cyrilzakka/clinical-trials huggingface dataset:
Diabetes Mellitus at the University Medical Center of Mannheim

Development of a training concept for health care professionals (nursing and medical staff), according to the current guidelines on treatment of in-patients with Diabetes. Primary endpoint is the change in hypoglycaemia rates comparing data before and after the training. Hereby we can derive the effects of staff training on the quality of health care in this patient population.

The prevalence of Diabetes in in-patients is about 32% and therefore exceeds significantly the prevalence in general population.

In most cases Diabetes is only a secondary diagnosis the medical staff has to deal with daily. The diagnosis which leads to hospital admission and the often multiple comorbidities complicate the metabolic control. Blood sugar imbalances present an additional risk for these patients and increase in-hospital mortality, length of hospital stay and general complications as nosocomial infections.

To improve hospital care for diabetics the Endocrine Society and the American College of Physicians published new guidelines on blood glucose management for non-ICU wards. Primarily they contain recommendations for blood glucose target range and standards to improve inpatient hospital care like standard operating procedures for blood glucose monitoring as well as hyper- and hypoglycaemic disturbances through to discharge management.

We developed a training concept for health care professionals (nursing and medical staff), according to the current guidelines on treatment of in-patients with Diabetes. Primary endpoint is the change in hypoglycaemia rates comparing data before and after the training. Hereby we can derive the effects of staff training on the quality of health care in this patient population.

So far there was only one comparable study published which showed a significant improvement of treatment quality by reducing hypoglycaemia rates considerably . The results of this study cannot be transferred due to substantial structural differences. More over there are no national diabetes management guidelines for inpatient treatment in Germany.

The following data will be collected:

* Anthropometric data (Age, Sex, Bodyweight, Height)
* Diagnosis
* POCT blood glucose values
* Other laboratory values
* Length of hospital stay

This study conforms to the requirements of the Declaration of Helsinki, Revision of 1996.

Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus

Exclusion Criteria:

* Age \<18 years
Coaching Dementia Caregivers to Master Care-Resistant Behavior

266 family caregivers will be randomly assigned to either immediate intervention or delayed intervention groups. All caregivers will complete baseline surveys and 3 weeks of daily diaries. The immediate intervention group will receive 12 weeks of CuRB-IT. They will complete 3 rounds of 3-week daily diaries followed by an intermittent survey at 12 week intervals for the next 33 weeks. The delayed intervention group will receive 12 weeks of attention, complete 1 round of 3-week daily diaries followed by an intermittent survey, then complete 12 weeks of CuRB-IT, and complete 2 rounds of 3--week daily diaries followed by an intermittent survey at 12-week intervals for the next 18 weeks.

The purposes of the delayed-intervention randomized clinical trial (N=266) are to:

Care-Resistant Behavior Internet Training (CuRB-IT).

1. examine the efficacy of CuRB-IT in increasing the self-efficacy of family caregivers of persons living with dementia to handle care-resistant behaviors (CRB);
2. further test the efficacy of CuRB-IT in improving caregivers coping strategies (a) among the experimental (immediate-intervention group) as compared to the control (delayed-intervention group) (between groups) and (b) within-person from pre- to post- intervention;
3. examine intervention decay at 3- and 6-months post intervention to determine performance of intervention and inform scheduling of booster sessions;
4. assess the efficacy of the CuRB-IT intervention in preventing onset of poor coping strategies by family caregivers;
5. test the hypothesized mechanism of action that increased CRB self-efficacy and use of CuRB-IT problem-focused coping strategies mediate the relationship between CRB stress appraisal and caregiving activities.

