cyrilzakka/clinical-trials huggingface dataset:
Closed Vitrification of Oocytes

This study is aimed to evaluate the use of a closed device for storage of vitrified oocytes.

The Cryotop method for oocyte vitrification is classified as "open system", which means that it requires direct contact with liquid nitrogen during the vitrification process. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed. Instead closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage. Open systems have proven highly effective in achieving similar outcomes with vitrified oocytes compared to those achieved with fresh ones. On the contrary, closed systems have failed to be as effective as open ones when used for oocyte vitrification. Although open systems have proven to be highly efficient, where many other methods have failed, they have been related to a theoretical risk of contamination due to direct contact with liquid nitrogen. Though to date there have been no reported cases of transmission of disease after cryo-transfers either for slow freezing or vitrification, some European countries prohibit the use of open systems for vitrification. In this study, we will evaluate the results after the donor oocyte vitrification, using a modification of a current device (Cryotop®), which makes it capable of being hermetically sealed. The current study is a prospective randomized trial aimed to assess the outcome of ovum donation cycles conducted with vitrified oocytes using the closed device versus oocytes vitrified using the traditional open device.

Eligibility Criteria:
Inclusion Criteria:

Donors:

* \< 35 years old
* Normal physical and gynecological examinations
* No family history of hereditary or chromosomal diseases.
* Normal karyotype
* Negative screening for sexually transmitted diseases.

Oocyte recipients:

* Oocyte recipients \< 50 years old
* Body mass index \< 30
* \< 2 previous IVF failures
* No severe male factor
* No recurrent miscarriage
* No hidrosalpinx
* No myoma
* No adenomyosis
* No AMH alterations

Exclusion Criteria:

Donors and recipients not meeting inclusion criteria
MRI of Infrapatellar Fat Pad in Osteoarthritis

In this study, the investigators use the clinical documentation and imaging data of MRI to do research. Clinical subjects were divided into two groups: osteoarthritis patients and healthy controls without osteoarthritis. Differences of MRI data were studied between two groups.

In this study, the investigators applied high precision MRI technique (with as less as a slice thickness of 0.35 mm and without inter-slice gap), and calculated not only the IPFP maximal sagittal area and IPFP volume, but also the quantitated signal, and compared the differences between healthy controls and osteoarthritis patients. This is an observational cross-sectional study without specific interventions to the subjects. MRI is a regular examination in our hospital. And all subjects are included for the reasons of osteoarthritis (need MRI) and healthy controls (pain but not osteoarthritis, also need MRI). The investigator does not assign specific interventions to the subjects of the study.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical knee osteoarthritis;
* The healthy controls who require MRI test.

Exclusion Criteria:

* Contraindications to magnetic resonance imaging;
* Rheumatoid arthritis patients;
* Gout;
* Hemophilic arthritis;
* Subjects who take non-steroidal anti-inflammatory drugs (NSAIDs);
* Subjects who take lipid-lowering agents;
* Subjects who have the history of knee trauma;
* Subjects who have the history of knee operation;
* Subjects who have the disease of musculoskeletal tumor near knee;
* Subjects who have joint loose bodies.
Assessing Covert Consciousness in Unresponsive Patients

In this study, the investigators explore anesthesia as a tool for providing further insight into the level of consciousness of individuals with a clinical diagnosis of unresponsive wakefulness syndrome (UWS), but who possess some neurophysiological signatures of conscious awareness. This group, who could potentially be conscious, will herein be referred to as the target population. Our goal is to assess whether or not neurological patterns of consciousness in the target population respond to anesthesia in a similar manner to neurologically compromised individuals with known consciousness (e.g. those in minimally conscious state (MCS). In healthy controls, propofol-induced unconsciousness results in an elimination of the mismatch negativity event-related brain potential (ERP) and a diminished directed connectivity. The investigators hypothesize that at doses well below those required for surgery, anesthesia will have similar effects on these neural patterns in neurologically compromised patients with the potential for conscious awareness, but will not affect these patterns in those who lack consciousness.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the intensive care unit at Hamilton General Hospital who:

  * Clinical status consistent with UWS (no responsiveness to commands)
  * Clinical status consistent with MCS (minimal response to at least one command)
  * Presence of an endotracheal tube (ETT) or a tracheostomy tube
  * Between 18 and 50 years of age

Exclusion Criteria:

* • Elevated intracranial pressure (ICP)

  * Hepatic or renal failure
  * Hemodynamic instability
  * Active vasopressor therapy
  * Previous open-head injury
  * Previous intracranial pathology requiring neurosurgical interventions in the past 72 hours
  * Anticipated ICU stay \< 24 hours
  * Documented allergy to propofol
  * Pregnancy
  * BMI \> 35 kg/m2
  * Anyone who is deemed medically unsuitable for this study by the attending intensivist
  * Patients who are already in a medically-induced coma for intracranial hypertension or status epilepticus
Safety and Efficacy of Folfox6 + Cetuximab Versus Folfiri +Cetuximab in Patients With Metastatic Colorectal Cancer

In Patients with metastatic colorectal cancer the following treatments first-line Folfiri+Cetuximab first-line Folfox6 + Cetuximab will be concerning efficacy and safety.

