cyrilzakka/clinical-trials huggingface dataset:
The Effect of β-hydroxy-β-methylbutyrate Supplementation on Physical Capacity and Body Composition in Trained Athletes

The purpose of this study was to verify the effect of 12-week with β-hydroxy-β-methylbutyrate (HMB) and a placebo (PLA) supplementation on body composition, anaerobic and aerobic capacity, as well as concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial.

The effect of HMB supplementation is of great interest in sport. In view of the inconclusive character of the results of the studies conducted to date and of a relatively low number of studies investigating the effectiveness of HMB supplementation over a longer period on a large population of trained athletes, the aim of this study was to verify the effect of 12-week with HMB and a placebo supplementation on body composition, anaerobic and aerobic capacity, as well as concentrations of the selected biochemical blood markers in trained athletes, in a randomised, double-blind, placebo-controlled crossover trial.

Eligibility Criteria:
Inclusion Criteria:

* written consent to participate,
* male
* a current medical clearance to practice sports,
* training experience: at least 5 years,
* minimum of 6 workout sessions a week (minimum 3 in the practiced sports discipline).

Exclusion Criteria:

* current injury,
* any health-related contraindication,
* declared general feeling of being unwell,
* unwilling to follow the study protocol.
Candesartan Cilexetil in Heart Failure Assessment of Reduction in Mortality and Morbidity (CHARM Added)

A study to evaluate the effect of Atacand on patients with heart failure with depressed left ventricular function


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 18 or above
* Congestive Heart Failure with symptoms for more than 4 weeks before starting study
* Provision of informed consent

Exclusion Criteria:

* Current low blood pressure with symptoms
* Liver disease considered significant by the study doctor
* Pregnant or lactating females
Using Technology to Reduce Youth Substance Use

The research project will focus on conducting a trial of whether a tailored SMS text-messaging intervention is efficacious in improving justice-involved youths' substance use or dual diagnosis treatment attendance and engagement.

The study will demonstrate how delivery of motivational/coaching messages to justice-involved youth and their caregivers will lead to greater youth substance use treatment attendance and engagement. The study will start with identifying the feasibility and acceptability of the SMS text-messaging intervention with community-supervised justice-involved youth. Then, the study will determine whether the tailored dyadic (youth and caregiver) SMS text-messaging intervention improves justice-involved youth substance use or dual diagnosis treatment attendance and engagement relative to standard of care (not receiving motivational/coaching messages). Finally, the study will characterize patterns of key justice and behavioral health system-level factors that promote or hinder eventual adoption and sustainability of mHealth technology as a tool to improve treatment attendance for justice-involved youth.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking youth with willing adult caregiver
* Ages 13-18
* Justice-involved while living in the community
* Own a mobile phone or tablet
* Are willing to send and receive text messages
* Are referred to community-based substance use and/or mental health treatment

Exclusion Criteria:

-
Improvement of the Health-related Quality of Life of Patients With Fibromyalgia Using Multidisciplinary Treatment

The purpose of this study is to assess improvement in health related quality of life of fibromyalgia patients following 6 weeks of interdisciplinary treatment compared to the usual treatment.

Fibromyalgia (FM) is the most common cause of diffuse pain in the bones and joints, with a prevalence in general adult populations estimated at between 0.7% and 3.3%. In Spain, the prevalence of FM is 2-3%; it affects mainly women, with new diagnoses peaking between the ages of 40 and 49 years. In certain populations, however, the prevalence may be much higher, as in 15% of patients referred from internal medicine units or 12% of patients referred to rheumatology specialists in Spain.

Fibromyalgia produces various degrees of disability and pain. It also has a clear impact on health-related quality of life (HRQoL). Burckhardt et al. observed lower HRQoL among patients with fibromyalgia than among healthy subjects. Indeed, the HRQoL for those with FM was similar to that of patients with insulin-dependent diabetes mellitus or chronic obstructive pulmonary disease. Among patients with non-cancer chronic pain referred to the pain management unit at our institution, those with bone and joint pain and with FM had the worst progress 6 months after diagnosis as measured by HRQoL.

