cyrilzakka/clinical-trials huggingface dataset:
Enhanced Ultrasound in Determining Extent of Disease in Women With Primary Breast Cancer

RATIONALE: New imaging procedures, such as enhanced ultrasound may improve the ability to determine the extent of breast cancer.

PURPOSE: Diagnostic study of enhanced ultrasound in women who have locally advanced primary breast cancer.

OBJECTIVES: I. Measure blood flow of primary breast lesions and corresponding lymph nodes by Power Doppler Ultrasound (PDU) and compare this information with metastatic potential and patient survival in women with primary breast cancer. II. Correlate intratumor/-nodal blood flow with pathological variables using standard histology and special stains in this patient population. III. Correlate intratumor microvessel density with total tumor blood flow and with the presence of axillary lymph node metastases using this diagnostic method in these patients. IV. Correlate tumor blood flow with various markers of angiogenesis using this diagnostic method in these patients. V. Compare tumor blood flow as measured with PDU before and after contrast enhancement in these patients.

OUTLINE: This is a diagnostic study. Patients receive ultrasound contrast agent IV. An ultrasound probe with Power Doppler facility is swept over the skin surface in a standard fashion before and after contrast enhancement. Blood flow data is acquired over the volume of the mass and/or lymph nodes using a video recorder. The scanning time ranges between 5 to 15 minutes depending on the size and exact location of the breast mass and axillary lymph nodes. Within 1 week of the ultrasound, patients undergo surgery and the mass and axillary lymph nodes are removed.

PROJECTED ACCRUAL: Approximately 200 patients will be accrued for this study within 1 year.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Clinically suspected locally advanced breast cancer where treatment indicated is primary surgery (wide local excision or simple mastectomy) and axillary dissection (clearance) Inflammatory breast cancer eligible No recurrent disease Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No New York Heart Association class III or IV heart disease At least 14 days since prior myocardial infarction Pulmonary: No severe chronic obstructive pulmonary disease Other: No galactosemia No mental illness or handicap

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior neoadjuvant chemotherapy Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics At least 1 month since prior core biopsy (Tru-cut) of breast cancer
Unraveling Metabolic Involvement in Facioscapulohumeral Dystrophy Through Metabolomics

The pathogenesis of facioscapulohumeral dystrophy (FSHD), one of the most prevalent types of inherited muscle disease, is unknown. The reasons underlying its significant clinical heterogeneity, incomplete penetrance, and sex specific differences in the age of onset, are not currently understood. While metabolic changes associated with this disease have so far deserved little attention, recent studies have pinpointed significant metabolic dysregulation as an emerging driving mechanism in the pathophysiology of this untreatable disease. To test this hypothesis, we will perform a deep metabolic phenotyping in a large cohort of highly clinically characterized FSHD patients at different stage of disease and age/sex-matched controls by state-of-art plasma metabolomic and mitochondrial biomarker profiling. These data will allow attributing specific metabolomic signatures to different stages of the disease in each sex. Metabolic pathway analysis will allow gaining insights into the type of metabolic dysregulation associated with the disease pathogenesis, leading to the identification of targeted metabolic/nutritional interventions and biomarker discovery.


Eligibility Criteria:
Inclusion Criteria:

* participant fasting for at least 8 h at the time of blood sampling
* patient with a molecular diagnosis of FSHD (know number of D4Z4 contractions)
* patient with a typical FSHD presentation (at least facial, pelvic ans scapular girdles signs)
* patient with a preserved ability to ambulate at the time of the selection (use of a cane is allowed)

Exclusion Criteria:

* Severe cardiac and respiratory dysfunction.
* Presence of severe systemic diseases unrelated to FSHD.
* Presence of uncontrolled diabetes or hypothyroidism.
* Alcohol or toxic abuse.
TRAUMEEL for Pain After Fracture of Neck of Femur

We hypothesize that Traumeel S is more effective than placebo in reducing 48-hour mean cumulative morphine consumption in patients scheduled for surgical correction of fracture of neck of hip.

