cyrilzakka/clinical-trials huggingface dataset:
Genetic Determinants of Cardiovascular Response to Coffee Drinking

Cardiovascular and neuropsychologic effects of coffee are still debated. The precise mechanism underlying the actions of caffeine on the cardiovascular and neuropsychologic systems is incompletely understood and a considerable variability in the response to coffee drinking was observed, in part ascribable to a genetic trait.

The aim of the study is to evaluate acute cardiovascular and neuropsychologic effects of coffee and explore whether such effects are influenced by the genetic asset of caffeine metabolism (by a polymorphisms of cytochrome P450 1A2), adenosine metabolism (by polymorphisms of adenosine receptor and adenosine monophosphate deaminase) or catecholamine receptors (by polymorphisms of adrenergic receptors).

Coffee is among the most widely consumed beverages worldwide. Despite the relationship between coffee consumption and the incidence of cardiovascular disease has been studied extensively, the effects of this drink on the cardiovascular apparatus and its role as a risk factor for coronary heart disease are still debated. Moreover, the effect of coffee on attention, sleep changes, anxiety and panic disorders was studied but a great variability was observed.

Many of the known or suspected cardiovascular and neuropsychologic effects of coffee have been attributed to caffeine. The main mechanism of action of caffeine is to antagonize adenosine receptors; a secondary effect is the inhibition of phosphodiesterases, with the subsequent accumulation of cyclic adenosine monophosphate and a intensification of the effects of catecholamines.

It is also well known that there is a considerable variability in the cardiovascular and neuropsychologic response to coffee drinking, explaining the inconsistency between different effects observed in the various studies. This variability may have a genetic basis.

The aim of the study is to evaluate acute cardiovascular and neuropsychologic effects of coffee and explore whether such effects are influenced by the genetic asset of caffeine metabolism (by a polymorphisms of cytochrome P450 1A2), adenosine metabolism (by polymorphisms of adenosine receptor and adenosine monophosphate deaminase) or catecholamine receptors (by polymorphisms of adrenergic receptors).

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 40 years
* Males (to avoid variation due to female hormonal cycle)
* No known active ongoing disease (apparent good health)
* Non-smokers (to avoid contributory effects of nicotine or other tobacco alkaloids to caffeine effects or tolerance)
* Average coffee intake (not less than one cup/day and not greater than three cups/day)

Exclusion Criteria:

* Treatment with any drug with known activity on the adrenergic system
* Hypertension
* Therapy with sympathomimetic drugs, theophylline, alpha- or beta-blockers, any antihypertensive therapy
* Body mass index (BMI) \> 30 kg/m2 (obesity)
* BMI \< 18.5 kg/m2
Safety and Efficacy of Low Intensity Shockwave Therapy in Treating Diabetic Foot Ulcers

Low intensity shockwaves for treating diabetic foot ulcers (DFUs) have been in evaluation for the past 5 years. Many researchers showed the effectiveness of Low intensity shockwaves of in accelerating the healing rate of non-ischemic chronic DFUs. Wang et al. showed, the use of Low intensity shockwaves on DFUs, significantly improved topical blood flow perfusion rate, increased cell proliferation and cell activity and decreased cell apoptosis.

The present study deals with the effect of low intensity shockwaves on DFUs. Shockwave treatment will be done together with the standard conventional treatment for DFUs, compared to a control group who will receive the same conventional standard of care.


Eligibility Criteria:
* Inclusion Criteria:

  1. Chronic non-healing diabetic foot ulcers for more than 2 months.
  2. Age 18-80 years
  3. Ankle Brachial Index (ABI) ≥0.6
  4. Diabetic Foot Ulcer with the long diameter of ≤7cm and a short diameter of ≥1cm
  5. The target ulcer is up to Wagner's grade 3
  6. Albumin level ≥25g/L
  7. Hemoglobin level ≥90g/L
  8. Estimated Glomerular Filtration Rate (eGFR) ≥30ml/min/1.73m2
  9. The patient agrees to comply with study protocol requirements, including the shockwave procedure, self-care of the ulcer (dressings, orthotics etc.) and all follow-up visit requirements
* Exclusion Criteria:

  1. Pregnancy or lactation
  2. ABI \<0.6
  3. The long diameter of the target ulcer is \>7cm and the short diameter is \<1cm
  4. The target ulcer is of Wagner's grade 4 or above
  5. Severe Hypoalbuminemia \<25g/L
  6. Severe anemia, Hemoglobin level \<90g/L
  7. eGFR \<30ml/min/1.73m2
  8. Patients suffering from acute Charcot foot
  9. Severe edema of the treated limb
  10. Patient with present malignancy or past malignancy in the treated area
  11. Systemic chemotherapy/ radiation treatment within the last 6 months
  12. Deep vein thrombosis within the last 6 months
  13. Any other experimental treatment or participation in other studies

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Physical Health of Residents in Psychiatric Institutions

Aim of the study: To investigate if the intervention described in this protocol has an effect on patients' and staff's physical health.