The characteristics of FM, such as its complex and unknown etiology, wide range of symptoms and signs, and multiple comorbidities make identifying effective therapies particularly difficult. As a result, no consensus yet exists regarding the best therapeutic approaches, and treatment of FM presents a challenge for clinicians. Clinical research suggests that pharmacologic treatment alone is not the best approach for FM, and that an integrated biopsychosocial approach that includes non-pharmacologic therapies along with pharmacologic therapies improves outcomes in these patients.

In our hospital, between 5% and 10% of patients newly diagnosed with FM are referred to the pain management unit. We established a clinical trial in this population to assess improvement in HRQoL following 6 months of interdisciplinary treatment compared to the usual treatment, as well as to identify predictors for improvement in HRQoL.

Eligibility Criteria:
Inclusion Criteria:

* a patient must have been diagnosed with FM according to diagnostic criteria of the American College of Rheumatology
* being 18 years or older and
* having had continuous chronic pain for at least 6 months.

Exclusion Criteria:

* Patients were excluded if they did not agree to participate in the study,
* were suffering from a severe psychiatric or organic disorder, or
* were involved in employment-related legal proceedings related to their FM. Participants in the trial were required to sign an informed consent form.
Differences in Blood Levels of Lopinavir/Ritonavir in HIV Infected Men and Women

Men's and women's bodies may process anti-HIV drugs differently. The purpose of this study is to determine the differences in blood levels of soft gel capsules and tablets of lopinavir/ritonavir (LPV/r) in HIV infected men and women.

It is estimated that 50% of people living with HIV/AIDS worldwide are women. HIV infected women face different psychosocial issues than men, and their bodies may react differently to HIV treatment. However, most of the data on the safety and efficacy of antiretrovirals (ARVs) used in the treatment of HIV infection are from studies conducted primarily in men. LPV/r in tablet form was approved by the FDA in October 2005. This study will determine the differences in pharmacokinetics (PK) in men and women taking a soft gel capsule and a tablet formulation of LPV/r.

No ARVs will be provided by this study. In Step 1, participants will receive soft gel capsules of LPV/r. All Step 1 participants will be asked to join Step 2 of the study upon completion of Step 1. In Step 2, participants will receive tablets of LPV/r. During the study, participants in both Step 1 and 2 will take a treatment regimen of LPV/r twice daily and one or more of the following: a nucleoside reverse transcriptase inhibitor (NRTI), tenofovir disoproxil fumarate, or enfuvirtide. Medical and medication history, blood collection, and clinical assessments will occur at study screening for both Steps 1 and 2. Participants in both steps will be asked to complete a medication diary from study entry to the day of the PK visit. The PK visit will occur within 30 days of study screening; blood collection for PK analysis will also occur at this visit.

Eligibility Criteria:
Note: Step 1 enrollment ended as of 06/28/06.

Inclusion Criteria

* HIV infected
* Have taken twice-daily LPV/r (soft gel formulation for Step 1 participants and tablet formulation for Step 2 participants) for at least 14 days immediately prior to step screening and are willing to continue taking LPV/r until the PK visit of that step
* Have taken LPV/r in combination with at least one of the following for at least 14 days immediately prior to study step screening: zidovudine, lamivudine, emtricitabine, stavudine, abacavir sulfate, didanosine, zalcitabine, tenofovir disoproxil fumarate, enfuvirtide, AND are willing to continue taking them until the PK visit of that step
* Body weight of more than 50 kg (110 lbs) for Step 1 participants only

Exclusion Criteria:

* Non-nucleoside reverse transcriptase inhibitor or dual protease inhibitor regimen within 30 days prior to study entry
* Require certain medications
* Current drug or alcohol abuse that, in the investigator's opinion, may interfere with the study
* Serious illness requiring systemic treatment or hospitalization within 30 days of study screening
* Acute AIDS-related opportunistic infection within 90 days of study entry
A Randomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction Preserved Ejection Fraction

