cyrilzakka/clinical-trials huggingface dataset:
Expression of G-protein Coupled Receptor 120 Receptor in Adipose Tissue of German Diabetes Center Cohort Subjects

G-protein coupled receptor 120 (GPR120) is a G-protein-coupled receptor whose endogenous ligands have been identified as long-chain fatty acids. Recently, it has been shown that GPR120 expression in human adipose tissue is higher in obese than in lean individuals. Interestingly, a GPR120 deficient mouse model presents an unfavorable phenotype when fed a high-fat diet with obesity, glucose intolerance and fatty liver, characteristics also found in type 2 diabetes (T2D).

Moreover, in obese subjects, a single nucleotide polymorphism (R270H) has been identified that inhibits GPR120 signaling activity.

The investigators now want to investigate if GPR120 expression in adipose tissue may be altered in patients with T2D compared to non-diabetic subjects and might contribute to diabetes-associated metabolic changes. Additionally, the investigators want to assess the frequency of the R270H mutant in T2D.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus / normoglycemia
* BMI \< 27,5 or \> 30 kg/m2
* Age 20 - 69 years

Exclusion Criteria:

* severe chronic diseases
* anemia
* medication altering fatty acid metabolism
Feasibility of Prediabetes Remission in Adults With Coronary Heart Disease

To evaluate the feasibility of a 6-month multidisciplinary program to reverse prediabetes in adults with coronary heart disease using the Mediterranean diet, intermittent fasting and exercise.

The proposed study will assess the feasibility of an intensive lifestyle program to reverse newly onset prediabetes (HbA1c ≥ 5.7% to 6.4%) in patients with coronary heart disease that would otherwise start a standard cardiac rehabilitation programme (12 weeks with twice weekly exercise, nutrition, and nursing counselling). The patients will be offered an upgraded 6-month intensive team-based multidisciplinary stepwise program with the goal of remitting prediabetes. The program will consist of a 3-month synchronous nutritional, exercise, and motivational intervention and of a 3-month maintenance and follow-up period.

The DIABEPIC prevent 1 study is a single-arm, open-label study aiming to demonstrate the feasibility of an intensive multidisciplinary stepwise intervention in newly diagnosed prediabetic and coronary heart disease patients, ultimately aiming to remit prediabetes.

The purpose of this first study is to devise and iteratively improve participant recruitment and adherence strategies for a possible future randomized controlled trial. It also includes as goals: to study the efficacy and adherence of an intensive multicomponent lifestyle intervention, to study the proportion of patients that improve or remit their insulin resistant state, to study the changes in a variety of anthropomorphic, physical, analytic, vascular and test parameters and to better characterize the factors associated with prediabetes remission.

Eligibility Criteria:
Inclusion Criteria:

* Coronary heart disease patients referred from the Montreal Heart Institute.
* Aged ≥ 40 years.
* Recently diagnosed prediabetes (HbA1c ≥ 5.7% to 6.4%) in the last 6 months.
* Referred to Centre EPIC because of stable angina, acute coronary syndrome (with or without ST elevation), after coronary revascularization (primary or elective) or bypass surgery.
* Able to perform a maximal exercise test and exercise training program in accordance with current cardiovascular rehabilitation recommendations.
* Able to use a smartphone application or to complete an adherence/compliance diary.
* Able to read, understand and sign the information and consent form.

Exclusion Criteria:

* Absolute and relative contraindication to exercise testing and/or physical training.
* Diabetic patients (HbA1c ≥ 6.5%) or patients with a HbA1c value of ≥ 5.7% to 6.4% but with the help of oral hypoglycemic agents.
* Taking psychotropic medications that may induce mass gain (tricyclic antidepressants, mirtazapine, paroxetine, lithium, valproate, clozapine, olanzapine) or other medications known to promote mass gain (cortisone).
* Taking recently introduced weight-loss medications (semaglutide).
* Unintentional mass loss of more than 10 kg in the past year.
* Pregnant or nursing women.
eHealth for the Elderly

Since internet usage as a complementing element in cancer care is becoming more and more important in oncological routine we launched My-eStEPs (eHealth Strategy for Elderly Patients with Multiple Myeloma) to investigate how specifically elderly patients and their Healthcare Professionals (HCPs) adopt electronic Health (eHealth) support during outpatient treatment. The purpose of this project is to explore how eHealth support influences patients' interaction with their HCPs and how both can benefit from this.


