cyrilzakka/clinical-trials huggingface dataset:
A Study of TAK-660 in Surgical Procedures for People With Hemophilia A.

This study is about a factor VIII medicine called Adynovate (TAK-660) used during surgery for people with hemophilia A who have low blood levels of factor VIII.

The aims of this study are as follows:

* To check for side effects from TAK-660.
* To check how well TAK-660 controls bleeding when used routinely during surgery and other invasive procedures such as tooth extractions.

The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.

During the study, participants will receive infusions of TAK-660 during their hospital stay for surgery according to their clinic's standard practice. The study doctors will check for bleeds and side effects from TAK-660 from surgery until discharge.


Eligibility Criteria:
Inclusion Criteria:

* Participants with blood coagulation factor VIII (FVIII) deficiency who received this drug during surgery or treatment after the start date of this survey.

Exclusion Criteria:

* None
A Taste and Acceptance Study of FruitiVits in Children Aged 4-8 Years Following a Ketogenic Diet.

Subjects will be asked to substitute their usual vitamin and mineral supplement/s with FruitiVits for seven consecutive days.

The study will involve 12 subjects between 4 and 8 years of age, who routinely use comprehensive micronutrient supplementation as part of their dietary management.

Primary Hypothesis:

FruitiVits is an acceptable source of vitamin, mineral and trace elements for patients on a Ketogenic diet.

Secondary Hypothesis:

FruitiVits will be well accepted and tolerated when given orally to children on a Ketogenic diet.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of condition requiring a Ketogenic diet
2. Currently on a Ketogenic diet
3. Aged 4 - 8 years
4. Routinely taking a complete micronutrient supplement
5. Oral feeding

Exclusion Criteria:

1) Children aged less than 4 years or older than 9 years of age
Vitamin D Levels in Children Undergoing Adenotonsillectomies and Controls

The investigators aim to evaluate the levels of serum Vitamin D in children having their tonsils removed and appropriate controls. The investigators hypothesize that children undergoing tonsil removal will have lower Vit D levels than accepted norms and when compared to controls. The investigators also hypothesize that Vitamin D deficiency will correlate with indicators of inflammation such as C-Reactive Protein (CRP) and tonsil size.


Eligibility Criteria:
Inclusion Criteria:

* children age 1-12 undergoing adenotonsillectomy (active) or elective surgery such as hernia repair (control)

Exclusion Criteria:

* children on systemic steroids or multivitamins containing vitamin D
* control subjects with: a history of snoring, recurrent tonsillitis or score equal to or higher than 5 on the OSA questionnaire.
Improving Quality of Life for Teenagers with Asthma

BACKGROUND: Asthma is a long-term lung condition affecting 1 in 11 children and young people in the UK. Many teenagers have well controlled asthma, but a significant number continue to experience regular symptoms and asthma attacks leading to hospitalisations. While non-adherence to medication is a factor, teenagers also face challenges like changing relationships with parents and peers, avoiding triggers like smoking, and fitting in treatment with daily life demands. Healthcare professionals (HCPs) also face difficulties in managing teenagers with asthma.

A previous study, funded by Asthma + Lung UK, developed a new approach to manage teenage asthma by focusing on self-efficacy, which is how confident one feels about performing a task. Teenagers completed the Adolescent Asthma Self-Efficacy Questionnaire (AASEQ), which identified areas where they needed more support. HCPs then tailored their consultations to address these needs. This approach improved the teenagers' confidence in self-managing their asthma.

Improving quality of life (QoL) is a key goal in asthma care. Therefore, the aim of this study is to determine if the self-efficacy approach improves QoL for teenagers with asthma.

METHODS: Teenagers aged 12-18 years with asthma will be recruited from hospital clinics. They will be randomly assigned to one of two groups:

1. Teenager will complete the AASEQ at the start of their appointment. The HCPs will use this to focus the consultation on areas where the teenager needs support in self-managing their asthma.
2. Teenager will have their usual consultation with the HCP.

Three months after the appointment, the QoL will be compared between the two groups using a standardised questionnaire.

