cyrilzakka/clinical-trials huggingface dataset:
The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects

Calorie restriction extends life span and prevents aging-related diseases in several species. Odorants from live yeast restrain the beneficial effects of calorie restriction in Drosophila Melanogaster. The investigators hypothesize that visual and odorous food stimuli impact the neuroendocrine and metabolic response to starvation in healthy humans.

In this randomized cross-over intervention study 12 healthy, young men will fast twice for 60-hours in the presence or absence of food-related visual and odorous stimuli. At baseline and on the last morning of each intervention an oral glucose tolerance test (OGTT) will be performed. During the OGTT blood is sampled and hypothalamic neuronal activity is measured by functional MRI.


Eligibility Criteria:
Inclusion Criteria:

* Caucasian male volunteers
* Age \> 18 years and \< 70 years
* Body mass index (BMI) \> 20 kg/m2 and \< 25 kg/m2
* Fasting serum glucose (FSG) \< 6.1 mmol/L

Exclusion Criteria:

* Any significant chronic of hereditary disease (including renal, hepatic or endocrine disease)
* Any significant abnormal laboratory results found during the medical screening procedure
* Any use of medication (except for NSAID)
* Anosmia or any other (acquired) loss of olfaction (ea. rhinitis)
* Recent weight changes or attempts to loose weight (\> 3 kg weight gain or loss, within the last 3 months)
* Difficulties to insert an intravenous catheter
* Smoking
* MRI contraindications
* Recent blood donation (within the last 3 months)
* Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year
State-wide Health Approach to Increase Reach and Effectiveness: Study 3

The investigators have shown that adding an internet behavioral weight loss program to a statewide campaign improves weight loss outcomes. However, our follow-up data suggest that once the intervention is stopped, participants begin to experience weight regain. Thus, the purpose of this project is extend this line of work and pilot test health coaches and monetary incentives for weight loss maintenance. The investigators hypothesize that coaching and incentives will improve longer-term weight outcomes.


Eligibility Criteria:
Inclusion Criteria:

1. Body Mass Index \>=25kg/m2
2. English speaking

Exclusion Criteria:

1. Health problems that make weight loss or unsupervised exercise unsafe
2. Current pregnancy or plan to become pregnant in the next 12 months
3. Planned relocation
4. Previous participation in Shape Up Rhode Island research studies
Erector Spina Plan Block in Patients With Lumbar Disc Herniation

Erector Spina Plan Block (ESPB) is a technique used in surgical interventions, acute and chronic pain. The aim of this study was to investigate the effect of ESPB and core stabilization exercises on functionality in patients with Lumbal Disc Herniation. ESPB will be applied to the patients in the study group. Stabilization exercises will be applied together with ESPB treatment. Only stabilization exercises will be applied to the patients in the control group. Patients will be asked to complete a questionnaire inquiring sociodemographic data (age, height, weight, BMI, smoking and alcohol use), VAS and Modified Oswestry Questionnaire at initial presentation and after 8 weeks of exercise (8 weeks 3 days a week).

Low back pain is defined as pain in the lower back and/or legs that negatively affects comfort. Low back pain lasting less than 6 weeks is defined as acute, 6-12 weeks as subacute, and more than 12 weeks as chronic low back pain. The goals of the exercise program include reducing pain, strengthening weak muscles, stretching tense muscles, reducing mechanical stress on spinal structures, mobilizing hypomobile segments and stabilizing hypermobile segments. Erector Spina Plan Block (ESPB) is a technique used in surgical interventions, acute and chronic pain. The aim of this study was to investigate the effect of ESPB and core stabilization exercises on functionality in patients with Lumbal Disc Herniation. ESPB will be applied to the patients in the study group. Stabilization exercises will be applied together with ESPB treatment. The needle will be inserted between the erector spinae muscle and the transverse process structures.The local anesthetic will be monitored to spread along the erector spinae muscle. Only stabilization exercises will be applied to the patients in the control group. Patients will be asked to complete a questionnaire inquiring sociodemographic data (age, height, weight, BMI, smoking and alcohol use), VAS and Modified Oswestry Questionnaire at initial presentation and after 8 weeks of exercise (8 weeks 3 days a week).

