cyrilzakka/clinical-trials huggingface dataset:
Effects of Inspiratory Muscle Training on Parkinson's Disease

Parkinson's disease (PD) is a neurodegenerative movement disorder that provoke motors and non-motors symptoms causing further dependence and disability. Among non-motor issues, orthostatic hypotension (OH) is a severe manifestation of autonomic dysfunctions, occurring in approximately 30% of those with PD. The fall in blood pressure (BP) during orthostatic position (ORT) is normally compensated to maintain adequate cerebral blood flow (CBF) through autoregulation of cerebral vessels (AC). However, if AC is compromised, CBF may decrease and cause pre-syncope symptoms such as dizziness and loss of balance. Inspiratory muscle training (IMT) is a non-pharmacological strategy to improve respiratory muscle strength, cerebrovascular, cardiovascular control in several populations. However, the effects of IMT on cardiovascular autonomic control (i.e. baroreflex sensitivity-BRS), hemodynamic and AC during ORT in PD patients with and without orthostatic hypotension have not yet been studied. Our hypothesis is that IMT will increase inspiratory muscle strength and influence spontaneous breathing pattern, improving BRS. In addition, IMT will cause a smaller drop in BP and CBF during ORT. Furthermore, maintaining CBF will reduce postural instability during ORT. PD patients without and with OH (PD-OH) will participate in the study and will be randomly divided into two groups recruited at the Antônio Pedro University Hospital. The experimental group will perform 6-8 weeks of training at 30-75% of maximum inspiratory pressure (MIP), and the placebo group will perform the same training protocol at 5% of MIP (sham). The home-based protocol will be of 30 repetitions twice a day, five days a week. In active ORT test, BP, R-R intervals, stroke volume, cardiac output, respiratory rate, ventilatory variables and mean cerebral blood flow velocity (MCAv) will be continuously monitored for 10 minutes in the supine position (SUP), 10 minutes in the sitting position and then 6 minutes in the ORT position. Oscillations of the body's center of pressure (COP), through a force platform, and neuromuscular responses of the gastrocnemius and tibialis anterior muscles, through surface electromyography, will be recorded while maintaining the ORT position. The orthostatic test will be performed before and after the interventions (placebo and experimental). We believe that IMT will promote an improvement in BRS, AC, and postural control, presenting itself as a potential non-pharmacological countermeasure in autonomic dysfunctions and in the prevention of falls in Parkinson's disease.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of idiopathic PD according to Movement Disorder Society (MDS) criteria
* treatment at Antonio Pedro Hospital (HUAP) for \>6 months;
* stable Parkinson's medication for at least 30 days prior to testing.

Exclusion Criteria:

* active smokers or those who quit \<5 years ago
* pulmonary or cardiovascular complications in the past 3 months
* arrhythmias or beta-blocker use
* Both groups required spirometry values \>80% of predicted age
Cancer Parenting Program for the Enhancement of the Quality of Life of Patients With Advanced Cancer and Their Children

This trial examines the usefulness of two educational programs for parents with late-stage cancer who have a 5 - 17 year old child. The programs are designed to enhance the quality of the parent-child relationship and add to the parent's confidence in managing the impact of their cancer on their child. Educational programs may reduce anxiety and depression and improve the well-being and quality of life of parents with advanced cancers and their children.

Recruitment occurs nationally via referral to the Fred Hutch/University of Washington Cancer Consortium team.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I (ENHANCING CONNECTIONS-PALLIATIVE CARE \[EC-PC\] PROGRAM): Patients receive the 5-session EC-PC program bi-weekly with a patient educator about ways to help them talk to and support their child.

GROUP II (CONTROL): Patients receive carefully selected educational booklet that discuss ways to talk about their cancer with their child and a scripted phone call from a trained phone counselor on study.

