cyrilzakka/clinical-trials huggingface dataset:
3D Transperineal Ultrasound of the Pelvic Floor Muscles in Women With Pelvic Floor Disorders: A Cross-sectional Study.

The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction.

The prevalence of Pelvic floor dysfunction is high, affecting millions of women worldwide in different conditions (social, sexual, physical, psychological, domestic relationships, financial, etc.), many people still have no, limited knowledge, or awareness of pelvic floor health and so do not have, or seek how to prevent or correct these disorders . This dysfunction may be presented as pelvic organ prolapse, stress urinary incontinence, fecal incontinence , chronic pelvic pain, sexual problems, and/or chronic constipation . Assessment of pelvic floor muscle activity plays a major role in Urogynecology and physiotherapy as a part of the conservative treatment of pelvic floor disorders (PFD) . Presence of Levator avulsion is a major risk factor for female pelvic organ prolapse (POP) and recurrence after surgical correction . This dysfunction can be diagnosed clinically using vaginal palpation . Palpation is subjective, less reproducible, and difficult to teach than imaging methods \[6\]. Studies that used ultrasound for assessment of pelvic floor muscle activity and strength are still few . The present study aimed to evaluate the levator ani muscle in both morphology (rest), and function (contraction and valsalva) in symptomatic women using 2D, 3D trans-perineum ultrasound (TPUS), to compare these features to clinical digital palpation and symptoms, and helping in diagnosis of muscle dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Women complaining of any of the pelvic floor disorder symptoms.

Exclusion Criteria:

* women with a history of chronic intestinal disease (Crohn's disease, ulcerative colitis), acute gastroenteritis within the week preceding consultation women who underwent any surgical or diagnostic procedure involving the anal canal
Comparison of 24-hour Holter Monitoring Versus 14-day Continuous ECG Patch Monitoring EZYPRO

This is an open-label study to investigate the functional features of prolonged monitoring by 14-day EZYPRO® to improve the medical care and/or diagnosis for the patient with arrhythmia. Patients will be enrolled by outpatient basis from two clinical study sites. Enrolled patients will wear a traditional 24-hour Holter monitor and an 14-day EZYPRO® which can provide monitoring data for up to 14 days. This study will allow a direct comparison between two devices.


Eligibility Criteria:
Inclusion Criteria:

* Provision of signed written informed consent before enrollment into the study
* Are able to communicate with the investigators
* With suspected arrhythmia related signs and symptoms, judged by the investigators
* Patients intend to wear ECG moniotrs
* Males and females, 20 years of age or older

Exclusion Criteria:

* Patients with skin allergies or injury, judged by investigators
* Patients with specific arrhythmia or specific treatments, interfere with study evaluations, judged by investigators
* Pregnant women
* Currently participating in another trial or who participated in a previous clinical trial
Generation of Prediction Equations to Analyze Body Composition of Adults Based on Bioelectrical Impedance Analysis (BIA)

Aim of the study is to develop prediction equations for calculating FFM, TBW, ECW and SMM based on the gold standard reference methods ADP, DXA, MRI, D2O and NaBr on the one hand and measurement data of the BIA devices on the other hand. The equations are necessary to use the device as a Body Composition Analyzer with an acceptable accuracy level for clinical practice.


Eligibility Criteria:
Inclusion Criteria:

The study will cover 130 healthy adults. 65 men and 65 women in an age range of 18 to 65 years with a BMI of 18.5 to 35 kg/m2 are planned to be recruited.

