cyrilzakka/clinical-trials huggingface dataset:
Use of a Patient Decision Aid for Gastrologic Endoscopy in a Pediatric Setting

Parents need understandable information in order to make appropriate choices for their child's health care. This is especially true when making decisions about invasive medical procedures. Parents need to understand what will happen, the risks involved, how these risks will be managed and what other options they have before they can decide what is best for their child. The present proposal involves the creation of a novel patient decision aid about the gastro endoscopy procedure, called a "scope." The purpose of the aid is to provide parents with information so they are able to discuss the options with their child's health care providers.

True informed consent depends on effective, bi-directional communication between parents and their child's healthcare providers. Many things affect the quality of the consenting process including the parents' level of health literacy, English proficiency and cultural perspectives. Our long-term goal is to develop a standardized consenting process that ultimately addresses the needs of the patient and the patient's family so that a truly informed decision can occur. The specific hypothesis is that incorporating the use of a multimedia patient decision aid to assist in the education of patients and their families about an invasive medical procedure (i.e. gastro-endoscopy) will improve knowledge and positively impact the ability of the parent to act on this knowledge when making decisions regarding their child's health care.

Eligibility Criteria:
Inclusion Criteria:

* parents or LARs who are considering a gastro-endoscopy for their child

Exclusion Criteria:

* child has previously undergone an endoscopy
* parent of child has undergone an endoscopy
* non-English speaking
The Impact of Immunostimulating Nutrition on the Outcome of Surgery

The aim of the study was to assess the clinical effect of immunostimulatory enteral and parenteral nutrition in patients undergoing resection for gastrointestinal cancer. 205 subjects were randomly assigned into four study groups, standard and immunostimulating, enteral and parenteral. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery.

All patients qualified between June 2001 and December 2005 to total and distal subtotal gastrectomy or pancreaticoduodenectomy were screened for eligibility to participate in the study. Additional eligibility criteria included: age between 18 and 80 years, Karnofsky performance status score of 80 or more, and adequate organ function measured by routine blood tests. Patients requiring preoperative nutritional support, as well as those with disseminated tumors, serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5), and renal or liver failure were excluded. The study was designed to test the hypothesis that immunonutrition and enteral nutrition would reduce the incidence of infectious complications following upper gastrointestinal surgery. Therefore, patients were randomly assigned in a 2×2 factorial design to four groups receiving immunostimulating versus normal diets, and enteral versus intravenous nutritional support. The secondary objective of the study was to evaluate the effect of nutritional intervention on overall morbidity and mortality rates, and the length of hospital stay.

After completing tumor resection, patients who met the eligibility criteria were intraoperatively assigned to either of the treatment groups using sealed envelopes containing computer-generated allocation numbers. The following groups were generated: standard enteral nutrition (SEN), immunostimulating enteral nutrition (IMEN), standard parenteral nutrition (SPN), and immunostimulating parenteral nutrition (IMPN). The study was carried out following the international ethical recommendations stated in the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* resectable gastric or pancreatic cancer
* age between 18 and 80 years,
* Karnofsky performance status score of 80 or more,
* adequate organ function

Exclusion Criteria:

* unresectable gastric or pancreatic cancer
* patients requiring preoperative nutritional support,
* disseminated tumors,
* serious comorbidities (American Society of Anesthesiologists risk class of 4 or 5),
* renal or liver failure were excluded
Effective Conversion of Individuals at Risk

This study aims to guide participants in recognizing their OSA (obstructive sleep apnea) and AFib (atrial fibrillation) symptoms, realizing what medical conditions can cause these symptoms (if any) and inform the participants on their possible diagnosis

The primary objective is to analyze how many patients at risk of medical conditions will be converted to a health care professional by a smartphone application. Historical data (number of patients at risk of OSA and/or AFib that seeked help for their condition in the past year) from institute will be used as a reference. We will refer to this as the 'baseline conversion rate', reflecting the natural transition of patients in the general healthcare system.

Eligibility Criteria:
Inclusion Criteria:

* High risk of OSA and/or AFib, as defined by the risk algorithm developed by Sanford health
* 18 years or older, with sufficient English language skills
* Owning a smartphone with a relatively new operating system (iOS v. 14 (Iphone 6S or higher) or an Android device v.11\<)
* Able to download and handle an app on a smartphone
* Willing and able to give informed consent

Exclusion criteria:

* Diagnosed with OSA and/or AFib
* Diagnosed health issues that are potentially life threatening or causing mental issues (stroke, Alzheimer's Disease, depression, etc.)
* Pregnancy/breast feeding
The Leadless AV Versus DDD Pacing Study