Eligibility Criteria:
Inclusion Criteria:

* Parents with any type of late-stage, non-curable cancer (determined by TNM stage IV cancer for solid tumors or 2 or more cycles of treatment failure with disease relapse in non-solid tumors)
* All therapies are allowable
* 23 years (yr.) to 68 yr. Age restriction exists for the patient based on parent having a child ages 5-17
* Patient must have a child (5yr. -17 yr.) living in the home at least 50% of the time and residential with non-ill parent or parent surrogate
* Read and write English as one of their languages of choice
* Have access to a telephone
* Ability to understand and the willingness to sign a written informed consent document. Read and write English as one of their languages of choice

Exclusion Criteria:

* Patient is in hospice at time of enrollment
* Non-ill co-parent does not consent to join study
Irinotecan in Patients With Advanced Metastatic Breast Cancer Who Have Experienced Failure of an Anthracycline, a Taxane, and Capecitabine

The purpose of this phase II, randomized, open-label clinical trial is to study 2 schedules of single-agent Irinotecan in women with metastatic breast cancer who have experienced failure of prior therapy with an anthracycline, a taxane, and capecitabine. Patients will receive Irinotecan capsules either once each day for 5 days, or once a day for 14 days in 3 week cycles.


Eligibility Criteria:
Inclusion Criteria:

* Women with diagnosis of primary adenocarcinoma of the breast
* Presence of locally advanced or metastatic disease non-amenable to surgery or radiation therapy with curative intent
* At least one measurable lesion \>20mm (or \>10 mm with spiral CT scan)
* Must have received (and failed) prior treatment with an anthracycline, a taxane, and capecitabine in the adjuvant and/or advanced disease treatment setting
* Women at least 18 years old, with performance status 0-2

Exclusion Criteria:

* Prior treatment with another topoisomerase I inhibitor
* Current enrollment in another clinical trial
A Study to Determine the Effect of Multiple Doses of BMS-955176 on the Electrocardiograph of Healthy Subjects

The purpose of the study is to determine the effect of multiple doses of BMS-955176 on the QT interval corrected with Fridericia's method (QTcF) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Written Informed Consent
2. Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination findings, 12-lead ECG measurements, physical measurements, and clinical laboratory test results
3. Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, at screening and Day 1. BMI = weight (kg)/\[height(m)\]2
4. Women must have a negative serum pregnancy test, must not be breastfeeding, and women of child bearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period
5. Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with BMS-955176 in addition to a post-treatment completion period

Exclusion Criteria:

1. Any significant acute or chronic medical illness
2. Any GI disease or surgery that can affect absorption of the study drug
3. A personal history of clinically relevant cardiac disease, long QT syndrome, symptomatic or asymptomatic arrhythmias, presyncope or syncopal episodes, or additional risk factors for torsades de pointes (eg, heart failure)
4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
5. History of allergy to moxifloxacin, HIV maturation inhibitors, or related compounds
Visuo-Vestibular Adaptation in Virtual Reality

The vestibulo-ocular reflex (VOR) stabilizes the gaze during rapid head movements by inducing an eye rotation of equivalent amplitude but in the opposite direction to the head rotation. Normally, the ratio of eye rotation amplitude to head rotation, or VOR gain, is 1. Under some conditions such as growth or the use of corrective glasses, this gain is adapted to the new visuo-vestibular conditions. This well-known sensorimotor adaptation phenomenon can be achieved through the experimental creation of a conflict between vestibular and visual information.

Incremental velocity error (IVE) allows for a rapid adaption of the VOR at high speed by synchronously projecting a laser target that moves to create a progressively increasing visuo-vestibular conflict. However, this method does not correspond to the ecological conditions of VOR use, as the training is conducted in darkness and the visuo-vestibular conflict does not involve the entire visual scene.

Recreating this type of adaptation in a virtual reality environment could allow for adaptation with a visual stimulus involving the entire visual scene, thus more closely resembling the physiological conditions of VOR use. We hypothesize that a visual simulation of the entire scene would be more effective than an isolated target in VOR adaptation during high velocity head rotation.


Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 60
* Understanding of the experimental instructions
* Informed Consent

Exclusion Criteria:

* Underlying ENT or neurological disorders
* Corrected Visual Acuity lower than 5/10
* Other conditions leading to oscillopsia or ataxia
* Oculomotor palsy, ocular instability in primary position
* Treatment that may affect ocular motility (psychotropes)
* Cervical rachis pathology with instability
* Cochlear Implants
* Non-stabilized medical disease
* Subject suffering from debilitating motion sickness or Virtual Reality sickness
* Pregnant women
* Patients under tutelage
* Patient without social security
Safety of Transition From Selexipag to Remodulin® Then Oral Treprostinil in Symptomatic Adult PAH

This is a multicenter, single-arm trial to evaluate the safety of the transition from Selexipag to Remodulin® then Oral Treprostinil in Symptomatic Subjects with Pulmonary Arterial Hypertension (PAH). The study will include about 30 subjects at approximately 10 clinical trial centers. The treatment phase of the study will last approximately 16 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Subject has a diagnosis of symptomatic idiopathic or heritable PAH, PAH associated with connective tissue disease, PAH associated with HIV infection, PAH associated with repaired congenital systemic-to-pulmonary shunt (at least 1 year since repair with respect to the date of providing informed consent), or PAH associated with appetite suppressant or toxin use.
2. The subject must be classified as WHO FC II or III at Baseline.
3. The subject is receiving selexipag for the treatment of WHO Group 1 PAH for a minimum of 90 days from Baseline.
4. Subject is in need of escalation of therapy, as determined by the Investigator.
5. Subject must be receiving a Food and Drug Administration (FDA)-approved PDE5-I or sGC stimulator and/or an ERA and has been at the current stable dose for at least 28 days prior to Baseline.

Exclusion Criteria:

1. The subject is receiving selexipag for any other disease or condition other than the treatment of WHO Group 1 PAH.
2. The subject has a Baseline 6MWD of less than 150 meters.
3. The subject's Baseline 6MWD has decreased more than 40% from the pre-selexipag baseline.
4. The subject has a history of ischemic heart disease (defined as either symptomatic or requiring anti-anginal therapy or experienced a documented myocardial infarction within the previous 6 months of Baseline), or a history of left sided myocardial dysfunction as evidenced by a PAWP greater than 15 mmHg or a left ventricular ejection fraction less than 40%.
5. The subject has previously been treated with any parenteral prostacyclin or oral treprostinil for a period of 90 days or more.
6. The subject has a history of 1 or more of the following signs of relevant lung disease within 180 days before Baseline:

   1. Total lung capacity less than 60% of predicted normal.
   2. Forced expiratory volume in 1 second is less than 55% of predicted normal.
Effect Mechanism Investigation of a Non-invasive Stimulation Device for Rapid Alleviation of Parkinson's Disease Symptoms

Effect Mechanism Investigation of a Wearable Electrostimulator for Rapid Alleviation of Parkinson's Disease Symptoms

Activation levels of interested regions of the brain will be measured through fMRI technique prior and after the dry needling and active stimulation applications.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's Disease
* H\&Y Stage \>= 2
* Existing bradykinesia symptoms
* Existence of one of the symptoms below
* Resting Tremor
* Rigidity
* Walking disorder

Exclusion Criteria:

* Cardiac Pacemaker
* Psychiatric diagnosis
* Irregular heart/respiration rate
* Pregnancy
* Alcohol consumption
* Cardiovascular disease history
* Wearing an electro-active prosthesis
* Brain surgery history
* Ongoing TENS/PENS therapy-
High Intensity Interval Training or Strength Training in Women With Polycystic Ovary Syndrome

The aim is to investigate whether strength training or high intensity interval training is effective in improving insulin sensitivity, cardiovascular outcomes, body composition and reproductive outcomes in women with Polycystic Ovary Syndrome (PCOS).

Few studies have examined the effect of strength training alone on insulin sensitivity, reproductive outcomes and body composition in women with PCOS. Most previous studies on aerobic exercise in PCOS have applied moderate exercise intensity.


