cyrilzakka/clinical-trials huggingface dataset:
Smartphone Application, Mood and Stress

The purpose of this study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color.

The overall goal of the outlined study is to investigate the placebo effect in a smartphone-based training, ostensibly designed to improve mood and perceived stress by daily exposition to either mock sound or color. During 14 days, subjects will participate in regular daily training sessions. During another 6 days, subjects will transfer the smartphone-based training to daily life.

Eligibility Criteria:
Inclusion Criteria:

* Access to smartphone during study period

Exclusion Criteria:

* Severe visual impairment
* Dyschromatopsia
* Severe defective hearing
* Regular intake of medication (excl. contraceptives)
* Severe mental disorders
Immunology of Failing Metal-on-Metal Hip Replacement

Metal-on-metal total hip replacement (MoM THR) has been targeted at younger patients with anticipated long-term survival since the bearing surfaces wear less than the traditional metal-on-plastic (MoP) replacements. However, the production of metal ions as a result of the wear is a concern because of the possible toxicity to cells. In Norwich England a number of different metal-on-metal implants have been trialed of which one, the Ultima TPS, has had very poor results. A total of 545 patients have had 652 MoM THRs with the Ultima TPS of whom more than 20% have now been revised. There is an ongoing MHRA program to screen for problems using MRI scans with a technique developed in Norwich. Investigations so far show massive corrosion in the implants with a catastrophic immune response causing death of cells. This may include death of bone leading to fracture. In a third of patients revised there has been pain but normal plain X-rays. In some patients without pain who have been screened there are abnormal changes on an MRI scan. We wish to investigate the immune cells in patients to find out why this has happened. The study will include patients coming for a new hip to act as a comparator, as well as those with a MoM THR and patients being revised with MoM THRs, and MoP THRs. We shall also investigate patients with other MoM THRs opportunistically.

To characterize dendritic cell (DC) populations in MoM THR patients. Dendritic cells are cells that migrate from the circulating blood into tissues and mop up foreign material such as viruses with their abnormal surface makers (antigens)and metal debris, activating specialist white blood cells (such as T cells) that kill viruses and remove abnormal material.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have undergone Ultima TPS THRs in Norwich
* Patients with a MoP THR under going revision.
* Patients undergoing primary hip replacement with osteoarthritis
* Patients with other MoM THRs undergoing revision

Exclusion Criteria:

* Patients undergoing primary THR with rheumatoid arthritis or other inflammatory arthritides, or secondary to infection
Surveillance of Invasive Pneumococcal Infections in Adults (Excluding Meningitis)

Given the frequency and severity of invasive pneumococcal infections and questions about the place of VPC-13 in the prevention of pneumococcal infections in adults based on the presence of risk factors, current laboratory surveillance should be supplemented with data on the clinical features of adult invasive pneumococcal infections (IPI) cases. In particular it is necessary to collect for these cases, the clinical forms, the severity and the existence of risk factors and to make the link between these characteristics and those strains of pneumococci responsible for the IPI in particular, their serotype. The follow-up of the evolution of the cases according to the presence of risk factors, their clinical form and their serotype coverage (vaccine strain or not) must to guide recommendations for adult VPC-13 and to monitor the effects of VPC-13 vaccination recommendations. These effects are indirect, linked to the effect of vaccination of children with VPC-13 since 2010, which modifies the serotypes responsible for infections in vaccinated and unvaccinated patients, and the direct effects of possible use of the conjugate vaccine in adults (according to the recommendations that will be given by the Vaccination Technical Committee of the High Council of Public Health). The project is based on the existing network of 23 Regional Pneumococcal Observatories (ORP) located in metropolitan France and the network of infectious diseases by completing the microbiological collection of strains of pneumococci isolated from invasive infections in adults by a clinical collection in hospitals or voluntary clinics where the laboratory participates in the ORP. Given the establishment in 2012 of an adult bacterial meningitis observatory, to which the ORP are associated, this project does not include the surveillance of pneumococcal meningitis in adults.