Cardiac pacemaker (PM) implantation is the established treatment for relevant bradyarrhythmias. Conventional PMs require 1-3 pacing leads to register the heart's intrinsic activity ("sensing") and to deliver the electrical stimuli to the heart ("pacing"). These leads are responsible for the vast majority of morbidity after implantation and PM failures. Therefore, a leadless PM system (Micra TPS™, Medtronic, United States) has been introduced a few years ago. This system overcomes the limitations of leads, however, the first generation of the Micra TPS™ only allowed sensing and pacing in the right ventricle. More recently, an upgraded version has been introduced and gained market approval (Micra AV, Medtronic, United States). According to published results from several clinical trials, this device allows sensing the atrial activity and, thus, timing the delivery of the ventricular pacing impulse in a physiological manner similar to a conventional dual-chamber PM with two leads. Clinical feasibility and safety for this concept have been established already. However, it is unclear if this translates into a direct clinical benefit for patients in comparison to conventional PM systems.

The aim of this trial is to compare the therapeutic efficacy of the Micra AV™ PM and conventional dual-chamber PM systems in patients with intermittent or permanent atrioventricular conduction block and a PM indication according to the latest European guidelines. Thus, patients will be randomized to either a conventional dual-chamber PM implantation or the implantation of a leadless Micra AV™ system. Patients will be stratified for gender (female/male) and a priori estimated physical exercise capacity ("fit"/"unfit"). The primary outcome will be the physical exercise capacity of the patients.

The null hypothesis with regards to the primary endpoint is that the leadless pacemaker arm shows an inferior VO2 anaerobic threshold than the conventional pacemaker arm. Hence the alternative hypothesis postulates that the leadless pacemaker arm shows a non-inferior VO2 anaerobic threshold compared to the conventional pacemaker arm. Rejection of the null hypothesis is needed to conclude non-inferiority.


Eligibility Criteria:
Inclusion Criteria:

* Patients (≥70y) undergoing a de-novo pacemaker implantation due to intermittent or permanent AV block, qualifying for a conventional or leadless pacemaker
* Written informed consent

Exclusion Criteria:

* Permanent atrial fibrillation or atrial standstill
* Evidence of sinus node disease and need for right atrial pacing (not possible with Micra AV)
* LVEF \<50% and permanent high-degree or total AVB (requiring CRT/His-Bundle/CSP pacing)
* Preoperative E/A ratio \>1.5 in the echocardiography
* Any co-existing ICD indications (no leadless ICD systems available)
* Hemodialysis
* Presence of a mechanical tricuspid valve prosthesis
* Unwilling or unable to comply fully with study procedures and follow-up
Evaluation of Ezetimibe and Atorvastatin Coadministration Versus Atorvastatin or Rosuvastatin Monotherapy in Japanese Patients With Hypercholesterolemia (Study P06027)(COMPLETED)

The purpose of this study is to evaluate the efficacy and safety of atorvastatin 10 mg and ezetimibe 10 mg coadministration in Japanese participants with hypercholesterolemia whose low-density lipoprotein (LDL)-cholesterol levels have not reached the lipid management target value with atorvastatin 10 mg alone, versus increasing the dose of atorvastatin to 20 mg or changing to rosuvastatin 2.5 mg.


Eligibility Criteria:
Inclusion Criteria:

* atorvastatin 10 mg monotherapy for 4 weeks or longer before the start of the 4-week washout and low density lipoprotein-cholesterol (LDL-C) levels that had not reached the following lipid management target values during treatment: Category I (low-risk group) with no other risk factors - LDL-C \<160 mg/dL; Category II (mid-risk group) with 1-2 risk factors other than LDL-C levels - LDL-C \<140 mg/dL; Category III (high-risk group) with 3 or more other risk factors - LDL-C \<120 mg/dL; and for participants with history of coronary artery disease - LDL-C \<100 mg/dL.
* outpatient men or women, age 20 years and older

Exclusion Criteria:

* fasted triglyceride level at the start of washout or treatment period exceeding 400 mg/dL.
* homozygous familial hypercholesterolemia.
* creatine phosphokinase (CPK) \>2 times the upper limit of normal (X ULN) at start of washout or treatment period.
* glycosylated hemoglobin (HbA1c) \>=8％ at start of washout or treatment period.
* severe hepatic function disorder, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>2X ULN at start of washout or treatment period.
* hypersensitivity to ezetimibe, atorvastatin, or rosuvastatin tablets.
* pregnant or lactating
* discontinued use of atorvastatin 10 mg for less than 4 weeks at start of treatment period (however, if participant had taken atorvastatin 10 mg before the test conducted at the start of the observation period, a period of discontinuation of 27 days is allowed.)
* cyclosporine treatment
* hyperlipidemia associated with hypothyroidism, obstructive gall bladder or biliary disease, chronic renal failure, and/or pancreatitis.
* hyperlipidemia associated with drug administration that causes adverse serum lipid effects.
* participation in a clinical study within 4 weeks of washout
* cancer or cancer history within previous 5 years, except for successfully treated basal cell carcinoma of the skin.
A Study Comparing the Impact of Mini-exchange-room and Usual Care on Physical Activity and Quality of Life in Peritoneal Dialysis Patients