Exclusion Criteria:

* acute and chronic diseases
* regular intake of medications (except for contraceptives)
* amputation of limbs
* electrical implant as cardiac pacemaker
* insulin pumps
* artificial joints
* metallic implants (except tooth implants)
* claustrophobia
* pregnancy or breastfeeding period
* probands who cannot provide an ICF by themselves
* probands who might be dependent from the sponsor or the inv. site
* current alcohol abuse
* frequent hypersensitivity reactions/allergies determ. anamnestically
* body weight of more than 150 kg
* extensive tattoos at arms or legs
Does Immediate Lymphatic Reconstruction Decrease the Risk of Lymphedema After Axillary Lymph Node Dissection

The researchers are doing this study to see if having immediate lymphatic reconstruction after axillary lymph node dissection (ALND) can decrease the development of lymphedema, a side effect of ALND. Other purposes of the study include:

Comparing the approach of immediate lymphatic reconstruction after ALND with the approach of ALND alone Looking at whether having immediate lymphatic reconstruction after ALND improves a person's quality of life Seeing if adding standard of care radiation therapy to either study approach (immediate lymphatic reconstruction after ALND or ALND alone) has an effect on development of lymphedema


Eligibility Criteria:
Inclusion Criteria:

* Female breast cancer patients 18-75 years of age
* Patients consenting for unilateral ALND (prior history of SLNBx allowed if \<6 months from consent) OR patients consenting for unilateral SLNBx with possible ALND, with a clinically or radiographically positive lymph node OR a high likelihood of ALND per the Breast Surgeon
* Identification of at least one transected lymphatic channel and at least one vein to be used for bypass at the time of ALND during surgery

Exclusion Criteria:

* Male breast cancer patients
* Non-English speaking participants
* Female breast cancer patients with axillary recurrence
* Female breast cancer patients who have a history of ALND
* Female patients requiring bilateral ALND for the treatment of their breast cancer
* Female breast patients treated with SLNBx only
Correction of Fixed Knee Flexion Deformity in Children Distraction by Cast Wedge and Rod Lengthening

The aim of our study is to produce gradual correction of FKFD in younger children.

Management of pediatric fixed knee flexion deformities (FKFD) has always been a challenge for orthopedic surgeons. They occur due to a variety of causes, including cerebral palsy, arthrogryposis, spina bifida, trauma, and many others. The deleterious effects of FKFD include instability of gait and balance, exhaustion of extensor mechanism, and anterior knee pain, which together produce marked limitation of the activities of daily living in affected children .

Many options have been proposed for the correction of FKFD, with each having its pros and cons. Hamstring release and posterior capsulotomy are frequently used. However, extensive soft tissue release may be needed to treat severe deformities with the risk of neurovascular compromise and genu recurvatum. Supracondylar extension osteotomy with patellar tendon advancement requires postoperative non-weight bearing for at least three weeks and is associated with risk of neurovascular damage and coronal plane deformities and it is mostly used in older children and adolescent . Gradual distraction by ring fixators may be complicated by pin tract problems, fractures, and recurrence .

Our study entails the application of a simple method for correction of FKFD in younger children using a simple cast distraction technique. This conservative method aims at avoiding the complications of surgery in children while achieving a reasonable amount of correction.

Eligibility Criteria:
Inclusion Criteria:

1. Children with FKFD.
2. Age \< 4 years.
3. FKFD due to congenital, traumatic, neuromuscular, infections, metabolic disorders and skeletal dysplasias.

Exclusion Criteria:

* 1. Older children less than 4 years 2. Recent Post-burn contractures and cases with unsuitable skin conditions.
Niraparib in the Treatment of Patients with Advanced PALB2 Mutated Tumors

The purpose of this study is to further evaluate the efficacy and safety of niraparib in patients with locally advanced or metastatic solid tumors and a pathogenic or likely pathogenic tumor PALB2 (tPALB2) mutation.


Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years of age or older.
* Participants must have a histologically or cytologically confirmed diagnosis of locally advanced or metastatic solid tumor(s).
* Participants must have tested positive for a pathogenic or likely pathogenic tPALB2 gene mutation using a CLIA-certified laboratory as described in the Next-Generation Sequencing (NGS) Laboratory Manual.
* Participants who have stable and asymptomatic Central Nervous System (CNS) disease must be receiving a stable (for at least 7 days) or decreasing corticosteroid dose at the time of study entry.
* Participants must submit fresh or archived (collected within 24 months of enrollment) Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample to the central laboratory for post-enrollment confirmation of tPALB2 status.
* Participants must have received all standard therapies appropriate for their tumor type and stage of disease or, in the opinion of the Investigator, the patient would be unlikely to tolerate or derive clinically meaningful benefit from appropriate standard of care therapy, or the participant has no satisfactory alternative treatments.

Exclusion Criteria:

* Participants have other active concomitant malignancy that warrants systemic, biologic, or hormonal therapy.
* Participants who have ovarian or prostate cancer.
* Participants who have variants of undetermined significance (VUS), but not pathogenic variants of PALB2, at the time of screening.
* Participants who relapsed while receiving platinum based therapy in the adjuvant/curative setting.
* Participants progressing within 14-18 weeks while receiving platinum based therapy in the metastatic setting.
* Participants who have received Poly (ADP-ribose) polymerase (PARP) inhibitor(s) in prior lines of treatment.
* Participants with leptomeningeal disease, carcinomatous meningitis, symptomatic brain metastases, or radiologic signs of CNS hemorrhage.
* Participants with germline or somatic BRCA1 or BRCA2 mutations.
* Participant has systolic blood pressure (BP) over 140 mmHg or diastolic BP over 90 mmHg, despite optimal medical therapy.
* Participants have previously or are currently participating in a treatment study of an investigational agent within 3 weeks of the first dose of therapy preceding the study.
* Participants have received prior systemic cytotoxic chemotherapy, biological therapy, or hormonal therapy for cancer, or received radiation therapy within 3 weeks of the first dose therapy preceding the study.
Orthopaedic Conservative Treatment in the Time of Covid-19 Pandemic

This is a one centered retrospective study. Tendency for surgical interventions in the pre-pandemic period was reduced to protect surgical team and patients. The investigators aimed to find out the answer to the following question: will conservative treatment be the shining star in the post pandemic period?

The researchers compared the treatments performed for fractures during the Covid 19 pandemic period with the treatments performed in the prepandemic period. For this purpose, they tried to measure the effectiveness of the treatments according to clinical scoring by forming 2 groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients with extraarticular distal radius fracture, proximal humerus fracture and Weber type B ankle fracture were treated conservatively during March 11, 2020 and 11 August, 2020

Exclusion Criteria:

* Surgically treated patients during March 11, 2020 and 11 August, 2020
Effects Magnesium Sulfate and Labetalol Infusion on Peripheral Perfusion and Pain in Nasal Surgeries

One of main risk of controlled hypotension during nasal surgeries is impaired perfusion. Peripheral perfusion of non-vital organs usually impaired earlier than vital organs. So, evaluation of perfusion of non-vital organ is considered to be adequate measure of patient safety during surgery.

Many hypotensive agents such as dexmedetomidine, B blockers, magnesium sulfate and nitroglycerine had been used but we are in need to investigate its effects on peripheral perfusion.

Postoperative pain related to nasal surgeries due to surgical trauma itself which induces the release of inflammatory mediators from neuronal and immune cells resulting in peripheral and central sensitization significantly affects recovery of patients. Magnesium sulfate and labetalol have analgesic actions besides their hypotensive effects but with different mechanisms.

To compare between the effects of magnesium sulfate and labetalol infusion during induced hypotension on peripheral perfusion and postoperative pain in nasal surgeries

OBJECTIVES:

To measure peripheral perfusion index (PPI) as an indicator for peripheral perfusion To calculate the total postoperative rescue analgesic requirements.

Double -blind randomized comparative Clinical Study. All Patients will be randomly allocated into two equal groups (group M and Group L).