Eligibility Criteria:
Inclusion Criteria:

* multiple myeloma patients
* treated by oral IMiDs

Exclusion Criteria:

-
A Bioequivalence Study of the Fixed Dose Combination Tablets of Canagliflozin and Metformin Extended Release (XR) With Respect to the Individual Components

The purpose of this study is to assess the bioequivalence of the fixed dose combination (two components combined in one tablet) of canagliflozin and metformin extended release (XR) tablet (dose of 2 X 150 mg/1,000 mg) with respect to the individual components of canagliflozin (1 x 300 mg) and metformin XR tablet (4 x 500 mg) in healthy fed participants.

This is a randomized (the study medication is assigned by chance), open-label (physicians and participants know the identity of the assigned treatment), single-center, single-dose, 3-treatment, 3-way crossover (the same medications are provided to all participants but in different sequence) study of canagliflozin (CANA) and metformin extended release (MET XR) combined in one tablet, in comparison with tablets containing the individual components. Two Fixed Dose Combinations (FDCs) will be evaluated during the study (two types of tablets).

The tablets will be of the same strength (150 mg CANA/1,000 mg MET XR) and will be compared with equal doses of the individual drugs: canagliflozin (1 x 300 mg tablet) and metformin XR (4 x 500 mg tablets). Thus, there will be 3 treatment periods in the study: Treatment A: "Reference" treatment of individual components administered concurrently; Treatment B: CANA/MET XR FDC, formulation 1; and Treatment C: CANA/MET XR FDC, formulation 2. Approximately 42 healthy adult participants will be randomly assigned to 1 of the 3 treatments groups, and then each group will receive all three treatments in different sequences (3-way crossover). The study will consist of 3 phases: a Screening Phase of approximately 3 weeks, an Open-Label Treatment Phase consisting of 3 single-dose Treatment Periods of 5 days each separated by a washout period of 10 to 14 days and a Follow-up Phase occurring 7 to 10 days after the last study-related procedure of Treatment Period 3. The total duration of the study will be about 70 days for each participant.

Eligibility Criteria:
Inclusion Criteria:

* Must sign an informed consent document indicating they understand the purpose of the study and procedures
* Must have a body mass index (BMI) of between 18 and 30 kg/m2, inclusive
* Must have a body weight of not less than 50 kg - Must have a blood pressure between 90 and 140 mmHg inclusive, systolic, and no higher than 90 mmHg diastolic at screening
* Must have normal renal function and no evidence of kidney damage (including abnormalities in blood or urine tests)

Exclusion Criteria:

* History of or current clinically significant medical illness
* Use of any prescription or nonprescription medication (including vitamins and herbal supplements)
* History of clinically significant allergies, especially known hypersensitivity or intolerance to drugs or lactose
* Known allergy to heparin or history of heparin induced thrombocytopenia
* Donated blood or blood products or had substantial loss of blood within 3 months before screening
Association Between Nonalcoholic Fatty Liver Disease and Acute Pancreatitis

The early evaluation of AP severity are vital. Previous studies have shown non-alcoholic fatty liver disease (NAFLD) is associated with severity of acute pancreatitis (AP). This study is aimed to investigate the relationship between NAFLD and AP severity.

Acute pancreatitis (AP) is a potentially lethal disease capable of wide clinical variation. Severe acute pancreatitis (SAP) is devastating, with a mortality rate ranging from 10% to as high as 85%. So it's important to identify severe patients which require aggressive early treatment and prolonged specialist care. There are a lot of multifactorial scorings and specific laboratory tests in predicting AP severity, such as Ranson's, Acute Physiology and Chronic Health Examination (APACHE)-II, serum Interleukin-6 (IL-6), and C-reactive protein (CRP) level. However, they have limitations in predicting outcomes of AP patients. The biochemical markers are not accurate enough. Ranson's scores were calculated after 48 hours of admission. Their practical utilization as predictors of severity is tough. Novel prognostic biomarker is needed to further develop for prognosis in AP patients.