To compare the effect of mini-exchange-room and usual care on physical activity and quality of life in peritoneal dialysis (PD) patients through a randomized controlled study. A total of 80 incident CAPD patients with age of 18\~80 years old will be enrolled, who are medically stable and regularly followed up. The one group perform traditional PD procedure (G1), and the other group will utilize disposable mini-exchange-room group (G2). Two groups will be followed for 6 months. Biochemistry data, types of space for bag exchange, physical activity and quality of life will also be collected for all subjects at the 3rd and 6th month. During the study period, peritonitis episode, acute comorbidity and hospitalization will be recorded. The change of physical activity, quality of life and peritonitis rate will be compared between the two groups.


Eligibility Criteria:
Inclusion Criteria:

* The study will be conducted in the Division of Nephrology, Beijing University First Hospital. A total of 80 incident CAPD patients with age of 18\~80 years old will be enrolled, who are medically stable and regularly followed up. Informed consent is required for each patient.

Exclusion Criteria:

* Those who have (1) intolerance to the study protocols, (2) severe and unstable conditions within one month, acute or chronic inflammation disease, (3) high probability (assessed by the recruiting physician) of receiving a kidney transplant or transferring to HD or drop-out due to socioeconomic causes within 6 months, (4) cognitive or psychological dysfunction, communication barrier, and (5) bag exchange by unfixed manipulator, are excluded.
"MiniMed 640G System" User Evaluation With the Question of Reducing the Rate of Hypoglycemia

The Minimed®640G system (MM640G) consists of a combination of insulin and glucose sensor for continuous glucose monitoring (CGM). Here, the glucose sensor transmits not only the continuous glucose data on the display of insulin pump but, in the case of hypoglycemia also interrupt their insulin delivery of pump. In the currently available system Paradigm®VEO, the interruption takes place at a settled threshold level. In difference in the new system MM640G the shutdown algorithm can already be proactive and help avoid hypoglycemia completely. The so called PLGM algorithm (predictive low glucose management) should be tested in the user evaluation. The main objective is to answer the question of reducing the rate of hypoglycemia by application of the new PLGM algorithm.

Included are a total of 24 patients, aged 1-21 years, in three pediatric diabetes centers.

In the first phase of two weeks, the sensor-augmented pump therapy (SaP) is carried out without these interruption PLGM algorithm. In a second phase for 6 weeks, the PLGM function is set. Both phases are compared in terms of the rate of hypoglycemia, the time spent and the area under the curve (AUC) glucose range (values \<70 mg / dl (3.9 mmol / l)).

Eligibility Criteria:
Inclusion Criteria:

* type 1 diabetes, diagnosed since 12 month at least
* continuous subcutaneous insulin infusion (CSII) since 3 month at least
* stable outcome since 3 month at least
* willingness of patients/ parents to wear a glucose sensor for 2 month
* willingness of patients/ parents to use the Minimed®640G system
* willingness of patients/ parents to complete a diary
* willingness of patients/ parents to comply the requirements of the study protocol

Exclusion Criteria:

* longer absence of the patients (not able to attend the study visits)
* subject with allergy of sensor or specific sensor components
* communication problems
* significant history of eating disorder, anorexia, bulimia
* pregnancy
* significant history of drug abuse or/ and alcoholism
* patient do not want to attend the trial
* missing informed consent
Clinical Study of Escitalopram Oxalate Combined With taVNS in Depression and Concomitant Inflammatory Symptoms

This study is expected to include 90 patients with major depressive disorder and rheumatoid arthritis as study subjects.Randomly divided into 3 groups: drug + VNS stimulation group, drug + sham stimulation group and drug group, each group had 30 patients.The treatment period of each group was 8 weeks.Age and sex were matched in all three groups.Scale evaluation and inflammatory factor test were performed before treatment (baseline), at week 4 and week 8 after treatment.Head MRI, evoked potential, and electrocardiogram were performed at baseline and at the end of week 8.

1. Drug +VNS stimulation group: both VNS and escitalopram oxalate tablets were treated for 2 months. VNS stimulation was treated once a day for 30 minutes at the intensity of 1-2mA. Drug treatment: the dose of escitalopram oxalate tablets was maintained at 10-20 mg/ day
2. Drug + sham stimulation group: the patients were treated with escitalopram oxalate tablets and sham VNS for 2 months. Sham VNS stimulation: the sham stimulation device automatically stops after 30 seconds of stimulation. Drug treatment was the same as the above group.
3. Drug group: the dose of escitalopram oxalate tablets was maintained at 10-20 mg/ day without VNS stimulation

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 years old, in accordance with DSM-5 diagnostic criteria for major depressive disorder, or meet the diagnostic criteria for rheumatoid arthritis. The major depressive disorder is first or at least not used in the 5 half-life of the drug. Antidepressants, antipsychotics or anticonvulsants.
* Hamilton Depression Rating Scale (HAMD) 17 scores over 17 points.

