cyrilzakka/clinical-trials huggingface dataset:
Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem

The purpose of this multicentre, prospective study is:

* Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3 years, 5 years, 7 and 10 years.
* Report Safety and Survivorship up to 10 years F/up.

This study intends to evaluate the safety and performance of the Sirus cemented hip stem in terms of function improvement postoperatively, stability and fixation of femoral stem and survivorship.

Eligibility Criteria:
Inclusion Criteria:

Selection of subjects for this evaluation should be in accordance with the indications of Sirus stem:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
5. Revision procedures where other treatments or devices have failed. The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties

Exclusion Criteria:

* Absolute contraindications include:

infection, sepsis, osteomyelitis

Additional contraindications include:

* Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
* Osteoporosis,
* Metabolic disorders which may impair bone formation
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy or neuromuscular disease.
Study of Low-intensity Focused Ultrasound Effects on Human Memory

This research project is examining the effects of noninvasive brain stimulation on human memory. This study will help to better understand noninvasive brain stimulation techniques that may have the potential to aid in memory dysfunction. Subjects will undergo a magnetic resonance imaging (MRI) and a computed tomography (CT) scan, to take pictures of their brain and skull. They will receive noninvasive brain stimulation using low-intensity focused ultrasound (LIFU) sound waves, to temporarily change brain activity. Their brain signals (MRI or EEG) will be monitored to measure changes in their brain signals. Their heart rate, blood pressure, respiratory rate, eye movement and skin moisture will be monitored as well. They will complete neuropsychological batteries and memory tasks. They will complete questionnaires.

This study employs a two-arm, sham-controlled, repeated measures design conducted across eight sessions:

Overall Structure

* Session 1: Baseline Assessment and Imaging
* Session 2-8: LIFU Stimulation \*The order of Sessions 2-8 is ideally randomized to control for order effects. The study design allows for flexibility to accommodate varying levels of participant completion while maintaining scientific validity.

Detailed Session Breakdown Session 1: Baseline Assessment and Imaging

* Structural \&amp; Functional imaging: MRI and CT anatomical scans
* Administration of questionnaire battery Session 2-8: LIFU Stimulation or Sham
* Memory task performance
* Neuropsychological battery administration
* EEG recording
* Collection of physiological measures (HR, BP, RR, and EDR)

Design Considerations: There will be at least one week between Session 1 and Session 2, and at least 48 hours between each subsequent session. This design allows for within-subject comparisons across stimulation conditions, as well as between-subject comparisons if the full protocol is completed. The study protocol is designed to accommodate potential variability in participant availability. While full completion of all sessions is ideal, partial completion can still yield valuable data.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of all ethnicities, who understand and speak English.

Exclusion Criteria:

* The exclusion criteria below are regularly implemented in MRI, CT, and EEG experiments for the safety of the subjects and for data quality assurance.

  1. Claustrophobia (scanning environment may be uncomfortable).
  2. Contraindications to MRI: including pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, steel worker, or other implants.
  3. Contraindications to CT: pregnancy
  4. Active medical disorder or treatment with potential CNS effects (e.g. Alzheimer\&#39;s)
  5. History of neurologic disorder. (e.g. Parkinson\&#39;s, Epilepsy, or Essential Tremor)
  6. History of head injury resulting in loss of consciousness for \&gt;10 minutes.
  7. History of alcohol or drug dependence (through self-report).
Postpartum Diabetes Screening in Women With Gestational Diabetes

Assess postpartum diabetes screening in GDM patients with initiation of a reminder system in the postpartum period


Eligibility Criteria:
Inclusion Criteria: GDM, english speaking -

Exclusion Criteria: Non english speaking. Younger than 18 years of age

-
The Association Between Anemia and Cardiomegaly

Anemia is one of the major global problems that continues to this day. According to World Health Organization (WHO) data, anemia is found in 1.62 billion people or equivalent to 24.8% of the world's population while, the prevalence of anemia in children under 6 years of age in Indonesia reached 38.4%. Anemia, if undiagnosed or untreated for a long period of time can lead to multiorgan failure. The cardiovascular system is the most commonly affected system in chronic anemia. Between one-third and two-thirds of patients with severe anemia have cardiomegaly and this will return to normal within a few weeks after the anemia is well managed. This abnormality can be evaluated on chest radiograph or echocardiography.