Eligibility Criteria:
Inclusion Criteria:

* 1)Caregiver of any race or gender who is aged \>18 years
* 2) provides unpaid care,
* 3) cares for a spouse/common-law, sibling, parent or grandparent (or in-law, aged 60+ years),
* 4) lives with or shares cooking facilities with the care recipient,
* 5) Care recipient has mild cognitive impairment or dementia as identified using the Quick Dementia Rating System instrument,
* 6) the care provided consists of help with at least 2 Instrumental Activities of Daily Living or one Activity of Daily Living,
* 7) the care recipient is resistant to receiving assistance with, or refuses to do, at least one instrumental or activity of daily living

Exclusion Criteria:

* 1) persons who cannot speak/read English
* 2) who do not have reliable access to a smart phone or internet
Efficacy of Visual Training in Beach Tennis

The proposed protocol is going to study the importance of wide spread of visual functions defined by but not limited to visual perception, visual function, visual exploration, involved in the performance of beach tennis. The investigators intend to examine the basic and important visual function that are required for the better performance in the field. The aim is to assess the efficacy of general training that uses the visual channel as the main one. The investigators suspects the improvement in the visual and motor skills after a predefined 8 weeks of visual training.


Eligibility Criteria:
Inclusion Criteria:

* experienced beach tennis player
* participants able and willing to participate in the study (including telemedicine supervision during the training phase)
* known and using full spectacles correction or its equivalent in contact lens correction

Exclusion Criteria:

* inability to give an informed consent
* any disease that causes visual opacity that unable to perform visual training
* participant unable to conduct full visual training course of the study
Feasibility in France of a Mindfulness-based Group Therapy for Adolescents With Chronic Pain

The main objective is to study the feasibility of a program for the management of chronic painful adolescents in meditation groups. This program is an adaptation of the MBI-A (Mindfulness-based intervention for adolescent) program developed in another socio-cultural context (i.e. in Canada). The secondary objectives will be to study the effect of a mindfulness meditation program for adolescents on pain, quality of life, acceptance of pain, functional disability, catastrophism, anxiety-depression, emotional repercussions and acceptance of mindfulness

Paediatric chronic pain can lead to serious consequences in terms of daily functioning (school absenteeism and loss of social interactions) and global quality of life. Mindfulness-based interventions (MBI's) approaches which emphasize acceptance rather than control of pain have gained increasing attention in adults with chronic pain. The effectiveness of MBI's for chronic pain in paediatric population remains largely unknown. An MBI program for adolescent was conducted in Toronto's Hospital for Sick Children and happened to be feasible and well received for adolescents with chronic pain conditions. The aim of the present program is to study the feasibility in France of a mindfulness program dedicated for adolescents with chronic pain.

An eight-session, two hour Mindfulness Based Intervention dedicated to adolescents will be provided. The intervention will focus on skill building and will incorporate mindfulness meditation, exercises and activities specially adapted to teenagers with chronic pain. Topics will include mind body connection, the effect of stress on pain, living in the present moment, focused awareness, responding versus reacting to pain and/ or difficult situations, non judgement, gratitude, kindness and compassion towards self and others.

Eligibility Criteria:
Inclusion Criteria:

* Teenagers from 12 to 17 years of age followed at the Children's Hospital of Toulouse, as part of the Multidisciplinary Consultation of Pain
* including French.
* With the consent of the teenager and the parents
* Affiliated person or beneficiary of a social security scheme.

Exclusion Criteria:

* intellectual deficit not allowing to participate in a meditation program
* participating in research involving body therapies
Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke

The purpose of this study is to develop and assess the effectiveness of robot-assisted movement therapy in enhancing hand motor function in subjects with chronic hemiparetic stroke, and to identify predictors of treatment response.


Eligibility Criteria:
Inclusion Criteria:

1. At least 18 years old
2. Had stroke between 11-26 weeks ago
3. Have some weakness in one of your wrists or hands due to stroke
4. Did not have too much disability prior to stroke
5. Do not have major depression

Exclusion Criteria:

1. Non-English speaking
2. If you have trouble keeping good attention
3. Pregnant, advanced liver, kidney, heart, or lung disease
4. Terminal medical diagnosis or major neurological or psychiatric disease apart from stroke
5. Cannot undergo MRI scanning
6. Have history of brain surgery or seizures
Surgical Outcome and Differences on Histopathology in Patients With Alcoholic & Non Alcoholic Chronic Pancreatitis

Numerous treatment modalities have been proposed to treat pain in alcoholic and non-alcoholic chronic pancreatitis such as analgesic medication, inhibition of gastric acid production, enzyme substitution, somatostatin analogues, nerve blockade,reduction of oxidative stress and endoscopic pancreatic duct stenting, but none of these concepts have shown long lasting benefits as surgery in clinical studies.Comparison of surgical outcome in non-alcoholic chronic pancreatitis and alcoholic chronic pancreatitis has limited data and differences on the basis of outcome in between alcoholic and non-alcoholic chronic pancreatitis are not available in literature.