IMPACT: If the self-efficacy approach proves to be beneficial, it could help HCPs to empower teenagers to better manage their asthma and ultimately improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Adolescent aged 12-18 years
* Attending a paediatric respiratory clinic
* Informed consent from adolescent aged ≥16 years, and assent plus parent/guardian consent for adolescents aged ≤16 years
* Paediatric Asthma Quality of Life Questionnaire score \<5.5 points

Exclusion Criteria:

* Aged 0-11 or over 18 years
* Other significant long-term medical condition that has a day-to-day impact on their lives (except for co-existing allergic conditions)
* Adolescent or parent/guardian unable to communicate sufficiently to complete consent forms.
A Comparative Open-Label Crossover Study of Respiratory-Gated Versus Non-Respiratory-Gated Transcutaneous Auricular Vagus Nerve Stimulation for the Treatment of Non-Motor Symptoms in Parkinson's Disease

The goal of this clinical trial is to compare the effects of different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS) on non-motor symptoms in people with Parkinson's disease. The main questions it aims to answer are:

Which mode and frequency of taVNS is most effective in improving non-motor symptoms? Are there any side effects or safety concerns with different taVNS frequencies? Researchers will compare three types of taVNS: 25 Hz non-expiratory gated, 25 Hz expiratory gated, and 100 Hz expiratory gated stimulation.

Participants will:

Receive each type of taVNS in three 2-week cycles, with 2-month breaks between cycles Undergo neuropsychological assessments, imaging, eye-tracking, and biological sample collection before and after each cycle.

This study employs a three-cycle crossover design to compare the effects of three different modes and frequencies of transcutaneous auricular vagus nerve stimulation (taVNS). The interventions include: 25 Hz non-expiratory gated taVNS, 25 Hz expiratory gated taVNS, and 100 Hz expiratory gated taVNS. Participants will be randomly assigned to one of three groups, with each group receiving a different intervention during each cycle, lasting 2 weeks per cycle. A 2-month washout period will be implemented between cycles to eliminate any carryover effects.The study design will include neuropsychological assessments, imaging, eye-tracking data collection, and biological specimen collection before and after each intervention.

Eligibility Criteria:
Inclusion Criteria:

* Age: 40 years or older.
* Confirmed diagnosis of Parkinson's disease (PD) per the United Kingdom Brain Bank Criteria by a neurologist specialized in movement disorders.
* Participants must be on a stable dose of all medications for at least 2 weeks, with no planned adjustments to anti-PD medications for the next 3 months.
* In the second version of the Non-Motor Symptoms Scale (NMSS-2) for Parkinson's disease, a score of ≥1 is assigned to either question 4 or question 8.
* Participants must be in good mental health and capable of completing behavioral tests and transcutaneous auricular vagus nerve stimulation.

Exclusion Criteria:

* Mini-Mental State Examination (MMSE) score \<24.
* History of head injury, stroke, or other neurological disorders.
* Includes implanted cardiac pacemakers post-DBS operation, local infections, ear loss, or metal implants at the stimulation site.
* Current use of nonsteroidal anti-inflammatory drugs (NSAIDs) or corticosteroids.
* Inability to complete follow-up assessments.
PK Study of YH22189 FDC Compared to Combination of Telmisartan/Amlodipine and Rosuvastatin

This is a Randomized, open-label, single-dose, 3-treatment, 3-period, 3-sequence crossover design.

This is a 6 by 3 cross-over study to evaluate pharmacokinetics of YH22189 FDC compared to reference telmisartan/amlodipine and rosuvastatin co-administered in three groups enrolling healthy adult male subjects under fasting conditions.