Eligibility Criteria:
Inclusion Criteria:

* Anemia patients aging maximum 18 years old
* Anemia patients who had undergone chest radiograph and echocardiography

Exclusion Criteria:

* Anemia patients who had undergone definitive surgery
* Anemia patients who had took iron supplementation in the last 3 months
* Anemia patients who had other anemic conditions such as chronic kidney disease or hemolytic anemia
Randomized-controlled Trial of Yoga for Ulcerative Colitis

The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention compared to self-care on quality of life, stress, psychological health, and physiological parameters in 77 patients with ulcerative colitis.


Eligibility Criteria:
Inclusion Criteria:

* Ulcerative colitis (clinical, endoscopic and histological diagnosis)
* Disease duration at least 12 months
* Clinical remission for at least 4 weeks and less than 12 months
* CAI \< 5
* IBDQ \< 170
* Physical and mental ability to perform yoga
* No regular practice of yoga or Pilates in the previous 12 months

Exclusion Criteria:

* Clinically active disease (CAI \> 4 Rachmilewitz)
* Complete resection of the colon
* Acute, infectious or chronic active ulcerative colitis
* Severe disease precluding yoga practice
* Malignancy with a disease-free survival \< 5 years except curatively treated basalioma of the skin
* Alcohol or drug abuse
* Dementia
* Pregnancy
Paediatric Chronic Tracheostomy Care: An Evaluation of an Innovative Competency-based Education Program for Community Health Care Providers

This project will evaluate a new course developed for nurses that provide care to children with breathing technology including breathing tubes and home breathing machines. The investigators plan to assess the nurses' knowledge and comfort of their ability to care for these medical technologies prior to the course as well as their ability to retain their knowledge 6 weeks and 6 months after course completion.

A structured program evaluation considering a hierarchy of outcomes is essential to determine whether the tracheostomy module is associated with improved knowledge and skills for CHPs (community health providers). This investigators proposed study is guided by the evaluation of knowledge acquisition and self-efficacy as a theoretical framework 24. CHPs' sense of self-efficacy or perceived capability in caring for this population is important to foster to potentially mitigate significant morbidity and mortality, while ultimately striving for safe, high-quality clinical care for these medically complex children.

Eligibility Criteria:
Inclusion Criteria:

* Course registrants for the competency-based tracheostomy education course from VHA Home Healthcare agency
* Consent to study participation
* English speaking

Exclusion Criteria:

• Previously attended the competency-based tracheostomy course at SickKids
Satavaptan in the Prevention of Ascites Recurrence in Patients With Ascites Due to Cirrhosis of the Liver

Primary To evaluate the efficacy of satavaptan on top of diuretic drugs in reducing the recurrence of ascites.

Secondary To evaluate the tolerability and safety of satavaptan on top of diuretic drugs over a 52-week treatment period in participants with cirrhosis of the liver and recurrent ascites.

The one-year double blind placebo controlled period is extended up to 2 years in a long term safety study (PASCCAL-2).


Eligibility Criteria:
Inclusion Criteria:

* Participants with cirrhosis of the liver.
* Participants with recurrent ascites having undergone both of the following:

  * therapeutic paracentesis for the removal of ascites in the previous 24 hours with the removal of \> 4 litres of fluid.
  * at least one other therapeutic paracentesis in the previous 3 months.

Exclusion Criteria:

* Participants with an existing functional transjugular intrahepatic portosystemic shunt (TIPS) or other shunt.
* Known hepatocellular carcinoma.
* Participants with ascites of cardiac origin or due to peritoneal infection (e.g. tuberculosis) or peritoneal carcinoma.
* Participants previously exposed to satavaptan in the past 12 months.
Lumen-apposing Metal Stent With or Without Coaxial Plastic Stent for Treatment of Walled-off Pancreatic Necrosis

A prospective randomized cohort study to compare whether the placement of a double-pigtail plastic stent (DPS) within a lumen-apposing metal stent (LAMS) may improve the efficacy and safety of endoscopic ultrasound guided transmural drainage of walled-off pancreatic necrosis (WON) and thus prevent potential adverse events related to LAMS insertion.

The aim of the study is to compare endoscopic ultrasound guided transmural drainage using lumen-apposing metal stent with (1.) or without (2.) coaxial plastic stent in the management of walled-off pancreatic necrosis. The usage of LAMS has been evaluated as a safe and effective method for the drainage of walled-off pancreatic necrosis in various studies. However, complications such as bleeding, infection due to stent obstruction, stent migration, or buried stent syndrome have been reported. A preventive measure to minimize adverse events related to LAMS insertion by means of placing an anchoring DPS through the LAMS have been suggested but there has been no prospective randomized study to assess the utility of such measure to date.

