effective as traditional three-incision esophagectomy in lymph node dissection and is equal or superior in long-term survival. The purpose of this large scale prospective observational study is to compare the minimally invasive thorascopic/laparoscopic esophagectomy with traditional three-incision esophagectomy in lymph node dissection, postoperative recovery, postoperative complications, and long-term survival.

Esophageal carcinoma is an aggressive malignancy with poor prognosis,For these patients, radical esophagectomy is the cornerstone of multimodality treatment with curative intent. Transthoracic esophagectomy is the preferred surgical approach worldwide allowing for en-bloc resection of the tumor. However, the percentage of cardiopulmonary complications associated with the traditional three-incision esophagectomy is high.Recent studies have shown that the minimally invasive thorascopic and laparoscopic esophagectomy is at least equivalent to the open transthoracic approach for esophageal cancer in terms of short-term oncological outcomes,including reduced blood loss, shorter ICU stay,and lower pulmonary complication rate, but the evidence is not ample because the sample size is not enough.The objective of this study is to compare the efficacy, perioperative complications, lymph node dissection and long term survival between the thoracic esophageal cancer patients treated by minimally invasive thorascopic/laparoscopic esophagectomy and open transthoracic esophagectomy by three incisions.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with histologically proven squamous cell esophageal cancer, without any previous anti-tumor therapy;
2. Preoperative clinical TNM stage:cT1b-3N0-1M0;
3. Adequate cardiopulmonary, liver, brain and kidney function which can tolerate the esophagectomy either via traditional tree-incision or minimally invasive thorascopic/laparoscopic esophagectomy;
4. Preoperative assessment by CT and EUS is fit for minimally invasive thorascopic/laparoscopic esophagectomy;
5. Willing to participate the clinical trial and sign the informed consent before being enrolled into clinical trail.

Exclusion Criteria:

1. Previous use of anti-cancer therapy;
2. Preoperative clinical TNM stage: N2-3 or M1;
3. Inadequate cardiopulmonary,liver, brain and kidney function for surgery;
4. Previous malignancy history;
5. Unwilling to participate the clinical trial and refuse to sign informed consent.
Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, Dacarbazine

The purpose of this clinical research study is to learn the pharmacokinetics of Ipilimumab when combined with Paclitaxel/Carboplatin or Dacarbazine


Eligibility Criteria:
Inclusion Criteria:

* Histologic diagnosis of advanced malignant melanoma
* Eastern Cooperative Oncology Group (ECOG) performances status 0-1
* Measurable/evaluable disease as per modified World Health Organization (mWHO) criteria

Exclusion Criteria:

* Evidence of active brain metastases
* Prior treatment with anti-cytotoxic lymphocyte antigen 4 (CTLA-4) or anti-CD137 (type of tumor necrosis factor) antibody
* Total Bilirubin greater than (\>) 1.5 \* upper limit of normal (ULN) and aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \> 2.5 \* upper limit of normal (ULN)
* Prior Autoimmune disease
* Use of immunosuppressing therapies
Effect of Low-Calorie Diet and Lifestyle Intervention on Reversal of T2DM

An increase in body fat, even when within the normal BMI range is one of the essential drivers of T2DM in Asian Indians. In this context, the relationship between excess hepatic fat and pancreatic fat appears to be necessary. A low-calorie (high protein and low carb) vegetarian diet with appropriate exercise, in a protocol similar to the DiRECT study, may lead to weight loss, reversal of diabetes, and decrease in ectopic fat.

Diabetes is one of the biggest global public health problems. India has 100 million people living with diabetes as per the 2023 data. Reversal of T2DM, the holy grail of diabetes management, was not deemed possible until recently. Primary care-led weight management for remission of type 2 diabetes (DiRECT) trial has been conducted in obese patients with T2DM patients for a period of 2 years in the UK. Research on the effect of dietary intervention would be necessary for Asian Indians since liver fat deposition is more severe than in white Caucasians. Although some nutritionists and physicians are replicating methods of DiRECT study in their patients, it is not clear if similar diets will work effectively in community-dwelling Asian Indians.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with T2DM within the previous 3 years
* Age 20-65 years
* BMI \>25-45kg/m2
* HbA1c\> 6.5% at baseline (on current treatment, if any)

Exclusion criteria:

* Recent or screening HbA1c of 9% or higher
* Weight loss of \>5 kg within the previous 6 months
* Significant cardiopulmonary
* Hepatic, or another endocrine disease
* Current participation in any other research drug study in the previous three months
* Past history of bariatric surgery Malignancy other than minor skin lesions and Possibility of pregnancy
Decrease in Temperature as a Pagtonomic Sign by Scorpion Sting

The scorpion sting is a medical disease, for the signs and symptoms presented; Sometimes patients do not know the animal that causes these symptoms; the bibliography marks the decrease in temperature as a sign to be presented.

