cyrilzakka/clinical-trials huggingface dataset:
Acceptability of Hip Protector Airbags in Older People

Pilot study evaluating two different airbag hip protectors to see if community-dwelling older people will wear them and find them comfortable and acceptable.

Traditional hip protectors are specialised pads designed to shield the greater trochanter on (fall) impact. They have uncertain benefits in reducing hip fracture risk and have very poor uptake due to discomfort. Recently, airbag technology has allowed radical change in design and wearability of hip protectors. Despite these airbags being commercially available, there is little evidence of their acceptability/wearability, and as with all hip protectors, virtually no research exists in community-dwelling people. A study of traditional hip protectors found that they may reduce fear of falling (FoF) in community dwellers but activity levels or quality of life were not assessed. A non-randomised study is ongoing of hip airbags on fractures in nursing homes, but none in community dwellers. Two Hip Protectors available in Europe are CE marked as personal protective equipment and approved for sale. There is a need to evaluate their acceptability and usefulness before considering larger clinical trials evaluating their efficacy in preventing hip fractures. This study will evaluate the two hip protectors and gain patient feedback in their use.

Eligibility Criteria:
Inclusion criteria:

* Age 65 years and older
* 1 or more falls in the last year requiring medical attention
* Fear of Falling (single question Y/N)
* Able to give informed consent

Exclusion criteria:

* Nursing home resident
* Immobile, or requires another person to assist with transfers and mobility
* Unable to apply or remove the hip airbag independently
* Waist circumference \<70cm or \>125cm (Helite device is sized by waist) and
* Hip circumference \<84cm or \>125cm (Wolk device sized by hip)
Application of 3D Printing in Laparoscopic Surgery of Liver Tumors

To explore the utility of personalized 3D printed liver models in planning and navigating laparoscopic resections.

Project goal is to evaluate utility of personalized 3D printed models in preoperative planning and performing laparoscopic liver resections. Models will be developed with unique, low-cost approach. Project will consist of three overlapping modules/stages evaluating:

1. Accuracy of 3D printed liver models compared to computed tomography and standard surface or volume rendering
2. Whether 3D printed utilized in planning surgery affects the decision making regarding the surgical plan
3. Whether 3D printed models utilized in planning and navigating laparoscopic resections affect perioperative outcomes

Methodology of developing 3D models is described elsewhere. Printed models will be delivered to surgical team at least 5 days prior to the resection. Surgery will be performed in both arms according to the department's procedures and surgical oncology guidelines.

Eligibility Criteria:
Inclusion Criteria:

* Age over 18
* Patient qualified to undergo liver tumor resection (either primary of metastatic; both benign and malignant lesions)
* Quality of imaging (CT or MRI or PET (positron emission tomography)/CT) satisfactory to develop 3D models
* Laparoscopic approach
* Informed consent

Exclusion Criteria:

* Open approach
* Technical limitations to model development
* No informed consent
Study Of Palbociclib (PD-0332991) In Renal Impairment

Since the amount of palbociclib eliminated in urine is 6.9%, renal impairment is not expected to have much impact on palbociclib. However, the Federal Drug Administration (FDA) Guidance recommends a study in subjects with renal impairment when the drug is likely to be used in patients with impaired renal function. Palbociclib is intended for chronic use in cancer patients who may have some degree of impaired renal function.


Eligibility Criteria:
Inclusion Criteria:

* Personally signed and dated informed consent document.
* Renal function calculated by the Cockcroft Gault equation: normal function (CLcr \>=90 mL/min), mild: CLcr \>=60 mL/min and \<90 mL/min, moderate: CLcr \>=30 mL/min and \<60 mL/min, severe: CLcr \<30 mL/min but not requiring hemodialysis.
* Subjects with normal renal function matched for age, weight, gender and race to subjects in impaired renal function groups.

Exclusion Criteria:

* Any condition possibly affecting drug absorption.
* Renal allograft recipients.
Validation of Radioisotope Guided Lymphadenectomy for Loco-regional Staging in Patients With Intermediate or High-risk Prostate Cancer

The diagnosis of a ganglionic infringement(achievement) at a patient reached (affected) by a prostate cancer is a factor(mailman) of bad forecast. The locoregional ganglionic staging is a very important element in the coverage (care). He allows to determine the local extension of the disease and the type(chap) of therapeutics to implement(operate) after the surgery. The standard cleaning out at present recommended by the European company (society) of urology at the patients at intermediate or high risk of second offense (recurrence) after local treatment(processing), has to concern the obturating pit, the internal and external iliac territories. However this type(chap) of cleaning out does not seem to solve all the problems of locoregional stratification. Indeed, several studies concerning the radio-controlled cleaning out highlighted that 10 in 30% of ganglions.


Eligibility Criteria:
Inclusion Criteria:

* Subject man, whose age is greater than or equal to 18 years
* Carrier of cancer intermediate risk non-metastatic prostate or high relapse
* Subject with an initial balance sheet expansion, regional and general negative by Scanner, abdominopelvic MRI or bone scan,
* Subject has undergone a medical examination in connection with the study,
* Topic for which a radical prostatectomy is considered curative purposes,
* Supported by Subject surgical teams involved in the study,
* Topic affiliated to a social security scheme,
* Subject who signed informed consent.