Heart failure with preserved ejection fraction (HFpEF) is a common and serious complication of obesity and type 2 diabetes (T2D). HFpEF occurs when the heart muscle unable to relax efficiently to pump the blood around the body. This leads to fluid build-up, breathlessness and inability to tolerate physical exertion. People who develop HFpEF do less well because treatment options are limited. Pilot data in patients with obesity and diabetes and a small number of patients with HFpEF have shown improvements in exercise capacity and reversal of changes in the heart and blood vessels. This study will assess if this is achievable in a multi-ethnic cohort of patients with established HFpEF. A total of 102 adults will be invited and allocate by chance into two groups: either a 12-week diet or health advice on how to lose weight. The study will determine if weight loss over 12 weeks can improve heart function, symptoms and ability to exercise. Additionally, participants' views on changing their diet and how this has impacted their symptoms will be sought during the study in an optional interview. This will help guide treatments planning in the future to get maximum benefits, and to individualize support to patients from different cultural backgrounds.

Heart failure (HF) with preserved ejection fraction (HFpEF) is a heterogenous syndrome, typified by severe exercise intolerance and with limited treatment options. Weight loss achieved through a low energy meal-replacement plan (MRP) has been shown to lead to reversal of cardiovascular remodelling in ethnically diverse asymptomatic adults with pre-HFpEF and HFpEF. This trial will translate this experience with the pragmatic low energy MRP into a symptomatic, multi-ethnic cohort of obese HFpEF, across three sites (Leicester, Manchester and Oxford) to assess its efficacy in improving exercise intolerance, symptoms, quality of life, cardiovascular remodelling, and skeletal myopathy.

Eligibility Criteria:
Inclusion Criteria:

1. Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF\>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse
2. Clinically stable for ≥ 3 months (no admissions to hospital)
3. Obesity (BMI ≥30kg/m2 if white European or ≥27kg/m2 if Asian, Middle Eastern or Black ethnicity)
4. Age ≥18

Exclusion Criteria:

1. Inability to walk/undertake 6-minute walk test
2. Inability to follow a low-energy MRP
3. HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease95
4. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension
5. Severe chronic obstructive pulmonary disease (FEV1\< 1.0L)
6. Severe primary valvular heart disease
7. Anaemia (Hb\<100g/L)
8. Severe renal disease (eGFR \< 30 ml/min/1.73 m2)
9. Weight loss \> 5kg in preceding 3 months.
10. Known gallstones/previous biliary colic
Magnetocardiography as a Non-Invasive Tool for Detecting Tissue Rejection in Heart Transplant Patients

Heart transplantation is a great procedure for selected patients with end-stage heart failure, but graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of immunosuppression. The only reliable method used today to detect rejection is doing repeated biopsy of the heart. This is expensive, invasive, inconvenient to the patient, and associated with a significant risk of serious complications, as a piece directly from the inner surface of the patients heart is needed. The magnetocardiograph (MCG) device is an invention that may provide new means to assess changes in the heart tissue, as it may detect small changes that happen in the heart cells when they are undergoing rejection.

Heart transplantation is an advantageous procedure for selected patients with end-stage heart failure. Graft rejection remains a major factor limiting long-term survival despite continued advancement in the scientific skill of immunosuppression. Hyperacute rejection occurs rarely since screening of recipient for anti-donor antibodies was introduced. Focal or diffuse acute cellular rejection is diagnosed by endomyocardial biopsy (EMB). Coronary angiography (CA) is used to monitor for allograft arteriopathy, also described as chronic rejection. Repeated endomyocardial biopsy (EMB) remains the only surveillance method available. Endomyocardial biopsy is expensive, invasive, inconvenient to the patient, and associated with a significant incidence of serious complications. The MCG device is an invention that may provide a sensitive and objective means to assess alterations in the heart tissue. Because the acute inflammatory process of rejection deleteriously affects myocyte structure and function, we hypothesize that either or both the de- and re-polarization changes will occur in the cardiac cycle with subsequent changes in the cardiac magnetic fields and may give altered readings in the affected patient over time.

