cyrilzakka/clinical-trials huggingface dataset:
Health Effects of Coffee Consumption

Epidemiological studies have indicated a positive health impact of coffee. Nevertheless, intervention studies testing the effect of daily coffee consumption over a longer period are lacking so far. Moreover, there is a lack of knowledge about the properties of different coffees and their influence on weight development. Therefore, we tested the effect of two coffees differing in their alkyl pyridine content over a period of 3 months on weight development.

Participants were randomly associated to two groups, a test coffee group and a control coffee group. After coffee abstinence of 1 months, participants in both groups got a coffee machine and coffee pads for three months. Clinical data have been assessed before and after coffee abstinence and after 3 months of coffee consumption.

Eligibility Criteria:
Inclusion Criteria:

* age 18-69 years
* BMI ≥27 kg/m2
* coffee consumption of ≥3 cups per day

Exclusion Criteria:

* new diagnosed type 2 diabetes during the last 6 months
* severe diseases with hospital stay during the last 3 months
* change of body weight of more than 2 kg per week during the last 4 weeks
* smoking cessation during the last 3 months or planned during the study
* acute infects
* chronical diseases with except of type 2 diabetes mellitus
* regular pharmacological therapy with except of oral antidiabetic medication or contraception
* lack of contraception in women
* breastfeeding
* physical activity of more than 1 hour per day
The Effect of Patellar Eversion on Functional Outcomes in Primary Total Knee Arthroplasty

Short and long term outcomes of total knee arthroplasty patients surgically exposed with patellar eversion are compared to those patients exposed by laterally retracting the patella. It was hypothesized that there would be no difference.

Background:

Patellar mobilization during total knee arthroplasty (TKA) has been debated, with some proponents of minimally invasive TKA suggesting that laterally retracting, rather than everting the patella may be beneficial. It was our hypothesis that by using randomized, prospective, blinded study methods, there would be no significant difference in clinical outcome measures based solely on eversion of the patella during total knee arthroplasty.

Methods:

After an a priori power analysis was done, 120 primary total knee replacements indicated for degenerative joint disease were included in the study and randomized to one of two patella exposure techniques: lateral retraction or eversion. Collaborating investigators and patients were blinded to randomization.

Eligibility Criteria:
Inclusion Criteria:

* Patients eligible for study participation included all comers for primary total knee arthroplasty indicated for degenerative joint disease. All operations were performed by three well-established arthroplasty-fellowship-trained orthopaedic surgeons using surgical techniques based on that of a senior surgeon. All implanted devices were cruciate-substituting tricompartmental total knee replacements placed through a medial parapatellar approach. All patients were anaesthetized with spinal anesthesia, received a peri-operative cocktail injection, and had tourniquet times between 0 and 120 minutes. Multi-modal post-operative pain management and accelerated physical therapy were performed as previously described.

Exclusion Criteria:

* Patients were excluded from the study if on the operative side they had undergone prior total knee replacement, prior knee arthrotomy, prior osteotomy at or about the knee, or had preoperative angular deformity greater than 20 degrees.
A Comparison of Advanced Imaging Techniques in Aortic Stenosis

In patients with aortic stenosis the valve through which blood is pumped out of the main heart chamber is narrowed. This results in heart muscle working harder to open the valve so blood can circulate around the body. The muscle adapts to the increased pressure load to maintain efficiency. This can cause long-term muscle damage. To predict when this deterioration will require a valve replacement is difficult and untimely operation exposes patients to unnecessary risk.

We aim to compare all validated techniques looking at different aspects of heart muscle strain in these patients. These will be a blood sample measuring a specific hormone (BNP) and enzyme (Troponin), a nuclear scan to assess nerve activation, an MRI identifying scarring and an exercise echocardiogram that measures heart muscle response and pressure changes across the valve. Tests will be performed at recruitment and either after one year or after valve replacement, which ever comes first.

