cyrilzakka/clinical-trials huggingface dataset:
The Effect of GLP-1 on Glucose Uptake in the Brain and Heart in Healthy Men During Hypoglycemia

Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence world wide with an increased risk of myocardial infarction and stroke. GLP-1 has convincing effects on the high glucose levels in type 2 diabetic patients and is well tolerated. New animal studies indicate a protective effect of GLP-1 in the brain and the heart. The mechanism behind this is yet not known.

The study hypothesis is that during hypoglycaemia GLP-1 will stimulate glucose-uptake in the brain and heart independent of insulin and thereby exert protective effects in the brain.

Type 2 diabetes mellitus, T2D is a disease characterized by an immense growing prevalence world wide. T2D is associated with a three-fold increase in cardiovascular complications (myocardial infarction and stroke) leading to significantly higher morbidity and mortality in this group of patients. The prospective British Diabetes Study (UKPDS) showed that neither diet alone nor the pharmaceutical treatment utilized (Sulphonylurea, Metformin, Insulin) were able to reduce these macrovascular complications. GLP-1 (glucagon-like-peptide-1)is an incretin with convincing effects on glycaemia in type 2 diabetic patients with little or no risk of hypoglycaemia. New research in animal models has shown a potential protective effect in the brain and heart in association with ischaemic damage. The mechanism behind this protective effect is not known. During hypoglycaemia the brain lacks glucose which is the main fuel for sufficient brain function. The brain will compensate by increasing glucose uptake across the blood brain barrier and similarly in the heart.

The effect of native GLP-1 on glucose uptake in the brain and heart will by visualized by fluoro-deoxy-glucose FDG-PET-scan during hypoglycaemia in healthy men. At the same time a pancreatic/pituitary clamp will be performed. The hypothesis is that GLP-1 directly will stimulate glucose uptake independent of the pancreatic hormones and through this mechanism exert neuro- and cardioprotective actions.

Comparisons: FDG-uptake in the brain and heart with GLP-1 infusion compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men
* Age 20-50 years
* Caucasian
* BMI 20-30 kg/m2

Exclusion Criteria:

* Diabetes in subject and 1.degree relatives
* Any disease of clinical relevance
The PK/PD of Deoxycholic Acid Amphotericin B in Invasive Fungal Infection Patients With Sepsis/Septic Shock

To explore the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with sepsis/septic shock;To compare the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with sepsis and septic shock.

This was a single-center study.Patients who were diagnosed with in invasive fungal infection receieved deoxycholic acid amphotericin B during the study period.The information was recored including the general condition, infection index, PK/PD index and drug-related side effects.

Eligibility Criteria:
Inclusion Criteria:

Patients age more than 18 years old; Meet the criteria of Sepsis 3.0; Admitted to ICU; Patients were suspected or diagnosis of IFI,doctors determined the use of deoxycholic acid amphotericin B.

Exclusion Criteria:

Serum creatinine≥221umol/L; Deoxycholic acid amphotericin B or amphotericin B liposome were used for the past 7 days; Patients being treated with rifampicin; Unable to tolerate treatment of deoxycholic acid amphotericin B; BMI\<18.5 or \>30; Tumors; Pregnancy; Estimated time of survival\<24h; Patients who participated in other studies within 30 days.
Robot-assisted Versus Laparoscopic Surgery for Mid/Low Rectal Cancer

The purpose of this study is to evaluate the safety and oncological feasibility of robot-assisted surgery for mid/low rectal carcinoma compared with laparoscopic surgery.

Laparoscopic surgery as the treatment for colon cancer has been widely recognized. But its use for rectal cancer is still controversial. Previous trials have shown that although the long-term survival outcomes were similar, laparoscopic surgery did not reach the non-inferiority in terms of local tumor radical resection, compared with open surgery. Robotic techniques are considered to improve the quality of surgery with three-dimensional vision, stable camera platform and flexible robotic arms. Meta-analyses have shown that compared with laparoscopic surgery, robotic surgery could improve surgical quality in terms of open conversion, circumferential resection margin, postoperative complications, postoperative recovery, and quality of life, with similar long-term survival. However, these evidences mainly came from retrospective studies and small-scale randomized controlled trials with low quality. There still needs high-quality clinical trials to confirm the advantages of robotic surgery for rectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class I - III;
* Histologically proved rectal adenocarcinoma;
* Inferior tumor edge ≤ 10 cm from anal verge, measured by rigid rectoscopy;
* Tumor assessed as cT1-T3 (mesorectal fascia not involved) N0-1, or ycT1-T3 Nx after preoperative radio- or chemoradiotherapy, measured by pelvic MRI;
* No evidence of distant metastases;
* No other malignancies in medical history except adequately treated basocellular carcinoma of the skin or in situ carcinoma of the cervix uteri;
* Suitable for both robotic and laparoscopic surgery;
* Informed consent.

