cyrilzakka/clinical-trials huggingface dataset:
DaVita Assessment of Nutritional Supplement Effects (DANSE)

This is a Phase IV randomized controlled study assessing the effectiveness of a commercially available nutritional supplement on malnourished prevalent hemodialysis patients. Patients will be randomized to either receive one can of Nepro with Carb Steady at each dialysis treatment for 6 months or to receive the standard of care counseling for malnutrition. The primary hypothesis is that hypoalbuminemic maintenance hemodialysis patients will demonstrate an improvement in albumin levels with oral nutritional supplement provided in-center thrice weekly in addition to standard of care as compared to malnourished maintenance hemodialysis patients provided standard of care alone.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Patient has been on hemodialysis \>6 months at the time of study entry
* Patient dialyzes three times a week
* Patient agrees to try ONS for the 6 month study period.
* Patient has demonstrated an albumin \<3.5 g/dL on last available lab drawn in dialysis facility
* Patient is adequately dialyzed with a Kt/V \> 1.4 at the most recent lab draw
* Patient is capable of reading and comprehending Informed Consent Form and provides written informed consent

Exclusion Criteria:

* Peritoneal dialysis
* Dysphagia
* Aspiration risk
* Difficulty swallowing
* History of symptomatic intolerance to food or liquid consumption during dialysis treatments
* Terminal illnesses with life expectancy \<6 months, e.g. stage IV cancer or full blown AIDS
* Concurrent appetite stimulants
* Use of IDPN in last 3 months
* Inability to follow and to comply with the instructions and guidelines
* Severe liver disease defined as most recent SGOT \> 78
* Active malignancy (other than skin)
* Major surgery within previous 6 months or anticipated during the 90-day study period
* Females who are pregnant or are breast-feeding
* Considered clinically unstable by the treating nephrologists
* Noncompliance with dialysis treatments ( Missed \> 2 treatments in prior month due to noncompliance)
* Extended or frequent hospitalizations defined as hospitalization of longer than 15 days with discharge within the last 30 days or greater than 3 admissions within the last 30 days
* Regular supplement use defined as consumption of \> 7 servings of a commercially available kcal/ protein supplement in the prior month
* Any clinically significant medical disease or condition that, in the investigator's opinion, may interfere with protocol adherence or a patient's ability to give informed consent
Depression Care for Hospitalized Coronary Heart Disease Patients: Prospective Cohort Study

The aims of this prospective, observational study are to assess the current use of depression care in Coronary Heart Disease (CHD) patients, and to provide estimates for the resources needed to implement guideline-oriented depression health care acceptable to CHD patients with comorbid depression.

In patients with established CHD, unipolar depression is up to three times more prevalent than in the general population and increases the risk for coronary events and mortality, higher health care consumption and decreased quality of life. Most hospitals in Germany have a unique infrastructure of psychiatric, psychosomatic and psychosocial services for CHD patients (psychiatric/psychosomatic consultation liaison services and a wide network of inpatient or outpatient cardiac rehabilitation centers). However, as of today, little is known about the current use and acceptability of depression health care from the perspective of CHD patients.

This project has two main aims:

1. to assess the current use of depression care in CHD patients who are hospitalized or receive ambulatory care at a cardiology clinic
2. to provide estimates for the resources needed to implement guideline-oriented depression health care acceptable to CHD patients with comorbid depression.

Specifically, the investigators will assess

* rates of and satisfaction with depression health care use in hospitalized CHD patients within one year after hospitalization
* perceived need for depression care and patient preferences for different types, settings and providers of these services
* correlates of depression health care use and patient preferences
* the amount of patients in need for depression health care according to existing recommendations

The secondary objective is to assess direct and indirect costs associated with depressive symptoms and depression care use across 1 year (as indicated by quality of life, event-free survival, productivity, and health care costs).

Eligibility Criteria:
Inclusion Criteria:

* chronic CHD (confirmed by a clinician)

Exclusion Criteria:

* chart-documented dementia disorder
* cognitive impairment
* life expectancy \< 1 year
* unavailability for follow-up
* insufficient proficiency in German or Turkish language
Documentation of the Efficacy of Desmopressin Within the Context of Surgical Procedures

In this non-interventional multicentre, prospective, observational cohort study, the efficacy of desmopressin is evaluated in patients with platelet dysfunction due to acetylsalicylic acid or cox-1-inhibitors within the context of surgical procedures.


