cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effectiveness of Dry Needling Versus Foam Roller

To compare the effects of dry needling and Foam roller in myofascial trigger points. Needling has been shown to decrease pain in the short term; however, its effects on muscle force production are unclear. There are differences between dry needling and foam roller after treatment?

Background: It has been shown that the decrease of the range of motion in the ankle, due to the presence of latent trigger points in the gastro-sole complex, can affect performance, as well as being a predisposing factor to injury. Objective: To compare the effects of Dry Needling and Foam roller in healthy athletes with limited dorsal ankle flexion by the presence of latent trigger points. Material and methods: This is a clinical trial, single-blind experimental study. The sample will have a total of 44 students, volunteers, healthy of the degree of physiotherapy of the the investigator's university (UCV). Participants who meet the inclusion criteria will be randomly assigned in two groups: Group 1 or Dry Needling (N = 22) and Group 2 or Foam Roller (N = 22). The range of motion of ankle will be assessed through the Leg Motion system (Check Your Motion®, Albacete, Spain). Assessed thought Ankle Test (post-intervention and 24 hours later). The reference values to consider the decreased ankle ROM will be \<11.5 cm, \<35º measured with Easy Angle® digital goniometer (Meloq AB, Sweden) and/or if it has a difference of 1.5 cm between both extremities. Thus, the effect on previous activity performance will be assessed thought the Counter Movement Jump. Data analysis: Once the distribution of the sample is determined, a descriptive analysis of the data will be carried out and an ANOVA of repeated measures. Will be used to compare the data found in the two groups that make up the study taking into account a 95% CI and an error less than 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Students of physiotherapy degree of the university
* All participants who present restriction on active ankle dorsiflexion (\<35º).
* They must be diagnosed through manual therapy of latent PG in the gastro-soleus complex.

Exclusion Criteria:

* Subjects suffering from belonephobia
* Pathology of connective tissue
* Coagulation problems
* Lymphatic disorders
* Diabetes
* Surgical history in the lower limb (last 12 months)
* Prior treatment with dry needling (last 6 months)
An Evaluation of Actigraphy as an Indicator of Sleep and Wake in Children

The purpose of this study is to learn how well an instrument called an Actiwatch-2 can determine whether a child is asleep or awake. The Actiwatch-2 (manufactured by Minimitter/Respironics of Bend, Oregon) is the brand name for an actigraphy monitor; that is, a motion sensor that is typically worn on the wrist and looks like a wrist watch. It measures and records the amount of movement a person makes each minute. After being worn overnight, data are transferred from the Actiwatch to a computer, and a program estimates whether a person is awake or asleep by analyzing the recorded movement data. The enrollment target is 80 participants. Although other actigraphy equipment has been used to monitor sleep in children, the Actiwatch-2 has not been validated in the pediatric population.


Eligibility Criteria:
Inclusion Criteria:

* Children (ages 6 months to 18 years) who are undergoing a medically necessary sleep study \[polysomnography (PSG)\] in the OHSU Sleep Disorders Laboratory
* ASA classification I and II (children in good health)

Exclusion Criteria:

* ASA classification III, IV (children with a chronic or severe disease).
* Children with developmental delay.
* Children born extremely prematurely (before 32 weeks gestation), as these children and their parents may react differently to experimental procedures
* Children who do not speak English or whose parents do not speak English.
Magnetic Resonance Imaging in Myocarditis

The purpose of this study is the assess the diagnostic performance of magnetic resonance imaging in patients with suspected myocarditis by applying different imaging sequences at different MR scanners

In patients with clinical suspicion of myocarditis biventricular endomyocardial biopsy is performed for definite diagnosis. In addition, patients undergo magnetic resonance imaging at 1.5 Tesla and 3.0 Tesla within 24 hours. The imaging protocol of both scan include assessment of myocardial edema respectively edema ratio; myocardial hyperemia respectively global relative enhancement (gRE); myocardial fibrosis/necrosis respectively myocardial LE and T1 and T2 mapping sentences. Diagnostic performance of different imaging protocols as compared to the findings of endomyocardial biopsies is calculated.

The protocol also includes a follow-up MR can at 3 months.

Eligibility Criteria:
Inclusion Criteria:

Symptoms such as:

* Dyspnea or Orthopnea or
* Palpitations or
* Exercise intolerance or
* Angina

Evidence of myocardial involvement:

* ventricular dysfunction on echocardiography or
* new or persistent ECG changes
* elevated Troponin T History of viral infection

Exclusion Criteria:

* Contraindication for magnetic resonance imaging
* Impaired renal function: glomerular filtration rate ≤ 30 ml/min/m2
* Patients presenting with pregnancy
* Patients without informed consent
* Participation in another trial.
Cardioverter DefIbriIlator PlacEMent for priMary Prevention of Sudden cArdiac Death in Patients Older Than 70 Years

The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.