The trial compares Folfiri + Cetuximab and Folfox6 + Cetuximab concerning efficacy and safety as first

The multicenter randomized phase II study will enroll a target of approximately 150 first-line patients with metastatic CRC.

EGFR expression is not required for study entry, however, the EGFR status will be measured retrospectively.

Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected. The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter every 12 weeks based on imaging Following permanent treatment cessation (stop of all study treatments) patients will be followed-up for.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* Metastatic colorectal carcinoma not suitable for curative-intent resection
* Availability of tumor sample (or able and willing to provide tumor sample) for EGFR assessment
* Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target lesion(s) must not lie within an irradiated area)
* ECOG performance status of \< 2 at study entry

Exclusion Criteria:

* Brain metastasis (known or suspected)
* Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy treatment free interval is \> 6 months
* Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study entry
* Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not indicated in the study protocol
* Any investigational agent(s) within 4 weeks prior to entry
* Previous exposure to EGFR-pathway targeting therapy
Genetic Predisposition for Chronic Non-specific Low Back Pain

Patients with inflammatory back pain were shown to differ from healthy controls in genotype of the Angiotensin-converting enzyme (ACE), which regulates vasoconstriction/-dilatation. The aim of this study is to investigate whether genetic reduction of muscle perfusion might be a pathophysiological pathway of how genes influence chronic non-specific low back pain (LBP).

The following genes will be investigated:

* Insertions-/deletions-polymorphism of the angiotensin-converting enzyme (ACE-I/D gene polymorphism; 3 genotypes: ACE-II, ACE-ID, ACE-DD).
* Anti-adhesive extracellular matrix protein Tenascin-C: gene polymorphism rs2104772

The goals of this study are to investigate whether these genotypes correlate with 1) endurance of back muscles, 2) comorbidities such as asthma and diabetes and 3) the risk for LBP as assessed by a LBP-classification tool.

Eligibility Criteria:
Inclusion Criteria:

* 18-65

Exclusion Criteria:

* Spinal surgery
* Spinal fracture
* Inflammation
* Tumour
* Severe chronic disease which make intensive physical activity impossible (osteoporosis, cardiovascular heart diseases)
Laser Speckle Contrast Imaging for Cutaneous Microvascular Dysfunction Detection in Systemic Sclerosis.

The aim of the study is to determine if postocclusive hyperemia of palmar and dorsal face of the hand with Laser speckle contrast imaging discriminate between patients with systemic sclerosis, subjects with primary Raynaud's phenomenon and healthy subjects.

Microvascular dysfunction is a key event in the pathogenesis of systemic sclerosis. There are currently no test measuring it in clinical practice. Response to humeral occlusion is interesting and this response has been studied with laser Doppler flowmetry. More recently, laser imaging has been used analysing the granularity of the laser: laser Speckle Contrast Imaging which allow combining high temporal resolution to high spatial resolution.

The investigators proposed, in this study, to compare this imaging at basal and after post-occlusive hyperaemia of dorsal and palmar face of hand in 3 groups: healthy subjects, primary Raynaud's phenomenon and systemic sclerosis.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects:
* Man ou woman 18 years old or more.
* Without Raynaud's phenomenon or systemic sclerosis.

Raynaud's phenomenon subjects:

* Man ou woman 18 years old or more.
* with primary Raynaud's phenomenon.

Systemic sclerosis:

* Man ou woman 18 years old or more.
* systemic sclerosis in accordance to Leroy's classification.