In comparing these different imaging techniques we aim to identify patients who will benefit from an early operation, those whose muscle is likely to recover back to normal and which patients it is safe to wait longer for the surgery, avoiding unnecessary risk.

The results of the study will benefit patients as it will help doctors more accurately assess the timing of valve surgery and improve their prediction of long term heart muscle recovery. It may also increase convenience in clinical management by reducing unnecessary tests and hospital trips. This would translate into cost savings for the NHS.


Eligibility Criteria:
Inclusion Criteria:

(Group A)

* Asymptomatic patients with moderate to severe Aortic Stenosis
* Ejection fraction greater than 50%
* Not yet being considered for valve surgery

(Group B)

* Severe Aortic Stenosis (as per ESC guidelines)
* Listed for immediate aortic valve replacement

Exclusion Criteria: (Group A and B)

* Inability to provide informed consent
* Concurrent primary valve lesions greater than mild (as defined by ESC criteria)
* Previous myocardial infarction (regional wall motion abnormality on resting echo)
* Cardiomyopathy
* Congenital heart disease
* Previous cardiac surgery
* Renal failure (CKD stage 3, eGFR \>30ml/min/1.73m2)
* Pregnancy, risk of pregnancy, breast feeding
Treatment of Complications to Diabetic Autonomic Neuropathy With Vagus Nerve Stimulation

The purpose of the DAN-VNS study is to investigate the effects of non-invasive vagal nerve stimulation on gastrointestinal symptoms such as nausea, vomiting, bloating, and diarrhea in people with diabetes.

The study is a randomized, double-blinded, sham-controlled, parallel group clinical trial, which will include participants with diabetes and gastrointestinal (GI) problems. These problems may be manifestations of diabetic autonomic neuropathy.

Participants are randomised to received either active non-invasive transcutaneous vagal nerve stimulation (tVNS) or inactive sham stimulation. The study period is divided in two phases. The first phase investigates the effects of short-term, high-intensity tVNS treatment on GI symptoms. The second phase investigates the effects of long-term, middle-intensity tVNS treatment. The primary outcome of both phases is subjective patient evaluation of GI symptoms by the use of validated questionnaires.

A third phase, conducted only on participants, who proved to be responsive to tVNS treatment, will investigate the acute endocrine and metabolic response to short-term tVNS in a randomised cross-over design.

Lastly, healthy volunteers will be included in a cross-sectional, descriptive study in order to provide a comparable baseline dataset.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Verified diagnosis of diabetes for a minimum of 1 year and with stable medication
* CAN-score ≥ 1 (measured by the Vagus device (Medicus Engineering, Aarhus, Denmark) OR COMPASS-31 score of ≥ 16 OR electrochemical resistance \<50µS (hands) and \<70µS (feet) assessed with the SUDOSCAN device
* Weighted composite score of Gastroparesis Cardinal Symptom Index (GCSI) and Gastrointestinal Symptom Rating Scale (GSRS) ≥ 2.3
* Ability to read and understand Danish
* Personally signed and dated informed consent documents
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures

Exclusion Criteria:

* Significant GI diseases not related to diabetes
* Significant cardiovascular diseases
* GI surgery within 3 months prior to study inclusion
* Swallowing disorders
* Blood pressure \< 100/60 or \> 160/105
* Clinically significant bradycardia or tachycardia
* Implanted portable electro-mechanical medical devices including pacemaker, defibrillator, cochlear implant, and infusion pump
* Previous surgery of the vagus nerve
* Active laser treatment for proliferative retinopathy
* Contraindications for MRI
* Any clinical abnormalities, that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results
* Pregnancy or intention to become pregnant or father a child during the course of the study
* Participation in other clinical trials less than three months prior to inclusion, unless such a participation is judged to have no influence on the recordings
Talking Card for Asthma

The research goal is to explore the use and effects of a custom-recordable audio discharge instruction card (Talking Card) in the pediatric health care setting. This study will address a primary, experimental research question: can pediatric asthma control be improved through the distribution of a custom-recorded audio asthma instruction card to parents at the health provider's office? Secondary, descriptive objectives will be to evaluate feasibility of Talking Card delivery and to collect and summarize parental reactions to the design and use of the audio discharge instruction card.