Rationale Although not recognized by guidelines, there is no available data demonstrating the benefit of Implantable Cardioverter Defibrillator (ICD) for primary prevention strategy of Sudden Cardiac Death (SCD) in elderly. Nevertheless, ICD are currently implanted in this population by extending the results obtained in randomized trials involving younger subjects to the elderly. Finally, if the absence of implantation in the elderly was not inferior to the implantation of such a device, the non-implantation would avoid the device-related complications and decrease the health costs.

Main objective The primary objective of DILEMMA study is to assess whether the "heart failure optimal therapy alone (HFOT)" strategy is non inferior to the "HFOT+ICD" strategy in terms of overall survival 48 months after randomization, in patients ≥ 70 years with an ICD indication for primary prevention of SCD whether there is an indication for cardiac resynchronization therapy or not.

Design This is a 2-arm parallel non-inferiority, randomized, open label, multicenter trial. 730 patients will be included over 4 years. Follow up will last 4 years.

Eligibility Criteria:
Inclusion Criteria:

* ≥70 years old,
* Left ventricular ejection fraction ≤ 35%
* NYHA class II or III
* Heart failure HFOT ≥ 3 months
* Providing informed consent
* Affiliated to a French Health Insurance system.

Exclusion Criteria:

* Enrolled in or planning to enroll in a conflicting interventional trial
* Prior unstable sustained ventricular arrhythmia requiring external cardioversion
* Myocardial infarction within the 40 days
* Coronary artery intervention (catheter or surgical) within 90 days
* History of syncope in the previous 6 months
* Advanced cerebrovascular disease
* Cognitive impairment leading to the incapacity of consent
* Any disease other than cardiac disease (e.g. cancer, uremia, liver failure), associated with a likelihood of survival less than 1 year.
* Patient under tutorship, curatorship, or legal safeguard
* Persons deprived of their liberty by judicial or administrative decision (prisoner)
Increasing Heart Healthy Behaviors in Youth With Type 1 Diabetes

This study is evaluating how to encourage teens to engage in heart healthy behaviors such as being more active or eating in a healthy way. Teens will be randomly assigned to either the usual care group or the group with education, goal-setting, and lifestyle challenges with teammates.

Specific Aim: To develop and pilot test a modular intervention to improve heart healthy self-efficacy and behaviors in teens with type 1 diabetes at elevated cardiovascular disease risk.

Intervention Objective: To evaluate the feasibility and efficacy of a psychoeducational and behavioral intervention to improve heart healthy self-efficacy and behaviors in youth with type 1 diabetes (T1D) at elevated cardiovascular disease (CVD) CVD risk.

Secondary Objective: Assess participation in challenges involving healthy eating and physical activity.

Synopsis of Study Design

Study Design: Randomized, attention-matched trial with 1:1 randomization at a single center. Subjects will be randomized in two strata, by age (14-16 years and 17-19 years).

Study Population: Teens with type 1 diabetes.

Intervention: This pilot study involves a 6-month randomized controlled trial (RCT) comparing 2 study conditions, the behavioral intervention vs. an attention control. Youth will be randomized in 2 strata, by age (14-16 years and 17-19 years). Enrollment will end after 60 participants.

The intervention group will receive 2 modules (one in in person and one by video conference) and will receive follow-up phone calls/emails by study staff 3 weeks following each visit to review education and strategies for and barriers to reaching goals. Intervention sessions must include teen; parents may attend if they wish. Challenges will occur every 2 weeks. Participants will be on teams of about 3-5 teens and the teams may change over the course of the intervention due to staggered enrollment. As team members finish the study, newly randomized teammates will be assigned.

There will be a delayed intervention for the control group with study handouts after 3 months. The control group will meet with the research assistants (RAs) for demographic and survey completion and receive reminder phone calls/emails in order to match for attention.

Eligibility Criteria:
Inclusion Criteria:

* Teens ages 14-19 years old with T1D for ≥6 months
* Current patients at Joslin Diabetes Center
* Teens will have dyslipidemia (defined as LDL ≥100 mg/dl, HDL \<40 mg/dl or triglycerides ≥130 mg/dl in past year), overweight or obesity (BMI percentile ≥85th at screening), prehypertensive or hypertensive blood pressure on day of screening visit, or A1c ≥8.0%
* Youth and parents must be English speaking, without significant learning disabilities, and intend to continue care at our center.
* Access to a smart phone with video conferencing capabilities

Exclusion Criteria:

* Participation in an interventional study within the past 3 months.
* Unwilling to comply with study procedures
* Prescribed BP and/or lipid-lowering medications (besides over-the-counter supplements)
* Contraindication to exercise
Addition of Platelet Rich Plasma (PRP) in Microfat Lipofilling (MG) in the Treatment of Cranial Flap Scars: A Randomized, Double-blind, Superiority Study

The objective is to show the superiority of the PRP + microfat (MG) mixture compared to microfat alone, in the filling of large subcutaneous depressions of the face and skull. The investigators chose to study the post neurosurgical sequelae after removal and reinstallation of the cranial flap, with, for example, damage to the temporal muscle and asymmetry of the temples or sinking of the cranial flap

This clinical superiority study will be conducted in a double-blind, randomized fashion. The follow-up of each patient will be 6 months post injection.