Eligibility Criteria:
Inclusion Criteria:

* 18 years old patients or older hospitalized with invasive pneumococcal infection confirmed by isolation of a strain from a usually sterile site: blood or pleural fluid

Exclusion Criteria:

* Pneumococcal meningitis identified by pneumococcal isolation or pneumococcal positive polymerase chain reaction (PCR) in cerebrospinal fluid
Exergaming Training Among Hypertensive Patients

Since Hypertension affects all body systems and importantly postural balance control. So, the evidence indicates a strong link and connection between balance and hypertension through somatosensory, visual, vestibular, musculoskeletal, and CNS integration of inputs from both peripheral and motor systems. Therefore, to fill this gap of how much balance and each of its aspects/components are affected, this study will be done for a detailed examination of this genuine integration and clinical interaction among hypertensive with game-based techniques on all three balance components (concerning Intensity, frequency, duration and dosage of VRET). Secondly, on the other hand (CR) programs, have shown very low compliance with recommended Physical Activity, which is why; by utilising this alternative, Virtual reality exergaming can be used as a quick, appropriate and equivalent alternative to traditional exercise programs. Also, in future, it could be suggested with promising effects in the provision of engaging, goal-oriented training for patients with hypertensive besides a sound, economical and clinically beneficial alternative to traditional Cardiac Rehabilitation. Finally, by exploring detailed clinical integration of Postural Balance with Hypertension using Virtual Reality the study will be able to highlight hypertension as a potent risk factor for future impaired balance and risks of falls. Thereby, hypertension's early identification (considering all biological, psychological, and social factors) and prevention may avert hypertensive to future debilitating complications and outcomes as a result of it.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Community dwelling controlled Hypertensive (particularly Stage 1, 130 to 139 (systolic) or 80 to 89 (diastolic) or Stage 2 hypertension from 140 or higher (systolic) or 90 (diastolic) if present with any (controlled diabetes or overweight patients) with a medical referral form for medical specialist with physiotherapeutic treatment provided by the local public or private healthcare system
2. Any race or gender with age 20 or older
3. No history of any orthopedic, neurological, Pulmonary or psychological disorders, Cognitive impairments etc.
4. Had not performed physical activity in the previous three months.

Exclusion criteria:

1. Grade III or grade IV heart failure according to the New York Heart Association (NYHA) Functional Classification.
2. Recent acute myocardial infarction; unstable angina; acute pericarditis. pulmonary hypertension; uncontrolled diabetes mellitus; Hypertensive crises or uncontrolled Hypertension or Pregnancy
3. Patients who had three consecutive absences during the intervention
4. Unable to answer or understand the gaming or exercise protocols and quality of life questionnaires and fulfil the exercise protocols, due to any severe cognitive deficit
5. Pain with ambulation or dizziness when standing or walking.
6. Contraindications to treadmill walking or VR gaming
The Effect of Pre Surgery Dog Visits on Post Surgery Consumption of Pain Medication

The objective of this study is to examine the effects of pre surgery dog visits as compared to a costumed character or parents-only on the consumption of pain medication after surgery. It is hypothesized that pre surgery dog visits will reduce post surgical stress and anxiety.

Recent research has revealed that children who are highly anxious prior to surgery experienced more problems post surgery. These problems included reporting of more pain and requested more pain medication during hospitalization and home follow up. Consumption of pain medication may not be the optimal pain management program. In contrast, numerous human-animal interaction studies have shown that animals tend to have a calming effect on people, reduce stress, and lesson anxiety. Therefore, the primary objective of this study is to examine the effect of pre surgery dog visits as compared to a costumed character or parents-only on the consumption of pain medication after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Tonsillectomy and Adenoidectomy (T/A)
* 4-7 years old
* Prescribed codeine and/or analgesics for postoperative pain

Exclusion Criteria:

