cyrilzakka/clinical-trials huggingface dataset:
The Safety and Efficacy of Adjunct Carvedilol in Children With Moderate Heart Failure

We would like to see if using Carvedilol in adjunct with Ace inhibitors will increase ejection fraction of the heart under echo. All interpretation of data will be sent to Boston Children's Hospital to be reviewed, which is the primary research center in this study. There are 5 hospitals participating in this study. The population targeted are children with moderate heart failure and must be on Ace inhibitors at the time of enrollment. Our outcome after placing them on Carvedilol is to change their ejection fraction on echo. The patients will be seen every 1-2 weeks, while we will titrate their medication to a maintenance dose. Secondary outcome is to increase quality of life, exercise tolerance and decrease their symptom scores as noted on their questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Etiology of heart failure in Group 1 or Group 2
* Moderate heart failure as evidenced by ventricular shortening fraction \<= standard deviations below the mean, or ejection fraction \<= 40% d) documented shortening fraction or ejection fraction that meet criteria for greater than 3 months
* Standard medical therapy include ACE inhibitors plus or minus diuretics plus or minus digoxin; all efforts will made to maximize therapy prior to entry. Medication doses must be stable for 3 months prior to entry
* Willingness to comply with followup testing
Evaluation of the Immunopharmacology of EDP1815 and EDP2939

A single-center, randomized, double-blind, placebo-controlled, multiple dose platform trial.

This study will evaluate the pharmacodynamic effects of multiple doses of EDP1815 and EDP2939 on immunological responses to keyhole limpet hemocyanin (KLH) and imiquimod (IMQ) dermal challenges in healthy volunteers.

EDP1815 is an essentially non-live, specific strain of Prevotella histicola, a natural human commensal organism. EDP2939 is a pharmaceutical preparation of microbial extracellular vesicles.

Four cohorts of volunteers (n=18 per cohort) will be studied using different capsule formulations and doses, administered for 60 days. Volunteers will be immunised with intramuscular KLH. Intradermal KLH re-challenge and topical IMQ challenge will commence on Day 57 with serial pharmacodynamic assessments to Day 60. Responses will be evaluated using dermal imaging (laser speckled contrast imaging; LSCI, and multi-spectral photography), as well as dermal and systemic immunological biomarkers.

Eligibility Criteria:
Key Inclusion Criteria:

* Capable of giving signed informed consent, and willing to comply with requirements of the study.
* Age 18 years to 45 years, inclusive.
* Body mass index of 18 to 35 kg/m2, inclusive.
* Caucasian.
* Healthy based on medical history, physical examination, blood pressure, ECG and blood and urine laboratory tests.

Key Exclusion Criteria:

* Use of Aldara® (imiquimod cream) within 3 weeks prior to the study.
* Has previously received Immucothel® or KLH.
* Allergy to Alhydrogel® or Aldara® (imiquimod cream).
* Current or recurrent skin diseases affecting the arms or back, or extensive tattoos in these areas.
* Previous diagnosis of psoriasis.
* History of pathological scar formation (e.g. keloid scar).
* History of skin cancer (basal cell carcinoma, squamous cell carcinoma, melanoma).
* Significant bowel disease (e.g. inflammatory bowel disease, coeliac disease)
* Currently has an infection or has needed antibiotics within 6 weeks before the study.
* Current smoker of more than 5 cigarettes per day
* Tanning due to sunbathing, excessive sun exposure or a tanning booth within 3 weeks before start of the study
* History of Schistosomiasis.
PNF Technique in Adhesive Capsulitis

Adhesive capsulitis is painful movement restricted condition linked with pain, restricted range of motion and difficulty in performing daily life activities. Multiple treatment options are there for its treatment. However, role of peripheral neuromuscular facilitation in this regimen is still under consideration.