Using computer generated randomization table, each group will be 25 patients.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent from the patient.
* Age: 21-45 years old.
* Sex: both sex (males or females).
* Physical status: ASA 1\& II.
* BMI = (20-30 kg/m2).
* Type of operations: elective nasal surgeries such as septoplasty, endoscopic sinus surgery and polypectomy.
* Duration of surgery ≤ two hours.

Exclusion Criteria:

* Altered mental state
* Patients on beta blocker or with known history of allergy to study drugs.
* Advanced hepatic, renal, cardiovascular or respiratory diseases.
* Diabetic patients.
* Patients receiving anticoagulants or on pain killers.
Vitamin D and Cardiac Autonomic Tone in Hemodialysis

Despite advances in treatment of conventional cardiovascular risk factors, patients with kidney disease remain at high risk for fatal cardiac events. To date, kidney disease affects approximately 2 million Canadians; however, this patient population remains grossly understudied due to the complex nature of the disease. The inadequacy of the literature to address the cardiovascular-related mortality rates in those with kidney disease reflects the urgent need for investigation of novel risk factors.

One cardiovascular risk factor which has recently been validated is the clinical measurement of cardiac autonomic tone (CAT). CAT refers to the amount of activity contributed by the stimulatory and inhibitory limbs of the cardiac autonomic nervous system, which work in concert with one another to control heart rate. CAT can be quantified computer analysis of heart rate over time, captured by a simple Holter electrocardiogram (ECG) recording. Abnormal CAT, which occurs when the autonomic system does not control heart rate properly in response to physical demands or stress, is associated with risk of adverse cardiovascular events in both healthy and high risk populations. It has recently been shown that patients with severe kidney disease demonstrate significant CAT abnormalities, thus exaggerated susceptibility to cardiac death.

Vitamin D (VD) deficiency is also common in this patient population due to the fact that the kidney plays a crucial role in VD metabolism. Given that VD deficiency is an established cardiovascular risk factor on its own, it is possible that kidney disease patients experienced compounded risk due to the combination of VD deficiency and abnormal CAT. However, no study has ever investigated whether VD deficiency influences CAT in healthy or diseased populations. To our knowledge, this will be the first trial to ever examine the effect, if any, of different VD supplementation treatments (standard of care vs. combination) on CAT in a population burdened with overwhelming risk and incidence of cardiovascular and sudden cardiac death risk.


Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* 3x weekly hemodialysis outpatient within Calgary for at least 3 months prior to enrolment
* physician consent to participate in VD supplementation regimen
* ability and agreement to cease any VD medication for 4 weeks prior to initiation of study
* able to comprehend study and provide oral and written consent in English

Exclusion Criteria:

* any major cardiovascular event (new onset arrhythmia, hospitalization for a cardiac event) noted in patient chart within the 6 month period prior to initiation of the study
* currently on VD therapy/refusal to cease VD therapy for 4 weeks prior to initiation of study
* physician anticipates death or adverse event within the next year- known discharge from hemodialysis (transfer to peritoneal dialysis, kidney transplant)
Combination Chemotherapy in Treating Patients With Metastatic Colorectal Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic colorectal cancer that has not responded to previous chemotherapy.

OBJECTIVES: I. Determine the efficacy of oxaliplatin, leucovorin calcium, and fluorouracil followed by irinotecan, leucovorin calcium, and fluorouracil in terms of progression free survival in patients with metastatic colorectal cancer. II. Evaluate these treatment regimens in terms of overall survival, response rate, toxicity, and quality of life in this patient population.

OUTLINE: This is a multicenter study. Patients receive 4 courses of oxaliplatin IV and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Following the initial 4 courses of therapy, patients receive 4 courses of irinotecan IV over 30-90 minutes and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed every 8 weeks. Patients are followed every 3 months until death.