* Participant must not be afraid of dogs, or allergic to animal dander
* Chronic medical conditions other than T/A
* Developmentally delayed
* On psychotropic medications
Comparing the PrePex™ Device to Surgical MC for Rapid Scale Up of MC in Resource Limited Setting

The protocol, approved by the Medical Research Council, was issued to assess the safety and efficacy of the non-surgical device for applying it to the national scale up of adult male circumcision in Zimbabwe

Models show that to have the highest impact on the HIV epidemic, circumcision of up to 80% of men in high prevalence countries, where MC rates are low, needs to be achieved (UNAIDS 2009; Manicaland HIV/STD Prevention Project, 2008; Bollinger, et al, 2009). Hallett and colleagues in 2008 showed that for Zimbabwe specifically, HIV incidence could be reduced between 25% to 35% if about 50% of men are circumcised. All modelings conducted show that MC programs must be part of a comprehensive HIV prevention package as MC alone will not tip the HIV epidemic into a terminal decline.

The PrePex Device offers hope for rapid scale up of adult male circumcision in resource limited settings.

Once the safety and efficacy have been established, it is important to conduct operations research to determine how best to implement both device and surgical circumcisions in the national program. Thus, the Zimbabwe MOHCW is planning a three phase trial in order to determine the safety of the PrePexTM device, its performance and the ease of use in an implementation roll out.

Eligibility Criteria:
Inclusion Criteria:

* Ages 18 - 30 years
* Uncircumcised
* Wants to be circumcised
* Agrees to be circumcised by any of the study methods,PrePexTM or Surgical as appropriate
* HIV sero-negative
* Able to understand the study procedures and requirements
* Agrees to abstain from sexual intercourse and to keep caution not to directly rub the cut area if masturbating, for 8 weeks post removal (9 weeks total)
* Agrees to return to the health care facility for follow-up visits (or as instructed) after his circumcision for a period of 8 weeks post removal (9 weeks total)
* Subject able to comprehend and freely give informed consent for participation in this study and is considered by the investigator to have good compliance for the study
* Subject agrees to anonymous video and photographs of the procedure and follow up visits
* Agrees to stay overnight at the Hospital in order to follow pain measurements in the first 16 hours

Exclusion Criteria:

* Active genital infection, anatomic abnormality or other condition, which in the opinion of the investigator prevents the subject from undergoing a circumcision
* HIV sero-positive
* Subject with the following diseases/conditions: phimosis, paraphimosis, warts under the prepuce, torn or tight frenulum, narrow prepuce, hypospadias, epispadias
* Known bleeding / coagulation abnormality
* Uncontrolled diabetes
* Subject that to the opinion of the investigator is not a good candidate
* Subject does not agree to anonymous video and photographs of the procedure and follow up visits
* Refusal to take HIV test.
Study Of Investigational Regimen Combining FDA Approved HIV Drugs In HIV Subjects Experiencing Early Virologic Failure

This study is a 48-week study to evaluate the efficacy and safety of an investigational regimen combining FDA approved HIV drugs in antiretroviral-experienced subjects failing on their first highly active antiretroviral therapy regimen.


Eligibility Criteria:
Inclusion Criteria:

* Currently on an initial HAART (highly active antiretroviral therapy) regimen of 3TC/ZDV or 3TC/d4T and a PI (protease inhibitor) -boosted or unboosted- or NNRTI (non-nucleoside reverse transcriptase inhibitor).
* Plasma HIV - 1 RNA was \<400 copies/ml on at least 2 documented occasions prior to viral rebound.
* Have a plasma HIV - 1 RNA value \>400 copies/ml and \<10,000 copies/ml on 2 documented successive occasions (including screen) separated by at least 2 weeks.
* A CD4+ lymphocyte count less than or equal to 100.

