cyrilzakka/clinical-trials huggingface dataset:
Effect of Gemigliptin or Acarbose on Endothelial Function in Type 2 DM Patients

This is a phase 4, single center, randomized, open-labeled study. The primary objective of the study is to compare effect of gemigliptin and acarbose on endothelial function.

Subjects are randomized to gemigliptin or acarbose group and maintained intial treatment for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* age: 20-80yrs
* patients with type 2 diabetes (duration of diabetes \>=3 months)
* HbA1c :\>7.0 and \<=9.0% on metformin monotherapy
* no changes on medications during recent 3 months.

Exclusion Criteria:

* patients with type 1 diabetes
* history of medications including α-glucosidase inhibitor, glinide, GLP-1 analogue, other DPP-4 Inhibitors, or insulin during recent 3 months.
* history of acute diabetic complication, acute coronary events, or coronary bypass surgery/interventions during recent 6 months.
* patients with congestive heart failure (NYHA II\~IV) or clinically significant ventricular arrhythmia
* serum ALT or AST\> 2.5 x upper normal range
* serum direct bilirubin \> 1.3 x upper normal range
* serum creatinine \> (men) 1.5 mg/dL, (women)\>1.4 mg/dL
* smoker
* pregnant women, or breast-feeding women
* medication with acetylsalicylic acid or vitamin K antagonist
Evaluation of the "Platform Model" for Staffing in Psychiatric and Psychosomatic Clinics

This study aims to evaluate the so-called platform model and its suitability to determine staffing in hospitals for psychosomatic medicine and psychotherapy.

The aim of the study is to test the suitability of a structural model (so-called platform model) developed by a working group of various scientific societies and professional associations for staffing in psychosomatic medicine and psychotherapy. For this purpose, in three steps (1.) the four treatment clusters developed in the platform model will be quantified and empirically validated on the basis of the therapeutic services provided in health care practice; (2.) the current staffing for the four treatment clusters will be described ("as-is analysis"); and (3.) prototypical therapy plans will be developed as a basis for estimating the target staffing requirements. On this basis, a target staffing estimate will be made for all professional groups.

For the study, a total of 80 psychosomatic clinics from Germany will be randomly selected, belonging in equal parts to the groups of psychosomatic university clinics, psychosomatic specialist hospitals, and psychosomatic departments in somatic or in psychiatric hospitals. In addition, 20 day clinics are included. In these clinics, the structural framework conditions including staffing will be surveyed and the routine documentation of therapy units will be evaluated by cluster analysis in order to empirically validate the presumed treatment clusters and to describe the necessary staffing requirements.

The empirical examination and validation of the platform model, including the four assumed treatment clusters, has the potential to positively influence care practice in the long term by adjusting staffing levels in psychosomatic clinics to actual care requirements.

Eligibility Criteria:
Inclusion Criteria for Clinics:

* belong to the predefined nationwide population of psychosomatic specialist clinics and departments
* randomly selected for inclusion in the study,
* the clinic management (head physician or comparable) agrees to participation in the study
* possibility of electronic recording of the qualified therapy units for all treating professional groups.

Inclusion Criteria for Patients:

* patient treated in one of the selected clinics on the corresponding ward or day clinic
* at least 18 years old

Exclusion Criteria:

* none
CEDATA GPGE - a Patient Registry for Children and Adolescents with Inflammatory Bowel Disease

CEDATA GPGE collects clinical data of children and adolescents with IBD from paediatric gastroenterology centers in german-speaking countries.

Data is obtained from participating centers in pseudonymized way via an online platform at the beginning and during followup of the disease. The leading working group of the paediatric gastroenterology society GPGE e.V. includes 15 experts in the field who meet twice yearly and coordinate research and quality improvement initiatives.


Eligibility Criteria:
Inclusion Criteria:

* Inflammatory Bowel Disease

Exclusion Criteria:

* none
Mannitol Versus Supportive Care in Ciguatera Fish Poisoning

Ciguatera poisoning, caused by the ingestion of ciguatoxin-containing fish, is a global public health concern. In the US, the vast majority of ciguatera poisonings occur in Florida, followed by Hawaii and California. Equipoise exists in the medical literature regarding the effectiveness of mannitol therapy in treatment of ciguatera poisoning. While there are many case reports attesting to its utility, the only randomized control trial (RCT) comparing mannitol therapy with supportive care failed to show any significant benefit from mannitol treatment for a variety of clinical outcomes. Investigators therefore propose a second, larger RCT to test this question.