Nonalcoholic fatty liver disease (NAFLD) refers to fat deposition and oxidative stress of free radicals in hepatocytes. NAFLD is the most common chronic liver disease worldwide. The prevalence averages 30% in developed countries, and estimated to be 10% in developing countries. Its presentation ranges from asymptomatic steatosis to fibrosis, and cirrhosis with 3-5%. It is evident clinically with increased risk of developing obesity, cardiovascular diseases (CVD), hyperlipidaemia, and type 2 diabetes mellitus (T2DM). Acting as an endocrine organ, the liver is the source of adipokines and inflammatory cytokines. Alterations in the production and secretion are increased in patients with NAFLD. It is strongly related to insulin resistance (IR) and metabolic disorders. Previous studies noted that NAFLD is closely related to severity of AP. CT scans are usually performed at admission to diagnose AP severity, which are also helpful to assess NAFLD. It could act as a valuable prognostic factor in AP patients and help to recognize potential severe patients.

However, no clear pathways could explain the association between NAFLD and AP at present. Besides, the data is scarce. More research will pay more attention to this topic. In this study, the investigators investigated the association between NAFLD and AP.

Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with AP
2. age \>18 years

Exclusion Criteria:

1. an age of \<18 years
2. without complete data and CT scans
3. previous splenectomy or hepatectomy
4. a past history of AP
5. an ambiguous pancreatic margin
Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy

This clinical investigation is intended to explore the performance and safety of two newly developed ostomy products with regard to the products fit to body properties.


Eligibility Criteria:
Inclusion Criteria:

1. Have given written informed consent and in DK: signed a letter of authority 2. Are at least 18 years of age and have full legal capacity 3. Have had their ileostomy or colostomy for at least 3 months 4. Are able to use a baseplate cut-max 15 to 40 mm 5. Are able to handle the product themselves 6. Currently using a 1-piece flat product 8. Willing to use an open bag size maxi during the investigation 9. Are able to use a custom cut (custom fit) product 10. Are suitable for participating in the investigation - this means that the subjects must be able to follow all elements of the study procedures.

Exclusion Criteria:

1. Are currently receiving or have within the past 2 months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
2. Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area, e.g. lotion or spray. Systemic steroid treatment (e.g. injection, or tablet) are allowed.
3. Are pregnant or breastfeeding\*\*
4. Are participating in other interventional clinical investigations or have previously participated in this investigation
5. Use irrigation during the investigation (flush the intestines with water, this is mostly for people with a colostomy)
6. Are currently suffering from peristomal skin problems i.e. bleeding and/or broken skin (assessed by the investigator)
7. Have a loop ostomy (also called double barrel ostomy)
8. Have known hypersensitivity towards any of the products used in the investigation

   * In DK: women in the child-bearing age will be ask to produce a negative pregnancy test and to sign a form ensuring the use of safe contraception during the investigation.
Impact of Maltodextrin on Glycemic and Hemodynamic Management During Cesarean Section

The goal is to evaluate the glycemic and hemodynamic stability in patients undergoing caesarean section in patients treated with maltodextrins two hours before the cesarean section

The patients undergoing elective cesarean section will be randomly divided in two groups: patients who drink 200 ml of clear liquid two hours before surgery or patients treated with 200 ml maltodextrins two hours before the surgery. The glycemic control will be done immediately before the maldodextrin administration and after the cesarean section by gluco stick. Standard hemodynamic monitoring ECG, Heart Rate, Blood pressure, Temperature, preipheral oxygen saturation will be done routinely.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* first cesarean section
* single fetus
* ASA I-II

Exclusion Criteria:

* BMI\<18
* BMI\>35
* contraindication to spinal anesthesia
* cardiovascular diseases
Administration of Hyperthermic Intraperitoneal Chemotherapy in the General Ward

Ovarian cancer is the most lethal gynecologic malignancy. The majority of patients get diagnosed with advanced disease with peritoneal dissemination.It has been demonstrated that the addition of Hyperthermic Intraperitoneal Chemotherapy (HIPEC) to interval debulking surgery can improve the prognosis. The National Comprehensive Cancer Network (NCCN) treatment guideline has recommended HIPEC as a first-line treatment for patients with advanced ovarian cancer. However, the guideline recommended the "Dutch model" of HIPEC, which is limited for routinely being performed in China. So we propose a HIPEC treatment modality, the bedside closed HIPEC in the general ward (C-HIPEC), which is suitable for the clinical characteristics of China. The aim of this study was to evaluate the safety of this model as a way to lay the foundation for subsequent efficacy evaluation and clinical promotion.