Exclusion Criteria:

* active digital ulceration
* Bosentan, iloprost ou sildenafil treatment
* History of axillary dissection , trauma or surgery
* history of thromboembolic disease or thrombophilia
* minor or law-protected major
* exclusion period in another study
* No affiliation to medicare
* pregnant, parturient or breasting woman
* concomitant serious disease: progressive cancer, liver failure, history of myocardial infarction less than 5 years, angor
* smoking in the 6 last months
* person deprived of liberty by a legal or administrative decision, person under legal protection
* maximal annual indemnification reached.
Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France

This is a multicentre, non-interventional, single arm study that aims to describe the treatment patterns in France: patients' characteristics, disease characteristics, prior treatments for Severe chronic rhinosinusitis with nasal polyposis and treatment prescription modalities. As well as to assess the clinical outcome after initiation of dupilumab (Dupixent®) and safety of the product during the two years of treatment


Eligibility Criteria:
Inclusion Criteria:

* Patient aged \>= 18 years old at the time of the initiation of the treatment with dupilumab (Dupixent®).
* Decision to initiate Dupixent® prior to inclusion in the study, initiation of Dupixent® for severe Chronic rhinosinusitis with nasal polyposis (CRSwNP) maximum 3 months before inclusion.
* Informed consent and willingness to participate.

Exclusion Criteria:

* Conditions or legal situations resulting in impossibility to consent or impacting the interpretation of the results.
* Patient participating in an interventional clinical trial with experimental product at inclusion.
Validating the Novel Classification for the Assessment and Grading of Unexpected Events in Pediatric Surgery: The Clavien-Madadi Classification

Despite appraisal of the Clavien-Dindo classification in the pediatric surgical literature, some criticize the transfer of the grading systems for adults in a pediatric cohort without modifications. In a recent study it has been shown that few items of the classification do not offer additional information in pediatric cohorts and organizational and management errors have been integrated, not being part of the initial proposal by Dindo et al.

In a group of pediatric and general surgeons, methodologists and statisticians of the ERNICA network the Clavien-Dindo classification has been modified for the application in pediatric surgery. The aim is to test and validate the novel Clavien-Madadi classification in a pediatric surgical cohort.

Based on the protocol by Dindo et al. for the assessment of the international acceptability and reproducibility of the Clavien-Dindo classification, the aim is to circulate case scenarios (of complications/ unexpected events) within the ERNICA (European Reference Network for Rare Inherited Congenital Anomalies) network. Those case scenarios (15-20) should be graded by the respondents according to the Clavien-Dindo and Clavien-Madadi classification and preferences for future practice should be reported.

Milestones

1. All members of the working group send the PI´s 1-2 case scenarios with unexpected events in the management and treatment of neonates (preferably congenital diseases) and children for each grade of the Clavien-Madadi classification
2. All case scenarios will be circulated within the working group and will be ranked with a Likert scale (1 not accurate - 5 accurate) regarding the plausibility for an international survey
3. A final proposal of 15-20 case scenarios will be circulated within the working group
4. Circulating the case scenarios and the additional questionnaire via the ERNICA email distribution system and newsletter

Eligibility Criteria:
Inclusion Criteria:

* Case scenarios of unexpected events
* Case scenarios on neonatal surgery
* Case scenarios on congenital malformations
* Case scenarios with (re-)interventions
* Case scenarios with organ impairment
* Case scenarios with fatal result

Exclusion Criteria:

* Complex constructed case scenarios
* Case scenarios with adult patients
* Case scenarios with multiple events
Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting

Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. The investigators objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a single arm intervention pilot trial in the ICU setting, which will pave the way for a future stepped wedge randomized control trial (stepped wedge trial entered separately in clinical trials.gov as NCT03702270)


Eligibility Criteria:
Inclusion Criteria:

* VUMC patients age 18 or older with a penicillin allergy reported in their chart and are medically stable, currently admitted to ICU.

Exclusion Criteria:

* Patients with a penicillin allergy reported in their chart under ICU care, but who are currently medically unstable.
MaxART: Early Access to ART for All in Swaziland

The purpose of this study is to evaluate the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's government-managed health system.

The clinical evidence in support of offering antiretroviral treatment (ART) for all HIV-positive individuals to improve patient health outcomes and reduce HIV incidence is building, and the resource-limited countries where this approach could have the biggest impact want to evaluate if this is a feasible and effective intervention to turn the course of their HIV epidemics. The MaxART Early Access to ART for All (EAAA) implementation study was designed to determine the feasibility, acceptability, clinical outcomes, affordability, and scalability of offering early antiretroviral treatment to all HIV-positive individuals in Swaziland's government-managed health system.

This is a 3-year randomized stepped wedge design with open enrollment for all adults 18 years and older across 14 rural health facilities in Swaziland's Hhohho Region. Primary endpoints are retention and viral suppression. Secondary endpoints include ART initiation, adherence, drug resistance, tuberculosis, HIV disease progression, and cost per patient per year.

Sites are grouped to transition two at a time from the control (standard of care) to intervention (EAAA) stage at each 4-month step. This balanced design will result in approximately one half of the observations being under an intervention clinic, and the other half under control.