Eligibility Criteria:
Inclusion Criteria:

* History consistent with ciguatera poisoning

Exclusion Criteria:

* Minors
* pregnant patients
* those unable to give consent
* severe congestive heart failure or renal failure
Neoadjuvant Chemotherapy or Chemoradiotherapy in Resectable Oesophageal Carcinoma（NewEC Study）

To provide comprehensive efficacy and safety profiles of neoadjuvant chemoradiotherapy (NCRT) versus neoadjuvant chemotherapy (NCT) versus surgery alone in resectable oesophageal carcinoma.

Neoadjuvant chemotherapy (NCT) or neoadjuvant chemoradiotherapy (NCRT) has been shown to be better than surgery alone in patients with resectable oesophageal carcinoma, but higher quality evidence is needed as new findings have emerged regarding this issue.Previous evidence-based findings and the current guidelines have not established a survival advantage of NCRT over NCT or an acceptable safety profile of the addition of radiotherapy to NCT; whether NCRT or NCT is more effective for the treatment of adenocarcinoma or squamous cell carcinoma of the oesophagus is unclear.This study aims to provide comprehensive efficacy and safety profiles of NCRT versus NCT versus surgery alone in resectable oesophageal carcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically documented untreated SCC or adenocarcinoma of the oesophagus or gastro-oesophageal junction.
* Patients clinically staged as stage I-III (T1-3, N0-1 and M0) as assessed by a contrast-enhanced multislice computed tomography (CT) scan, positron emission tomography, or endoscopic ultrasonography.
* Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.

Exclusion Criteria:

* Patients had received any previous treatment for oesophageal cancer.
* Patients who were unsuitable for surgery because of comorbidities.
* Patients had evidence of distant metastatic disease by history and physical examination.
Pharmacokinetic and Pharmacodynamic Effects of Escitalopram Depending on Genetic Polymorphisms of the ABCB1-gene

The ABCB1-gene product P-glycoprotein is an integral membrane protein that actively transports substrates out of the intracellular compartment. One of the major sites of its action is the blood-brain-barrier. It is highly expressed in brain capillary endothelial cells and involved in limiting the access of substrates such as antidepressants to the central nervous system. A single nucleotide polymorphism (SNP) of the ABCB1-gene was recently identified showing a different treatment response to antidepressant drugs depending on the genotype. Therefore, it is assumed that healthy subjects with different genotypes of that SNP will be associated with significantly different brain levels of the antidepressant escitalopram after 6 days of intake. Sleep recordings are a useful bio-marker for effects of antidepressants on the CNS. Selective serotonin reuptake inhibitors (e.g. escitalopram) cause a suppression of REM sleep and a stronger fragmentation of sleep compared to untreated subjects. Higher plasma levels of antidepressants affected the sleep to a greater extent than lower levels. In line with this finding, we suppose that sleep EEG recordings of healthy subjects with different genotypes of the above mentioned SNP will be differently affected after taking 6 days escitalopram. In addition, effects of drug intake on the gene expression in lymphocytes and metabolic changes will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* healthy males 20-30 years

Exclusion Criteria:

* any medication
Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography

The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).

Patients suspected of coronary artery disease were submitted to coronary CT angiography using either iobitridol or contrast agents with higher iodine concentrations (iopromide or iomeprol). Independent off-site readers evaluated image quality regarding the ability to identify coronary artery stenosis (score 0- non evaluable to 4- excellent quality). The study was aimed at showing the non-inferiority of iobitridol in its ability to provide evaluable CT scans for the identification of coronary stenosis.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adult patient (having reached legal majority age)
* Symptomatic patient suspected for coronary artery disease scheduled for a coronary CT angiography

Exclusion Criteria:

* Patient with a heart rate \> 65 beats per minute (bpm) and contraindication or intolerance to b-blocker administration
* Patient with arrhythmia or non-sinus rhythm
* Patient with decompensated heart failure
* Patient with evidence of ongoing or active clinical instability (suspected or known acute myocardial infarction, cardiac shock, acute pulmonary oedema)
* Patient who has previously undergone coronary artery bypass graft
* Patient who has previously undergone percutaneous transluminal coronary stent placement
* Patient with artificial heart valve
* Patient with known moderate to severe aortic stenosis
Prognostic Value of CD4/CD8 Ratio in Patients with Nasopharyngeal Carcinoma

In our previous retrospective study, we identified circulating immune cell counts and the CD4/CD8 ratio as significant prognostic markers in nasopharyngeal carcinoma. Building on these findings, this study aims to conduct a multi-center prospective observational study to evaluate the prognostic value of the circulating lymphocyte CD4/CD8 ratio in nasopharyngeal carcinoma patients prior to treatment.


Eligibility Criteria:
Inclusion Criteria:

* 1.Histopathological diagnosis of nasopharyngeal carcinoma;2.Patients with nasopharyngeal carcinoma without distant metastases after AJCC/UACC 8th edition;3.The radiation therapy technique is IMRT;4.Age 18-70 years;5.Has good organ function;6.Patients who are willing and able to comply with visit schedules, treatment plans, laboratory tests, and other study procedures; 7.Willing to comply with the arrangement during the study period and can no longer participate in any other clinical studies related to drugs and medical devices;8.Patients sign a formal informed consent form to indicate that they understand that this study is in accordance with the hospital's policies.

Exclusion Criteria:

* 1.Concomitant with other tumors;2.Those with a history of severe immediate allergies to any of the drugs used in this study;3.Lack of or limited capacity for civil conduct;4.Addiction to drugs or alcohol, with a physical or psychiatric disorder;5.Previous diagnosis of immunodeficiency or known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related disease;6.Pregnant or lactating female patients, male or female patients of childbearing potential who are unwilling or unable to use contraception throughout the study period and for at least 1 year after the end of the treatment regimen.
Influence of Patient Choice of Intrathecal Morphine on Post-cesarean Delivery Pain.

This is a randomized controlled study that will place patients into a "choice" and a "no choice" group. The choice group will be able to choose between receiving 100 mcg or 200 mcg intrathecal morphine. The no choice group will be randomized to receive either 100 mcg or 200 mcg of intrathecal morphine. Following casarean delivery, pain scores will be measured at 3, 6, 12, 24, and 36 hours.

This randomised controlled study will include pre-operative screening with a 2 simple questionnaires and the patient will be randomised into a "choice" and "no choice" groups.

The group with the choice will be offered 2 different doses of intrathecal morphine (100, 200 mcg) which they can decide on after being given a standard script explaining advantages and disadvantages of each dose. Following cesarean section patients will be followed up at 3, 6, 12, 24, 36, 48 hours following spinal injection to assess severity of pain, time to first analgesia, total analgesia requirements, treatment of nausea, vomiting and pruritus.

Eligibility Criteria:
Inclusion Criteria:

* Women age 18-50 with singleton, term gestation fetuses and scheduled for their 1st, 2nd, or 3rd elective CS (not in labor) will be included.

Exclusion Criteria:

* Patient refusal.
Efficacy of HIPEC in Patients With Colorectal Cancer at High Risk of Peritoneal Carcinomatosis

The purpose of this study is to determine the efficacy of adjuvant HIPEC with Mitomycin C after colectomy in the treatment of colorectal cancer patients at high risk of peritoneal carcinomatosis.