The Dutch Model is limited for the following reasons: 1) The HIPEC treatment requires to be done in the operating room, which means the operation time would be lengthened. 2) High rate of exposure to chemotherapeutic drugs among healthcare workers. 3) It has significant safety concerns because it does not take into account racial differences in drug toxicity. This study is an investigator-initiated prospective multicenter feasibility study with a non-inferiority design, so as to provide evidence-based medical evidence for the use of the C-HIPEC model as an alternative to the "Dutch model" in clinical practice in China.

Eligibility Criteria:
Inclusion Criteria:（The following conditions must be met at the same time）

1. Pathologically confirmed primary epithelial ovarian, fallopian tube, and primary peritoneal cancers in FIGO stages III-IV.
2. Previous neoadjuvant chemotherapy with platinum + vincristine and ≤ 4 courses of neoadjuvant chemotherapy.
3. The residual tumor diameter is ≤1 cm after interval debulking surgery, and the reason for receiving IDS is that the patient cannot tolerate PDS due to the poor condition or the PDS cannot achieve optimal cytoreduction due to high tumor burden.
4. Age from 18 to 70 years.
5. Bone marrow reserve was well functioning. Leukocytosis ≥ 3.0×10\^9/L, neutrophilic granulocyte ≥ 1.5 × 10\^9/L, platelet count ≥ 100 × 10\^9/L, and hemoglobin ≥ 80 g/L.
6. Organs work well. AST ≤ 2.5 × ULN, ALT ≤ 2.5 × upper limit of normal(ULN), total serum bilirubin ≤ 1.5 × ULN, and creatinine ≤ 1.5 × ULN.
7. ECOG score 0-1.
8. Patients voluntarily sign an informed consent form

Exclusion Criteria: (None of which was eligible)

1. Patients diagnosed with other malignant tumors within 5 years (excluding skin and thyroid cancers).
2. Patient is allergic to erythroxylanes.
3. Patients treated with anticancer drugs in other clinical trials.
4. High risk of anastomotic fistula or intestinal obstruction assessed during interval debulking surgery.
5. Any situation of disease instability or potentially impact safety and adherence of patient.
Calcium for Prevention of Ovarian Hyperstimulation Syndrome

There are many protocols for prevention of ovarian hyperstimulation syndrome, intravenous calcium is a novel protocol. But still there is lack of evidence of it is real effect in prevention of OHSS \& the mechanism of its action is still questionable . In the study the investigators try to search for the evidence for its effect \& the real mechanism for its action.

The study population will be divided into 2groups each containing 100 infertile couples candidate for ICSI.

Group (A)active group: administration of 10% Intravenous calcium gluconate 10 ml in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes.

Group (B): placebo group: administration of 200 mL of 0.9% saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup. Intravenous infusion was performed within 30 minutes

Eligibility Criteria:
Inclusion Criteria:

* infertile women aged 20 to 38 years.
* BMI ranged from 18 to 40.
* serum FSH within normal limits( 1-12IU /l)
* presented with ovarian response suggestive of being at risk of developing OHSS because of the presence of at least 15 follicles of 10 mm or greater on the day of hCG administration.

Exclusion Criteria:

* endocrinopathies.
* a systemic disease.
* using any medication (e.g., insulin-sensitizing drugs and GnRH antagonists.
* patients need coasting for high risk of OHSS.
* patients need cycle cancellation.
* severe male infertility requiring testicular sperm extraction.
Short-term Effects of Thoracic Manipulation in Shoulder Impingement

The hypothesis of this study is that thoracic spine manipulation would reduce pain in subjects with SIS and cause changes in scapular kinematics and muscle activity in subjects with impingement symptoms and in asymptomatic subjects. With this study, the investigators want to answer if possible changes in scapular motion and muscle activity following a TSM depend on the symptoms or if it is generic to individuals without shoulder dysfunction and not specific to subjects with shoulder impingement.