Eligibility Criteria:
Inclusion Criteria:

* 18-50 years old
* Patients diagnosed with disc herniation by clinical, physical examination and MR imaging
* Low back pain for \>6 weeks

Exclusion Criteria:

* Severe spinal stenosis
* Diagnosis of pregnancy, infection or malignancy
* Presence of systemic inflammatory rheumatic disease
* Having neurological, orthopedic or congenital problems that prevent physical activity
* History of spinal surgery
Dissemination and Implementation of Stroke Prevention Looking at the Care Environment

The Dissemination and Implementation of Stroke Prevention Looking at the Care Environment (DISPLACE) study is a multi-center, national, National Heart, Lung and Blood Institute (NHLBI)-funded grant to look at the real-world implementation of stroke prevention guidelines (STOP Protocol) in which transcranial Doppler (TCD), a measure of cerebral blood vessel velocity, is used to screen for stroke risk in children ages 2-16 with sickle cell anemia (SCA). Part 3 of the DISPLACE study is an implementation clinical trial designed to test novel implementation strategies with the goal of improving adherence and implementation of stroke screening. 16 of the lowest scoring implementation rates from DISPLACE Part 1 will participate in DISPLACE Part 3. All original 28 sites from DISPLACE Parts 1 and 2 will receive a patient and provider educational intervention including a re-branding of the TCD as "Sickle Stroke Screen" with a new infographic and educational materials. The 16 sites with moving to Part 3 will be provided a Provider reminder strategy, which is a web based application designed to remind providers of when patients are due for their Sickle Stroke Screen. These 16 sites will be randomized and 8 will be given an additional Patient Communication Strategy. These sites will have a single designed coordinator with whom patients will communicate with about scheduling, rescheduling, and any other questions regarding their Sickle Stroke Screen. Upon completion, data will be analyzed to compare those who have had TCD screenings done appropriately and those who did not as well as the overall effect of the multi level interventions on the changes in TCD rates.


Eligibility Criteria:
Inclusion Criteria:

* Patients with sickle cell anemia (SCA) identified at each institution through International Classification of Diseases 9/10 (ICD-9/ICD-10) codes and local patient databases.
* Patients must have been seen by the designated institution (documented in medical record) a minimum of two times in the either inpatient or outpatient setting at the institution between the years of 01/01/2018-12/31/2019.
* Patients identified will include those currently aged 2-7. Thus children born from 2012 and onward.
* Patients already receiving primary or secondary stroke prevention therapy with CRCT will be included in registration in Web Data Coordination Unit (WEBDCU) but not included in PROVIDER MINDER as they do not require ongoing TCD/SICKLE STROKE SCREEN based on protocol.

Exclusion Criteria:

* Patients who do not have SCA
* Patients who were born before 2012 and therefore do not meet age criteria.
Benefits of Insulin Supplementation for Correction of Hyperglycemia in Patients With Type 2 Diabetes

The purpose of this study is to test whether using extra doses of aspart insulin to correct blood sugars before meals improves the care of patients with type 2 diabetes in the hospital who are already receiving the standard of care treatment with glargine and aspart insulin injections to control blood sugar levels. Studies done in the past indicate that blood sugar levels are controlled on the standard treatment of insulin and that most patients do not need the small extra dose of insulin at bedtime. The investigators want to test if there is any benefit to giving patients extra doses of insulin during the day to correct the high blood sugars.

The management of patients with Type 2 diabetes involves treatment with two different types of insulin injections to control blood sugar levels. The doses of the two types of insulins, glargine insulin and aspart insulin are adjusted daily through the hospital stay based on blood sugar levels. Many times, in addition to glargine and aspart insulin at meals, additional small doses of aspart insulin are given to correct high blood sugar levels. It has not been determined if using these extra doses of aspart insulin to correct blood sugars before meals improves care of the patients. Studies done in the past indicate that blood sugar levels are well controlled on the standard treatment of the two insulins and that most patients do not need the small extra dose of insulin at bedtime. This study will test if insulin supplementation improves glycemic control and prevents hypoglycemia in insulin treated patients with type 2 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects admitted to the hospital with acute or chronic medical illnesses or for elective and emergency surgical illness or trauma
2. Known history of Type 2 diabetes mellitus for \>3 months
3. Treated with either diet alone, any combination of oral antidiabetic agents, non-insulin injectables or insulin therapy
4. Blood glucose levels between \>140 mg and \<400 mg/dL without laboratory evidence of diabetic ketoacidosis