Eligibility Criteria:
Inclusion Criteria:

* Women
* Age 18-45 years old
* PCOS

Exclusion Criteria:

* Regular high intensity endurance or strength training (two or more times per week of vigorous exercise).
* Concurrent treatments (insulin sensitizers or drugs known to affect gonadotropin or ovulation, with a wash out period of 1 months prior to inclusion).
* On-going pregnancy.
What Are the Brakes and Levers of Physical Activity Practice for Patients With Chronic Lower Back Pain?

Non-specific chronic lower back pain is a common pathology which is a real public health problem. Around 84% of the population could have non-specific chronic lower back pain at least once in their lives and 8% of that non-specific lower back pain could become chronical (pain that would last at least 3 months). This proportion of patients represents 85% of the costs related to this pathology.

Physical activity practice is involved in medical care for plenty of chronical diseases and particularly for chronic lower back pain. In 2003, World Health Organization pointed out the poor adhesion of patients with chronical diseases to medical prescriptions and the after-effects it could have on illness evolution. Therefore, adhesion to physical activity practice for patients with chronic lower back pain is one of the most challenging matters for medical teams.

The aim of this study was to identify the brakes and levers of physical activity practice for these patients. Sixteen individual interviews and four focus groups have been carried out on patients with chronic lower back pain who were taken care of either by a rachis functional restoration program or by primary care.

Non-specific chronic lower back pain is a common pathology which is a real public health problem. Around 84% of the population could have non-specific chronic lower back pain at least once in their lives and 8% of that non-specific lower back pain could become chronical (pain that would last at least 3 months). This proportion of patients represents 85% of the costs related to this pathology.

Physical activity practice is involved in medical care for plenty of chronical diseases and particularly for chronic lower back pain. In 2003, World Health Organization pointed out the poor adhesion of patients with chronical diseases to medical prescriptions and the after-effects it could have on illness evolution. Therefore, adhesion to physical activity practice for patients with chronic lower back pain is one of the most challenging matters for medical teams.

The aim of this study was to identify the brakes and levers of physical activity practice for these patients. Sixteen individual interviews and four focus groups have been carried out on patients with chronic lower back pain who were taken care of either by a rachis functional restoration program or by primary care.

Eligibility Criteria:
Inclusion Criteria:

* Male or female who are at least 18 years old
* Patients with non-specific chronic lower back pain

Exclusion Criteria:

* Mental or physical disabilities incompatible with focus groups/individual interviews and filling out questionnaires.
* Inability to understand or speak French properly
* Symptomatic lower back pain
Heads up Messages to Increase Call Pick-up Rates

The study aims to investigate whether notifying health insurance members about an upcoming call can increase their pick-up rates. The study will randomize participants into three groups: control group (no message), treatment group 1 (message variation 1), and treatment group 2 (message variation 2). The primary outcome of interest is the call pick-up rate, and the study will also examine the message opt-out rates for the two different messages.


Eligibility Criteria:
Inclusion Criteria:

* The study will include members enrolled in the health insurers' Relay Texting system due to receive an outreach call during the study timeframe.
* Enrollment in the study will end when we meet our enrollment target (N=2000)
EP Device Registry

This study will provide ongoing, high quality data on the safety, performance, and clinical benefits of Abbott's EP devices in a real-world setting.


Eligibility Criteria:
Inclusion Criteria:

* Subject underwent an electrophysiology imaging (diagnostic procedure) and/or ablation procedure that used one or more Abbott devices covered by this Registry.
* Subject is willing and able to comply with the site's standard of care follow-up schedule.