The effectiveness of cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy (HIPEC) have been addressed for the treatment of peritoneal carcinomatosis in selected patients. However, prophylactic HIPEC in colorectal cancer patients at high risk of metachronous peritoneal metastases remained controversial. In this study, patients with colorectal cancer cT4N0-2M0(AJCC/UICC staging system 8th edition) and planed to undergo intentionally colectomy (laparotomy, laparoscopy，or robotic ) are randomized into HIPEC group and control group. In HIPEC group, closed HIPEC is performed with Mitomycin C(30mg/m2) at 43 °C for 90 minutes, simultaneously or within 2 days after colectomy and followed by systemic chemotherapy. For the patients in the control group, systemic chemotherapy were administered after colectomy. The primary endpoint is peritoneal recurrence-free survival (pRFS) rate. Secondary end points include overall survival (OS) rate, disease free survival (DFS) rate, liver metastatic rate, toxic effects, quality of life scores. All efficacy analyses are conducted in the intention-to-treat population, per-protocol population and pT4 subgroups due to pathologic tumor invasion can not be acquired before HIPEC. Safety analysis include only patients who receive their randomly assigned treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 70 years
* Nonpregnant or breast-feeding women
* ECOG status 0-1
* Colorectal adenocarcinoma or mucinous adenocarcinoma;
* Intraoperative confirmed cT4N0-2M0 Colorectal cancer (visual determination - according to AJCC 8th edition) without previous anti-cancer treatment and R0 resection could be achieved
* Laboratory tests within 2 weeks before Randomization：Neutrophil ≥ 2.0 /mm3, , platelets ≥ 100,000/mm3, hemoglobin≥90g/l, Alanine transaminase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 ×ULN), total bilirubin(TBIL)≤ 1.5 × ULN, serum creatinine ≤ 1.5 ×ULN
* Written informed consent

Exclusion Criteria:

* Rectal cancer below peritoneal reflection
* Concurrent with or have other cancer within the past 5 years ( except for skin basal cell carcinoma, or cervical carcinoma in situ, who have received radical treatment)
* Severe abdominal infection or extensive fibrosis of peritoneal cavity that lead to impossible separation
* Surgical procedures conversion(from robotic or laparoscopic surgery to laparotomy) or emergency surgery due to perforation or obstruction
* Existence of distance metastasis during surgery (M1) or can not achieve R0 resection
* Contraindiction of mitomycin c(chickenpox or shingles)
* Poorly controlled respiratory or cardiac disease, severe hepatic or renal dysfunction,drug abuse or uncontrolled mental disease
Preemptive Local Anesthesia in Vaginal Surgery

Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a painful stimulus. This trial is examining the effects of a local anesthetic given at the point of innervation prior to performing a vaginal hysterectomy with suspension sutures.


Eligibility Criteria:
Inclusion Criteria:

* Women undergoing vaginal hysterectomy with McCall's culdoplasty
Orthopaedic Hand Service Data Repository

The purpose of the research is to investigate multiple facets of non-traumatic and traumatic health issues. The majority of our research deals with mind-body aspects of health. The investigators often correlate different psychological measures against one another or match psychological and depression scores against standard of care objective measurements (grip strength and range of motion).

The data repository also serves to streamline our studies and amalgamate many studies that are no more than minimal risk and do not involve randomization in any way.


Eligibility Criteria:
Inclusion Criteria:

* Over 18 years
* Patients presenting to Hand Service for traumatic or non-traumatic issues.
* English Speaking

Exclusion Criteria:

* under 18 years
* vulnerable population
Biological Mesh Closure of the Pelvic Floor After Extralevator Abdomino Perineal Resection for Rectal Cancer

Rationale: Approximately 800 abdominoperineal resections (APR) are performed for rectal cancer each year in the Netherlands. The extralevator approach (eAPR) reduces the rate of positive margins and improves oncological outcome in distal rectal cancer. However, wider excisions increase wound healing problems and development of perineal hernia. This has resulted in a progressive increase of the use of musculocutaneous flaps and biological meshes associated with a substantial increase of costs, which is not supported by proper data.

Objective: The aim of this study is to determine the cost-effectiveness of pelvic floor reconstruction using a biological mesh after standardized eAPR with neo-adjuvant (chemo)radiotherapy.

Study design: This is a multicenter study in which patients undergoing an eAPR are randomized between standard care using primary closure of the perineum and the experimental arm with assisted closure using a biological mesh.

Study population: Patients with a clinical diagnosis of primary rectal cancer who are scheduled for eAPR after neo-adjuvant (chemo)radiotherapy. A total number of 104 patients will be randomized.

Intervention: The intervention in the experimental arm consists of suturing a biological mesh derived from porcine dermis in the pelvic floor defect, followed by perineal closure similar to the control arm.