Exclusion Criteria:

1. Hyperglycemia without a history of diabetes
2. Subjects with acute critical illness admitted to the ICU or expected to require ICU admission
3. Subjects receiving continuous insulin infusion
4. Clinically relevant hepatic disease
5. Corticosteroid therapy
6. Serum creatinine ≥ 3.5 mg/dL and/or glomerular filtration rate (GFR) \<30
7. Subjects unable to sign consent
8. Pregnancy
Reduction of Secondhand Smoke Exposure in Healthy Infants

The purpose of this study is to assess the effects of a health center based counselling method for the prevention of infant exposure to secondhand smoke.

This study, a two group randomised controled trial, investigates whether an intervention for parents would persuade them to enforce smoking bans inside the home and in other locations. A total of 130 parents with children aged 12 months or younger will be recruited. Each group (n=65) will complete a baseline and follow up questionnaire. Urine samples from the infants will be collected to measure the amount of cotinine, a metabolite of nicotine. The parent-report and infant's urinary cotinine measures will be obtained at baseline and at a 3-month follow up. In the intervention group, parents will be given three counselling sessions. For mothers, one being face to face and two telephone counselling and for fathers we will conduct three telephone counselling. The control group receives no intervention. Both groups will also complete a Fagerstrom test for nicotine dependence.

Eligibility Criteria:
Inclusion Criteria:

* Families with healthy infants under 12 months of age
* The infant resides with at least one smoking parent
* Parents being able to speak Persian and having a telephone

Exclusion Criteria:

* Parent(s) reporting consumption of other addictive substances
* Parent(s) in smoking cessation treatment
Non-interventional Study Describing Epidemiology, Prognosis and Patient Healthcare Costs in France, 2010-2017

Interstitial lung diseases (ILDs) are a heterogeneous group of disorders, which encompass a wide range of conditions. In some patients with fibrosing ILDs, a progressive phenotype similar to that observed in idiopathic pulmonary fibrosis (IPF) may develop during the course of the disease (PF-ILD), including patients with systemic sclerosis (SSc)-related ILD.

The aim of the study is to estimate the incidence and prevalence and to describe the characteristics of patients diagnosed with non-IPF PF-ILD and SSc-ILD, to describe the natural course of disease, and to explore the correlation between mortality and Forced Vital Capacity (FVC) of the patients with non-IPF PF-ILD.

This study will be based on two data sources: the French national medico administrative database (SNDS) and the ILD cohort from the National French center for rare pulmonary diseases in Lyon, France.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized for PF-ILD and SSc-ILD in France between 01/01/2010 and 31/12/2017
* Men or women aged ≥ 18 years old at diagnosis

Exclusion Criteria:

* Patients treated by anti-fibrotic
* Patients diagnosed with IPF
One and Two-visit Root Canal Retreatment

A hundred previously root canal treated asymptomatic single-rooted teeth with periapical lesions were treated in single versus multiple visit root canal retreatment. Half of the teeth were randomly assigned to the one-visit (OV) group. The other teeth were treated in two visits (TV). All patients were recalled and investigated clinically and radiographically for 24 months.

The aim of the study was to evaluate the radiographic evidence of periapical healing in previously root canal treated teeth with apical periodontitis treated in a single visit and to compare the results with conventional two-visit root canal treatment .100 asymptomatic single rooted teeth with periapical lesions were included. The root canal filling material was removed and reinstrumentation was performed using hand files with 2.5% sodium hypochlorite (NaOCl) and 5% ethylenediaminetetraacetic acid (EDTA) as irrigants. Half of the teeth were randomly assigned to the one-visit (OV) group. The other teeth were treated in two visits (TV), after completion of root canal instrumentation calcium hydroxide paste was placed into the root canal and root canal obturation was performed in second visit. All patients were recalled and investigated clinically and radiographically for 24 months. Changes in apical bone density indicating radiographic healing were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* with a non-contributory medical history,
* single-rooted teeth with periapical lesions,
* previously root canal treated but no reduction in the lesion after the treatment
* diagnosed as asymptomatic apical periodontitis