The study is to be conducted at a tertiary institution with an expertise in treating hepato-pancreato-biliary diseases. The main timeframe of the study is 3 weeks following LAMS insertion with or without DPS. All LAMS will be extracted 3 weeks after the initial procedure. The extraction will be preceded by a CT scan of the abdomen to assess whether the DPS needs to be left in place/ inserted in patients with incomplete resolution of the collection. In addition, material from the collection will be collected for cultivation at every endoscopic intervention to assess colonization by microbial flora over time. All patients will be closely followed with clinical, laboratory, and radiological assessment for 12 months in total.

Our experience has shown failure of the (2.) method in 70 % of patients so far. Assuming a clinically significant difference to be a reduction to 40 % in failed patients using the (1) method, the required study population size was calculated to 62 patients (31 in both arms) by power analysis (at standard alpha and beta values). The final number was set to 70 as a safety measure.

Eligibility Criteria:
Inclusion Criteria:

* walled-off pancreatic necrosis (WON) indicated for endoscopical drainage
* signed informed consent form

Exclusion Criteria:

* patient disagreement with the study
* types of collections other than WON
* drainage with stents other than LAMS
* previous attempts at drainage of WON
* severe coagulopathy or thrombocytopenia
A Study of Onartuzumab in Combination With Erlotinib in Patients With MET-Positive Stage IIIB or IV Non-Small Cell Lung Cancer Carrying an Activating Epidermal Growth Factor Receptor (EGFR) Mutation

This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient, \>/= 18 years of age
* Histologically confirmed, unresectable Stage IIIB or IV non-small cell lung cancer (NSCLC)
* No prior treatment for unresectable Stage IIIB or IV NSCLC
* Measurable radiographic evidence of disease according to RECIST v1.1
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Exclusion Criteria:

* Prior exposure to agents targeting either the Hepatocyte Growth Factor (HGF) or MET pathway
* Exposure to an investigational or marketed agent that can act by EGFR inhibition
* Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
* Brain metastasis or spinal cord compression not definitively treated with surgery and/or radiation, or previously diagnosed and treated central nervous system (CNS) metastases or spinal cord compression without evidence of clinically stable disease for \>/=4 days. Note: Patients with treated CNS metastases who are asymptomatic and on a stable dose of corticosteroids for \>/= 14 days prior to randomization are eligible.
* History of another malignancy in the previous 5 years, unless cured by surgery alone and continuously disease-free
* Radiographically evident interstitial lung disease , concurrent infection, or a history of any of these conditions
* Inadequate hematologic, biochemical, and organ function
* Pregnant or lactating women
* Life expectancy of \< 12 weeks
* Receipt of an investigational drug within 28 days prior to initiation of study treatment
P16 Staining as Prognostic Biomarker in Serous Papillary Endometrial Cancer

P16 is a tumor suppressor protein implicated in serous papillary endometrial carcinoma. Evidence from previous trials indicates that it may be used as a diagnostic biomarker distinguishing this disease from endometrioid endometrial cancer. Additional evidence points to its prognostic value.

The current study will evaluate p16 both as a diagnostic tool for serous papillary endometrial cancer and as a prognostic biomarker.

following anonymization, histology blocks will be microtomed and stained for P16 and P53 proteins.

Blocks from endometrioid endometrial cancer will be used as a control group.


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of endometrial cancer
* histology block exists in hospital's library

Exclusion Criteria:

* none
Effects of a Variety of Meals on Satiety

The primary objective of this study is to assess the acute effects of different meals on satiety. It is hypothesized that a lower carbohydrate meal will result in greater feelings of satiety and reduced food intake at a subsequent meal compared to the higher-carbohydrate or meal skipping conditions.

Satiety refers to feelings of fullness or lack of desire to eat following consumption of a food or meal. A number of dietary factors have been shown to influence satiety, including food volume, food weight, energy density, food palatability, and certain food ingredients. The nutritional composition of a meal appears to also play a significant role in an individual's feelings of satiety and ability to stay full until the next meal.

Eligibility Criteria:
Inclusion Criteria:

* premenopausal Females
* Ages 18-55
* BMI between 18.5-29.9
* Willing to maintain weight throughout study period

Exclusion Criteria:

* Subject has a history of any surgical intervention for the treatment of obesity
* Recent history or use of weight loss drugs, herbal supplements or on a dieting program or trying to loose weight
* Gains or loses more than 6 pounds over the study period
* Current or history of an eating disorder
* Restrained eater
* Excludes any foods or meals from their diet
* History or presence of clinically important cardiac, renal, hepatic, endocrine, pulmonary, gastrointestinal, biliary, pancreatic or neurologic disorders
* Signs of an infection
* Heavy user of caffeine or alcohol
* Unconventional sleep patterns (e.g. works 3rd shift)
* Subject is pregnant or planning to become pregnant during the study period
An Implant for Hearing Loss Due to Removal of Neurofibromatosis 2 Tumors

This is a study to gather some information on the safety and efficacy of the penetrating auditory brainstem implant (PABI) in patients with neurofibromatosis type 2.