224 patients, meeting all inclusion and none of exclusion criteria, will be enrolled in the trial. Patients will be randomized to receive either intraoperative injection and post operative oral Traumeel S Tablets or placebo injection (normal saline) and indistinguishable oral placebo tablets. Baseline measurements of relevant outcome measures will taken preoperatively. Immediately after surgery, patients will receive an initial dose of morphine of 0.1mg/kg body weight. Patients will take the oral study medication for 21 days. Every four hours after surgery, patients will be asked to grade their pain on an NRS. Subsequent doses of morphine will be calculated based upon the patient's weight and current NRS, according to a preplanned scheme. Patients will be permitted to request additional morphine, beyond their calculated dose.


Eligibility Criteria:
Inclusion Criteria:

* Patients of either sex undergoing surgical correction of unilateral fracture of neck of hip.
* Age over 18 years.
* Signature upon informed consent form

Exclusion Criteria:

* Participation in another clinical trial within 4 weeks prior to enrollment.
* Refused to give verbal consent to the telephone interviews
* Impossibility to be reached during the 14-17 days post operative
* Inability to comply with the study protocol for any other reason
* Previous major surgical procedure on ipsilateral hip.
* Current use of analgesics for any other reason.
* A history of chronic pain syndrome.
* Abused legal or illicit drug use.
* Hypersensitivity to botanicals of the Compositae family
* Known sensitivity to paracetamol, codeine or tramadol.
The Effectiveness of Adhesive Versus Conventional Nasoalveolar Molding on Children With Unilateral Cleft Lip and Palate

The present study will compare the effectiveness of adhesive nasoalveolar molding (GS-NAM) and conventional nasoalveolar molding on the alveolar ridge, nasal, and labial growth in children with unilateral cleft lip and palate.

objectives: -

1. Evaluation of the anatomical position of the greater and lesser segments of the maxilla related to a stable midline anatomical point.
2. Evaluation of the nasal symmetry.

cleft lip and palate can manifest as an independent anomaly, be associated with a syndrome, or present as a complex condition. Unilateral clefts are notably more common, occurring nine times more frequently than bilateral clefts. Additionally, it predominantly affects males, with a male-to-female ratio of 2:1. Common clinical features in unilateral cleft lip and palate cases involve structural changes in the nose, lip, palate, and alveolar arch. Peri-oral tissues lack continuity, and on the affected side of the nose, you can observe wider nostrils and a downward-pointing alar rim. Additionally, the columella and nasal tip shift towards the unaffected or normal side, accompanied by the displacement of the maxillary alveolar segments towards the lateral side.

Conventional treatment for cleft lip and palate historically comprised numerous surgical procedures, including secondary revisions and alveolar bone grafting. However, even with these multiple interventions, concerns persisted regarding suboptimal aesthetics. Therefore, the pursuit of non-surgical treatment options that can mitigate the severity of this deformity during early life is greatly desirable. The introduction of the presurgical Nasoalveolar molding (NAM) procedure has offered an alternative, allowing for the avoidance of traditional secondary surgeries while achieving improved outcomes. . These interventions should be initiated within the narrow time frame from birth to four months, as estrogen levels decrease within the first four months after birth, making this period optimal for tissue manipulation.

Eligibility Criteria:
Inclusion Criteria:

* Age: 1- 8 weeks.
* Gender: male and female.
* Patients with a unilateral cleft alveolus and lip.
* No developmental syndromes or atypical cleft pathology in medical history.
* No previous history of unilateral CLP correction.
* Motivated parents toward the treatment.