22 patients will be included and randomized into 2 arms: PRP + microfat or microfat alone. The primary endpoint will be assessed by a radiologist in a blinded fashion, using 3 MRI scans: the month before the procedure, the day after, and at 6 months (time at which fat resorption decreases).

Eligibility Criteria:
Inclusion Criteria:

* Men and women of age
* Desiring a procedure with an aesthetic aim
* Having a minimum of 6 months after the neurosurgical procedure for cranial flap replacement
* In the absence of need for neurosurgical revision,
* Informed consent signed by the patient
* Be affiliated with the health insurance

Exclusion Criteria:

* Contraindication to MRI
* Patients who have already undergone lipofilling at the site of interest before inclusion in the study.
* Contraindication to general anesthesia
* Considered neurosurgical revision
* Carcinological neurosurgery (With the exception of benign tumors with complete excision and/or non-evolving residue requiring no further treatment)
* Healing of the site of interest not acquired at the 1st consultation
* BMI \> 35
* Thrombocytopenia\< 150 G/L
* Thrombocytosis \> 450 G/L
* Known thrombopathy
* HB anemia \< 10g/dl
* Active HIV1 and 2 infections, Agp24, HCV Ac, HbS Ag and AcHbc, HTLV I and II Ac, TPHA
* Chronic treatment with corticoids or NSAIDs or anticoagulant
* Immune deficiency
* Infectious diseases
* Minors
* Pregnant or breastfeeding women
* Patient participating in another clinical trial
A Trial of Paclitaxel and Bevacizumab vs. Gemcitabine, Paclitaxel, and Bevacizumab in Advanced Breast Cancer

This study will compare the cancer response to both treatments for locally advanced or metastatic breast cancer


Eligibility Criteria:
Inclusion Criteria:

* Females diagnosed with breast cancer and the cancer has spread to distant areas of the breast or organs.
* Must be able to measure the disease by specific medical parameters
* May have received breast cancer treatment in the early stage of the disease
* May be restricted in physically strenuous activity but able to carry out light work.
* Must have adequate organ function as seen in blood test results.

Exclusion

Criteria:

* Cancer that has spread to the brain.
* Unstable heart problems
* Unstable high blood pressure.
* Breast cancer treatment after the disease has considered to spread to other areas or organs.
* Unable to agree with the requirements of the study
Coronary and Structural Interventions Ulm - Transcatheter Mitral Valve Repair (CSI-Ulm-TMVR)

To evaluate the long-term results after transcatheter mitral valve repair

Patients with transcatheter mitral valve repair are followed for 10 years to demonstrate efficacy and safety.

Eligibility Criteria:
Inclusion Criteria:

* mitral valve regurgitation
* transcatheter mitral valve repair

Exclusion Criteria:

* no written informed consent
A Study to Compare the Actions in the Body of Healthy Subjects of Three Modified Release Formulations of YM178 Under Fasted and Fed Conditions With One Immediate Release Formulation of YM178 Under Fasted Conditions

The purpose of the study is to investigate how quickly and to what extent YM178 is absorbed and eliminated from the body, and how well it is tolerated, when given in three different tablet formulations (sustained release) once a day with and without food, and to compare the results with the profile of the YM178 immediate release formulation taken twice daily without food.

Subjects reside in the clinical research unit for 3 periods of 11 days each, with a washout period of at least 7 days between treatment periods. . Each subject is treated with multiple oral doses of the IR formulation (b.i.d.) under fasted conditions and, OCAS-F, OCAS-M or OCAS-S formulation (q.d.) under fasted and fed conditions (high fat breakfast).

The study is completed with a post-study visit between 7 and 14 days after discharge of period 3.