Exclusion Criteria:

* Tumors assessed as clinical complete response after preoperative radio- or chemoradiotherapy;
* Tumors assessed as cT1N0 and suitable for local excision;
* Signs of acute intestinal obstruction, bleeding or perforation needing emergency surgery;
* Multiple colorectal tumors or other schedules needing for synchronous colon surgery;
* Hereditary colorectal cancer (familial adenomatosis polyposis, Lynch Syndrome, etc.);
* Co-existent inflammatory bowel disease;
* Pregnancy or lactation;
* Patients received treatment other than preoperative radio- or chemoradiotherapy.
Randomized WAD Study

Background: The majority of patients suffering a whiplash injury (WAD) will recover, but some may have symptoms for years despite all kinds of conservative treatment. The Neck Pain Task Force (2008) found no existing evidence for positive effects of fusion operations in such patients. Some of them, however, present with symptoms that might indicate pain from a motion segment, possibly the disc. Our aim was therefore to test this possibility by performing a randomized study comparing cervical fusion and multimodal rehabilitation in chronic WAD patients.

Methods: Patients with a specified symptomatology, all with pronounced symptoms for long periods of time, were recruited and randomized to surgery (25 pat.) or to multimodal rehabilitation (24 pat.). All patients were investigated before start of the study and at follow-up approximately two years after treatment by four independent examiners from disciplines usually involved in treating WAD patients. The patients also gave their own assessments of the treatment results. Seven patients in each group did not undergo the allocated treatment for various reasons.

Outcomes:

representing different disciplines: neurology, orthopedics, physical medicine and psychology. Each patient´s perceived change in outcome was also assessed. Assessment was made before treatment and at follow-up two years afterwards.

In addition to the assessments of outcome made by the examiners, the patients completed the SF-36, EQ-5D and BIS (Balanced Inventory for Spinal Disorders) questionnaires before treatment and at follow-up. The results of these assessments will be given in a forthcoming paper.

6b. No changes in trial outcomes were made during the study.

Eligibility Criteria:
Inclusion Criteria:

* The patients were to have been involved in a traffic accident as the origin of their pain and to have had pronounced symptoms lasting for at least one year.
* They should be in the age group 18 to 60 years,
* have been actively working up until the accident,
* should not have had previous neck pain.
* All patients should have had a plain X-ray and an MRI showing no specific changes.
* The patients should present with pronounced neck pain with the origin in the midline.
* The character of the pain should be dull, aching, and, with sudden movements, stabbing in the same area.
* Palpation and pressure in that area should provoke deep pain..

Exclusion Criteria:

- Previous pain in the neck, previous surgery
Chinese FMDs Registry

The purpose of the Chinese Functional Movement Disorders Registry (FMDs-China) is to develop a database of patients with Functional Movement Disorders (FMDs) in China.

Functional movement disorders (FMDs), also known as psychogenic movement disorders (PMDs), formerly known as "hysteria or hysteria", is a representative functional nervous system disease. It has been reported in Europe and America that FMDs patients account for 3% - 6% of all patients in the outpatient department of motor disorders, but there is no relevant data report in China so far. From the current research, the incidence rate has gradually increased significantly. However, the research about the pathogenesis and diagnosis of such diseases is rare. These studies have the problem of small sample size and still lack large randomized controlled studies to demonstrate the long-term efficacy of different treatments. And in China, there are nearly no reliable research and the lack of basic understanding makes it a "gray area" for the diagnosis and treatment of FMDs.

