cyrilzakka/clinical-trials huggingface dataset:
Evaluating New Surgical Technique in Management of Female Patients With Operable Multifocal Breast Cancer

Multi-focal Breast Cancers(MFBC) still have undiscoverable Clinical Significance reflecting on a debatable surgical decision for this Category of breast cancer. A prospective study was conducted using certain surgical technique as a surgical treatment for female patients with operable breast cancer managed at the Surgical Oncology Unit, Alexandria University from May. 2017 to May2018 and will be followed for 3 Years.Analysis will be done to settle a paradigm for surgical management of Multi-focal Breast Cancer

* Age at diagnosis: young patients are defined as younger than 35 years.
* Surgical techniques: Preoperatively all patients will undergo physical examination of both breasts and axillae as well as bilateral mammograms and ultrasonography of both breasts. Histopathological diagnosis of cancer will be made prior to surgery. The planned procedure will be discussed. Different oncoplastic techniques will be utilized to achieve oncologically appropriate margins with either sentinel lymph node detection or axillary lymph node dissection according to the triple assessment of the patients . Surgical margins were determined by macroscopic and histologic examination of frozen sections of the breast specimens in the operating room. An adequate safety margin of 1cm was always insured. Breast remodeling will be done according to breast size, degree of ptosis and size of defect.
* Tumor characteristics: size, nodal status, presence of lympho-vascular invasion, amount of intraductal component, tumor grade, margin status, hormone receptor, and Her2 neu status.
* Margins will be regarded as negative when permanent histological examination found no ink on the tumor.
* Postoperative surgical complications will be documented if happened; seroma formation, hematoma and or wound dehiscence.
* Cosmetic outcome: The postoperative esthetic result will be evaluated asking the patients to rate the postoperative cosmetic result and their degree of satisfaction compared to the preoperative breast using a five-point scale (excellent, 5; good, 4; fair, 3; poor, 2;bad, 1). Objective assessment of the cosmetic result was done by two surgeons, rated on a visual analog scale from 1 (unacceptable result) to 10 (excellent result). Evaluation is based on 5 criteria, namely: breast symmetry, glandular tissue defects, nipple and areola reconstruction, scar quality and/or retraction, and the resultant breast shape. (14)
* The occurrence of loco-regional recurrence or distant metastases during the follow-up period was recorded and considered as an end point for follow-up.

Eligibility Criteria:
Inclusion Criteria:

* all operable female patients affected with multifocal breast cancer

Exclusion Criteria:

* inflammatory breast cancer
* patients need receiving neoadjuvant therapy
Safety of EVG+RTV Administered With Other Antiretroviral Agents for the Treatment of HIV-1 Infection

The main objective of this study is to observe the long-term safety of elvitegravir (EVG) boosted with ritonavir (RTV) in combination with other antiretroviral (ARV) agents in participants who have completed a prior EVG+RTV treatment study.


Eligibility Criteria:
Inclusion Criteria:

* Completion of a prior EVG+RTV treatment study without treatment-limiting toxicity.
* Males and females of childbearing potential must agree to utilize effective contraception methods.
* Ability to understand and sign a written informed consent form.

Exclusion Criteria:

* Females who are pregnant or breastfeeding.
* Participation in any other clinical trial without prior approval from the Sponsor.
* Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study.
* Subjects receiving ongoing therapy with contraindicated drugs.
Individualized Fortification of Breast Milk

The proposed research will investigate individualized fortification of breast milk based on daily milk analysis of carbohydrate, protein, and fat content in a randomized double blind controlled trial. The combination of additional fat, carbohydrate and protein and commercial fortifier will be added to ensure that the milk contains the target amounts of nutrient. Growth and development of these infants will be compared with that of infants fed mother's milk that has been supplemented with the current standard amounts. The postnatal growth of the infants will be assessed by measuring weight, length and head circumference and fat and lean mass using highly accurate, non-invasive methods throughout the intervention period and at the first follow-up visit after discharge at 3 months. Neurological development will be analyzed at the age of 18 months.