Subjects with shoulder impingement signs will be evaluated and will be compared with subjects asymptomatic for shoulder symptoms. Both subjects will be randomly assigned to one of two intervention groups: thoracic spinal manipulation (TSM) or sham intervention. We want to know if possible changes in scapular motion and muscle activity following a TSM depend on the symptoms or if it is generic to everyone. Also, we want to know if TSM reduces shoulder pain immediately and in a short-therm period.

Eligibility Criteria:
Inclusion Criteria (symptomatic subjects): To present with at least 3 of the following findings:

* positive Neer impingement test,
* positive Hawkins impingement test,
* positive Jobe test,
* pain with passive or isometric resisted shoulder lateral rotation,
* pain with active shoulder elevation,
* pain with palpation of rotator cuff tendons,
* pain in the C5 or C6 dermatome region.

Exclusion Criteria (symptomatic subjects):

* signs of "red flags" for spinal manipulation (eg, fracture, osteoporosis, malignancy, infection, and active inflammatory process),
* pregnancy
* systemic illnesses
* if received physical therapy or manual therapy treatment within the 6 months prior to the evaluation
* signs of complete rotator cuff tear or acute inflammation
* cervical-thoracic spine related symptoms (ie, positive cervical compression test and excessive kyphosis)
* scoliosis
* glenohumeral instability (ie, positive apprehension, anterior drawer, or sulcus tests)
* previous upper extremity fracture or shoulder surgery.

Exclusion Criteria (asymptomatic subjects):

* any positive test for shoulder impingement
* signs of "red flags" for spinal manipulation (eg, fracture, osteoporosis, malignancy, infection, and active inflammatory process),
* pregnancy
* systemic illnesses
* if received physical therapy or manual therapy treatment within the 6 months prior to the evaluation
* signs of complete rotator cuff tear or acute inflammation
* cervical-thoracic spine related symptoms (ie, positive cervical compression test and excessive kyphosis)
* scoliosis
* glenohumeral instability (ie, positive apprehension, anterior drawer, or sulcus tests)
* previous upper extremity fracture or shoulder surgery.
Safety of Treatment Initiation With Biphasic Insulin Aspart 30 in Hospitalised Patients With Type 2 Diabetes

This study is conducted in Europe. The aim of this study is to evaluate the safety and efficacy of biphasic insulin aspart (NovoMix® 30) in hospitalised patients with type 2 diabetes with the aim of intensifying their treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes
* Treated with oral anti-diabetics and/or human insulin

Exclusion Criteria:

* Persons previously included in the trial
* Hypersensitive to biphasic insulin aspart or any of the excipients
* Pregnant or lactating women, or those who plan to get pregnant within the next 12 months
GMA-Tulip, I-gel and the LMA-Supreme (LMA-S) Devices in Airway Management

Patients were randomly assigned to three supraglottic airway devices (SADs) groups for airway management after anesthesia induced. Fiberoptic bronchoscope (FB) guided glottic exposure grading was performed and other airway management quality was recorded.

Mechanical ventilation was volume controlled and time cycled with tidal volumes (6-8 ml/kg) set to maintain peak inspiratory pressures of less than 20 cm H2O and ventilatory frequency adjusted to maintain end-tidal carbon dioxide (PETCO2) at 35-45 mmHg. Then a fiberoptic bronchoscope was passed through airway tube into the device to perform glottic exposure grading. Peak airway pressure, incidence of pharyngalgia, bleeding, hoarseness, and dysphagia were recorded.

Eligibility Criteria:
Inclusion Criteria:

* 18-75 years old;
* American Society of Anesthesiologists (ASA) I-III;
* Body mass index (BMI)\<30Kg/m2;
* Scheduled for elective breast or lower abdominal surgery with an estimated duration of less than 4 hours;
* Providing written inform consent.

Exclusion Criteria:

* History of oropharyngeal surgery and anatomical abnormalities;
* Limited movement of the cervical spine;
* High risk of reflux/aspiration;
* Emergency surgery;
* Acute throat inflammation and upper respiratory infection;
* History of chronic bronchitis or asthma;
* Cognitive dysfunction and inability to communicate;
* Participating in other clinical trials.