Exclusion Criteria:

* Brain organic lesions (such as cerebral hemorrhage, large area cerebral infarction, encephalitis, epilepsy); cardiac QTc interval \> 450ms;
* Currently or have been diagnosed with other major diseases (such as coronary heart disease, pulmonary heart disease, etc.)
* Those who are currently or have been diagnosed with other mental disorders other than major depressive disorder (except for anxiety disorder);
* Patients who have a serious risk of suicide or who have had suicide attempts;
* Those who are using or have been treated with escitalopram oxalate are not effective;
* Those who are participating in or have participated in vagus nerve or transcranial electrical stimulation for less than 3 months;
* MRI scan taboos and high-risk groups;
* Pregnancy, breastfeeding or planning for pregnancy during the trial;
* Refusal to sign informed consent.
Galvanic Vestibular Stimulation and Motor Training in Traumatic Brain Injury Survivors

The overall goal of the proposed project is to perform a preliminary study to assess the potential effects of galvanic vestibular stimulation (GVS) on the outcomes of a cognitive test of attention and the outcomes of robot-assisted upper-limb rehabilitation.

We plan to explore the use of GVS on the severity of attention span deficits and motor training delivered using a spring-based robot. We intend to carry out the study in a small cohort of traumatic brain injury (TBI) survivors (20 subjects). Subjects with attention span deficits but no significant motor impairments will solely undergo a cognitive test of attention with/without GVS. Subjects with both attention span deficits and significant motor impairments will undergo a cognitive test of attention and robot-assisted upper-limb rehabilitation with/without GVS.

Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe traumatic brain injury involving cognitive and/or motor deficits.
* Neurological injury \>1 year prior to study enrollment
* Significant attention deficit
* For subjects with motor deficits (arms 2 and 3), sufficient voluntary movement and range of motion in the most-affected upper extremity to use the robotic arm system (Armeo Spring)

Exclusion Criteria:

* Pregnancy
* History of seizures within 6 months of study enrollment
* Major depression
* Cognitive impairment that may interfere with understanding instructions
* Severe limitations of upper extremity range of motion
* Agitation
* Other major neurological or psychiatric diseases
* Participation in other forms of therapy/ intervention for upper extremity motor recovery
* End-stage liver, kidney, cardiac or pulmonary disease
* A terminal medical diagnosis with survival \<1 year
* History of drug or alcohol abuse in the last 3 years
* Adjustment of, or plan to adjust, psychoactive medications within the preceding 1 month, or within the study period.
* Current participation in another interventional trial targeting TBI
* Previous GVS treatment
* Contraindications to GVS such as implants
Evoke Data Collection Study Germany

The objective of this multicentre study is to collect electrophysiological and device data from the Evoke Closed-Loop SCS system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use.


Eligibility Criteria:
Inclusion Criteria:

* Patient approval for data collection and transfer of de-identified data to sponsor.

Exclusion Criteria:

* No further exclusion criteria.
Assessing Peripheral Nerve Block Scoring Systems for Intra-Operative and Post-Operative Analgesia

The purpose of this study is to determine if Peripheral Nerve Block scoring systems are effective in predicting the achievement of intra-operative anaesthesia and post-operative analgesia.

Upper and lower extremity surgery is particularly suited to regional anaesthesia. Peripheral nerve blocks (PNB) can produce surgical anaesthesia in less than 30 minutes. PNBs have been associated with early outcome improvements when surgery is conducted awake or with light sedation. These benefits include reduced nausea and vomiting, improved patient satisfaction and accelerated recovery room and hospital discharge. PNBs can also provide effective postoperative pain relief.

Currently there is no globally accepted standard by which to assess when surgical anaesthesia has been achieved following administration of PNBs. The decision as to when adequate surgical anaesthesia has been achieved and when surgery can then proceed is usually left to the discretion of the anaesthetist. The anaesthetist can assess nerve blockade though several motor and sensory function tests: cold, heat, touch and pinprick sensitivity. Several scoring systems have been described using these tests to estimate when surgical anaesthesia has been achieved but none have been independently validated outside of the original studies in which they have been described.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists Grade I-IV

Exclusion Criteria:

* Contraindications to regional anesthesia
* Language barrier
* Existence of neurologic disease affecting the operative site
* Severe psychiatric disease
* Pregnancy