Adhesive Capsulitis or peri-arthritis or Frozen Shoulder is self-limiting condition of unknown etiology that usually affects middle aged population of 40-70 years and rarely it occur secondary to rheumatoid arthritis, osteoarthritis, trauma or immobilization of shoulder joint. It is characterized by development of dense adhesions, capsular thickening and restrictions which limits active and passive shoulder range of motion (ROM) with scapular dyskinesia.The aim of the of the study is to investigate the effects of scapular proprioceptive neuromuscular techniques with routine physical therapy on pain, scapular dyskinesia, shoulder ranges of motion and functionality in patients with adhesive capsulitis. Proper functioning of upper extremities requires both motion and stability of scapula on thorax. Prolonged immobilization of shoulder joint leads to ankylosis of joint and scapular dyskinesia. This study will help with a positive effect by using a non-invasive, less painful, cost effective and time saving approach of scapular proprioceptive neuromuscular facilitation techniques among joint mobilization and other therapeutic approaches like intra articular injections and manipulation under anesthesia on alleviating pain, muscle strength, shoulder ranges of motion and early restoration of normal functioning of shoulder joint.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed cases of stage II \& III adhesive capsulitis
* Referred by orthopedic physician
* Duration of stage approximately 1 month
* Both male and female
* Age: 40-70 years

Exclusion Criteria:

* Recent history of trauma
* Dislocation or fractures of shoulder
* History of diabetes and hypertension
* Congenital shoulder deformity
* Previous surgery patients
* Patients with diagnosed cardiovascular disease
* Patients with malignancy
Study Evaluating the Effect on Gastroduodenal Mucosa of PA32540, PA32540 and Celecoxib, and Aspirin With Celecoxib

We will evaluate the effect on the gastroduodenal mucosa from oral dosing of three different treatments


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or non-pregnant female subjects greater than or equal to 50 years as well as other standard inclusion criteria for a study of this nature

Exclusion Criteria:

* Standard exclusion criteria for a study of this nature
WISE Cortical Strip for Intraoperative Neurophysiological Monitoring

The WIN Study is a prospective, interventional, multi-center, open-label premarket study designed to confirm the safety, performance and intended use of the WISE Cortical Strip (WCS) for CE certification purposes. Participants with documented diagnosis of epilepsy or brain tumor requiring intracranial surgery, who meet all eligibility criteria, will undergo IntraOperative Neurophysiological Monitoring (IONM) during a neurosurgical intervention with the WCS and a comparator device.

The IONM is the use of electrophysiological methods to identify important neural structures in the operative field, including eloquent areas, in order to monitor their functional integrity during the neurosurgical lesion resection. The benefit of performing functional monitoring of the areas surrounding the lesion is to minimize neurological damages during surgical lesions resection and thus to avoid and/or limit significant post-operative impairments. During the therapeutic resection of brain tumors or epileptogenic lesions, the use of the IONM is associated to other intraoperative techniques (e.g. brain mapping techniques) that, together to combined efforts of a multidisciplinary team of neurosurgeons, neuroradiologists, neuropsychologists, and neurophysiologists, contribute to the definition of location, extension, and extent of functional involvement that a lesion causes in an individual participant.

The principal electrophysiological methods to perform the IONM are the recording of brain's electrical activities (Somatosensory Evoked Potentials, SEPs and ElectroCorticoGraphy, ECoG) and electrical stimulation of motor regions (to elicit Motor Evoked Potentials, MEPs) using cortical strips placed on surface of the brain.

Thus, the WCS is intended to be used intraoperatively on the brain surface, to perform brain monitoring.

Eligibility Criteria:
An Observational Study on Epithelioid Sarcoma

Prospective Italian study aimed to provide a description of the population affected by Epithelioid Sarcoma (ES)

The present prospective national study aims to provide a description of the population affected by ES, an insight into the natural history of the disease and an answer some on the outstanding questions on its management. Also, it will focus on enhancing any differences between the two ES variants (classical-type and proximal-type) in order gain a better understanding of the disease, tailor the treatment and lastly improve outcome.