The specific aims of this study are:

1. To compare the change in mean Childhood Asthma Control Test (C-ACT) scores for children aged 4 through 11 years with uncontrolled asthma receiving a custom-recorded asthma instruction card to the change in mean C-ACT scores for those receiving usual care.
2. To measure the use and impressions of a custom-recordable audio asthma discharge instruction card among primary caregivers of children with uncontrolled asthma through quantitative and qualitative survey questions.

The investigators hypothesize that:

1) Asthma control in children 4 through 11 years of age with uncontrolled asthma, as measured by the C-ACT, will improve to a greater extent among those receiving a custom-recordable audio discharge instruction card than among those receiving usual care.


Eligibility Criteria:
Inclusion Criteria:

* Child age 4 through 11 years old
* English-speaking primary caregiver
* Enrollment in Medicaid insurance company within 12 months of study recruitment (original Kansas City site criterion, removed on revision)
* Diagnosis of asthma (ICD-9 code 493.0) within 12 months of study recruitment
* Visit to study site clinic for asthma within 12 months of study recruitment

Exclusion Criteria:

* History of premature birth less than 33 weeks gestation or requirement of a significant level of respiratory care including mechanical ventilation as a neonate
* Any major chronic illness including but not limited to non-skin cancer, cystic fibrosis, bronchiectasis, sickle cell anemia, endocrine disease, congenital heart disease, congestive heart failure, stroke, severe hypertension, insulin-dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, significant neuro-developmental delay or behavioral disorders (excluding mild attention deficit hyperactivity disorder), or other conditions that would interfere with participation in the study
* Visit to any primary care provider giving asthma action plan advice during the previous month
* Anticipated departure from study area before study period ends (3-month follow-up)
Traumatic Brain Injury Feasibility Study (EPIC-011)

The purpose of this research study is to evaluate whether data made by the ClearView System can be used to detect whether someone has a traumatic brain injury and how severe the injury is.

Traumatic brain injury (TBI) is a significant cause of death and disability in the U.S. The severity of a TBI may range from "mild" (i.e. a brief change in mental status or consciousness) to "severe" (i.e. an extended period of unconsciousness or memory loss after the injury). However, most TBI's that occur each year are mild and are commonly called concussions. Unfortunately, TBI terminology does not adequately describe the injury or impairment, its treatment, or the resulting outcomes. Due to the complexity of the human brain, each person's physiology can result in different patterns of impairment and secondary conditions, requiring different treatment or rehabilitation. The intent of EPIC ClearView™ TBI Feasibility (EPIC-011) is to collect data to further develop the ClearView™ Response Scale to measure electrophysiology associated with TBI

Eligibility Criteria:
Inclusion Criteria:

Suspected TBI population:

1. Acute head trauma within 24-72 hours of presentation
2. 18-65 age inclusive
3. GCS of 3-15 on initial evaluation in ED

Control population:

1. 18-65 age inclusive
2. GCS score of 15

Exclusion Criteria:

1. Current neurological disease
2. Current severe psychological disorder
3. History of substance or alcohol abuse
4. Under drug or alcohol influence, if so, must wait at least 24 hrs. prior to consent
5. Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)
6. Current treatment to the head/brain (radiation, whole brain therapy, gamma knife)
7. Head injury in the last two years
8. Unwilling to sign informed consent
9. Pregnant or potentially pregnant
10. Pacemaker, automatic implanted cardiac defibrillator or other implanted electrical device
11. Connected to an electronic device that cannot be removed
12. Missing all or part of fingers or cuts/burns on pads of fingers
13. Long fingernails and unwilling to cut them and keep them cut for the duration of the study
14. Hand tremors or involuntary oscillations ("shaking") of the hands that prevents clear imaging