Eligibility Criteria:
Inclusion Criteria:

* Body weight between 60.0 and 100.0 kg, and BMI between 18.0 and 30.0 kg/m2

Exclusion Criteria:

* Known or suspected hypersensitivity to β-adrenergic receptor agonists or constituents of the formulations used
* Clinically significant elevation of serum creatinine or liver enzymes as evidenced by creatinine and/or abnormal serum bilirubin
* Any clinically significant history of asthma, eczema, any other allergic condition or previous severe hypersensitivity to any drug
* Any clinically significant history of upper gastrointestinal symptoms in the 4 weeks prior to the first admission to the Research Unit
* Any clinically significant history of any other disease or disorder -gastrointestinal, cardiovascular, respiratory, renal, hepatic, neurological, dermatological, psychiatric or metabolic
* QTcB interval of \>430 msec at screening (mean QTcB of two measurements\>430msec)
* Abnormal pulse rate measurement (\<40 or \>90 bpm) at the pre-study visit after subject has been resting in supine position for 5 min
* Abnormal blood pressure measurements taken at the pre-study visit after subject has been resting in supine position for 5 minutes
* Positive orthostatic test at screening i.e. any symptoms of dizziness, light-headedness etc. and a fall of \> 20 mmHg in systolic blood pressure after 2 min standing (as outlined in section 12.5) and an increase in pulse rate of ≥ 20 bpm
* History of smoking more than 10 cigarettes (or equivalent amount of tobacco) per day within 3 months prior to first admission to the Research Unit.
* History of drinking more than 21 units of alcohol per week within 3 months prior to first admission to the Research Unit
* Donation of blood or blood products (more than 400 ml) within 3 months prior to first admission to the Research Unit or plasmapheresis within 4 weeks preceding the start of this study
* Positive serology test for HBsAg, HAV IgM, anti-HCV or anti-HIV 1+2
* Subject who is not willing to complete standard FDA high fat breakfast
The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge

Whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.

Patient-reported penicillin allergies result in poor health outcomes for patients and drive inappropriate antibiotic prescribing, antimicrobial resistance and healthcare costs. Our group has internally and externally validated a novel penicillin allergy clinician decision rule (PEN-FAST) that is able to identify low risk penicillin allergies with a negative predictive value of 96% (95%; 94-98%). Therefore, whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.

Eligibility Criteria:
Inclusion Criteria:

1. Adult patients referred to the outpatient allergy clinic for a penicillin allergy history;
2. Willing and able to give consent.

Exclusion Criteria:

1. Patient age is \< 18 years;
2. Patients with a PEN-FAST score less than 3
3. Pregnancy;
4. Any other illness that, in the investigator's judgement, will substantially increase the risk associated with subject's participation in this study;
5. Patients with history of type A adverse drug reaction, drug-associated anaphylaxis, idiopathic urticaria/anaphylaxis, mastocytosis, serum sickness, blistering skin eruption or acute interstitial nephritis;
6. Patients where the allergy history was not able to be confirmed with patient;
7. Patients on concurrent antihistamine therapy;
8. Patients receiving more than stress dose steroids (i.e. \> 50mg QID hydrocortisone \[or steroid equivalent\]).
Refining Novel Culturally Tailored Behavioral Weight Loss Treatment Components for Sexual Minority Women With Obesity

Obesity disproportionately impacts sexual minority women. Behavioral weight loss programs are the gold standard treatment for mild to moderate obesity. The investigators have developed an online behavioral weight loss program that is effective, low-cost, and highly scalable. However, existing research suggests that tailoring treatment to address 3 well-established weight loss barriers in sexual minority women will be critical for maximizing the relevance and efficacy of behavioral weight loss for this group. The goal of the first phase of this K23 is to develop 3 novel treatment components targeting sexual minority women's weight loss barriers (i.e., minority stress, low social support, and negative body image), to pilot the program in sexual minority women with overweight/obesity, and to conduct individual qualitative interviews to elicit feedback on the intervention's acceptability, cultural relevance, usability, and feasibility that will be used to refine the program. After a pre-piloting phase (consisting of initial content piloting, interviews, and intervention refinement; anticipated n=12), 8 participants will pilot the full 3-month weight loss program and will be randomized to pilot 0-3 novel tailored components (targeting minority stress, negative body image, and social support) over the 3-month period. Participants will complete quantitative and qualitative assessments of intervention acceptability and appropriateness post-treatment and the intervention will be refined.


Eligibility Criteria:
Inclusion Criteria:

* Assigned female at birth and currently identify as female
* Self-identify a minority sexual orientation (e.g.,lesbian, bisexual)
* BMI\>25kg/m2
* 18-70 years old
* Interested in losing weight
* Regular internet and e-mail access
* Fluent in English

Exclusion Criteria:

* Significant weight loss within past 6 months (\>5%)
* Unable to participate in moderate physical activity
* Currently enrolled in a weight loss program
* Currently taking weight-loss medication
* Currently pregnant or trying to get pregnant
* Participated in a previous Phase of this study
* Reports a serious mental/physical health condition that would increase potential risks of treatment to the participant (e.g., active symptoms of psychosis, suicidality, mania, alcohol/substance use, or a medical condition that is serious, active, unstable, and degenerative (e.g., CHF)).