Exclusion Criteria:

* Have not taken Abacavir (ZIAGEN or TRIZIVIR) or tenofovir (VIREAD) previously.
* Have not had an AIDS defining illness within 30 days of screen.
* Pregnant or breast-feeding.
* Specified viral genotypes upon screening.
* And other inclusion or exclusion criteria to be evaluated by the physician.
Effects of Music Therapy on Huntington's Disease

The purpose of this study is primarily to assess the ability of a music therapy program to improve holistically the psychological, somatic, and social symptoms of patients with Huntington 's disease (HD). We hope to demonstrate the benefits of applying music therapy interventions to the management methods of HD, thus paving the way for the development of an effective music therapy program for individuals with HD.

ABSTRACT

Background: Recent studies show that music therapy helps improve the symptomatic manifestations of Parkinson's Disease. Few studies have looked at music therapy as a treatment for the psychiatric, cognitive and motor symptoms of patients with Huntington's disease (HD).

Objective: To examine the feasibility and tolerability of a treatment program of music therapy for patients with Huntington's disease. Also, to determine if music therapy improves the mood and motor features of HD while improving quality of life.

Methods: Subjects with HD were recruited to participate in a six-week study that included one individual, half-hour music therapy session and one hour-long group session per week. The music therapy protocols were adapted from the Colorado State University's Neurological Music Therapy program and were targeted to HD symptoms including balance and posture, fine motor skills, memory and attention, vocalizations, and mood. In particular the protocols included Rhythmic Auditory Stimulation (RAS), Pattern Sensory Enhancement (PSE), and Therapeutic Instrumental Music Playing (TIMP). Primary outcome of tolerability was to be assessed by the subjects' adherence to the therapeutic protocol, attendance, and the results of an exit survey inquiring about their feelings toward the use of music therapy in HD. A secondary outcome of the study was the change in the Unified Huntington's Disease Rating Scale (UHDRS) score between baseline and study completion.

Results: Five subjects were recruited for study participation (one female and four males). Music therapy was found to be a tolerable and feasible treatment for patients with HD (100% adherence and 98% attendance). Exit surveys demonstrated strongly positive feelings towards the music therapy treatment program in four of the five subjects (one survey was completed with contradictory answers by the subject). While there was improvement in UHDRS scores for finger tapping, pronation/supination and the Luria, these changes did not achieve statistical significance with the small sample size in this study.

Conclusions: Music therapy was well tolerated among subjects with HD in this small study. Future studies are now being planned to look at the efficacy of this intervention in a larger population of HD subjects.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of HD
* Over the age of 18
* Patients must be ambulatory, use of a walker or human support is acceptable
* Patients must be able to communicate their thoughts and feelings

Exclusion Criteria:

* Anyone without the preceding characteristics
Optic Nerve Perfusion Following Treatment with Latanoprost Versus Brimionidin Tartrate

This study aimed to evaluate the effects of topical Latanoprost 0.005 % versus Brimionidin tartrate 0.2% on perfusion of optic nerve head This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral primary open angle glaucoma equally divided into two groups with 28 patients in each group

This study aimed to evaluate the effects of topical Latanoprost 0.005 % versus Brimionidin tartrate 0.2% on perfusion of optic nerve head This prospective interventional randomized study included 56 naive patients recently diagnosed with bilateral POAG equally divided into two groups with 28 patients in each group. The whole VD was increased and also increased in all four nasal, temporal, superior, and inferior quadrants around optic disc from the initial vessel density before treatment (p\<0.001) in both groups significantly with superior improvement in group (1) compared to group (2) that was statistically significant

Eligibility Criteria:
Inclusion Criteria:

* age more than 18 years newly diagnosed naive patients with POAG

Exclusion Criteria:

* optic nerve lesions other than glaucomatous changes patients with previous glaucoma surgery
A Phase I Trial to Investigate the Safety and Tolerability of PF-06412562

This study will determine the safety and tolerability of PF-06412562 given orally to healthy volunteers. To determine the optimal dose for future studies, the concentration of the drug over time will be determined by periodic blood samples. The rate of eye blinks will be measured as an indicator of PF-06412562 action on the receptors of interest in the brain.