Eligibility Criteria:
Inclusion Criteria:

* Adult heart transplant recipients referred for surveillance biopsies
* Age greater than 18 years old
Participative Rehabilitation in Stroke Patients

Primary objective of this study is to determine whether a case management of stroke patients after discharge to home or to nursing home results in improving physical and cognitive capacity one year after discharge.

In a randomized trial, the project Participative rehabilitation process management "Stroke in Saxony-Anhalt" (PaReSiS) implements a case management trial, explicitly including all providers in the course of illness, treatment and rehabilitation. To achieve this, patients in the intervention group have the opportunity to choose, specifically and according to their own needs, from the offers of a web portal and a telephone hotline, from individual counselling and info sessions as well as from home visits. Patients in the control group receive patient-information-notes beyond primary care. There will be qualitative interviews with the persons concerned and/or their relatives in both groups in order to validate the instruments.

Eligibility Criteria:
Inclusion Criteria:

* Acute cerebrovascular event (ischemic stroke or intra-cerebral bleeding) with signs and symptoms of an acute stroke according to the diagnosis I61 and I63 of the ICD-10-GM 2008
* Differentiation between ischemic or haemorrhagic stroke by the use of CT or MRT
* Resident in Saxony-Anhalt or Saxony or Thuringia
* Able to understand German language

Exclusion Criteria:

* Reinfarction
* Alcoholism
* Death in acute care
* NIHHS \> 25
* Homelessness
Post-Marketing Surveillance of Dehydrated Human Amnion/Chorion Membrane (DHACM) in Non-Ischemic Chronic Wounds

The purpose of this survey is to observe the efficacy and safety of EPIFIX® dehydrated human amnion/chorion membrane (DHACM) for the treatment of intractable diabetic foot ulcers or venous leg ulcers.

The study will enroll 75 subjects diagnosed with intractable diabetic foot ulcers or venous leg ulcers at 5 plastic surgery sites in Japan. Subjects will be treated with weekly applications of EPIFIX for up to 12 weeks, followed by 6 months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

Patients with intractable diabetic foot ulcers or venous leg ulcers that have not decreased in surface area by at least 50% after 4 weeks of conventional therapies, such as radical wound management (removal of necrotic tissue, infection control, wound cleansing, etc.), glycemic control for diabetic foot ulcers, compression therapy for venous stasis ulcers and moist therapy using wound dressing materials.

Exclusion Criteria:

1. Areas of active infection or latent infection.
2. Patients with disorders that would cause an intolerable risk of postoperative complications.
3. Ulcers that cannot be sufficiently debrided.
4. Ulcers that, after debridement, have blood flow disorders where wound bed necrosis progresses at an early stage.
5. Wound surfaces with multiple ulcer surfaces and exposed bone, and no blood flow in the wound bed.
6. Patients with hypersensitivity to the aminoglycoside antibiotics used during manufacturing.
Food Intake and Epigenetic Alteration in the Spermatozoa of Singletons and Twins

The purpose of this study is to elucidate the role of acute dietary intake in male populations, and its impact on spermatozoa quality, integrity, content and epigenetic programming.

The FEASST study has been designed to determine the impact of diet on the content, quality, and genetic programming of sperm. They are specifically interested in determining if a man's diet plays a role in influencing the health of his potential, future offspring through modifications of the sperm. Previous research has highlighted that certain dietary patterns in fathers-to-be may lead to variable health outcome for their children. However, the specific effect of a man's diet has yet to be fully understood. This study will help understand the impact of a man's diet on semen quality and potential downstream implications for child health, to aid in the development of dietary guidelines for future fathers-to-be.

For this study, male participants will be provided with two prescribed diets for three-week increments punctuated by a three month break. Health information and biological samples such as blood, semen, and saliva will be collected from study participants throughout the five month period. The diets will consist of a 'Processed diet', mimicking a traditional Western dietary intake pattern and an 'Unprocessed diet', based upon current dietary guidelines at quantities either adequate for the participants energetic needs or 500 calories in excess per day.