The investigators hypothesize that individualized fortification of breast milk improves the nutritional intake of preterm infants, optimizing growth, and thus this will positively impact neurodevelopment and health.


Eligibility Criteria:
Inclusion criteria:

1. Gestational age \< 32weeks (maternal dates or early fetal ultrasound);
2. Tolerating an enteral intake of ≥ 100 ml/kg/d for ≥ 24h;
3. Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥ 150 mL/kg/d) has been achieved; and
4. Written informed consent has been obtained from the infant's legal representative.

Exclusion criteria:

1. Infants with intrauterine growth restriction, small for gestational age defined by a weight less than 3rd percentile using sex specific reference data for birth weight
2. Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
3. Babies with enterostoma or short gut syndrome;
4. Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3);
5. Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen 10 mmol/L79 and creatinine of 130 mmol/L80;
6. Hepatic dysfunction, defined by jaundice (direct bilirubin \>1.0 mg/dl) that is associated with one or more abnormal liver function tests (AST, ALT or GGT);
7. Participation in another clinical trial that may affect outcomes of this study; or
8. Probability of transfer to another NICU or level II nursery outside the McMaster Children's Hospital before the minimum period of three weeks is completed.

Post-randomisation exclusion criteria:

1. Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
2. Fluid restriction \< 140mL/kg/d for ≥ 3 consecutive days;
3. Sepsis - all infants with gram-negative sepsis will be removed from the study.
Eribulin Mesylate in Treating Patients With Advanced or Recurrent Cervical Cancer

This phase II trial studies how well eribulin mesylate works in treating patients with advanced or recurrent cervical cancer. Drugs used in chemotherapy, such as eribulin mesylate, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing

PRIMARY OBJECTIVES:

I. To evaluate the activity of eribulin (eribulin mesylate) in the management of advanced or recurrent cervical cancer (progression-free survival \[PFS\].

SECONDARY OBJECTIVES:

I. To describe the toxicity profile of eribulin in patients with advanced or recurrent cervical cancer.

II. To estimate the survival of patients with advanced or recurrent cervical cancer treated with eribulin.

III. To evaluate potential correlative studies as predictive or prognostic makers in this patient population (glucose-regulated protein 78 \[GRP78\] levels in tissue and blood, tumor protein p53 \[p53\] expression, apoptosis with terminal deoxynucleotidyl transferase dUTP nick end labeling \[TUNEL\] assay, apoptosis-related proteins B-cell lymphoma 2 \[Bcl-2\] and Bcl2-associated X protein \[Bax\] using immunohistochemistry \[IHC\], proliferation with Ki-67 IHC, and expression levels of microtubule-associated variables, including tau protein, total alpha- and beta-tubulin, and classes II-IV beta-tubulin isotopes with IHC.

OUTLINE: Patients receive eribulin mesylate 1.4 mg/m2 intravenously (IV) bolus over 2-5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of invasive cervical cancer
* Measurable disease
* 0-1 prior chemotherapy regimens for recurrent or advanced disease; platinum based chemotherapy administered as a radiation sensitizer agent is allowed and does not count as prior therapy
* Absolute granulocyte count (AGC) \>= 1,500
* Platelet \>= 100,000
* Serum creatinine \< 2.0 mg/dl
* Bilirubin =\< 1.5 times the upper limit of the normal range (ULN)
* Alkaline phosphatase =\< 3 x ULN (in the case of liver metastases, =\< 5 x ULN)
* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =\< 3 x ULN (in the case of liver metastases, =\< 5 x ULN)
* Peripheral neuropathy grade 0-2
* Recovery of all chemotherapy or radiation-related toxicities to grade =\< 1, except for alopecia and peripheral neuropathy
* Performance status 0-2
* Signed informed consent

Exclusion Criteria:

* Prior treatment with eribulin
* Chemotherapy, radiation, or biological or targeted therapy within 3 weeks
* Hormonal therapy within 1 week
* Any investigational drug within 4 weeks
* Known brain metastases, unless previously treated and asymptomatic for 3 months and not progressive in size or number for 3 months
Saccadometry in Primary Headache Syndromes

Migraine is one of the commonest neurological disorders, affecting up to 12% of the general population, but remains relatively under-diagnosed and under-treated. Migraine has a wide socioeconomic impact and brings a large economic burden; estimates suggest that disability due to migraine costs \> €27 billion per annum across Europe. Despite its prevalence and impact, migraine pathophysiology is poorly understood. A wider understanding of the functional changes in this disorder would be beneficial to both diagnosis and treatment.

Saccades are the rapid eye movements we make when moving the eyes to a new object in our visual field. Reaction time studies have been used to investigate Huntington's disease and Parkinson's disease with great success. These use saccadic tasks (monitoring eye movements). Even at rest we make approximately three saccades per second, so a lot of data can quickly be gathered with non-invasive testing. We hope to understand more of the underlying mechanisms of migraine by studying reaction time in migraine patients.

Our previous pilot study, with less stringent inclusion and exclusion criteria, looked at fewer patients (32 migraineurs and 32 controls), and found that migraineurs showed significantly different saccadic patterns to non-migraineurs.

This study firstly seeks to corroborate the saccadometric findings of our earlier pilot study in a group of migraineurs, and secondly to explore the specificity of these findings in migraine by also studying patients with another primary headache syndrome, namely cluster headache.

Migraine is known to be a dynamic disorder, with previous studies showing longitudinal changes in the migraine brain. To explore this further we hope to record longitudinally (Every day for 21 days) in a small subset of migraineurs to identify potential longitudinal changes in saccadic reaction time. Because of the portability of the equipment this could be done in the subjects own home if they preferred.

As above

Eligibility Criteria:
Inclusion Criteria:

1. Male or female and aged between 18 and 60 years in good general health apart from suffering from headaches (test group).
2. Migraine and cluster headache will be diagnosed according to ICHD-II diagnostic criteria (6).
3. Migraineurs must suffer at least two migraine attacks per year and no more than 5 attacks per month.

   -

Exclusion Criteria:

1. Any other neurological disorder such as stroke, multiple sclerosis, epilepsy, concussion within the past year, psychiatric disorders, visual disorders.
2. Use of migraine prophylactic medication in the last month or acute migraine therapy in the 3 days prior to testing.
3. Patients on any medication to treat depression in their case
4. Headache during testing or within 3 days before and after testing.

   -
Phase 3 Study to Evaluate IOP Lowering Therapy in Open Angle Glaucoma and Ocular Hypertension C-02-41

To compare intraocular pressure lowering effectiveness of a combination drug vs. two individual drugs dosed alone.


Eligibility Criteria:
Adult subjects of either sex and any race with open-angle glaucoma or ocular hypertension; visual acuity of 20/80 to 20/400 or better (Snellen equivalent) or logMAR visual acuity not worse than 0.6. Clinically relevant ophthalmic or systemic conditions may be excluded.
Falls Prevention and Balance Rehabilitation in Multiple Sclerosis

Background. Balance disorders and falls are common in People with Multiple Sclerosis (PwMS) Objective: Our hypothesis was that PwMS treated for balance disorders would reduce balance disorders and frequency of falls.

Methods: A bi-centre randomised Rater-blinded controlled trial. Participants in both groups received 20 treatment sessions. Participants in the intervention group received treatment aimed at improving control of the position and movement of the centre of mass and body segments. Participants in the control group received treatments to reduce limitations at activity and body function level.

Group allocation was done by an independent clinician by a randomization list made before the beginning of the study. Group allocation was kept concealed throughout the study and participants were not aware of group assignment.

Data was analyzed according to a preplanned protocol by using an intention to treat approach.


Eligibility Criteria:
Inclusion Criteria:

Clinical diagnosis of Multiple Sclerosis Must be able to walk (also with aid) for 6m Must be able to maintain standing position with open eyes for at least 30".