Exclusion Criteria:

* clinical symptoms, drainage,
* more than 5 mm loss of periodontal attachment,
* non-restorable tooth
Non-invasive Measurement of Gastric Motility

Clinical evaluation to compare performance of the physiological recordings from the Gastric Alimetry System vs a predicate reference device (Medtronic Polygram NET / Polygraf ID EGG System

A prospective, non-randomised, single centre investigation on patients with suspected motility disorders comprising a simultaneous head-to-head comparison of device performance between the Gastric Alimetry System and the Medtronic Polygram NET / Polygraf ID EGG System.

Eligibility Criteria:
Inclusion Criteria:

* Age 22 years old or older
* Able to provide written informed consent
* Patients with a suspected motility disorder, meetingRome IVCriteria for functional dyspepsia or chronic nausea and vomiting syndromes or having a diagnosis of gastroparesis as confirmed by a standardized gastric scintigraphy study, including having \>10% gastric meal retention at 4-hours.

Exclusion Criteria:

* BMI \>35 kg m(2)
* Known metabolic, neurogenic or endocrine disorders known to cause gastrointestinal dysmotility e.g. multiple sclerosis, Parkinson's disease, hypothyroidism
* Known current gastrointestinal infection (includes H.pylori when being actively treated)
* Known current inflammatory bowel disease
* Known current gastrointestinal malignancy
* Previous gastroduodenal surgery
* Open abdominal wounds or abdominal skin not intact (e.g.rash, abrasions, weeping tissues)
* Fragile skin evidenced by high susceptibility to skin tears or skin that bruises easily
* Regular cannabis use
* Allergy to adhesives
* Pregnancy
Study to Investigate the Seropersistence of TBE Virus Antibodies Approx. 3 Years After a Booster Vaccination With FSME-IMMUN 0.25 mL JUNIOR in Children

The objective of this study is to assess the TBE antibody persistence approximately three years after administration of a TBE booster vaccination with FSME-IMMUN 0.25 ml Junior in children who received either 0.25 mL or 0.5 mL TicoVac for their primary vaccination series in Study 146A.


Eligibility Criteria:
Inclusion Criteria:

* Male and female children who participated in Study 146A if:
* they and/or their parents/legal guardians understand the nature of the study and agree to its provisions
* written informed consent is available from the child (according to age and capacity of understanding) and the parents/legal guardians
* they received the complete 3-immunization primary vaccination series with either 0.5 ml or 0.25 ml TicoVac in Study 146A
* they received FSME-IMMUN 0.25 ml Junior for their first booster vaccination approximately 3 to 4 years after their third vaccination in Study IMAG-146A

Exclusion Criteria:

* Subjects who received any further TBE vaccination since their first TBE booster vaccination
* Subjects with a history of infection with, or vaccination against, other flaviviruses (e.g. dengue fever, yellow fever and/or japanese B encephalitis virus) since their third vaccination in Study 146A
* Subjects who have suffered from a disease (e.g. autoimmune disease) or have undergone a form of treatment (e.g. systemic corticosteroids) that can be expected to influence immunological functions within 30 days before and after their first TBE booster vaccination
* Subjects who have been known to be HIV positive (a special HIV test is not required for the purpose of the study) since their third vaccination in Study 146A
* Subjects who have received a blood transfusion or immunoglobulins within 30 days of study entry
Effect of Short Peripheral Electrical Stimulation (PES) on Blood Glucose

The epidemic nature of type 2 diabetes mellitus, along with the downsides of current treatments, has raised the need for therapeutic alternatives. The aim of this study is to evaluate safety, tolerability, and the glucose-lowering effect of noninvasive peripheral electrical stimulation (PES) as an alternative treatment for diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with type II diabetes, for at least one year prior to randomization
* Body mass index BMI \< 35 Kg/m2
* Stable glucose lowering drugs regimen for at least one month prior to randomization
* Capable of giving informed consent

Exclusion Criteria:

* Pregnancy, or nursing
* 10\< HbA1c \< 6
* Permanent pacemakers
* Metal prosthesis
* Resting blood pressure \> 160/ 100 mmHg
* Skin disease
* Treatment with steroids or beta-blockers treatment with psychiatric medications
Investigating Hope and Expectations in Open-Label Placebos

Research has shown that placebo effects contribute substantially to clinical outcomes. Recent evidence suggests that placebos remain effective even if they are openly described as placebos (so-called Open-Label Placebos). In this study, the investigators examine hope and expectations as components of open-label placebos in an experimental study investigating pain..