Eligibility Criteria:
Inclusion Criteria:

* Pre-, peri- or postoperative treatment with a standard dose of desmopressin as a result of platelet dysfunction (disturbance of blood platelet function) due to treatment with acetylsalicylic acid or cox-1-inhibitor.
* Decision on the therapy with MINIRIN parenteral 4 Microgram/ml solution for injection has already been made independently by the physician beforehand
* The patients (≥ 18 years) have been informed about the non-interventional study and have given their written consent for participation

Exclusion Criteria:

* Participation in a clinical trial
* Treatment with acetylsalicylic acid for cardiovascular indications
Dietary Sodium Restriction in Hemodialysis Patients

Excess dietary sodium can lead to poor outcomes, such as hypertension, edema and increased risk for cardiovascular diseases. These complications are associated with end stage renal disease (ESRD) progression and mortality in renal patients. This study aims to evaluate the effects of nutritional counseling restricting dietary sodium and its relation to clinical and diet factors, nutritional knowledge and quality of life in hemodialysis patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical stable patients on dialysis for at least 3 months, over 18 years old, of both sexes, who agree to participate in the study.

Exclusion Criteria:

* Patients with low cognitive ability, psychiatric disorders, with acute or infectious disease.
Long-term Atrial Pacing and Central Blood Pressure

This is a randomized controlled single-centre clinical trial with a cross-over design to compare non-invasively evaluated central blood pressure and related parametres in sick sinus syndrome patients with hypertension who are paced long-term at a slower vs faster heart rate


Eligibility Criteria:
Inclusion Criteria:

* age 18-80 years
* sick sinus syndrome
* permanent cardiac pacemaker with right atrial and right ventricular leads
* at least 3 months from implantation
* sinus rhythm
* percentage of atrial pacing at or above 80% since last interrogation
* percentage of ventricular pacing at or below 3% since last interrogation
* primary arterial hypertension
* antihypertensive drug treatment
* mean office brachial blood pressure below 140/90 mmHg
* mean home brachial blood pressure below 135/85 mmHg
* ability to understand and follow study protocol
* signed informed consent form

Exclusion Criteria:

* inclusion criteria not fulfilled
* violation of study protocol by subject, investigator or third part
* high quality central hemodynamic measurements cannot be perfomed
* inter-arm difference in brachial systolic blood pressure 15 mmHg or above
* intrinsic QRS complex 130 ms or above
* more than three antihypertensive agents in use
* treatment with digoxin or agents from Vaughan-Williams classes Ic, III või IV
* frequent high atrial rate episodes
* coronary artery disease
* secondary hypertension
* resistant hypertension
* orthostatic hypotension
* heart failure with decreased or preserved left ventricular ejection fraction
* implantable cardioverter-defibrillator or cardiac resynchronization therapy
* significant valvular heart disease
* significant congenital heart disease
* body mass index ≥35 kg/m2
* type I diabetes
* type II diabetes with cardiovascular complications or on insulin therapy
* other significant endocrine disease
* history of cerebrovascular attack
* carotid artery disease
* lower extremity arterial disease
* severe chronic obstructive pulmonary disease
* severe asthma
* severe sleep apnea
* interstitial pulmonary disease
* inhaled beta adrenergic agonist therapy
* active cancer treatment
* central nervous system degenerative disease
* systemic connective tissue disease
* abnormal TSH at present
* glomerular filtration rate ≤30 ml/min/m2
* hemoglobin \<100 g/L (female), \<110 g/L (male)
* hepatic dysfunction
* alcohol abuse
* pregnancy or breastfeeding
* no health insurance provided by Estonian Health Insurance Fund
* withdrawal of informed consent
* loss of contact with a subject during study
An Extension of Istradefylline in North American Parkinson's Disease Patients Who Have Completed Study 6002-INT-001

This is an, open-label, long-term safety extension for patients in North America who have completed the prior istradefylline study 6002-INT-001.

Patients with Parkinson's disease with motor complications on levodopa therapy who completed the prior double-blind study 6002-INT-001 are eligible to enter into this long-term open safety study with a starting istradefylline dose of 20 or 40mg per day.

Eligibility Criteria:
Inclusion Criteria:

* Completion of study 6002-INT-001
* Not of childbearing potential

Exclusion Criteria:

* Cancer within 5 years of enrollment
* ALT/AST levels \> 2.5 times ULN
Efficiency of Three Different Methods in Reducing Pain in Children During Intravenous Cannulation

Purpose: This study investigates the effects of squeezing a soft ball, using a kaleidoscope, or blowing bubbles during intravenous cannulation on the pain and fear of children between the ages of 4 and 6.

Design and Methods: This study is a randomised controlled study. In the study, there were 30 children in the soft ball group, 30 children in the kaleidoscope group, 30 children in the bubbles group, and 30 children in the control group.