The purpose of this observational study is to prospectively register the information of patients with FMDs nationwide, establishing a Chinese multicenter FMDs China cohort; understanding the demographic characteristics, clinical characteristics and symptom characteristics, neuropsychological test, electrophysiological and imaging characteristics, drug use, etc. what's more, it lays a foundation for the research on the etiology and treatment in the second stage of this study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female;
* Age 18-80;
* Patients clinically diagnosed with functional movement disorders according to the Fahn-Williams criteria;
* Patients who are willing to provide information such as disease history and cooperate with physical examination and examination;

Exclusion Criteria:

* Patients with definite organic dyskinesia;
* There are other causes of dyskinesia such as fatigue, pain, hyperthyroidism, chronic alcoholism, and drug use;
* Those who suffer from serious physical diseases and are unable to cooperate;
* Those who do not cooperate or refuse to sign informed consent.
Non-invasive Vagus Nerve Stimulation in Acute Ischemic Stroke

The main objective of the study will be to investigate whether treatment with non-invasive vagus nerve stimulation (nVNS) on top of best medical practice in acute ischemic stroke patients results in less infarct growth in the penumbra and smaller infarct volumes compared with those of patients not treated with nVNS. The study will be a prospective randomized clinical trial with blinded outcome assessment (PROBE design). 150 patients will be randomized to nVNS with the gammaCore Sapphire™ device on top of best medical practice versus best medical practice alone (including intravenous thrombolysis and/or thrombectomy if indicated). If patients are randomized to nVNS, two stimulations of two minutes each will be applied in the neck every 15 minutes in the first 3 hours. Thereafter two stimulations will be applied every 8 hours over the next 5 days or until discharge, whichever occurs first. The stimulation side in the neck will be the radiological side of the stroke. The primary endpoint will be the final infarct volume on MRI scan on day 5 of patients treated with nVNS compared with those of patients not treated with VNS.


Eligibility Criteria:
Inclusion Criteria:

* Ischemic stroke
* NIHSS ≥1
* Perfusion deficit on the admission CTP scan; the penumbra must comprise at least 1/3 of the total ischemic area (ischemic core and penumbra)
* The infarct has to comprise the anterior circulation
* Treatment has to start \<12 hours after stroke onset
* Patients or their representatives need to give their informed consent

Exclusion Criteria:

* A life expectancy of less than three months
* mRS \>2 prior to admission
* Contra-indication for contrast CT
* Contra-indications for VNS:

  * An active implantable medical device such as a pacemaker, deep brain stimulator, or any implanted electronic device
  * Symptomatic stenosis or dissection of the carotid artery (in these patients the other side will be stimulated unless a significant stenosis on the other side is present as well)
  * Structural abnormality e.g. lymphadenopathy, previous surgery or abnormal anatomy (in these patients the other side will be stimulated)
  * Metal cervical spine hardware or metallic implant near the stimulation site
  * Cervical vagotomy (in these patients the other side will be stimulated)
  * Pregnancy
Quality of Life of Taiwan People Living With HIV

To survey QoL and relevant factors in PLWH


Eligibility Criteria:
Inclusion Criteria:

* adult patient living with HIV, aged \>= 18 years old

Exclusion Criteria:

* known cognitive dysfunction or attention deficient to complete the survey
Safety and Efficacy of SFPP in Knee Osteoarthritis

The objectives of this study are to demonstrate the non-inferiority of esflurbiprofen plaster (SFPP) 40 mg applied for 2 weeks to diclofenac gel, the comparator, in terms of efficacy in patients with knee osteoarthritis (OA) and to examine the safety of SFPP.


Eligibility Criteria:
Inclusion Criteria:

* Patients who had unilateral knee pain and were classified as Grade II or III according to Kellgren-Lawrence (KL) grading and whose non-assessed knee is not graded higher than the assessed knee based on x-ray in standing, weight-bearing extension position within 90 days before screening visit (1st visit)
* Patients whose knee pain on rising from the chair assessed by visual analogue scale (rVAS) of the assessed knee meets all the following criteria for the level of pain; \< 80 mm at washout visit (2nd visit), ≥ 40 mm at baseline visit (3rd visit), Worsening of ≥ 15 mm at baseline visit (3rd visit) compared with rVAS at washout visit (2nd visit) as a result of discontinuation of use of NSAIDs

Exclusion Criteria:

* Patients with complication of rheumatoid arthritis, history of knee surgery, malignant tumor, neuropsychiatric disease, or serious disease
Applied Clinical Neuroscience and Its Effect on Self-reported Stress and Other Physiological Markers

The purpose of this study is to see if an applied clinical neuroscience (ACN) approach to the symptom of 'stress' has a measurable effect on an individual's self-reported stress level. Physiological markers will be measured and analyzed to potentially allow for greater insight and aid in setting up any future research on this topic. This is an independent research study.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age or older.
* Must be presenting to the clinic for treatment for 'stress'.