Patient information and samples will be collected before and after each dietary intervention. Aspects of patient health examined at various time points include weight, body fat percentage, sperm quality, epigenetic sequencing, serum levels of metabolic parameters, and survey information surrounding health history, typical diet, physical activity patterns, and treatment adherence.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 20 to 35 years old
* BMI 18.5 to 30
* Located within the Copenhagen region
* Fluent in English and/or Danish language
* Sperm concentration of \>15 mil/mL according to the WHO's criteria for semen quality
* Semen volume of \>1.5mL mL according to the WHO's criteria for semen quality
* Clinician approval for participation in study
* Obtained informed consent

Exclusion Criteria:

* Self-reported history of serious or chronic illness
* Self-reported history of Obesity
* History of any food restrictions
* History of allergies to any food products
* History of disordered eating
* Record of current use of drugs, alcohol (\>14 units per week and/or chronic binge drinking), and/or tobacco/nicotine products within the past month
* Current use of prescription medication
* Engage in \> 200 minutes of vigorous aerobic exercise per week
* Currently actively trying to conceive a child
* Diagnosis of infertility or disease of the reproductive system
* Evidence of dysregulated metabolism, characterized by the occurrence of any one of the following:

  * Waist circumference \>102 cm
  * Blood pressure \> 130/85 mm Hg
A Neuro-Technological Intervention for Adolescents with GAD

This study aims to evaluate the safety and acceptability of a basic neuro-technological intervention in the treatment of adolescents with Generalised Anxiety Disorder (GAD). Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro- / bio-feedback-based virtual reality (VR) game interface that is driven by a novel algorithm.

This study is a single-arm open-label test of feasibility. The recruitment target is 30. Outpatient adolescents diagnosed with GAD will be recruited to undergo 8 x 30 minutes intervention sessions over 4 weeks. Participants who are enrolled will continue to receive treatment-as-usual prescribed by their treating psychiatrist, except for the use of psychotropics. This population is selected as they could elucidate whether our intervention can be beneficial as an early intervention program for GAD.

During the 8 bi-weekly intervention sessions, participants will don a head-mounted VR display set and a mobile EEG-biosensor. The hardwares are non-invasive.

Eligibility Criteria:
Inclusion Criteria:

* Between 13 to 18 years of age inclusive
* Literate in English Language
* Newly diagnosed with Generalised Anxiety Disorder: current episode, based on Computerised Diagnostic Interview Schedule for Children (C-DISC)
* If on medication, dosage stable or unchanged for at least preceding 8 weeks
* Has parental consent

Exclusion Criteria:

* Diagnosis (as defined by DSM-5) of: anxiety disorder induced by medication, substance, or another medical condition; obsessive compulsive disorder; bipolar disorder; any psychotic disorder (lifetime); intellectual disability (i.e. IQ\<70); autism spectrum disorder; attention-deficit/hyperactivity disorder
* History of substance or drug use disorder (as per DSM-5 criteria) within the last 3 months
* Neurological disorders or insults (e.g. epilepsy, cerebrovascular accidents)
* Metal in the cranium, skull defects, or skin lesions on scalp (e.g. cuts, abrasion, rash) at proposed electrode sites
* Irregular heart rhythms or heart problems
* Severe visual or hearing impairment
* Prior experience with mindfulness-based therapy (e.g. mindfulness-based stress reduction \[MBSR\], mindfulness-based cognitive therapy \[MBCT\])
Thoracoscopic Vascular Rings Chart Review

The purpose of this study is to review the use of diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome.

In addition to dividing the vascular ring, some surgeons stress the importance of performing a diverticulopexy (an additional stitch which holds the ring open and prevents recurrence). This is a difficult step to perform through the thoracoscope.

We plan to review the use of this step, the diverticulopexy, and collect data regarding the ease of the procedure and the overall outcome. Once we have accomplished this, we hope to present our initial results of this new procedure.

Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing vascular ring division at Children's Healthcare of Atlanta at Egleston Hospital between 2001 and 2004