PROJECTED ACCRUAL: A total of 14-39 patients will be accrued for this study over 12 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the colon or rectum Measurable or evaluable lesion or residual disease (e.g., ascites, bone metastases) Failure after first line therapy Fluorouracil and leucovorin calcium OR Raltitrexed No oxaliplatin or irinotecan Relapse within 6 months of adjuvant therapy Relapse within 6 months of hepatic artery infusion chemotherapy for resected hepatic metastasis No symptomatic brain metastasis

PATIENT CHARACTERISTICS: Age: 18 to 80 Performance status: WHO 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Hepatic: AST and ALT no greater than 3 times upper limit of normal (ULN) Alkaline phosphatase no greater than 5 times ULN Renal: Not specified Other: No bowel obstruction No other significant, uncontrolled underlying medical or psychiatric condition No serious active infection Neurologically stable No other prior malignancy except nonmelanomatous skin cancer or carcinoma in situ of the cervix No psychological, social, familial, or geographical condition that would preclude study Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics Endocrine therapy: Not specified Radiotherapy: At least 2 weeks since prior radiotherapy Surgery: At least 2 weeks since prior surgery Other: No other concurrent experimental drugs
This Present Study Can be Used by Clinicians Who Treat Psychiatric Patients: Dentists Might Expect Xerogenic Side Effects of Specific Psychiatric Drugs Which Can Affect Dental Treatment, and the Results Can Help Psychiatrist to Choose the Less Xerogenic Psychiatric Medication

The goal of this observational study is to learn about the effects of psychiatric drug therapies on intra- and extra-oral sicca symptoms and salivation. The main question it aims to answer is:

Does taking psychiatric medication cause oral dryness and/or any changes on whole and minor saliva secretion ? Participants taking psychiatric medication answered a 16-question questionnare, and their saliva production was measured by Periotron device and by spitting method.


Eligibility Criteria:
Inclusion Criteria:

In the psychiatric group, the inclusion criteria was taking specific psychiatric medications.

Exclusion Criteria:

In the control group the exclusion criteria was reporting any diseases and taking medicines.
An Investigation to Evaluate Sound Coding Enhancements in Adult Cochlear Implant Recipients

This study will evaluate a range of experimental sound coding strategies that may improve hearing for cochlear implant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Users of an approved Nucleus cochlear implant.
* Aged 18 years or older (no upper age limit).
* Open set speech understanding sufficient to complete the study protocol as judged by the investigator.
* Fluent speaker in the language used to assess speech perception performance, as determined by the investigator.
* Willing and able to provide written informed consent.

Exclusion Criteria:

* Unable or unwilling to comply with the requirements of the clinical investigation as determined by the investigator.
* Additional health factors, known to the investigator, that would prevent or restrict participation in the audiological evaluations.
* Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling.
* Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation
* Current participation, or participation in another interventional clinical study/trial in the past 30 days, involving an investigational drug or device (unless the other investigation was/is a Cochlear sponsored investigation and determined by the investigator or Sponsor to not impact this investigation).
The Impact of COVID-19 Pandemic on Thyroid Surgery in Italy: Results From a Nation-wide Multicentric Study

Italy has been on the frontline of the COVID-19 pandemic, caused by the coronavirus SARS-CoV-2, the need to focus resources to deal with the pandemic led to a disruption of routine surgical care, as well as activity for oncologic and chronic disease. The aim of this study was to evaluate the impact of COVID-19 pandemic on surgical activity of the Italian Units of Endocrine Surgery belonging to the SIUEC (Italian Society of Endocrine Surgery), the most important national scientific society of endocrine surgery.The aim of this study was to evaluate the impact of COVID-19 pandemic on surgical activity of the Italian Units of Endocrine Surgery belonging to the SIUEC (Italian Society of Endocrine Surgery), the most important national scientific society of endocrine surgery.


Eligibility Criteria:
Inclusion Criteria:

* patients that had undergone thyroidectomy during COVID-19 pandemic (from the 9th March to the 31st August 2020), defined as case group, or during the same period of the previous year (from the 9th Match to the 31st August 2019), defined as control group.

Exclusion Criteria:

* incomplete data