Although it is well known that pain is the main symptom of chronic pancreatitis, it has until now been assessed in very common and varying categories. Pain, however, is only one aspect of the large variety of sensitive facets of daily life. In addition to an improvement in pain symptoms and the preservation of pancreatic exocrine and endocrine function and other parameters, occupational rehabilitation of these mostly young patients and quality of life also should be considered in the evaluation of surgical outcome in alcoholic and non-alcoholic chronic pancreatitis.

In this prospective study, we intend to find out if there are any differences in the surgical outcome on the above mentioned parameters in alcoholic and non-alcoholic chronic pancreatitis.We also plan to see if there are differences in the histopathology in these two disease settings.


Eligibility Criteria:
Inclusion Criteria:

Diagnosis of chronic pancreatitis confirmed by at least 2 of the following:

1. Typical Chronic epigastric abdominal pain
2. Elevation of serum Amylase\>3 times upper limit normal or
3. Fecal elastase less than 200ug/g stool.
4. Confirmatory findings on cross-sectional imaging:

   1. Changes in size, shape and contour of pancreas
   2. Dilatation of main pancreatic duct
   3. Calcification
   4. Pseudocyst
   5. Pancreatic duct stricture
5. Patients who fulfill the criteria for surgical intervention

Exclusion Criteria:

* Not agreeing for surgical management
* On going acute pancreatitis
* Postop alcohol intake
* Pregnancy.
* Chronic pancreatitis with Malignancy
Oral Ketones and Exercise Among Patients With Long-chain Fatty Acid Oxidation Disorders

The purpose of the study is to determine if an oral ketone beverage is safe and well-tolerated during moderate intensity exercise in participants with long-chain fatty acid oxidation disorders and if it will raise blood ketones to levels similar to that reported among normal healthy subjects.

Purpose: Subjects with long-chain fatty acid oxidation disorders (LC-FAOD) do not make ketones during fasting or with exercise. Ketones are an important alternative energy substrate during moderate exercise, sparing the oxidation of glucose and providing a source of ATP to the central nervous system and exercising muscle. Fatty acid oxidation in the liver is required to make ketones. Subjects with a LC-FAOD cannot generate ketones because of their block in fatty acid oxidation during exercise. Providing ketones in an oral ketone beverage may increase blood ketones with exercise to levels normally observed in humans.

Aim: To determine the safety and tolerability of an oral ketone beverage during moderate intensity exercise among subjects with a LC-FAOD compared to an isocaloric maltodextrin beverage, and to determine blood ketone concentrations.

Hypothesis: Oral consumption of a ketone beverage before moderate intensity exercise will be safe and well-tolerated, and will raise blood ketones among subjects with a LC-FAOD to concentrations similar to that reported in the literature among normal healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* confirmed diagnosis of VLCAD, LCHAD/TFP or CPT2 deficiency
* speak English
* willing to complete 2 moderate intensity exercise treadmills

Exclusion Criteria:

* subjects actively participating in another research study that prohibits their participation
* pregnant females
* subjects with diabetes or taking medications to treat diabetes
Adolescent Vaccination in Pharmacies

The study aims to expand the evidence supporting pharmacy provision of adolescent vaccines, including human papillomavirus (HPV) vaccine. In the first part of the study, we will characterize parents' attitudes and support for pharmacy provision of adolescent vaccines in a national survey. In the second part of the study, we will provide HPV vaccines and other vaccines (Tdap, meningococcal, varicella, influenza) to 200 adolescents in a local community pharmacy in Chapel Hill, North Carolina. This portion of the study will identify the systems and workflow needed to provide vaccines effectively and safely, characterize parents' and their adolescents' attitudes toward receiving vaccine services in a pharmacy, and characterize pharmacists' attitudes toward providing adolescent vaccine services in a pharmacy.


Eligibility Criteria:
NATIONAL SURVEY (probability sample)

Inclusion Criteria:

* Being a member of the GfK Knowledge Panel
* Having a child age 11-18.