Exclusion Criteria:

* Patients with a bilateral cleft alveolus and lip
* Syndromic patient
* Uncooperative caregiver
Left Bundle Branch Area Pacing in Heart Failure Patients With Ejection Fraction Below Normal

While cardiac resynchronization therapy remains the mainstay for advanced HF, it is not always feasible due to unfavorable anatomy of coronary sinus or pacing characteristics. In such cases, left bundle branch area pacing itself or left bundle optimized cardiac resynchronization therapy could be a rescue therapy for failed or unsuccessful biventricular cardiac resynchronization therapy. However, the efficacy and safety of left bundle branch area pacing (or left bundle optimized cardiac resynchronization therapy) as rescue therapy for biventricular cardiac resynchronization therapy is largely hypothetic and lack concrete evidence still.

Therefore, there is an unmet need for the registry purposed for left bundle branch area pacing among heart failure with mid-range (or mildly reduced) ejection fraction and heart failure with reduced ejection fraction patients to investigate its efficacy and safety.

This study aims to investigate the efficacy and safety of left bundle branch area pacing in heart failure patients with ejection fraction below normal using Selectra catheters.


Eligibility Criteria:
Inclusion Criteria:

* Patients previously diagnosed with heart failure with mid-range(or mildly reduced) ejection fraction and heart failure with reduced ejection fraction, which was documented by an appropriate echocardiographic study (Left ventricle ejection fraction \<50%), and
* Patients with indications of cardiac pacing or cardiac resynchronization therapy

Exclusion Criteria:

* Patients aged less than 19 years.
* Pregnant.
* Patients with an expected life expectancy of less than 1 year.
* Patients with a mechanical valve for the tricuspid valve.
* Patients who need atrial pacing only.
* Patients who are not capable of receiving a transvenous pacemaker for any reason.
Patient Registry to Observe Outcomes Following Implantation of the VariLift Interbody Fusion Device

The registry has been designed as a prospective, observational program for patients undergoing lumbar or cervical fusion using VariLift device with the ultimate goal to aid in the development of strategic treatment pathways and improved patient care. All patients who agree to participate in the registry will sign an informed consent form and subsequently be treated by their surgeon with the VariLift device. Potential treatment procedures include bilateral posterior lumbar interbody fusion (PLIF), unilateral transforaminal lumbar interbody fusion (TLIF), or bilateral anterior lumbar interbody fusion (ALIF) for the lumbar spine, or cervical unilateral or bilateral ACDF procedure. Surgical procedures can be performed in either an inpatient or outpatient facility. It is anticipated that the VariLift devices will improve patient outcomes and lead to the development of treatment pathways to improve patient care.

The registry is design to collect data prospectively on patients undergoing spinal fusion using the VariLift-L, VariLift-A, or VariLift-C device patients will be enrolled in the registry after reviewing the protocol with their health care provider and signing the informed consent. Data will be collected at recommended time points based on the standards of care of the participating sites. The registry will serve as a database in which retrospective analysis and exploratory analysis of specific research questions will be answered.

Follow up visits will be defined by the treating physicians based on their standard practice. Typical clinical follow up schedules for patients undergoing this type of surgery are pre-operative and 12 months post-operative.

Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing a procedure with unilateral or bilateral placement of VariLift
* This is the first surgery at the index level
* Patient has understood and signed the informed consent
* Patient is skeletally mature

Exclusion Criteria:

* Revision Surgery
* Is a Worker's Compensation Case
* Infection at the operative site
* Sustained trauma with instability
* Sustained fracture of the vertebra at any of the lumbar spinal levels
* Has a primary diagnosis of degenerative or isthmic spondylolisthesis greater than Grade 1
* Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or drug abuse)
* Has a diagnosed systemic disease that would affect the subject's welfare or overall outcome of the clinical study (i.e., moderate to severe osteoporosis, Paget's disease, renal osteodystrophy, metastasis to vertebrae, adult onset diabetes, active rheumatoid arthritis, etc.)
* Is an immunologically suppressed or receiving steroid in excess of usual doses
* Is obese (as defined by a Body Mass Index (BMI) of \> 40 kg/m2 (BMI equals (weight in pounds x 703) / (height in inches x height in inches))
* Has disabling and daily narcotic dependency greater than 18 months
* Has a known malignancy
* Has a known allergy to metal implants
Losartan and Emotion Processing