Neurofibromatosis Type 2 (NF2) is characterized by multiple tumors of the cranial and spinal nerves, and, in particular, by bilateral acoustic tumors. Surgical resection of these tumors generally results in the transection of the VIIIth nerve, destruction of the cochlea and auditory nerve, and total hearing loss. Due to the loss of the auditory nerve, these patients are not candidates for cochlear implantation. The Auditory Brainstem Implant (ABI) provides the only available intervention to restore some auditory sensation to these patients. An ABI is an implantable prosthesis that produces sound sensation by electrical stimulation of the ascending auditory pathway at the level of the cochlear nucleus.

The PABI may be placed surgically during tumor resection. Efficacy will be assessed using psychophysical and standard speech reception measures.

Eligibility Criteria:
Inclusion criteria:

* Diagnosis of neurofibromatosis type 2
* Speak English as a primary language

Exclusion criteria:

* Physical, psychological, or medical conditions that contraindicate the surgical procedure
Quality of Life Assessment of Children With Congenital Heart Disease Aged 5 to 7 Years

Congenital heart diseases (CHD) are the firt cause of congenital malformations (8 for 1000 births). Since the 90's, great advances in prenatal diagnosis, pediatric cardiac surgery, intensive care, and cardiac catheterization have reduced morbidity and early mortality in this population. Prevalence of " GUCH ", grown-ups with congenital heart disease has thus been significantly increasing. Nowadays, quality of life (QoL) assessment of this population is in the foreground. Our team is a reference center in the management of patient with CHD, from the fetal period to adulthood. The investigators have been conducting a clinical research program on health related QoL in pediatric and congenital heart disease. The investigators thus demonstrated the link between cardiopulmonary fitness and QoL in children with CHD aged 8 to 18 years, the correlation between functional class and QoL in adults with CHD, and the impact of therapeutic education on QoL in children under anticoagulants. Currently, no controlled cross-sectional quality of life study assessment has been leaded in the youngest children with CHD. This present study therefore extends our work in younger children aged 5 to 7 years.

248 patients will be enrolled in this study.

Patient from groups 1 is included during his annual medical check-up. Quality of life questionnaire and other examinations are performed during this site visit. Its is a part of his usual care. No supplementary visit, directly related to the research, are necessary. 2 sites will participate to the enrollment, belonging to the French national network for complex congenital heart diseases (M3C) .

Participants (healthy children) from groups 2 are included from schools.The prior agreement of the Ministry of National Education was obtained before any procedure related to this study. 3 schools will participate to the enrolment

Eligibility Criteria:
Inclusion criteria:

• Children with CHD (as defined in the ACC-CHD classification) aged 5 to 7 years or same aged school children.

Exclusion criteria:

* Other comorbidity affecting quality of life (polymalformative syndrome, extracardiac organ failure, neurodegenerative disease, severe genetic disease, psychomotor retardation).
* Surgical procedure during the last 6 months.
* Inability to understand the QoL questionnaire (parents and / or child): non-french speaker, severe intellectual disability.
Implementation of a "Remission" Consultation in the Management of Patients Treated for Localized Breast Cancer

The main objective of this study is to describe the evolution in quality of life (QLQ-C30) for patients receiving breast cancer care at 3, 6 and 12 months after a "remission" consultation.

The secondary objectives of this study are:

A. to describe changes in body image (Image Body Scale Version F) at 3, 6 and 12 months after a "remission" consultation.

B. to describe changes in psychological distress (visual analog scale) at 3, 6 and 12 months after a "remission" consultation.

C. to assess the time of resumption of work (date of last chemotherapy - date of the actual resumption of work) after a "remission" consultation.

D. to evaluate the acceptance rate for the "remission" consultation.

E. to describe the modes of the observed management, their distribution and the characteristics of the patients according to different monitoring arrangements.

Eligibility Criteria:
Inclusion Criteria:

* The patient is receiving care for localized breast cancer and finished her adjuvant treatment (chemotherapy, radiotherapy)
* The patient has completed his/her adjuvant therapy in the last 6 months (chemotherapy, radiotherapy).

Exclusion Criteria:

* The patient is participating in another study
* The patient is under judicial protection
* It is impossible to correctly inform the patient
* The patient has a metastatic form of the disease at diagnosis