Null hypothesis: There is no difference in waist circumference, body weight, quality of life and the rate of polypharmacy between the intervention and control groups after six months.

Background:

The prevalence of physical health problems among patients suffering from psychiatric illnesses is above that seen in the average population (1). Cardiovascular diseases (2) and metabolic disorders (3;4) are common in persons diagnosed with schizophrenia (5;6). A fact that has been known for many years (7), and there has been no decrease in the prevalence of physical illness in connection with the decentralization of the psychiatric treatment which has taken place in the Western world during the last 30-40 years (8).

Meta-analyses describe increased physical morbidity among patients with psychiatric diseases and increased mortality on account of somatic diseases (7). One of the reasons for the increased mortality could be the use of second generation antipsychotics that in some cases cause weight gain and metabolic syndrome which is associated with a two to threefold increase in cardiovascular mortality and a twofold increase in all-cause mortality (3;9). These effects would be expected to contribute to even higher mortality in the following years (10).

The use of more than one antipsychotic drug, polypharmacy, might also play a role (11;12). Psychiatric societies, national and international health authorities advise against the use of polypharmacy (13).

The quality of the general health care in patients with severe mental illness and the consensus about the prevention of somatic illness in this group of vulnerable patients need to be improved and there is evidence signifying the importance of the situation (14;15).

We need more knowledge about how to integrate the prevention and care of somatic illness to this group of patients with severe psychiatric illness.

This study investigates ways to improve the physical health of people with a psychiatric diagnosis.

Eligibility Criteria:
Inclusion Criteria:

* Living in one of the 6 institutions in Region Nordjylland

Exclusion Criteria:

* Not capable of speaking Danish
GST-moms: Effects of Group-schematherapy on Mother-child Attachment Relations

The birth of a baby can be a stressful period. Dysfunctional schemas of the 'new' parent can be triggered making it more difficult to discern what the baby needs are. In schema therapy terms, mentalizing capacity is best described as the "healthy adult mode". A parent who responds to her baby from a healthy adult mode provides the baby a safe environment for self-development. However, interpreting the baby's signals can be a constant challenge for some parents. This can trigger early attachment relationships and schemas. At such times, the parent may become overwhelmed by their own emotions and respond less adequate to the child's needs. Distorted parental reflective functioning is associated both with insecure attachment and poor affect regulation in the parent and with various psychological disorders in the child. Treatments aimed at improving parental reflectiveness seem to have a positive impact on the quality of the attachment between parents and their baby.

The objective of this study is to measure the effects of the group-schematherapy for mothers with young children (GST moms) on mother-child attachment relations. The aim is to help moms regulate their own emotions, by understanding their own modes and schema's. In doing so will help them feel more confident to mentalize about their child and to adequately respond to their needs and emotionally bond with their baby. The researchers anticipate it will improve the quality of attachment between mother and child. Many studies have been done on the effectiveness of group schematherapy however there are no studies specifically for schematherapy for parents, in this case mothers. GST moms can be an early intervention aimed at prevention of psychological problems with the child.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients for the group schematherapy are mothers with young children (0-5 years), with a cluster C personality disorder.

Exclusion Criteria:

* Acute Suicidal or chronic suicidality
* Psychotic disorder
* Autistic spectrum disorder
* Bipolar disorder
* Developmental disorders
* Any other AS-I disorder that requires treatment first (severe depression, alcohol and/or drugs abuse)
* Cluster A or B personality disorders (traits of cluster B in combination with Cluster C personality disorder is included)
* Neuropsychological damage
* General problems for group therapy (auditory impairment, severe physical disability, insufficant Dutch comprehension, IQ \< 80)
* Self-mutilation
Eletric Stimulation for Hipossalivation Induced by Radiotherapy

Currently, cancer is a disease of high incidence, already considered a public health problem. Among the most prevalent are head and neck neoplasms, and depending on the location and extent of the lesion, the treatments are surgery, chemotherapy and / or radiotherapy that have a great impact on the quality of life. Radiation therapy is a frequently chosen treatment, and depending on the dose of radiation, causes changes such as hyposalivation. There are techniques for salivary flow stimulation, however, most of the options involve the use of medications, which limits administration to part of the patients. Transcutaneous electric nerve stimulation (TENS) is an alternative that has been used to stimulate salivary flow, however there is a limited number of studies that have tested this technique after radiotherapy. The aim of this study was to verify the effect of TENS in increasing the salivary flow of individuals receiving radiotherapy to treat tumors of the head and neck. The sample will have 80 patients randomly divided into two groups: TENS group and Control group. In both groups, a quality of life questionnaire (UW-QOL) will be applied and a speech-language assessment will be performed. The hypothesis of this research is that TENS is effective in increasing the amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.