Additional exclusion criteria for control population:

Previous head trauma
Effect of Trunk Stabilizing Exercises on Patients With Median Sternotomy After Heart Valve Surgery

PURPOSE:

The aim of this study is to investigate the effect of trunk stabilizing exercises on sternal instability in patients with median sternotomy after heart valve surgery

Valvular heart disease constitutes a growing healthcare problem with a general prevalence of 2%-5% and a prevalence of 13% after the age of 75 years. Heart valve surgery can be a lifesaving procedure for patients with severe symptomatic heart valve disease. Nevertheless, following the surgery, up to 27% of patients may require readmission within 30 days after discharge. Following heart valve surgery, some patients report anxiety and worries related to readmission and reoperations, postoperative complications, and deconditioning which may prevent or delay return to work and limit activities of daily living Trunk stabilizing exercises train and activate the abdominal and anterior thoracic cage muscles to assist in stabilizing the bisected sternum, thereby decreasing the undue motion in both sagittal and transverse planes during trunk movement. Patients' complaints of pain and discomfort associated with sternal instability post-cardiac surgery may be managed by diminishing the degree of this undue motion between the edges of the divided sternum, and thus provides a conservative treatment for sternal instability forty female patients will be divided into two groups. group A received trunk stabilizing exercise and group B will receive routine cardiac rehabilitation; three times/week for four weeks. the outcome variables were sternal instability and sternal separation and measured before and after completion of treatment

Eligibility Criteria:
Inclusion Criteria:

1. age between 40 and 50 years, female gender
2. hemodynamic stability
3. BMI from 25 to 29.9 kg/m2
4. they will have acute sternal instability.

Exclusion Criteria:

1. previous thoracic surgery
2. elective and urgent coronary artery bypass surgery
3. respiratory insufficiency after surgery manifesting hypoxemia with partial pressure of oxygen in arterial blood \<60 mmHg
4. renal insufficiency with serum creatinine ≥1.8 mg/dl after surgery
5. low cardiac output syndrome with ST segment elevation in multiple electrocardiogram leads, cardiac arrhythmias, or hypotension, according to the American College of Cardiology Foundation and American Heart Association
6. other medical conditions such as diabetes, uncontrolled hypertension and obesity
7. Past medical history that include conditions that may have influenced the provision of physiotherapy interventions such as (severe asthma, chronic airflow limitation, bronchiectasis, ankylosing spondylitis or lumbar disc prolapse
A Pharmacokinetic and Pharmacodynamic Study of Omecamtiv Mecarbil in Healthy Volunteers

This study will assess the safety, tolerability, and pharmacodynamics of omecamtiv mecarbil infusion in healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is male
2. Subject is aged between 18 and 50 years inclusive.
3. Subject has given signed informed consent.
4. Subject's Body Mass Index (BMI) is between 18 and 30 kg/m2 inclusive.
5. Subject weighs less than 100 kg.
6. Subject is considered to be in good health in the opinion of the investigator, as determined by:

   1. A pre-study physical examination with no clinically significant abnormalities.
   2. Vital signs within normal ranges (supine after 3 minutes rest - heart rate: 40 to 80 bpm; systolic BP: 100 to 140 mmHg; diastolic BP: 50-90 mmHg; respiration rate: 8 to 18 breaths per minute; oxygen saturation: 96-100%)
   3. An ECG with no clinically significant abnormalities.
7. Subject's pre-study clinical laboratory findings are within normal range or if outside of the normal range not deemed clinically significant in the opinion of the investigator.
8. Cardiac troponin I is less than the upper limit of the laboratory reference range.
9. A screening echocardiogram demonstrates normal cardiac function, an ejection fraction of between 40% and 70% with no significant valvular regurgitation (grade 1) and/or stenosis and images are deemed to be of good quality by the sonographer.