Exclusion Criteria:

● None

PHARMACY DEMONSTRATION PROJECT (convenience sample)

Inclusion Criteria:

* Having an adolescent child, ages 11-18 years old, who is healthy, and for whom HPV vaccine is indicated
* Child is with the parent

Exclusion Criteria:

● Being the parent of an adolescent who is immunocompromised, or has other chronic illness, has known anaphylactoid/hypersensitivity reactions to components of HPV vaccine used, or is pregnant or plan to be pregnant within a month of vaccination.
DPP-4 Inhibition and TZD for DM Prevention

To determine whether treatment with the diabetes medication, Januvia (sitagliptin), with or without another diabetes medicine, Actos (pioglitazone), will improve insulin secretion and insulin response individuals with Impaired Glucose Tolerance (IGT), a form of prediabetes.


Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance (IGT) by oral glucose tolerance test

Exclusion Criteria:

* History of diabetes mellitus
* History of congestive heart failure
* History of coronary artery disease or other macrovascular disease (stroke, peripheral vascular disease)
* History of liver disease (ALT or AST \>2.5 times the upper limit of normals)
* History of renal disease (serum creatinine \>1.5 mg/dl)
* History of severe osteoporosis (frequent fractures, failure on osteoporosis treatment)
* Current treatment with glucocorticoids
* History of immune disorder, including HIV
* Women of child-bearing age who are pregnant, desire to become pregnant, are breastfeeding, or who refuse to take the recommended birth control measures
Does Acoustic Stimulation During Sleep Boost Slow Wave Sleep and Memory Performance?

With aging the amount of slow wave sleep decreases drastically and this disruption is markedly exaggerated in older adults suffering from mild cognitive impairment and Alzheimer's disease. Critically, the disruption of slow wave sleep and cognitive decline seem bidirectionally linked forming a vicious cycle. In the long run, improving slow wave sleep might be a useful intervention tool to delay the onset of cognitive decline. The present study aims at improving slow wave sleep and memory functions through a closed-loop acoustic stimulation approach. A closed-loop algorithm is used that detects slow waves in the electroencephalogram and is programmed to present short tones (50 ms) in the rhythm of these waves. This procedure has shown to boost both slow wave sleep as well as memory performance, mainly in young adults and when applied for one night. Here, the investigators apply tones via multiple consecutive nights and assess memory performance during this 3-night intervention.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Fluent in German
* Normal or corrected to normal vision
* Unimpaired hearing
* For healthy group: Montreal Cognitive Assessment Score ≥ 26
* For MCI group: Montreal Cognitive Assessment Score \< 26
* For at risk group: smoker, high cholesterol, high blood pressure and high fasting plasma glucose OR smoker, high BMI, physically inactive, unhealthy dietary habits

Exclusion Criteria:

* Known sleep problems such as Insomnia, restless leg syndrome, apnea
* Irregular sleep pattern
* Symptoms of depression
* History of untreated severe neurological and psychiatric diseases
* Alcohol or substance abuse
* Use of medication acting on the central nervous system
Comparing the Effect of Spinal Bupivacaine Versus Spinal Prilocaine on Maternal Blood Pressure in Cesarean Section

one of the most common complications associated with spinal anesthesia is hypotension, which can have adverse effects on both the mother and the fetus. The present study compare prilocaine versus bupivacaine in spinal anesthesia on hypotension and there effect on maternal outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant \>36 weeks singleton baby
* American Society of Anesthesiologists (ASA) physical status 2
* Age : between 18 years old and 35 years old

Exclusion Criteria:

* Pregnant women with cardiac disease and history of psychiatric illness
* Pregnant women who received spinal anesthesia and converted to general anesthesia
* Women who have sensitivity to local anesthetics,
* Women who have Eclampsia, abruption placenta or placenta previa
* Women who have coagulopathy, thrombocytopenia with platelet count less than 80,000/cm3, myasthenia
Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

Premature infants stand a risk of danger to the layer of the eye that creates sight that, if untreated, can cause severe vision problems, leading to blindness in some cases. This research study will use ultrasound to examine the eye for retinal changes of prematurity.