The sample will have 80 patients randomly divided into two groups: 1) TENS group; 2) control group. A quality of life questionnaire (UW-QOL) will be applied and a speech-language assessment will be performed. The hypothesis of this research is that TENS increasing the amount of saliva. Secondary outcomes involve the evaluation of the effect of this technique on the quality of life, mainly in the questions: speech, chewing, saliva and deglutition.

Eligibility Criteria:
Inclusion Criteria:

Starts radiotherapy treatment without previous hipossalivation

The inclusion criteria according to information contained in electronic medical records and referred by the participants are:

* Patients undergoing oncological follow-up for the treatment of head and neck cancer at Santa Rita Hospital through radiotherapy;
* Have completed radiotherapy for at least 90 days;
* Do not present a history of carcinogenic lesion in the salivary glands (sublingual, submandibular and parotid);
* Do not present oral history of oral cancer;
* Have not undergone cervical emptying level I;

Exclusion Criteria:

Intolerance to the TENS

The exclusion criteria are:

* No xerostomia;

  • Severe dysphagia;
* Stimulated salivary flow volume greater than 1.5 ml / minute;
* Use of glandular protective substances or salivary stimulants during the period of data collection;
* Use of a pacemaker or any other device that prevents electrical stimulation;
* Being pregnant;
* Unavailability of time to participate in the study (2x / week for one month);
* Excessive absences during treatment (\> 30% of total sessions).
A Study to Evaluate Corrected QT Interval and Drug-Drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients With HER2-Positive Metastatic or Locally Advanced Inoperable Cancer

This Phase Ib, multicenter, single-arm, open-label study is designed to evaluate the effect of trastuzumab on QTcF interval and to characterize the effects of trastuzumab on carboplatin pharmacokinetics in patients with HER2-positive metastatic or locally advanced inoperable cancer.

The QT interval is a measure of time between the start of the Q wave and the end of the T wave in the heart's electrical cycle. The QTcF interval is the QT interval as calculated using Fridericia's correction; the QTcB interval is the QT interval as calculated using Bazett's correction.


Eligibility Criteria:
Inclusion Criteria:

* Histologic documentation of a HER2-positive solid malignancy in patients with metastatic or locally advanced inoperable disease
* Left ventricular ejection fraction (LVEF) \>/= 50% by multiple-gated acquisition (MUGA) scan or two-dimensional echocardiography (ECHO) \</= 42 days prior to Cycle 1, Day 1

Exclusion Criteria:

* History of trastuzumab treatment \</= 100 days prior to Cycle 1, Day 1
* Pretreatment QTcF interval \> 450 ms as determined by local assessment
The Effects of Dog Therapy on Ambulance Staff Burnout Scores.

Problem During the COVID 19 pandemic, NHS staff have become increasingly burned out. Mental health is the leading cause of staff sickness and absence in the NHS. Ambulance trusts have the highest rates of sickness across all NHS professions. Reduced staffing levels directly impacts service delivery. Staff struggling with poor mental health are more likely to make errors, have reduced empathy, and patients have lower patient satisfaction.

The Solution? Dog therapy is used in hospital settings around the world for patient benefit and staff welfare.

Evidence suggests dog therapy improves mood and reduces anxiety. Yorkshire Ambulance Service (YAS) has a small, but established dog therapy scheme, organised by the health and wellbeing team.

This research aims to observe if dog therapy affects symptoms of burnout in YAS staff. We will use two sets of staff:

Patient facing staff Staff with remote patient contact

What will participants need to do?

Participants will be given a Copenhagen Burnout Inventory - a questionnaire focusing on three factors:

Personal burnout Work related burnout Client related burnout

Burnout will be measured in 4 categories; no/low, moderate, high and severe burnout.

The questionnaire will be completed at the beginning and end of 8 weeks of dog therapy.

* Some optional demographic questions
* Number of sessions attended
* Engagement with occupational health services
* Dog Ownership

We will calculate the difference in severity of burnout between baseline and after 8 weeks of dog therapy.

A PPI group has been consulted on methodology, wording of plain English summary and the dissemination plan.

This research will be distributed to all interested participants, published in an appropriate journal presented at conferences, and presented in the ICA dissemination event.