Exclusion Criteria:

Must not be able to maintain monopodalic-standing position for 10", Must not be able to to maintain tandem position for 30", cognitive disorders hampering the execution of the exercises/assessment.
Contrast Enhanced Ultrasonography to Detect Human Renal Transplant Rejection

The purpose of this study is to determine the feasibility and efficacy of detecting kidney transplant rejection using contrast enhance ultrasonography with the contrast agent Sonazoid.

This study will be divided into two stages. In the first stage the investigators will assess the transplant kidney with ultrasound after contrast injection (Sonazoid) to determine if contrast in the kidney is detectable by ultrasound and to determine if the amount of perfusion can be quantified directly or qualitatively. The investigators aim to have one to two subjects in this stage. If perfusion of the kidney can be assessed, then the investigators will move to stage two of the study.

In stage 2, the investigators will look to determine the ability of the contrast enhanced ultrasonography method to detect renal transplant rejection using Sonazoid. For this stage the investigators will recruit subjects with biopsy confirmed renal transplant rejection. Once subjects are consented, they will undergo contrast enhanced ultrasonography with Sonazoid and have images taken. These images will be compared to images of renal transplant patients that have displayed no rejection or clinical issues. These clinically normal subjects will have previously consented to a medical record review so that the investigators may use their images.

Eligibility Criteria:
Inclusion Criteria:

* Adults (ages 18-75) who have undergone renal transplant at the Brigham and Women's Hospital. \[For stage 1 or stage 2\]
* Experiencing acute and chronic renal allograft rejection - defined by by examining the histological sections of renal transplant biopsy for a renal pathologist. This is the most accurate way to evaluate the presence of absence of acute and chronic renal transplant biopsy. \[For stage 2\]
* Adults (ages 18-75) who have undergone renal transplant at the Brigham and Women's Hospital with normal serum creatinine values (\~1 mg/dl) \[For stage 2 medical record review only\]

Exclusion Criteria:

* Hemodynamic instability (e.g., blood pressure \< 90)
* Atrial fibrillation with rapid ventricular response
* Arrhythmia
* Poor acoustic windows
* Inability to provide informed consent
* Known right to left or bidirectional cardiac shunts
* Any contraindication such as the history of allergic reactions
* Pregnant or nursing women
Hyoscine Butyl Bromide in Reducing Pain During HSG

Many oral analgesic drugs such as nonsteroidal anti-inflammatory drug(NSAID) are used to relieve pain from gynecological procedure and dysmenorrhea. Hyoscine-N-butyl bromide, an antispasmodic drug are commonly used for relief of smooth muscle spasms and can use to relieve genito-urinary spasm. Some studies reported hyoscine can't relieve pain in minor gynecological procedures. So the efficacy of hyoscine use are still controversial and no previous studies investigated its efficacy for pain relief in HSG procedure.


Eligibility Criteria:
Inclusion Criteria:

The infertile women who indicated for HSG.

Exclusion Criteria:

* contraindications to Hyoscine or NSAID - known sensitivity to these drugs
* known sensitivity to contrast media
* abnormal uterine bleeding
* genital tract infection
* suspected pregnancy
Automated Algorithm Based Analysis of Phonocardiograms of Newborns

The purpose of this double-blind pivotal clinical utility study is to determine on a large patient population whether heart murmurs can be reliably detected with high sensitivity and specificity using a locked, automated algorithm-based phonocardiogram analysis (also referred to as computer aided auscultation (CAA)).

Each patient is auscultated and diagnosed independently by a medical specialist. Additionally, for each patient, an echocardiogram is performed as the gold-standard for determining heart pathologies. The CAA results are compared to the findings of the medical professionals as well as to the echocardiogram findings.

Hypothesis: The specific (locked) CAA algorithms used in this study are able to automatically diagnose pathological heart murmurs in premature babies and newborns with at least the same accuracy as experienced medical specialists.