Retinopathy of prematurity requires the early detection of retinopathy in neonates with a gestational age of \< 28 weeks and a birth weight \<1500 g. These evaluations require pupillary dilation, diagnostic expertise, consume much time and expense and are not without morbidity.

B-scan ultrasonography using a hand-held probe is part of the current ophthalmologist's armamentarium, providing a non-invasive view of the eye and avoiding the morbidity associated with mydriatic drops used for pupillary dilation.

We will use a simple water bath enclosure for a standard 20 MHz probe currently in general ophthalmic use to determine whether this simple technique might supplant indirect ophthalmoscopy as a screening technique. We will compare, using masked observers, the clinical findings of indirect ophthalmoscopy of neonatal infants with ultrasonic findings to determine if a correlation in the stages of retinopathy of prematurity (ROP) between the two techniques existed.

Eligibility Criteria:
Inclusion Criteria:

premature birth

Exclusion Criteria:

* none
Placebo Response of Different Types of Sham Acupuncture for Knee Osteoarthritis

This study aims to conduct a randomized controlled trial to investigate the difference in clinical efficacy and blinding effect between real acupuncture and various sham acupuncture techniques.

This study aimed to recruit 150 patients with knee osteoarthritis from the hospital outpatient department. Random coding was generated using a computer network-based random system, and the subjects will be divided into five groups: real acupuncture, non-acupuncture at real-acupoint, shallow acupuncture at real-acupoint, shallow acupuncture at non-meridian and non-acupoint, and waiting treatment group in a 1:1:1:1 ratio. Acupuncture sessions were conducted three times a week for two weeks. Patients in the waiting treatment group did not receive acupuncture therapy during the study period but received acupuncture treatment after the trial. Outcome measures included Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) score, Visual Analogue Pain (VAS) score, Massachusetts General Hospital Acupuncture Sensation Scale (MASS) needle sensation score, and blind evaluation scale. Data collection occurred at baseline, one week, and two weeks.

Eligibility Criteria:
Inclusion criteria:

* Clinical diagnosis of knee osteoarthritis.
* Age over 40 years old.

Exclusion criteria:

* Tuberculosis, tumors, rheumatism of the knee joint, and rheumatoid arthritis.
* Sprain or trauma in the lower limb.
* Mental disorders.
* Severe cardiovascular disease, liver or kidney impairment, immunodeficiency, diabetes mellitus, blood disorder or skin disease.
* Pregnancy or lactation.
* Use of physiotherapy for osteoarthritis knee pain in the past month; use of intra-articular injection of glucocorticoid or viscosupplementation in the past 6 months; received knee-replacement surgery; and positive floating patella test.
Liposomal Paclitaxel Combined Nedaplatin in Treatment of Advanced or Recurrent Esophageal Carcinoma

The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma

The purpose of this study is to evaluate the safety, tolerance and efficacy of Liposomal Paclitaxel With Nedaplatin as First-line in patients with Advanced or Recurrent Esophageal Carcinoma.Patients receive Liposomal Paclitaxel 175mg/m2 and Nedaplatin 80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.

Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

1. histological confirmed advanced metastatic or recurrent esophageal cancer
2. age between 18 and 80 years
3. ECOG performance status of 0 to 2
4. life expectancy ≥ 12 weeks
5. has evaluable disease by Response Evaluation Criteria in Solid Tumors (RECIST)
6. at least one prior chemotherapy regimen
7. adequate bone marrow function as defined by absolute neutrophil count more than or equal to 2000/mm3
8. platelet count more than or equal to 100,000/mm3 and hemoglobin more than or equal to 8 g/dL
9. adequate renal function defined by creatinine less than or equal to 1.25 × upper limit of normal(ULN) and creatinine clearance more than or equal to 60mL/min,
10. adequate liver function defined by bilirubin less than or equal to 1.0×ULN aspartate transferase(AST) and alanine transferase(ALT) less than or equal to 2.5 ×ULN.

Exclusion Criteria:

1. other primary malignancy
2. symptomatic central nervous system metastasis
3. pregnancy or lactation
4. cardiovascular events such as myocardial infarction in the previous 6 months or congestive heart failure
5. ongoing infection