15 minutes before the intravenous cannulation procedure, the second researcher interviewed the parents and the children in squeezing soft ball, kaleidoscope, blowing bubbles and control groups separately and filled in descriptive information form and Children's Fear Scale. After randomization, the second researcher, the child and the parent went to the blood collection room for the procedure. Children in the Kaleidoscope group were given the kaleidoscope before intravenous cannulation and they were shown how to use it. The children were told to look at the kaleidoscope during the procedure until the procedure ended. The children in the squeezing soft ball group were given the ball before the procedure. They were told to squeeze and loosen the ball with the hand that was not used for the procedure while intravenous cannula was being inserted. The children in the blowing bubble group were shown the bubble blower before intravenous cannulation and they were told how bubbles were formed and how they would blow. During intravenous cannulation, the child blew the blower. Routine procedures were applied on the children in the control group without any interventions. Inserting the intravenous cannula took 3-5 minutes. The procedure was carried out in the same room by the same nurse for four of the groups. After the intravenous cannulation procedure ended, a researcher and parents filled in Faces Pain Scale-Revised and Children's Fear Scale separately and independently to find out the level of pain and fear experienced by the child during the procedure.

Eligibility Criteria:
Inclusion Criteria:

* parents who agreed to participate in the study

Exclusion Criteria:

* visually impaired child
* mentally retarded child
* speech impaired children
Safety and Efficacy of TKI258 in FGFR1 Amplified and Non-amplified Metastatic HER2 Negative Breast Cancer

The purpose of this trial is to determine the efficacy and safety profile of TKI258 in 3 groups of patients with metastatic HER2 negative breast cancer (BC) stratified by FGFR1 and hormone receptor (HR) status.


Eligibility Criteria:
Inclusion Criteria:

1. Female presenting with metastatic breast cancer.
2. Tumor must have been tested by FISH/CISH for FGFR1 amplification.
3. HER2 and HR status must have been determined.
4. Patients must have HER2 negative breast cancer.
5. Patients must have a documented disease progression as define by RECIST at baseline.
6. Patients with HR+ disease:

   * Must have received at least one prior endocrine therapy in the metastatic setting.
   * Must have received no more than three lines of chemotherapy in the metastatic setting.
7. Patients with HR- disease must have received at least one and no more than three lines of chemotherapy in metastatic setting.

Exclusion Criteria:

1. Patients with known brain metastases or who have signs/symptoms attributable to brain metastases and have not been assessed with radiologic imaging to rule out the presence of brain metastases.
2. Impaired cardiac function or clinically significant cardiac diseases, including any of the following:

   * History or presence of serious uncontrolled ventricular arrhythmias or presence of atrial fibrillation.
   * Clinically significant resting bradycardia (\< 50 beats per minute).
   * LVEF assessed by 2-D echocardiogram (ECHO) or Multiple gated acquisition scanning (MUGA)\< 45%.
3. Any of the following within 6 months prior to study entry: myocardial infarction (MI), severe/unstable angina, Coronary Artery Bypass Graft (CABG), Congestive Heart Failure (CHF), Cerebrovascular Accident (CVA), Transient Ischemic Attack (TIA), Pulmonary Embolism (PE).
4. Uncontrolled hypertension defined by a SBP \> 150mm Hg and/or DBP \> 100mm Hg, with or without anti-hypertensive medication.

Other protocol-defined inclusion/exclusion criteria may apply
Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors

The purpose of this study is to determine whether Helicobacter pylori eradication could reduce the new tumor development after endoscopic resection of gastric tumor.

The association between Helicobacter pylori infection and development of gastric cancer has been established by epidemiologic studies. Conversely, eradication of H. pylori showed no significant reduction of the incidence of gastric cancer in a large-scale, double-blind, randomized controlled trial. Eradication of H. pylori to prevent cancer was only effective in the subgroup without precancerous lesions (i,e, dysplasia, intestinal metaplasia, and atrophy). In contrast, randomized prospective study in Japan showed that H. pylori eradication after endoscopic resection of early gastric cancer significantly reduced metachronous gastric cancer. To solve this conflicting issue is critical because gastric cancer is the second leading cancer incidence worldwide, particularly Korea, Japan, and China have highest cancer incidence, and its incidence might decrease by H. pylori eradication treatment.

With respect to therapeutic modality, endoscopic resection for early gastric cancer is currently the established treatment of choice in Korea and Japan because it has been proven to be both minimally invasive and effective in the curative treatment of early gastric cancer.

Endoscopic resection has also been performed in the gastric dysplasia because dysplasia has to some extent malignant potential although firm evidence is lacking. In comparison with surgical resection, endoscopic resection conserves remnant stomach. Accordingly, patients treated with endoscopic resection have higher possibility for metachronous gastric cancer than those treated with surgical resection.

So far, it has not yet been clearly established whether H pylori eradication for gastric tumors (early gastric cancer and gastric dysplasia) could reduce metachronous cancer. We performed randomized controlled, open-label trial on the effect of new cancer development after H pylori eradication for gastric tumors.