The aim of the study is to investigate the effect of losartan (50mg, single dose) on the extinction of conditioned fear

In a double-blind, between-subject, placebo controlled design the effects of a single dose of losartan (50mg) on fear extinction in healthy male participants will be examined. Participants will initially undergo a Pavlovian fear conditioning procedure, followed by the administration of 50mg losartan or placebo. 90 minutes after treatment subjects will undergo the fear extinction procedure. Neural activity and psychophysiological indices of arousal will be assessed by the simultaneous acquisition of functional magnetic resonance imaging (fMRI) and skin conductance data.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects without past or current psychiatric or neurological disorders

Exclusion Criteria:

* history of head injury
* medical or psychiatric illness
* hypertension
Management of Anticoagulants and Antithrombotics in Patients With CSDH

Primary objective of the study will be to compare, up to 6 months after surgery, number of relapses (post operative re-bleeding) or intracerebral hemorrhage (others than subdural hematomas) and thromboembolic or cardiovascular ischemic events, in patients undergoing surgery for chronic subdural hematoma (CSDH). These data will be correlated to the suspension or not of antithrombotics or anticoagulants before surgery or their re-introduction after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years old
* Informed consent
* Evidence of CSDH which needs surgery
* patients taking antithrombotics or anticoagulants

Exclusion Criteria:

* previous surgery for CSDH
Delirium, Agitation/Sedation, Pain and Dyspnea in Respiratory Intensive Care Unit (NIVILIUM)

Non-Invasive Mechanical Ventilation (NIV) has been increasingly used in the treatment of acute respiratory failure. Notwithstanding failure rates still remains high, ranging from 5% to 60%. The onset of delirium, agitation, pain and dyspnea may contribute to reduce the success rate of non invasive ventilation treatment. The aim of this study is to assess the incidence and impact of delirium, agitation, pain and dyspnea on clinical outcomes in a population of patient admitted to Respiratory Intensive Care Unit undergoing Non-Invasive Mechanical Ventilation for Acute Respiratory Failure.


Eligibility Criteria:
Inclusion Criteria:

* patients with acute respiratory failure admitted to the Respiratory Intensive Care Unit of the University Hospital of Modena undergoing non invasive mechanical ventilation

Exclusion Criteria:

* age lower than 18
* Glasgow Coma Scale lower than 10 within 24 hours from Respiratory Intensive Care Unit admission
* need for immediate orotracheal intubation
* pregnancy
* previously established psychiatric disease or dementia
Efficacy, Safety and Pharmacokinetics of QAV680 Versus Placebo in Patients With Asthma

This study will assess the safety and efficacy of QAV680 in patients with mild to moderate asthma


Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate persistent asthma

Exclusion Criteria:

* Smokers
* Any significant disease or illness, other than asthma

Other protocol-defined inclusion/exclusion criteria may apply
Safety and Efficacy of Tegaserod in Opioid-induced Constipation in Patients With Non-cancer Pain.

This study will evaluate the safety and efficacy of Tegaserod in opioid-induced constipation (OIC) in patients with non-cancer pain.

Patients who enter this study PRIOR to the core study (CHTF919N2201) interim analysis (IA) receive the treatment as follows:

Patients on tegaserod 6 mg twice daily (b.i.d.) or 12 mg once daily (o.d.) in the core study will remain on the same dose in the extension (double-blind).

Patients on placebo during the core study will receive tegaserod 12 mg o.d. (open-label)

Patients who enter this study AFTER the core study interim analysis will receive the selected tegaserod dose regimen (open-label) determined by the core study IA.


Eligibility Criteria:
Inclusion Criteria:

* Patient has completed the 12 week double blind treatment of study CHTF919N2201

Exclusion Criteria:

* Planned discontinuation of opioids during the study.
* Development of any of the medical conditions listed as exclusion criteria for the CHTF919N2201 study.