The scorpion sting is a medical emergency where 184 patients from the state of Guanajuato were divided into 2 groups according to the type of antivenom administered, the dose of antivenom were at the discretion of the attending physician, Birmex (n = 117) and Alacramyn (n = 67) for the temperature record of the site of sting and other vital signs, this to compare it with the bibliography as a pathognomonic sign.

Eligibility Criteria:
Inclusion Criteria:

* Scorpion sting
* All sex
* 3 - 90 ages

Exclusion Criteria:

* Application of ice at the sting site
Predictors for Retreatement of OAB After DC Mirabegron

Recurrence of female overactive bladder syndrome (OAB) is not uncommon. It is important to decrease the recurrence of female OAB. However, factors predicting recurrence of female OAB, especially for those women who need retreatment is undetermined. Thus, the aim of this study was to elucidate factors predicting retreatment of female OAB.

The medical records, including pad testing, urodynamic studies, lower urinary tract symptoms related questionnaires and bladder diaries of all consecutive women with OAB, who visited urogynecologic clinics in a tertiary referral center, were reviewed. Persistence interval was defined from the date of prescription of mirabegron to the date of discontinuation of mirabegron treatment. Statistical analysis was performed with Kaplan-Meier estimator. Multivariable Cox proportional-hazard model with all variables with p \< 0.25 in the univariate analysis was performed to predict OAB retreatment probability.

Eligibility Criteria:
Inclusion Criteria:

* Women with overactive bladder syndrome
* Women complete urodynamic study and bladder diary

Exclusion Criteria:

* Pregnant women
* Incomplete data
* Loss of follow-up
* Acute or chronic urinary tract infection
Impact of Exercise Medicine on Lower Limb Amputees According to the International Classification of Functioning

The purpose of this study is to determine whether exercise medicine in lower limb amputees has a impact on the three domains of the International Classification of Functioning of the WHO (function, activities and participation), and on quality of life.

Exercise medicine in lower limb amputees has a positive impact on physical condition and on some cardiovascular aspects (first domain of ICF). But as the investigators know, there is no evidence that this improvement is connected with a significant benefit on the performance of daily live activities and social participation (second and third domains of the ICF).

The investigators want to determine benefits of exercise medicine on all of these domains.

Eligibility Criteria:
Inclusion Criteria:

* unilateral lower limb amputation
* amputees with prothesis
* after learning how to walk with the prothesis
* walking with or without technical aids

Exclusion Criteria:

* previous exercise training
Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis

Diabetes is a important complication of cystic fibrosis (CF). The improved life expectancy of patients with cystic fibrosis, as a result of advances in medical therapy, has resulted in an increasing prevalence of cystic fibrosis-related diabetes (CFRD). CFRD is associated with accelerated pulmonary decline and increased mortality. Pulmonary effects are seen some years before the diagnosis of CFRD implying that impaired glucose tolerance may be very early detrimental. Insulin treatment is clearly indicated in patients with CFRD to control symptoms and reduce complications. However, at the state of impaired glucose tolerance or fasting hyperglycaemia, current screening methods are not suitable for the early management of hyperglycaemia.The recent introduction of the continuous glucose monitoring system (CGMS), which provides a continuous glucose profile, has revealed to be clinically relevant in the investigation of glucose excursions over a long period. This device, widely use in diabetic non cystic fibrosis patients, has been validated in non diabetic cystic fibrosis subjects. Previous studies of continuous glucose monitoring have been realized in CF patients with normal glucose tolerance and diabetes and compared with non CF controlThe aim of our study is to evaluate the glucose profile with continuous glucose monitoring the nutritional and respiratory status in cystic fibrosis subjects, according to their glucose tolerance.