Eligibility Criteria:
Inclusion Criteria:

* H pylori infected patients with gastric low-grade dysplasia, high-grade dysplasia, and early gastric cancer
* Gastric tumor is completely removed through endoscopic resection.

Exclusion Criteria:

* Patients underwent gastrectomy before enrollment
* patients underwent endoscopic resection before enrollment
* Previous history of eradication for H. pylori
* Pregnancy
* Aged \<20 yr old or aged \>75 yr old
* Patients underwent additional gastrectomy due to incomplete endoscopic resection
Evaluation the Role of Laparoscopic Management of Perforated Appendicitis

A laparoscopic appendectomy (LA) was first reported by Semm in 1983. Since then, its advantages, such as the aesthetic appearance of the wound, less postoperative pain, and faster recovery which facilitates early discharge, have been highlighted, and the number of procedures performed has been continuously increasing.

The LA was performed mostly on uncomplicated appendicitis due to negative opinions about its safety when it was first introduced. However, the application of the procedure has been extended to complicated appendicitis (CA), and it is now considered as an alternative procedure to an open appendectomy (OA) as its safety record has improved . Nevertheless, it is still controversial because there are still concerns about surgical difficulties in managing CA with laparoscopy, overall surgery time, possible post-op complications and conversion to an OA during the surgery.

this study aimed to evaluate the safety and the efficacy of LA for managing perforated appendicitis.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute perforated appendicitis
* fit for laparoscopy and general anesthesia.
* written informed consent.
* short term outcome data and agree to provide contact information.

Exclusion Criteria:

* high risk for general anesthesia.
* Appendicular abscess and appendicular mass .
* ongoing infections including chest infections .
* Children and pregnant females .
Long-term Study of Nateglinide+Valsartan to Prevent or Delay Type II Diabetes Mellitus and Cardiovascular Complications

This study is a test of the safety and effectiveness of two drugs, one for diabetes and one for hypertension, in keeping patients with high lab values of glucose from progressing to frank diabetes and developing cardiovascular complications. People in this study cannot have frank diabetes but are considered "borderline" based on blood tests. People in the study take none, one or both of the drugs and do not know which one(s) they are taking.


Eligibility Criteria:
Inclusion Criteria:

* Adults
* Impaired glucose tolerance
* Age dependent risk factors

Exclusion Criteria:

* Frank diabetes

For detailed information, call contact person.
A Mobile Phone App to Promote Healthy Diet and Physical Activity in 2.5-year-olds

Childhood obesity is still a major global health issue. The preschool age (2-5 years) has been identified as a critical period to intervene, Mobile technology (mHealth) has been successful for weight loss and behavior changes in adults. This proposed randomized controlled trial aims to assess the effectiveness of an 6-month intervention program, the Mobile-based intervention to stop obesity in preschoolers (MINISTOP) 2.0 mobile phone app integrated in primary child health care for parents of children aged 2.5 years. The MINISTOP 2.0 app is built on the previous MINISTOP 1.0 app. Five hundred children will be recruited at their routine visit at 2.5 years of age and after baseline measures randomized to the intervention or control group. In addition, the investigators will assess acceptability, feasibility and appropriateness of the app by parents and primary child health care nurses.


Eligibility Criteria:
Inclusion criteria:

-Children at the routine visit at 2.5-3 years of age at selected primary child health centers in Sweden

Exclusion criteria:

* Children diagnosed with neurological or endocrine diseases
* Children who have a parent suffering from a serious physical or psychological disease making the study too demanding for the family
* Children from families who will not be able to understand the content of the app (i.e. do not speak Swedish, English, Somali or Arabic)
Sedation During Microelectrode Recordings Before Deep Brain Stimulation for Movement Disorders.

The purpose of this study is to detect possible changes in the electrical activity of the Basal Ganglia related to sedation during deep brain stimulation surgery.

Deep Brain Stimulation is commonly used for the treatment of movement disorders. Electrode positioning is usually performed under local anesthesia in fully awake patients. The procedure is uncomfortable to the patients who have to remain motionless during the whole surgery. Previous reports of electrode positioning under general anesthesia was found to be less accurate. This result was probably due to the effect of the anesthetics on the electrical activity of the Basal Ganglia.

The purpose of this study is to detect possible changes in the electrical activity of the Basal Ganglia related to propofol sedation. Electrical activity of single neurons will be recorded before and after sedation.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for Deep Brain Stimulation Surgery.
* Informed concent obtained.

Exclusion Criteria:

* Suspected difficult intubation (by history or physical examination).
* Allergy to Propofol, eggs or soy-beans.
* History of sleep apnea syndrome.