Eligibility Criteria:
Inclusion criteria

1. Histological diagnosis of epithelioid sarcoma according to 2014 World Health Organization (WHO) classification, performed on biopsy or surgical specimen
2. Signed informed consent
3. Adequate patient compliance to treatment or follow up
4. No age limit

Exclusion criteria

1. Other malignancies within past 5 years, with exception of carcinoma in situ of the cervix and basocellular skin cancers treated with eradicating intent
2. Impossibility to ensure adequate compliance
Examining Choice Architecture for Genetic Testing Decisions

The goal of this application is to gain a deeper understanding of decision-making for genetic testing and identify effective choice-architecture-based strategies to improve decisions in genetic testing. The investigators hypothesize that choice architecture (i.e. framing) affects decision-making for hypothetical genetic testing scenarios.

After providing opt-in electronic consent, eligible consented participants will be randomized to one of two hypothetical genetic testing scenarios (rare, life-altering genetic condition or common, life-threatening genetic condition). The genetic testing scenarios include brief detailed information about genetic testing (i.e. how results may influence treatment decisions) as well as information about standard approaches to treatment. Subjects will be randomized to receive a framing conditions (e.g. choice, opt-in, opt-out, enhanced choice). Participants will select a preferred testing option to the hypothetical scenario and will complete several validated instruments.

Eligibility Criteria:
Inclusion Criteria:

* Adult participants (18-64 yrs) residing in North America (who are members of the Amazon Mechanical Turk platform)

Exclusion Criteria:

* age \<18yrs or \>65yrs or residing outside of North America
Concept Map on Toxic Stress in Newborns

This study will be conducted as a single-blind randomized control group intervention trial to examine the effect of using concept maps on the students' knowledge levels about toxic stress in newborns, which is explained to second-year nursing students.

The Newborn Toxic Stress Knowledge Test (1st Test) will be administered to intervention and control group students who agree to participate in the research, before the 4-hour High Risk Newborn theoretical lecture. Training on Toxic Stress in Newborns will be given to both groups, and then a post-training knowledge test (2nd Test) will be administered. The initiative group will be composed of students who apply concept maps and make in-class maintenance plans after theoretical training. The control group will consist of students who receive theoretical training and implement in-class care plans. After the concept map application, a knowledge test will be applied again (3rd Test).

The data of the research will be collected with the Personal Information Form and Newborn Toxic Stress Information Test.

The personal information form was prepared by the researchers. In shape; There are questions about the student's age, gender, secondary school graduation status, whether they choose the nursing profession willingly, whether they consider the nursing profession suitable for themselves, whether they have heard the term concept map and whether they have applied concept map.

Newborn Toxic Stress Information Test was prepared by researchers. The test consists of 25 multiple choice questions. It consists of true, false and I don't know options.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the course
* Had not taken this course before
* Accepted to participate in the research

Exclusion Criteria:

* Have any records of absence
* Taken this course before
* Graduate of health vocational high school
Evaluation of Prehabilitation as a Strategy to Minimize Surgical Risk in Pancreatic Surgery: Efficacy and Determining Factors.

Several studies in major abdominal surgery demonstrated that preoperative optimization of surgical patients through prehabilitation is associated with fewer postoperative complications. However, patients' response to preoperative optimization is unpredictable, and there are no studies confirming the real benefit in pancreatic surgery.

Aims: To assess the benefits of pre-rehabilitation in pancreatic surgery, and identify those factors associated with an effective optimization. Secondary aims: impact of prehabilitation on nutritional status, sarcopenia, quality of life, inflammation markers, postoperative complications and hospital stay compared to low-risk patients.

Design: An objective multimodal assessment will be performed on those patients who are candidates to pancreaticoduodenectomy (PD) to identify patients at high-risk of postoperative complications. These patients will undergo prehabilitation and response will be evaluated. Intervention:Multimodal Prehabilitation will include:

1. Physical and cardiopulmonary training followed by a personalized program according to basal aerobic capacity, patient circumstances and compliance, community-based and remote-controlled with information and communication technology (ICT).
2. Personalized nutrition program adapted to the underlying disease (exocrine insufficiency, cachexia and sarcopenia, diabetes).
3. Treatment of anxiety and depression.