Exclusion Criteria:

* Under 18 years of age
* No vulnerable populations (physical or mental disability, economically or educationally disadvantaged, pregnancy, minors, persons incarcerated).
* No participants that have an additional relationship beyond the doctor/patient relationship that exists by nature of a patient committing to treatment (a family member or clinic employee would be excluded from the study).
Presence Hallucination in Parkinson's Disease

Investigation on how robotically mediated sensorimotor stimulation induces and triggers presence hallucinations in patients with Parkinson disease

Parkinson's Disease (PD) is primarily known and characterized by motor symptoms such as tremor, rigidity and bradykinesia. However, a significant number of non-motor symptoms also accompany the unfolding of this disease. In fact, hallucinations are experienced by approximately 60% of the patients. The most common and amongst one of the earliest hallucinations in Parkinson's Disease, is the Presence Hallucination (PH), i.e., the strange sensation of perceiving someone behind when no one is actually there. In the present study the researchers aim at investigating the behavioural and neural mechanisms underlying symptomatic PH in PD. To do so the researchers intend to induce the PH in a repeated and controlled manner in the MRI scanner, with an extensively verified paradigm which gives rise to this sensation by means of robotically-mediated sensorimotor stimulation. This setup has in fact been shown to trigger the occurrence of symptomatic PH in these patients. The possibility to induce PH while the patient is in the MRI will allow the researchers to investigate online the brain networks associated with it.

With analysis on the fine brain connectivity changes during PH-induction, the investigators intend to pinpoint the exact mechanism behind the appearance of this hallucination in these patients, in a similar fashion to previous work with the PH-induction in healthy individuals.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Parkinson's disease
* Able to understand instructions and provide informed consent.
* Native speaking language of experimental site (or acquisition of language of experimental site before 6 years old).
* Montreal Cognitive Assessment (Nasreddine \& Patel, 2016) with score ≥ 22.
* Able to manipulate the robotic device.

Exclusion Criteria:

* Neurological comorbidities other than Parkinson's disease (e.g. Alzheimer's disease, vascular dementia, multiple sclerosis, stroke, traumatic brain injury, epilepsy, chronic migraine, etc.)
* History or current condition of substance abuse and/or dependence (e.g., alcohol, drugs).
* Suffering from or diagnosed with psychiatric illnesses according to DSM-V criteria (e.g., schizophrenia, bipolar disorders, autism, personality disorders, phobia etc.).
* Family history (1st and 2nd degree) of psychiatric disorders (e.g., schizophrenia or bipolar disorders).
* Severe somatic illnesses (e.g., cancer).
* Severe tremors or physical disability preventing optimal use of robotic device.
* Participating in a pharmacological study.
* Local or general anaesthesia 30 days prior experiment
* Inability to provide informed consent (legal guardianship)
* The following are due to the MRI scanner: body weight exceeding 160kg, implanted metallic devices, foreign metallic objects, unstable angina, cardio-vascular diseases, tattoos with metallic components, external metallic objects, claustrophobia, pregnancy.
Efficacy and Safety of SP2086 as Monotherapy in Patients With Type 2 Diabetes

SP2086 is a new dipeptidy1 peptidase(DPP)-4 inhibitors. This study aims to evaluate the efficacy and safety of SP2086 as monotherapy in patients with Type 2 Diabetes Mellitus in Metformin monotherapy Who Have Inadequate Glycemic Control treated with diet and exercise for 3 months


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type 2 diabetes mellitus
* Patients have treated with diet/exercise at least 3 months
* 7.5% ≤HbA1C ≤11.0% at screening,7.0% ≤HbA1C ≤10.5% after run-in

Exclusion Criteria:

* Patient has history of type 1 diabetes mellitus
* Patient has history of ketoacidosis
* Patient has history of severe unconscious hypoglycemosis
* Patient has history of acute and chronic pancreatitis or pancreatic injury that may lead to high risk of pancreatitis
* Patient has history of decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, persistence and clinical
* Patient has history of a history of hypertension, and after antihypertensive treatment, systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg
* Patient has severe liver or kidney disease,alanine aminotransferase \>2×UNL, Aspartate Aminotransferase \>2×upper normal limit(UNL)；total bilirubin \>2×UNL； creatinine\>1.5 mg/dL (Male,132.6μmol/L) ，\>1.4 mg/dL(Female，123.8μmol/L)
* Patient has severe chronic gastrointestinal disease or therapy that may affect drug absorption, such as gastrointestinal surgery
* Patient has severe haematological diseases or other diseases leading to hemolyze and red blood cell unstable (malaria、haemolytic anaemia eg. )
* Patient has other endocrine diseases, for example hyperthyroidism、hypothyroidism、hypercortisolism、multiple endocrine neoplasia and so on
* Patient has history of malignancy
* Patient has history of alcohol or drug abuse
Cell Phone Intervention to Support Antiretroviral Therapy (ART) Adherence in Kenya

A clinical study to evaluate the use of cell phones to support drug adherence and follow-up of patients taking antiretroviral therapy (ART) for treatment of HIV. The intervention involves health-care providers sending regular short-message-service (SMS) text messages to patients and following up their responses. The hypothesis is that the cell phone intervention will improve ART adherence and health outcomes compared with the current standard of care.

This RCT study focuses on enrolling and following patients initiating ART. Note, a second parallel prospective cohort study enrolls and follows ART experienced patients who have already been taking ART for at least one year before and after the same intervention.

Eligibility Criteria:
Inclusion Criteria:

* HIV infected and starting antiretroviral therapy
* Adequate (daily) access to a cell phone
* Intending to attend the enrollment clinic for 2 years
* Consent to participate

Exclusion Criteria:

* Not meeting inclusion criteria
A Study of Capecitabine (Xeloda) in Participants With Advanced or Metastatic Gastric Cancer

This study will evaluate the efficacy and safety of oral capecitabine (Xeloda) versus 5-fluorouracil (5-FU), in combination with intravenous (IV) cisplatin, in participants with advanced and/or metastatic gastric cancer. The anticipated time on study treatment is at least 6 weeks and continued up to disease progression, and the target sample size is 300 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 75 years of age
* Advanced and/or metastatic gastric cancer with at least 1 measurable lesion

Exclusion Criteria:

* Uncontrolled infection
* Evidence of central nervous system (CNS) metastases
* History of other malignancy within the last 5 years, except cured basal cell cancer of the skin or cured in-situ cancer of the uterine cervix
* Radiation therapy or major surgery within 4 weeks of study drug
* Previous chemotherapy
Coblation-Tonsillotomy vs Electrocautery-Tonsillectomy for the Treatment of Obstructive Sleep Apnea (OSA) in Children

Removal of the adenoid and tonsils, known as an adenotonsillectomy (AT) is one of the most frequently performed surgical procedures in North America. The two most prevalent indications for this procedure in children are recurrent bacterial tonsillitis and obstructive sleep apnea (OSA). OSA is a common childhood condition that is characterized by upper airway obstruction, disturbed sleep and disrupted normal respiratory gas exchange. In the majority of children with OSA, overgrowth of the adenoid and tonsils is the primary underlying aetiology, making tissue removal via AT the standard of care. The purpose of this study is to evaluate the effectiveness of two different surgical techniques, electrocautery-tonsillectomy and coblation-tonsillotomy, in the treatment of obstructive sleep apnea (OSA) in children.


Eligibility Criteria:
Inclusion Criteria:

* Moderate or severe OSA on PSG (AHI ≥ 5.0)
* Pronounced tonsillar hyperplasia on physical exam
* No previous tonsil or adenoid surgery
* No history of recurrent tonsillitis
* Participants and their families must be willing to comply with follow-up
* Parents/caregivers fluent in English

Exclusion Criteria:

* Severe co-morbidities, including, but not limited to, poorly controlled asthma, chromosomal abnormalities, and developmental delay