Subjects will be admitted to the clinic in the evening before Day 1. All subjects will receive a single oral dose of YH22189 FDC or telmisartan/amlodipine or rosuvastatin administered in the morning on Day 1. All the subjects will remain in the clinical unit until completion of all assessments on Day 2 including collection post-dose PK sample. Subjects will return to the clinic for pharmacokinetic samples at scheduled time. The three treatment periods will be separated by a washout period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female with a body mass index(BMI) between 18.5 and 25 kg/m2
* Who has not suffered from clinically significant disease
* Provision of signed written informed consent

Exclusion Criteria:

* History of and clinically significant disease
* A history of drug abuse or the presence of positive reactions to drugs that have abuse potential in urine screenings for drugs
* Administration of other investigational products within 3 months prior to the first dosing
* Volunteers considered not eligible for the clinical trial by the investigator (study doctor) due to reasons including laboratory test results, ECGs, or vital signs
* Sitting blood pressure meeting the following criteria at screening: 150 ≥ systolic blood pressure ≤100 (mmHg) and 100 ≥ diastolic blood pressure ≤ 60 (mmHg)
Implementation of Telerehabilitation In Support of HOme-based Physical Exercise for Heart Failure

ITISHOPE4HF is a randomized controlled trial of telerehabilitation in a heart failure population. The goal is to evaluate if a home-based telerehabilitation project can increase physical activity in heart failure patients. Patients will be provided telerehabilitation or advice on physical activity (standard care).

Outpatient cardiac rehabilitation programs are well documented as an important part of treatment and care for heart failure patients. Training with instruction gives the participant a commitment to participate. The result is increased activity compared to controls.

This trial will include participants from the about 75 % of heart failure patients who for some reason do not participate in regular outpatient rehabilitation. Distance to rehabilitation centers and the psychological burden of a group setting are believed to be important reasons for not participating. Telerehabilitation can hopefully overcome these hurdles for many patients, and thereby provide instructed training for these patients.

The trial will also include patients with renal disease. Heart disease is the main cause of death in patients with renal disease, even at younger ages. Because of the complexity of both optimal medical treatment and fluid balance, these patients are often not included in clinical trials. The cardiorenal crosstalk will be explored, how in influence the heart failure phenotypes and the response to exercise.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure (HFpEF or HFrEF) according to European guidelines.
* Moderate or severe signs and symptoms of heart failure (NYHA II-III) in the 6 months prior to enrolment.
* N-terminal pro brain natriuretic peptide (NT-proBNP) \> 300 pmol/L.
* Stable (\> 4 weeks) medical therapy for risk factor control.
* Capability to provide signed, informed, written consent.

Exclusion Criteria:

* Attendance at a rehabilitation program in the 6 months prior to enrolment.
* Non-heart failure causes of heart failure symptoms (significant valvular disease, coronary disease available for revascularization, uncontrolled hypertension, arrhythmia).
* severe or very severe pulmonary disease (eg. COPD GOLD III-IV).
* presence of conditions which might prevent patients from safely exercising at home.
ENAC Blockade and Arterial Stiffness

To determine whether treatment with the ENaC inhibitor, amiloride, improves endothelial function and arterial stiffness in obese insulin resistant subjects in a randomized placebo-controlled trial examining pre and postmenopausal women and age-matched men.

Overweight/obese males, pre- and post-menopausal females with insulin resistance, 30-70 years of age will be recruited. Following screening, eligible men and women will be randomly assigned to either amiloride (max dose 5mg) or placebo in a double-blinded design manner.

After randomization, subjects will be scheduled for an outpatient visit to the undergo baseline assessment of arterial stiffness (carotid femoral pulse wave velocity - cfPWV) and endothelial function (brachial popliteal artery flow mediated dilation). Subject assessment will be repeated at 12 weeks and at 24 weeks.

Eligibility Criteria:
Inclusion Criteria:

* 30 to 70 years of age at randomization
* Body mass index (BMI) 25.1-50 kg/m2 or waist circumference \> 88 cm (\> 35 in) in women and \>102 cm (\>40 in) in men. 3, 4
* One other characteristic of metabolic syndrome (elevated triglycerides ≥150 mg/dl; HDL cholesterol \<40 mg/dl in men and \<50 mg/dl in women; blood pressure ≥130/85 mm Hg or treatment for hypertension; impaired fasting glucose (≥100 mg/dl)) or fasting insulin level \>10 mU/L (correlates with insulin resistance).