Subjects: 56 consecutive patients who are high-risk candidates (anaerobic threshold 11ml/kg/min at CPET) for PD recruited at Hospital Clinic of Barcelona. Postoperative variables will be compared to low-risk patients evaluated during the same study period.

Analysis:

The main variable will be aerobic capacity (VO2max, AT). Secondary variables (before and after the program) will be nutritional status, sarcopenia, quality of life, inflammation markers and immune response, hospital stay, complications, 90-days mortality and costs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients eligible for pancreatic surgery (PD) who are considered high risk based on the findings of the CPET (anaerobic threshold, AU \<11ml/kg/min) (Older P et al. Crit Care. 2004;8:369-72) and accepted as candidates for said surgery by the multidisciplinary committee of our Institution.

Exclusion Criteria:

* Non-elective surgery;
* Palliative surgery;
* Unstable respiratory or cardiac disease;
* Locomotor or cognitive limitations that prevent adherence to the program;
* Refusal to participate in the study.
A Study to Investigate the Safety, Tolerability and Preliminary Efficacy of NGI226 Microparticles in Patients With Achilles Tendinopathy

The purpose of this study is to measure local and systemic safety and tolerability as well as improvement of Achilles tendon mechanical properties after a single peritendon injection of NGI226 MP in comparison to placebo MP in patients with mid-portion Achilles tendinopathy.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent must be obtained prior to all study specific screening procedures, as close to the start of the screening period as possible.
* Presence of clinically (local Achilles tendon pain on tendon-loading activities, pain on palpation at the level 2-6 cm proximal to the calcaneal insertion) and ultrasound (local tendon thickening with hypoechogenicities and irregular fibre orientation) or MRI diagnosed mid-portion Achilles tendinopathy with symptoms present ≥8 weeks but \<12 months at screening.
* The Achilles tendinopathy must have been refractory to at least 6 weeks of conservative treatment (physiotherapy, NSAIDS, RICE), but participants do not need to be in physiotherapy at the time of study entry.

Exclusion Criteria:

* Medical condition that would affect safety of peritendon injection (e.g., peripheral vascular disease, use of anticoagulant medication)
* History of recurrent, acute, symptomatic infections, including outbreaks of oral or genital herpes (\> 2 symptomatic infections or \>2 courses of anti-infective treatments required in the last 6 months; active systemic infection during last 2 weeks; known active infections (e.g. chronic or active Hepatis B or C, HIV) - simple cold excluded
* History or evidence of clinically significant cardiac or cardiovascular disease
* History of deep vein thrombosis, pulmonary embolism or evidence of primary or secondary hypercoagulable states
* History of surgical intervention for the treatment of tendinopathy, history of ankle surgery, ankle arthritis, traumatic, inflammation or deformity of ankle
* History of full-thickness tear or complete rupture of the Achilles tendon
A Study to Evaluate the Drug-drug Interaction and Safety Between "BR6001-1" and "BR6001-2"

The purpose of this clinical trial is to evaluate the drug-drug interaction and safety between "BR6001-1" and "BR6001-2" in healthy adult volunteers


Eligibility Criteria:
Inclusion Criteria:

* Those who weigh 50 kg or more and have body mass index (BMI) within the range of 18.0 to 30.0kg/m² at screening visit.
* Those who sign written consent spontaneously to follow the study directions after listening to and understanding sufficient explanation of this clinical trial.