Eligibility Criteria:
Inclusion Criteria:

Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years

Female subjects of non childbearing potential that meet at least one of the following criteria:

Achieved postmenopausal status, defined as: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle stimulating hormone (FSH) level confirming the postmenopausal status;

* Have undergone a documented hysterectomy and/or bilateral oophorectomy;
* Have medically confirmed ovarian failure.

Exclusion Criteria:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).

Any condition possibly affecting drug absorption .
Endometriosis and ATR-FTIR Spectroscopy

The goal of this study is to explore the use of mid-infrared spectroscopy (ATR-FTIR) as a detection tool for endometriosis in urine.

Endometriosis is a chronic gynecological disease that is considered debilitating and multifactorial. Its diagnosis is invasive and can be prolonged due to non-specific symptoms and erroneous or late investigations, which can lead to delays and impair the provision of adequate treatment.

ATR-FTIR Spectroscopy is a non-invasive technique with the capability to identify the chemical composition and molecular changes of samples through its interaction with mid-infrared radiation. The aim of this work is to develop a rapid test for the detection of endometriosis in urine samples using spectroscopy and machine learning algorithms.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Pelvic pain complain

Exclusion Criteria:

* Age under 18 or above 55
* Lack of informed consent
Speckle Tracking Echocardiography Analysis of Left Ventricular Myocardium After Percutaneous Intramyocardial Septal Radiofrequency Ablation for Hypertrophic Obstructive Cardiomyopathy

Objective to investigate the left ventricular (LV) systolic function by speckle tracking echocardiography before and after percutaneous intramyocardial septal radiofrequency ablation for hypertrophic obstructive cardiomyopathy (HOCM).

Percutaneous intramyocardial septal radiofrequency ablation (named Liwen Procedure) is a safe and effective treatment approach for HOCM and results in sustained improvement in exercise capacity and persistent in reducing left ventricle outflow tract (LVOT) gradient. However, the systolic function of the myocardial after Liwen procedure in HOCM patients is not well exploration and research. Strain evaluation using speckle tracking echocardiography is an excellent tool for assessing regional and global LV functions.

In this study, the investigators aimed to characterize regional and global strain using speckle tracking echocardiography to assess LV radial, circumferential and longitudinal systolic myocardial function in patients with HOCM before and after Liwen procedure.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with symptoms that limit daily activities (New York Heart Association functional class \>II, exercise-induced syncope) despite adequate medical treatment or when medical treatment is not tolerated
2. Patients with a peak LVOT gradient≥50 mm Hg

Exclusion Criteria:

1. Those with a peak instantaneous Doppler LVOT gradient of \<50 mm Hg
2. Those with an indication for septal reduction therapy and other lesions requiring surgical intervention (e.g., mitral valve repair/replacement and papillary muscle intervention)
3. Those with end-stage heart failure；and those the echocardialology image quality is not clear enough for strain analysis.
Lanreotide 120mg Effectiveness in Subjects With Pancreatic Neuroendocrine Tumours (PanNET) in Routine Clinical Practice.

The purpose of the protocol is to estimate the progression-free survival (PFS) rate in subjects diagnosed with PanNET, according to investigator assessment, at 24 months after treatment initiation with lanreotide 120 mg every 28 days.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged ≥ 18
* Subjects diagnosed of functioning or non-functioning PanNET, G1/ G2 (Ki67≤10%) unresectable locally advanced tumour or metastatic disease, who have been treated with lanreotide 120mg every 28 days for at least 3 months and a maximum of 12 months
* Subject not progressive at inclusion study visit according to investigator assessment, and using as a reference lanreotide initiation
* Subject with Eastern Cooperative Oncology Group (ECOG) ≤2

Exclusion Criteria:

* Subject who is participating in an interventional study
* Pregnant or breast-feeding women
* Subject who has received any previous therapy for PanNET (such as octreotide LAR, Molecular Targeted Therapy (MTT), Peptide receptor radionuclide therapy (PRRT), chemotherapy, etc.) except short-acting octreotide subcutaneous (SC) used for symptomatic control of functioning tumours