Exclusion Criteria:

* Subject is currently participating in another clinical investigation that may confound the results of this Registry.
Contrast Enhanced Spectral Mammography With Digital Breast Tomosynthesis For Patients With Newly Diagnosed Breast Cancer

This pilot clinical trial studies how well contrast enhanced spectral mammography works with digital breast tomosynthesis in imaging patients with newly diagnosed breast cancer. Contrast enhanced spectral mammography uses a special dye that is injected into the veins before mammogram images are taken. Digital breast tomosynthesis uses multiple x-ray pictures to produce a 3-dimensional rendering of the entire breast. Contrast enhanced spectral mammography with digital breast tomosynthesis may highlight areas of concern within the breast in more detail than a standard mammogram and improve the accuracy of tumor size.

PRIMARY OBJECTIVES:

I. To compare the index lesion size (the largest diameter) from each of the four readings (standard of care 2 dimensional \[D\], magnetic resonance imaging \[MRI\], contrast enhanced spectral mammography \[CESM\], 3D) to gold standard index lesion size from surgical pathology (the largest diameter).

II. To document the additional ipsilateral and contralateral breast cancer lesions detected by the MRI, CESM, and 3D readings listed above.

OUTLINE:

Patients undergo a clinical breast examination and a diagnostic mammogram with or without targeted breast ultrasound to the index cancer as part of their standard of care preoperative work-up. As part of the research study, patients receive contrast agent intravenously (IV) and then undergo a CESM with digital breast tomosynthesis (DBT) over 30 minutes. Patients also receive a contrast agent, gadolinium, IV and undergo bilateral breast contrast enhanced (CE)-MRI over 10 minutes.

After completion of study, patients are followed up within 24-96 hours.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed breast cancer patients

Exclusion Criteria:

* Women with history of surgical, medical, or radiation therapy for breast cancer
* Women with renal failure or insufficiency
* Women with iodine contrast allergy
* Women with gadolinium contrast allergy
* Women who are pregnant, possibly pregnant, or lactating
* Women undergoing neoadjuvant chemotherapy
LAMA2 Genetic Correction

Merosin-deficient congenital muscle dystrophy type 1a (MDC1a), or LAMA2 muscular dystrophy (LAMA2-MD) is a severe autosomal recessive form of muscular dystrophy that is caused by homozygous or compound heterozygous mutations in the laminin alpha 2 (LAMA-2) gene. Many different LAMA-2 mutations have been reported. In most cases, MDC1a is diagnosed within the first year of life, and is characterized by hypotonia, delayed motor development and white matter abnormalities. Currently, no efficient treatment is available for this patient group. Generally, MDC1a patients with mutations causing a premature stop codon are most severely affected (early onset LAMA2-MD) and patients with missense mutations are generally affected more mild affected and more late-onset (late onset LAMA2-MD). However, large variation in disease severity and clinical course is observed, even between individuals with the same mutation, e.g. the LAMA2 c.5562+5G\>C mutation, which is frequently observed in Dutch MDC1a patients. This study aims to isolate and culture fibroblasts and myogenic stem cells called mesoangioblasts from the skin and muscle biopsies of adult LAMA2 mutation carriers to explore if genetic correction of LAMA2 mutations using CRISPR-Cas9 can be achieved and subsequently assess the effect in vitro, as a first step towards therapy development.


Eligibility Criteria:
Inclusion Criteria:

* LAMA2 mutation carriers:
* Age \>18 years
* Heterozygous or homozygous LAMA2 c.5562+5G\>C mutation
* Written informed consent

Controls:

* Written informed consent
* Age \>18 years
* No muscular dystrophy or other disease known to affect muscle morphology or function

Exclusion Criteria:

* MDC1a patients and controls:
* No informed consent
* Use of anti-coagulants, anti-thrombotics and other medication influencing coagulation
* Have a weekly alcohol intake of ≥ 35 units (men) or ≥ 24 units (women)
* Current history of drug abuse
* A history of strokes
* Significant concurrent illness
* Ongoing participation in other clinical trials
* Major surgery within 4 weeks of the visit
* Pregnant or lactating women
* Patients unable and/or unwilling to comply with treatment and study instructions
* Any other factor that in the opinion of the investigator excludes the patient from the study