Main study parameters/endpoints: The primary endpoint is the percentage of uncomplicated perineal wound healing (Souphampton wound score less than II at day 30). Secondary endpoints are hospital stay, incidence of perineal hernia, quality of life, and costs.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Both primary perineal closure and biological mesh assisted closure are being performed in daily clinical practise. The potential benefit resulting from participation of the study in patients randomized for biological mesh assisted closure may be a higher chance of uncomplicated perineal wound healing and lower perineal hernia rate. On the other hand, the use of a biological mesh has been associated with increased postoperative pain and seroma formation.


Eligibility Criteria:
Inclusion Criteria:

1. Age of 18 years or higher.
2. Planned for eAPR for primary rectal cancer.
3. Life expectancy of more than 2 years.
4. Ability to return for all scheduled and required study visits.
5. Preoperative (chemo)radiotherapy.
6. Written informed consent for study participation.

Exclusion Criteria:

1. Previous pelvic irradiation for other cancers (i.e. prostate cancer).
2. Total exenteration or sacral resection above level S4/S5.
3. Sensitivity to porcine derived products or polysorbate.
4. Severe systemic diseases affecting wound healing (i.e. renal failure requiring dialysis, liver cirrhosis, and immune compromised status like HIV).
5. Collagen disorders (i.e. Marfan).
6. Enrolment in trials with overlapping primary endpoint or otherwise expected influence on wound healing (i.e. biological therapy like antiangiogenic agents).
Two-stage Arthroplasty for the Septic Arthritis of the Native Knee Joint

Septic arthritis (SA) of the native knee joint is rare but difficult to manage. Open or arthroscopic debridement is currently the most widely used approach. The problem is that there is a 71% and 50% chance of requiring revision surgery, respectively. Patients with recurrent sepsis may require arthrodesis or amputation, which would result in severe functional loss. Therefore, there is an urgent need to find more effective surgical procedures. Investigators developed a two-stage exchange with low-dose antibiotics for the treatment of SA and evaluated its efficacy.

Septic arthritis (SA) of the native knee joint is a rare but highly disabling disease. Epidemiologic studies have documented an incidence of 0.9 per 100,000. The treatment is challenging and the ideal treatment strategy is not well established. Over the past decades, open or arthroscopic debridement with systemic antibiotic therapy is the most widely used approach. However, a recent study has shown that these two methods have a failure rate as high as 50%-71%. Patients with recurrent sepsis may require arthrodesis or amputation, which would result in severe functional loss. Therefore, there is an urgent need to find more effective surgical procedures.

A few reports proposed two-stage exchange to address SA and showed satisfying clinical outcomes. Orthopedic surgeons removed the infected soft and bone tissue during the first operation and then implant antibiotic-loaded bone cement spacer. Once the infection had been addressed, a new prosthesis was inserted in a second operation. This approach could greatly boost the success rate to over 95%. However, the issue is that high-dose antibiotics bone cement may cause life-threatening complications such as acute kidney injury and drug-induced immune hemolytic anemia. Therefore, investigators developed a two-stage exchange with low-dose antibiotics for the treatment of SA.

Investigators summarized and analyzed the treatment processes and performed laboratory, imaging, and functional evaluations after treatment. The purpose was to introduce a new treatment regimen for SA and evaluate the technical points of the regimen, and prognosis over medium-term follow-ups.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with SA based on one or more of the following: clinical presentations (fever, joint pain, restricted mobility, swelling and redness, and/or a discharging sinus communicating with the joint); elevated inflammation markers; evidence of infection on images; purulence in the joint, and positive frozen section or cultures
* Without infections at other sites
* Without venous thrombosis of the lower limbs
* American society of Anesthesiologists (ASA) physical status classification was either 1 or 2
* With complete data for the main indicators (routine blood test results, C-reactive protein level, erythrocyte sedimentation rate, X-ray and/or MRI scans of the surgical site, and the Knee Society Function scores).

Exclusion Criteria:

* Patients (\<60 yrs) without progression to advanced osteoarthritis
* In poor general condition who could not tolerate surgery