Exclusion Criteria:

1. History of type 1 or type 2 diabetes
2. Known cardiovascular events within the last 12 months (stroke, acute coronary event, revascularization, heart failure hospitalization).
3. History of uncontrolled thyroid disease, chronic liver disease (cirrhosis) or GFR \<50 ml/min.
4. Use of potassium sparing medications (angiotensin II receptor blockers, angiotensin converting enzymes inhibitors or mineralocorticoid receptor blockers) or use of potassium supplements.
5. Active cancer (This criterion does not apply to those subjects with basal cell carcinoma or stage 1 squamous cell carcinoma of the skin)
6. Excessive alcohol consumption (\>14 drinks/week for men, \>7 drinks/week for women)
7. Current tobacco use
8. Non controlled hypertension
9. Participation in regular exercise \> 3 days/wk per week at a moderate or vigorous intensity
10. Pregnancy or lactation in women (or women not using contraceptives)
11. Women who plan to become pregnant during the duration of the trial
12. Chronic use of NSAIDs
13. Potassium level \> 5.0 mqE/L at time of screening
14. Blood pressure at screening \<110/70
The Effects of a Relaxation Intervention on College Students' Social-emotional Competence

Objective: To examine the impact of a psychomotor relaxation program on college students' social-emotional competence, personal and professional development. Participants: Twenty female college students participated. Methods: In this non-random one-group repeated measures study with a mixed approach (quantitative and qualitative analysis), participants were tested on two occasions 4 weeks apart (baseline measure), and then engaged in the psychomotor relaxation program twice weekly for 8 weeks. Participants were tested again after the intervention program (post-test).

This was a non-random one-group repeated measures study with a mixed approach (quantitative and qualitative analysis), where participants served as their own controls.

The investigators examined the chronic effects of the intervention program, collecting the instruments online at week 1 (pretest 1) and week 5 (pretest 2), to establish the baseline measures, and at the end of the 8-week period (post-test). In the post-test evaluation, participants also completed the questionnaire with open-ended questions. Investigators also measured salivary cortisol at the beginning and end of the 1st and the 15th sessions to evaluate the acute effects of the intervention program.

Students participated in a psychomotor relaxation program comprised by two 20-minute sessions per week for 8 weeks, combining body awareness, muscle tone regulation and breathing exercises

Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 30 years old
* not having participated in a similar intervention program within the last 6 months
* not have a physical condition that can affect participation in the program
* do not take medication that can influence the studied outcomes.

Exclusion Criteria:

* age under 18 or over 30 years old
* have participated in a similar intervention program within the last 6 months
* have a physical condition that can affect participation in the program
* take medication that can influence the studied outcomes.
Immunogenicity Bridge Between an Investigational Monovalent Vaccine and the Equivalent Component of Gardasil (V501) a Quadrivalent Vaccine (V501-012)(COMPLETED)

The purpose of the study is to determine if an investigational vaccine with a single component develops an immune response that is similar to the equivalent investigational vaccine with four components to reduce cervical disease.


Eligibility Criteria:
Inclusion Criteria:

* Female with an intact uterus with lifetime history of 0-4 sexual partners

Exclusion Criteria:

* Prior Human Papillomavirus Vaccine (HPV) vaccination;
* Prior abnormal paps;
* Prior history of genital warts
AVANTAGE® RELOAD Double Mobility Acetabular Cup -Clinical Study

This is a Post Marketing Clinical Follow Up study (PMCF) on the AVANTAGE RELOAD dual mobility system cup.

The study objective is to document the patients' survivorship at 10 years and evaluate the performances at 3 months, 1, 2, 3, 5, 7 and 10 years post-surgery of the AVANTAGE RELOAD cup. Secondary objective is to evaluate the polyethylene wear between E1 and ARCOM.

500 patients was the enrollment goal with 2 subgroups.

* Subgroup 1: prospective and non-controlled to satisfy ODEP (Orthopedic Device Evaluation Panel) requirements;
* Subgroup 2: randomized and controlled to compare the polyethylene wear between the Arcom and the E1 liners.