A growing body of research has indicated that placebos contribute substantially to clinical outcomes. Yet, the implementation of deceptive placebos in clinical practice is incompatible with key principles of openness and patient autonomy. However, recent research suggests that placebos remain effective even if they openly described as placebos (so-called Open-Label Placebos (OLP)), hence questioning the necessity of deception in clinical trials. However, research identifying the specific mechanisms underlying OLP is lacking. Therefore, the current study aims to examine hope and expectations as components of OLP in pain.

For this purpose, experimentally induced heat pain is examined. First, all participants receive heat pain stimuli and evaluate them. Next, participants are randomly assigned to one of four groups: (1) a traditional deceptive placebo (DP) group, which is told that they receive an effective analgesic cream, (2) an OLP group inducing hope among the participants that the placebo cream could help them tolerating painful stimuli (OLP hope), (3) and OLP group raising the expectation that the placebo cream will help participants tolerating heat pain (OLP expectation), (4) a control group receiving no cream. Finally, participants receive and evaluate heat pain again.

Eligibility Criteria:
Inclusion Criteria:

* sufficient German language knowledge
* at least 18 years old

Exclusion Criteria:

* current mental disorder
* current medical disease
* studying psychology or medicine
* pregnancy or breastfeeding period
* intake of drugs
* severely visually impaired
Safety and Tolerability of Lactoferrin/FOS in Very Low Birth Weight Infants

This study will examine the safety and tolerability of supplementation with bovine lactoferrin with fructo-oligosaccharide a simple sugar in very low birth weight infants. Lactoferrin is a major whey protein in mother's milk and plays a role in promoting a mature and healthy gut. It also has antimicrobial and immunomodulation activities.

Aim 1: To evaluate the safety and tolerability of three different lactoferrin/FOS doses in preterm infants

1. Lactoferrin/FOS related adverse events and serious adverse events
2. Time reaching full feeds while receiving lactoferrin/FOS (120 ml/kg/day)
3. Episodes of not receiving enteral feedings for \> 24 hours once feeding is initiated

Aim 2: To evaluate lactoferrin/FOS absorption and excretion

1. Examine lactoferrin/FOS levels in saliva, urine, plasma, and stool
2. Examine lactoferrin levels in materal and human donor milk

Aim 3: To evaluate the effect of lactoferrin/FOS on the intestinal microbiome structure

Eligibility Criteria:
Inclusion Criteria:

* \< 15 days of age and receiving enteral feedings
* \< 1500 grams birth weight
* \< 37 weeks gestation

Exclusion Criteria:

* Congenital bowel obstruction (esophageal, duodenal, small bowel or anal atresias, Hirschsprung disease, malrotation)
* Known necrotizing enterocolitis or bowel perforation
A Shared Decision-making Training for Inpatients With Schizophrenia

"Shared decision-making" is being promoted as a promising approach for engaging patients with schizophrenia in medical decisions and improving satisfaction and adherence.

To implement shared decision-making, both physicians and patients should commit to it and engage in a mutual decision process. Most research, however, has addressed interventions that either focus on the doctors' side (e.g. "communication skills") or on informing patients about treatment options (e.g. "decision aids"). These approaches have been shown to be feasible in clinical practice but had no strong effects on treatment patterns or adherence, possibly because they were insufficient to motivate and enable patients to engage actively in decision-making. Moreover, these interventions still rely on the doctor's willingness to share decisions, which has been shown to vary considerably.

To overcome these limitations and since many patients do not feel competent to participate in decision-making we developed an intervention that focuses on patients' communicative competencies. this intervention, a five session group-training, will be implemented for inpatients suffering from schizophrenia.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* icd diagnosis F2
* sufficient German language skills

Exclusion Criteria:

* debility