Exclusion Criteria:

* Those who have a medical history of gastrointestinal diseases(Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (Except for simple appendectomy, hernia surgery) that may affect the absorption of investigational products.
* Those who have hypersensitivity reaction to investigational products or their additives in addition to other painkillers, anti-inflammatory drugs, antirheumatic drugs, benzimidazole.
* Those who have a history of clinically significant hypersensitivity reaction.
* Those taking anticoagulants, atazanavir, Rilpivirine and methotrexate.
* Those who eat an abnormal food that may affect the absorption, distribution, metabolism and excretion of investigational products or who eat food that may affect drug metabolism.
* Those who take any prescription drugs(including herbal medicines) that may affect characteristics of investigational product within 14 days prior to the date of first administration or who take any over-the-counter (OTC) drugs or vitamins within 10 days prior to the date of first administration (however, if it don't affect subject's safety and study's result according to the judgment of the investigator, they may participate in the study.)
* Those who take inducer and inhibitor of drug metabolizing enzymes such as barbiturates, etc. within 1 month prior to the first administration
Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen

Phase 3b, single arm, simplification study with dual therapy including Lamivudine (300 mg QD) plus Raltegravir (1200 mg QD) in virologically suppressed HIV-1 infected patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen.


Eligibility Criteria:
Inclusion Criteria:

* Eligible patients will be males or females at least 18 years of age. Women of childbearing potential must have a negative pregnancy test within 10 days prior to randomization into the study.
* Patients seropositive for HIV-1 using standard diagnostic criteria.
* Patients experiencing inconvenience, toxicity, negative impact on comorbidities or risk of drug-drug interactions with their current regimen
* Patients virologically suppressed during at least 12 months prior to inclusion (viral load \<50 copies/mL).
* Patients who have signed informed consent to participate in the study.

Exclusion Criteria:

* Pregnancy, lactation, or planned pregnancy during the study period.
* Previous failure to an integrase inhibitor-containing regimen.
* Previous failure to a Lamivudine or Emtricitabine-containing regimen.
* Resistance mutations to Lamivudine or integrase inhibitor if any resistance test had been previously performed.
* Any disease or history of disease which, in the opinion of the investigator, might confound the results of the study or pose additional risk to patient treatment.
* Chronic hepatitis B.
ReActiv8 Implantable Neurostimulation System for Chronic Low Back Pain

The purpose of this trial is to evaluate the safety and efficacy of ReActiv8 for the treatment of adults with Chronic Low Back Pain when used in conjunction with medical management.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥22 years, ≤75 years
2. Chronic Low Back Pain that has persisted \>90 days prior to the baseline visit.
3. Continuing low back pain despite \>90 days of medical management.
4. Qualifying pain score.
5. Qualifying disability score.
6. Evidence of lumbar multifidus muscle dysfunction.
7. Be willing and capable of giving Informed Consent.
8. Ability to comply with the instructions for use and to operate ReActiv8, and to comply with this Clinical Investigation Plan.
9. Suitable for ReActiv8 surgery as determined by the implanting physician prior to inclusion.

Exclusion Criteria:

1. BMI \> 35
2. Back Pain characteristics:

   1. Any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of scoliosis.
   2. Lumbar spine stenosis, as defined by an anterior-posterior diameter of the spinal canal of \<10mm in subjects with lower extremity pain.
   3. Neurological deficit possibly associated with the back pain (e.g. foot drop).
   4. Back pain due to pelvic or visceral reasons (e.g.: endometriosis or fibroids) or infection (e.g.: post herpetic neuralgia).
   5. Back pain due to inflammation or damage to the spinal cord or adjacent structures (e.g. arachnoiditis or syringomyelia).
   6. Pathology seen on MRI that is clearly identified and is likely the cause of the CLBP that is amenable to surgery.
   7. Back pain due to vascular causes such as aortic aneurysm and dissection.
3. Any current indication for back surgery according to local institutional guidelines, or has indication for back surgery but cannot undergo surgery for other reasons.
4. Leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee.
5. Source of pain is the sacroiliac joint as determined by the Investigator.
6. Drug use.
7. Surgical and other procedures exclusions.
8. Any prior diagnosis of lumbar vertebral compression fracture, lumbar pars fracture, or lumbar annular tear with disc protrusion that is amenable to surgery.
9. Planned surgery.
10. Co-morbid chronic pain conditions.
11. Other clinical conditions.
12. Psycho-social exclusions.
13. Protocol compliance exclusions.
14. General exclusions.