Eligibility Criteria:
Inclusion Criteria:

* Selection of subjects for this evaluation should be in accordance with the indications of the AVANTAGE® RELOAD with E1™ or ArCom™ liner specifically

  * Primary osteoarthritis
  * Post-Traumatic arthritis
  * Inflammatory joint disease (e.g. Rheumatoid arthritis)
  * Femoral neck fracture
  * Femoral head necrosis
  * Sequelae from previous hip surgery, osteotomies, etc.
  * Congenital hip dysplasia

Additional inclusion criteria include:

* Male or female
* 18 years of age or older
* Subjects willing to return for follow-up evaluations
* Subjects who read, understand study information and give written consent (specific local regulatory requirements)

Exclusion Criteria:

* Exclusion criteria should be in accordance with Contraindications for the AVANTAGE®

RELOAD:

Absolute contraindications include:

* Infection
* Sepsis
* Severe muscular, neurological or vascular deficiencies of the extremity involved
* Bone destruction or poor bone quality

Additional contraindications include:

* Subjects unable to co-operate with and complete the study
* Dementia and inability to understand and follow instructions
* Neurological conditions affecting movement
* Patient over 18 under law supervision
Acceptance and Mindfulness for Exercise in Anxiety

Anxiety is a common experience, with the U.S. lifetime prevalence of any anxiety disorder at 28.8%. Exercise has shown large effect sizes relative to controls in reducing mood and anxiety symptoms. An anxious population generally has more difficulty when beginning or increasing an exercise regimen, due to a higher level of sensitivity to discomfort. Mindfulness practices may be helpful in improving adherence to an exercise program. A similar study has shown that mindfulness may reduce perceived effort and make exercise more enjoyable. Furthermore, mindfulness has been shown to be an effective intervention in reducing anxiety and physical discomfort. The investigators intend to use a brief intervention incorporating strategies of mindfulness and Acceptance and Commitment Therapy (ACT) in conjunction with exercise to ease the transition into regular/increased physical exercise. Measures of anxiety sensitivity and perceived stress will be included to measure whether they change, and their possible effect as moderating variables on exercise adherence.


Eligibility Criteria:
Inclusion Criteria:

* Students who are enrolled in Psychology 301 at the University of Texas at Austin, as well as adult and student volunteers recruited from the University of Texas at Austin campus and the greater Austin community, who are 18-65 will be eligible for this study.
* Participants must exercise less than 150 minutes per week doing moderate-intensity exercise consistently within the last two months.
* They will have at least mild anxiety, as measured with either a minimum score of 8 on the Beck Anxiety Inventory, or 5 on the Generalized Anxiety Disorder-7.

Exclusion Criteria:

* Those that are at moderate or high risk based on the pre-participation exercise health screening by the American College of Sports Medicine, or any participants that have been advised to not participate in exercise or aerobic activity by a qualified medical provider.
* Those with cardiovascular or pulmonary diseases, immunological diseases, neurological disorders, or have serious bone or joint problems.
* The Beck Depression Inventory's item on suicidality will be actively checked for a response of 2 or 3, with further screening given to those participants using questions from the C-SSRS to screen for current suicidal ideation and past suicidal behavior. Participants who endorse imminent intent or a plan to act on suicidal thoughts will be immediately referred to one of the IMHR's psychologists, or 911 will be contacted if they are at immediate risk of suicidal self-harm. Participants endorsing intent or a specific plan will not be included in the study. Participants expressing suicidal thoughts without imminent intent or a specific plan will be given resources to pursue mental health treatment.
Impact of VeinViewer® Vision to Guide Peripheral Venipuncture in Geriatrics

Peripheral venipuncture is a common procedure in geriatrics. This procedure due to altered cutaneous alteration and venous capital associated with age poses problems of comfort and quality of life of elderly patients hospitalized. There is little data from the literature that highlights the difficulties of venipuncture in the context of old age. New venous visualization technologies by infrared spectroscopy (NIR) such as VeinViewer® Vision (VVV) have been developed to guide the placement of a peripheral venous (VVP) or venipuncture (PV) route.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 75 years and over
* Patient hospitalized in a department of acute geriatrics, whose venipuncture was prescribed

Exclusion Criteria:

* Patient not affiliated to a social security scheme
* Patient under legal protection