Eligibility Criteria:
Inclusion Criteria:

Yorkshire Ambulance Service (YAS) Employee with patient contact. Patient contact includes face to face to face or remote patient contact. Taking part in YAS dog therapy scheme. Completed no more than 2 dog therapy sessions to date. -

Exclusion Criteria:

Staff with no patient contact as part of their role. Staff on bank contract

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Acupuncture for Symptoms of Nerve Damage

The purpose of this study is to compare the effects of real acupuncture with placebo acupuncture or usual care on symptoms of nerve damage from chemotherapy.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Age ≥ 18 years old
* Solid tumor survivors with no evidence of disease
* Moderate to severe CIPN, defined by symptoms such as numbness, tingling, or pain ratings of 4 or greater on a 0-10 numeric rating scale (NRS)
* Have completed neurotoxic chemotherapy at least 3 months prior to enrollment
* If taking anti-neuropathy medications, they are on a stable regimen (no change in 3 months)

Exclusion Criteria:

* Patients with a pacemaker
* Prior acupuncture treatment within 5 years of enrollment
A Short-term Mixed Exercise for Sarcopenic Hospitalized Aged 80+ Years

Most previous clinical trials that addressed exercise for sarcopenic elderly subjects focused on community-dwelling older adults who were relatively healthy. There is a notable paucity of high-quality research investigating the effects and feasibility of exercise for hospitalized or institutionalized older people, who are generally frailer and more severe in functional impairment than those living in the community. Moreover, most reported exercise programs were of long-term duration, which typically lasted 3 to 6 months with two sessions per week. It remains unclear whether short-term exercise would be effective for treating sarcopenia. Therefore, the investigators aimed to assess the effectiveness of short-term exercise for treating sarcopenia in hospitalized older patients aged 80 years and over.


Eligibility Criteria:
Inclusion Criteria:

1. aged ≥80 years;
2. being able to ambulate (assistance was acceptable);
3. being able to communicate and collaborate with the physiotherapist;
4. with sarcopenia defined by the AWGS criteria ;

Exclusion Criteria:

1. terminal illness;
2. uncontrolled heart failure;
3. myocardial infarction within the past three months;
4. uncontrolled respiratory failure;
5. bone fractures within the past three months;
6. acute pulmonary embolism;
7. major surgery within the past three months;
8. uncontrolled arrhythmia;
9. refusal to participate in this study.
Bioavailability of Fish Oils: Emulsified Versus Capsular Triglyceride

The primary objective of this investigation is to determine the relative percentage and rate of incorporation of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and total omega-3 (n-3) fatty acids after ingestion of 4 emulsified flavored triglyceride fish oil supplements versus an encapsulated triglyceride in defined plasma lipid pools.

The primary endpoints to be evaluated include the fatty acid composition of plasma lipids before and after consumption of a single dose of emulsified triglyceride based fish oil and triglyceride of similar n-3 compositions in capsule form. The investigators will measure changes in plasma phospholipid, and chylomicron fatty acids.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adults ages 18 to 60.
2. Body mass index between 22 and 32 kg/m2.
3. Medical history (interview) demonstrating good health.
4. Nonsmoker.
5. Consumption of a typical American diet with no unusual dietary habits.
6. Willingness to comply with the study protocol.
7. Low reported n-3 intake (\<100 mg/d) on the Omega-3 Checklist

Exclusion Criteria:

1. Any active, uncontrolled medical problem.
2. Consumption of essential fatty acid supplements within the past 6 months.
3. Use of lipid lowering drugs.
4. Fish consumption greater than 1 fish meal per week
A Study of the Effect of MK-8457 on Blood Pressure in Hypertensive Participants (MK-8457-004-AM1)

This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic blood pressure in participants with mild to moderate hypertension in addition to safety and tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure to a clinically significant extent, as measured by 24-hour mean ambulatory systolic blood pressure change from baseline after 10 days of dosing.


Eligibility Criteria:
Inclusion Criteria:

* If female, must be of non-childbearing potential
* If male with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug
* Body mass index (BMI) ≤35 kg/m\^2
* Mild-to-moderate hypertension requiring treatment with one or more antihypertensive agents
* Receiving stable treatment for hypertension for at least 8 weeks prior to the start of dosing and continuing therapy for duration of study
* No clinically significant arrhythmias or clinically significant abnormality on electrocardiogram
* Nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

* Any illness that might confound the results of the study or poses an additional risk
* History of stroke, chronic seizures, or major neurological disorder
* Clinically significant endocrine, gastrointestinal, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases
* Clinically significant cardiovascular disease or has active angina
* History of malignant neoplastic disease
* Taking 325 mg aspirin daily
* Taking 3 or more medications for the treatment of hypertension
* Unable to refrain from or anticipates the use of any non-steroidal anti-inflammatory drugs (NSAIDs)
* Consumes excessive amounts of alcohol and/or coffee, tea, cola, or other caffeinated beverages
* Has had major surgery, donated or lost 1 unit of blood or participated in another investigational study within 4 weeks
* Significant multiple and/or severe allergies
* Regular user of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 2 years