The following registry procedures and quality factors have been implemented:

* Quality assurance plan, including

  * data validation
  * proper registration procedures
  * regular site monitoring
  * regular auditing
* Data checks to compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry.
* Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources (medical records and paper case report forms).
* Standard Operating Procedures to address registry operations and analysis activities, such as patient recruitment, data collection, data management, data analysis, reporting for adverse events, and change management.
* Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect.
* Statistical analysis plan describing the analytical principles and statistical techniques to be employed in order to address the primary and secondary objectives, as specified in the study protocol or plan.
* Plan for missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results.

Eligibility Criteria:
Inclusion Criteria:

* any premature baby or newborn
* parental approval for study participation

Exclusion Criteria:

* none
Effects of Legumes on Glucose Regulation

Dietary prevention strategies are increasingly recognized as essential to combat the current epidemic of obesity and related metabolic disorders. The purpose of the present study was to evaluate the potential effects of legumes in relation to cardiometabolic risk markers and appetite regulating hormones.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between 20-35 years
* With normal BMI and
* No known metabolic- or gastro intestinal disease

Exclusion Criteria:

* BMI \> 25,
* Known metabolic disorder or
* Gastrointestinal problems or disease
Platelet Rich Plasma (PRP) Injections For Knee Osteoarthritis

It was conducted a prospective study with a series of 153 patients treated with PRP injections in patient affected by knee osteoarthritis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Score Society (KSS) score and the Visual Analogue Scale (VAS) were evaluated and recorded for each patient at each follow up.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 81;
* Body mass index (BMI) between 21.5 and 29.3;
* Chronic history (for at least 4 months) of knee joint pain;
* Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)

Exclusion Criteria:

* Radiographically severe documented knee osteoarthritis of grade 4 (K-L radiographic classification scale);
* Previous femur and tibia fractures;
* Knee previous surgical treatment (e.g., arthroscopy);
* Hyaluronic acid infiltration within the previous six months;
* Hemoglobin levels \<10 g/dL;
* History of oncohematological disease, infections, or immunodepression
Long-term Safety and Tolerability of Idalopirdine (Lu AE58054) as Adjunctive Treatment to Donepezil in Patients With Mild-moderate Alzheimer's Disease

To evaluate the long-term safety and tolerability of idalopirdine (Lu AE58054) as adjunctive therapy to donepezil in patients with mild-moderate Alzheimer's Disease (AD).

This is an interventional, multi-national, multi-site, open-label extension study in patients with mild to moderate AD who completed the 24-week lead-in study 14861A (NCT01955161) or 14862A (NCT02006641).

Patients received 28-weeks of open-label treatment with idalopirdine 60 mg/day (option to reduce to 30 mg/day) as adjunctive treatment to donepezil. Approximately 100 patients, who had completed the initial 28-week period (OLEX), were included in a 24 week open-label treatment period with memantine (OLEX-MEM) that evaluated the safety and tolerability of concomitant memantine therapy in patients who were already on a stable treatment with idalopirdine and donepezil and for whom memantine treatment was clinically indicated.

Eligibility Criteria:
Inclusion Criteria:

* the patient has completed Visit 7 (Completion Visit) in the lead-in double-blind, placebo controlled clinical studies 14861A/NCT01955161 or 14862A/NCT02006641

For patients in the OLEX-MEM:

* The patient has completed Visit 6 (Week 28) of the OLEX.
* The patient, according to the judgement of the investigator, requires initiation of treatment with memantine as per local label/SmPC/treatment guidelines.

Exclusion Criteria:

* The patient has a moderate or severe ongoing adverse event from the lead-in study considered a potential safety risk by the investigator.
* The patient has experienced seizures before Completion Visit in the lead-in study.
* The patient has evidence of clinically significant disease.
* The patient's donepezil treatment is likely to be interrupted or discontinued during the study.
* The patient is receiving therapy with another acetylcholinesterase inhibitors (AChEI).

Other protocol-defined inclusion and exclusion criteria may apply.