Power calculations were conservatively based on the estimated number of individuals expected to enroll in the study comparing the first 12-month measure of retention and 6-month of viral suppression on ART of those entering clinics during their control stage versus those that will be entering a clinic during intervention period.

A strategic mix of multidisciplinary research methodologies will be applied to meet the study aim, including implementation science, social science research, economic evaluations, and HIV incidence modeling.

Eligibility Criteria:
Inclusion Criteria:

* All ART-naive HIV-positive individuals who are 18 years of age or older - excluding pregnant or breastfeeding women - who attend the health facilities included in the study will be asked for their consent to enroll in the study.

Exclusion Criteria:

* All HIV-positive individuals who \< 18 years of age or older and pregnant or breastfeeding women.
* All HIV-positive individuals who did not consent to participate or who have already been initiated on ART.
Medications With or Without WeightWatchers

The study compares the effectiveness of adults living with overweight or obesity taking weight management medications alone vs taking them with behavioral and lifestyle support. The primary outcome is percent body weight lost at 12-weeks.


Eligibility Criteria:
Inclusion Criteria:

* BMI of \>30 or BMI of \>27 with one or more weight related medically qualifying condition (hypertension, dyslipidemia, sleep apnea, cardiovascular disease)
* Determined eligible for Bupropion/Naltrexone or Liraglutide by WW Clinic medical provider and initiated a medication management plan

Exclusion Criteria:

* Diabetes
* Uncontrolled hypertension
* History of seizures
* History of glaucoma
* History of chronic kidney disease
* Currently taking bupropion
* Currently taking naltrexone
* Current or previous history of anorexia or bulimia nervosa
* Engagement with vomiting or laxative use within the last 28 days with the aim of controlling their shape or weight
* Currently taking opioids
* Previous surgical obesity treatment
* Use of other anti-obesity medication in last 90 days or a GLP1 in the last 180 days
* Lost weight \>11 lbs in the last 90 days
* Pregnant, breastfeeding, intends to become pregnant, of child-bearing potential and not using a highly effective contraceptive method
* Any other reason rendering a participant unsuitable for trial participation, as determined by a clinician or study investigator
Diagnostics in the Leg Ulcer Pathway

This project aims to investigate 'The minimum diagnostic requirements for patients presenting to primary care with suspected venous ulcers.' In order to do this, the investigators intend to run a series of questionnaires with primary care services, vascular science services, and perform some cost effectiveness modelling on running diagnostic services in primary care and in secondary care settings. A one off questionnaire, designed in Qualtrics, will be sent out to primary care practitioners via social media and email contacts. This will be aimed at establishing their current role and any guidelines they follow with regards to the diagnosis and management of venous leg ulcers in primary care, and to determine their opinion of what this patient pathway should involve. A Delphi consensus will be carried out amongst vascular scientists across the UK to determine current and streamline future practice in diagnostics for patients with venous leg ulcers. The consensus will be achieved when there is ≥ 70% agreement. Cost effectiveness modelling will be carried out on two different scenarios of managing this cohort of patients, one in primary care and one in secondary care settings. Descriptive statistics will be performed on the results.

The main objective of this project is to determine the role/position of diagnostic imaging in the patient journey for a patient with active or healed ulceration.

1. To determine the current practice in primary care for venous leg ulcer management and availability of services to onward referral.
2. To determine the current practice for diagnosis and management of suspected venous leg ulcers in vascular scientist departments across the UK
3. To establish what the minimum diagnostics should be for this cohort of patients including what scans should be performed and can a set criterion be applied to this cohort of patients.
4. To determine the cost effectiveness of implementing this in both primary and secondary care settings.

Eligibility Criteria:
Inclusion Criteria:

* Primary care practitioners working in the UK will be recruited for the primary care questionnaire.
* Vascular Scientists working in a secondary care hospital in the UK will be recruited for the online delphi consensus.

Exclusion Criteria:

* Participants not meeting the inclusion criteria.
Total Knee Arthroplasty With Vitamin E Polyethylene

The aim of this observational study is to investigate if there is any difference in survival rate, clinical and radiological results after total knee replacement with vitamin E-blended polyethylene in comparison to conventional polyethylene at minimum 7-year follow-up


Eligibility Criteria:
Inclusion Criteria:

* Patient who received primary cemented total knee arthroplasty with GKS Prime Flex Mobile knee by Permedica Orthopaedics with vitamin E polyethylene bearing or with conventional polyethylene bearing.
* Minimum 7-year follow-up;
* Age ≥ 18 and \< 85 years;
* Patient who signed informed consent.

Exclusion Criteria:

* Patient who received primary cemented total knee arthroplasty with a different knee prosthetic design;
* Patient already enrolled in other clinical studies.