Eligibility Criteria:
Inclusion Criteria:

* patients 10 years and older with cystic fibrosis
* not known diabetics with fasting blood glucose \<1.26 g / l
* outside periods of exacerbation and / or glucocorticoid therapy
* affiliated to a social security scheme
* having received the results of the mandatory medical examination
* having signed an informed consent

Exclusion Criteria:

* Patient transplanted lung and / or liver
* Subject during participation in an interventional clinical trial
* unable to give informed about the information
* patient under judicial protection
* patient under tutorship or curatorship
* pregnancy
* breastfeeding
* patient treated with the combination lumacaftor and ivacaftor
Cirrhotic Ascites Treatment With Satavaptan in Patients With Ascites Due to Cirrhosis of the Liver (CATS)

Primary:To evaluate the efficacy of satavaptan on top of conventional treatment in the treatment of clinically evident ascites in participants with cirrhosis of the liver.

Secondary:To evaluate the tolerability and safety of satavaptan over a 52-week treatment period in participants with cirrhosis of the liver and ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).


Eligibility Criteria:
Inclusion Criteria:

* Participants with cirrhosis of the liver
* Participants with clinically evident ascites primarily managed by diet and/or diuretics
* Stable treatment of ascites for at least the previous 2 weeks without paracentesis
* Participants having undergone no more than one therapeutic paracentesis in the previous 6 months.

Exclusion Criteria:

* Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt
* Known hepatocellular carcinoma
* Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma
* Participants previously exposed to satavaptan in the past 12 months
Detection of Ischemia in Asymptomatic Diabetics

Asymptomatic subjects with Type 2 Diabetes Mellitus were randomized to either screening with Tc-99m sestamibi adenosine SPECT imaging or no screening. All patients will be followed for 5 years for the occurrence of cardiac death or non-fatal myocardial infarction.

The aims are:

1. To prospectively assess the prevalence of silent myocardial ischemia in asymptomatic subjects with Type 2 Diabetes Mellitus.
2. To identify on the basis of clinical and/or biochemical variables in a high-risk cohort in which screening for coronary artery disease is appropriate.
3. To assess progression of (silent) myocardial ischemia after 3 years.
4. To assess the occurence of cardiac death or nonfatal myocardial infarction during 5 years follow-up in screened and not screened subjects.


Eligibility Criteria:
Inclusion Criteria:

* Age 50-75 years
* Type 2 diabetes mellitus

Exclusion Criteria:

* Angina or anginal equivalent
* Abnormal rest ECG (Q or ST depression)
* Known CAD
* Stress testing within the last 3 years
Evaluation of the Effects of Virtual Reality Learning Environment on Nursing Student Non-technical Skills Development

The goal of this waitlist control study is to evaluate the benefits of virtual reality teaching pedagogy to developing non-technical skills in nursing students.

The main question\[s\] it aims to answer are:

1. What is the relationship between VR training programs and students' situation awareness skills development?
2. What is the relationship between VR training programs and students' communication skills development?
3. What is the relationship between VR training programs and students' satisfaction/self-confidence in learning?
4. What is the relationship between the sense of presence and satisfaction/ self-confidence in learning?
5. How does the student's learning experience after VR training programs?

Participants will attend the Virtual Reality training program. Researchers will compare the use of high-fidelity simulation to see if the non-technical skills were developed.

The study employed a quasi-experimental, pretest-posttest, non-equivalent waitlist control group design. First, the quantitative methods were applied to obtain numerical evidence regarding statistical trends across the experimental and waitlisted control groups.

A pretest-posttest non-equivalent waitlist control group design was employed.

Convenience sampling was adopted to recruit subjects. Participants were recruited from the students who had enrolled in the subject "Clinical Reasoning and Decision Making." They were assigned into two study groups according to the tutorial teaching schedule: the control and the experimental groups. The Control group attended the usual teaching activities: simulation followed by the intervention (VR), whereas the intervention group participated in the VR (intervention) session followed by the simulation session (control).

Eligibility Criteria:
Inclusion Criteria:

* Students studying Year 3 of the Bachelor of Science in Nursing program and enrolled in the subject "Clinical Reasoning and Decision Making"

Exclusion Criteria:

* Students diagnosed with diminished visual acuity were excluded from the study to prevent the diminished visual function from affecting the VR experience.