Exclusion Criteria:

1. Subject has had a clinically significant illness in the four weeks before screening.
2. Use of prescribed mediations in the 3 weeks prior to dosing or over-the-counter preparations (including vitamin supplements and herbal remedies) for 7 days prior to dosing, except paracetamol which will be allowed up to 48 hours prior to dosing.
3. Subject has a significant history of drug/solvent abuse or a positive drugs of abuse test at screening.
4. Subject with a history of alcohol abuse or currently drinks in excess of 28 units per week.
5. Subject smokes more than 5 cigarettes (or equivalent) per day.
6. Subject is not willing to refrain from caffeine/xanthine containing products from 48 hours prior to the screening medical and admission on Day -1 until the post study medical.
7. Subject is in the opinion of the investigator not suitable to participate in the study.
8. Subject who has participated in any clinical study with an investigational drug/device within three months prior to the first day of dosing.
9. Subject who has a positive result of HIV screen, Hepatitis B screen or Hepatitis C screen.
10. Subject has had a serious adverse reaction or significant hypersensitivity to any drug.
11. Subject has donated 500 ml or more of blood within the month prior to screening.
12. Subject has a history of cardiovascular disease or family history of premature cardiovascular disease or death.
Dexamethasone as an Immediate Intervention

To determine if a single dose of dexamethasone (5 mg) administered in the first 12 hours following a potentially traumatic event alters a) cortisol and FKBP5 RNA the next day in the periphery measured in saliva; b) FKBP5 methylation by 1 month; c) executive functioning and emotion regulation functioning; d) psychophysiological (heart rate, respiration, skin conductance) in response cued reminders of the trauma; e) enhances the likelihood of remission of PTSD symptom severity.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18-70 years
* Evidence of acute Post Traumatic Event (PTE) exposure defined by Diagnostic and Statistical Manual criterion 'A'
* Evidence of a significant stress response defined by DSM V PTSD criterion 'B' and meeting at least criteria for 'partial PTSD' or a minimum of 3 of 4 DSM V PTSD symptom criterion
* Score of 60 or higher on the Subjective Units of Distress Scale (SUDS)
* Living in New York tri-state area
* Fluency in English, Spanish

Exclusion Criteria:

* Admission to an intensive care unit or other overnight admission
* In the Emergency Department for more than 6 hours
* Evidence of ongoing traumatic exposure (e.g. domestic violence)
* Evidence of psychotic symptoms
* Evidence of homicidality/suicidality
* Adults with an open head injury, a positive CT scan, loss of consciousness \>30 seconds or survivors in a coma
* Adults in police custody or Department of Correction (DOC) patients
* Inability to understand the study's procedures, risks, or side effects, or otherwise unable to give informed consent.
* Females who are nursing or pregnant (as confirmed by a positive urine pregnancy test).
* Permanent cardiac pacer implant.
* . Self-reported medical conditions that may be affected by DEX including asthma, epilepsy,diabetes, liver disease, kidney disease, thyroid disorder, muscle disorder, history of malaria,tuberculosis, osteoporosis, glaucoma or cataracts.
* Self-reported adverse reactions to steroids
Kidney Stone Risk Factors in Patients Infected With HIV

The purpose of this study is to define the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.

This study aims at defining the cause of renal stones and the risk pattern for recurrence of renal stones episodes (any kind of stones) in HIV1 patients.

Primary Objective :

* Finding the cause of renal stone in HIV patients defined as stone composition if stone is available or more probable pathophysiological mechanism
* Risk profile for stone recurrences estimated on risk indices in HIV1 patients

Secondary Objective(s)

* Identify prevalence of recurrences and describe co-morbidities associated with stone disease
* Describe urological management for renal stones in HIV patients
* Describe the causes of drug induced renal stones

Eligibility Criteria:
Inclusion Criteria:

* Adult male or female HIV1 infected patients willing to participate in the study
* Having experienced a renal stone episode within the past six months or living with a renal stone
* Able to understand the protocol
* Giving oral consent

Exclusion Criteria:

* CT scan impossible
* Follow up impossible over 1 year