Other protocol-defined inclusion/exclusion criteria may apply
A Self-management Intervention for Adult Patients With Hearing Difficulties to Promote Hearing Aid Use and Benefit

The aim of the present study is to test I-PLAN as a self-management tool to promote hearing aid use and benefit (measured by self-reported questionnaires and hearing aid data-logging) among new adult hearing aid patients via a randomised controlled trial compared to treatment as usual. We hypothesized that the I-PLAN will increase hearing aid use and reduce self-reported hearing difficulty via promoting hearing aid use habits and self-regulation with respect to hearing aid use.

The aim of the present study is to test I-PLAN, an intervention designed to promote hearing aid use among adult hearing aid patients, for the first time. I-PLAN is the first intervention in audiology that has been developed using the behaviour change wheel. It consists of three components; i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 years old or above
2. Have never used a hearing aid before
3. Have good understanding of English
4. have sufficient mental capacity to provide informal consent based on audiologist's opinion

Exclusion Criteria:

1. Have inability to complete the questionnaires due to age-related problems (for example; dementia) based on audiologist's opinion
2. presence of medical contraindications for hearing aids as described by the British Academy of Audiology (BAA, 2007)
Viral Shedding, Symptoms and Exposure of SARS-CoV-2 in Non-hospitalized Children With COVID-19

Data on COVID-19 in children are still scarce, and their role in SARS-CoV-2 transmission is poorly described. Furthermore, documentation of the best SARS-CoV-2 sampling methods in children are limited. In adults, saliva seems like a promising specimen to collect by noninvasive procedure to diagnose and monitor viral load of SARS-CoV-2, but this has not been tested in children yet.

We want to test the following hypothesis:

1. Shedding load and duration of SARS-CoV-2 in children are related to age, gender, clinical symptoms and exposure
2. Salvia samples have equal or higher sensibility than nasal swaps in children for detection of SARS-CoV-2
3. Parental home testing of saliva and feces is feasible in children

The study is a prospective cohort study of SARS-CoV-2 PCR-positive children from two test centers in the Capital Region of Denmark. Children aged 0-17 years with a PCR-positive SARS-CoV-2 test from a nasal or pharyngeal swab is included from May 2020 to January 2021 and followed-up for a period of 28 days with weekly sample collection and questionnaires.

Samples include a saliva sample, a nasal swap and a rectal swap for children under four years of age. A semiquantitative RT-PCR method, will identify positive and negative samples and provide a Ct value estimating viral load. Saliva and fecal samples will be analyzed from November 2020-February 2021.

Shedding duration will be related to medial history, clinical presentation, exposure, gender and age.


Eligibility Criteria:
Inclusion Criteria:

* a PCR-positive SARS-CoV-2 test

Exclusion Criteria:

-
Long-Term Results of a Randomized Trial Comparing Banded-versus-Standard Laparoscopic Roux-en-Y Gastric Bypass

The purpose of the study is comparatively analyze the advantages and disadvantages of banded versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB).

The outcome variables of the general study included morbidity, maximal weight loss, and late weight regain.

Obesity is a public health problem that has grown exponentially worldwide. Bariatric surgery has been recognized as the most effective treatment for morbid obesity. However, the debate about the best surgical procedure is still considerable.

Among a wide range of operations that have been used for morbid obesity, Roux-en-Y gastric bypass (RYGB) has shown an appropriate risk/benefit balance and has achieved a high degree of acceptance in America.

The weight loss pattern in RYGB is characteristic and includes significant eight loss during the first 2 years after surgery, followed by some weight regain after the second or third postoperative year. To prevent this some authors suggest the placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy. This procedure has been called banded RYGB.

Eligibility Criteria:
Inclusion Criteria:

* body mass index of 40-55 kg/m2
* agreed to participate in this study with informed consent signed