Exclusion Criteria:

* Subject man, whose age is less than 18 years
* Subject who have received hormone therapy or radiation therapy for prostate cancer
* Subject who had surgery for prostate adenoma (transurethral resection or open surgery) because of potential difficulties injection of radioactive tracer in the gland,
* Subject has a history of pelvic surgery or radiotherapy,
* Subject with inguinal hernia repair history of laparoscopic,
* Subject refusing blood transfusions,
* Subject is not agreeing to participate in this study and did not sign the informed consent.
A Study With Arctic Root Compared With the Extract When Combined With Schizandra and Russian Root (Adapt 232), Standardized Ginseng Extract and Placebo Regarding Impact on the Level of Energy, Ability to Work Under Stress, Quality of Life and Wellbeing, in Middleaged Women Who Are Still Employed

This is clinical trial to document the efficacy of a proprietary standardized extract of Arctic root in comparison to a standardized commercial extract of ginseng and placebo from an every day consumer perspective to ameliorate mild depression, reduce stress and improve quality of life. A newly developed adaptogenic formulation, Adapt 232, was included into the study in order to evaluate its effect in comparison to the others.


Eligibility Criteria:
Inclusion Criteria:

* healthy females, over 40 years of age, who have stated that they for a longer period of time have felt stressed due to demanding daily activities at work and/or at home.

Exclusion Criteria:

* suffering from any known medical disease, e.g. cardiovascular, joint, and liver or kidney diseases, cancer, or psychiatric disease.
* with a psychiatric diagnose, using narcotics or suffering from HIV.
* with known allergy to any of the study medications.
* misusing euphorizing or pain killing drugs
* having used any adaptogenic product the last 2 months.
* having used cortisol or any other corticosteroid products the last 6 months
* being pregnant or breast-feeding
* which at the first interview are judged to be not cooperative or not to be able to finalize the study
Caffeine and Cataract After Pars Plana Vitrectomy

Assessment of cataract development in patients with regular caffeine consumption and those without caffeine consumption after pars plana vitrectomy.

Vitrectomy is a frequently used surgical procedure in ophthalmology for various indications like retinal detachment repair or macular pucker peeling. Amongst others, accelerated cataract development in phakic patients is a known complication after vitrectomy. A previous study found that especially patients receiving gas tamponade are at increased risk for postoperative cataract development. The assumed mechanism behind this finding is that vitrectomy leads to an increased partial pressure of O2 in the human vitreous - similar to that observed in posterior vitreous detachment - subsequently leading to accelerated lens opacification. Therefore, a possible target of cataract prevention is the inhibition of oxygen radical formation. One known antioxidant agent inhibiting oxygen radical formation is caffeine. For instance, in-vitro studies showed that caffeine consumption can reduce cataract development in ultraviolet (UV)-radiation-exposed rats and human lens epithelial cells through its capability of inhibiting oxygen radical formation. These in-vitro studies support the findings of epidemiological studies that caffeine also in-vivo has the potential to reduce cataractogenesis. Conflating the previous findings of accelerated cataract formation after vitrectomy and the preventive properties of caffeine for cataract development, there may be a benefit for patients regularly consuming caffeine-containing beverages like coffee undergoing vitrectomy regarding postoperative cataract formation.

Therefore, the aim of this comparative study is to investigate if patients undergoing small gauge pars plana vitrectomy regularly consuming caffeine have lower postoperative significant cataract formation rates than patients not consuming caffeine.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* Written informed consent
* No previous cataract surgery in the study eye
* Scheduled small gauge vitrectomy with intraoperative gas tamponade (SF6 or C3F8) due to retinal detachment or macular hole repair
* No regular caffeine consumption (drinking not more than one cup of a caffeine- containing beverage \[e.g. coffee, energy drinks\] at a maximum of two days per week during the past year)

Exclusion Criteria:

* Intake of systemic or topical corticosteroids within 3 months before study screening
* Increased risk for postoperative cataract development, for example due to ocular trauma in the history
* Severe cataract (LOCS III grading of any cataract form \>2) in the study eye at pre- study screening
* Scheduled phacovitrectomy in the study eye
* Participation in any clinical trial three month before study screening
* Ocular surgeries six month before study screening
The Effects of Telerehabilitation And Chair-based Yoga In The Elderly

The aim of the study is to investigate the effects of chair-based yoga with rehabilitation on quality of life is affected in elderly people. Depending on the changes in the body as a result of aging, people's quality of life is affected. In order to increase or protect the quality of life in elderly people, telerehabilitation practices are emphasized. Telerehabilitation is a promising system for the elderly thanks to its advantages.

As a practice, chair-based yoga, a modified form of yoga, was preferred. Chair-based yoga makes yoga more doable and safe for older people. Chair-based yoga with telerehabilitation was performed with the participants. Pain level, sleep status, functional capacity, quality of life, mental health and depression were followed by evaluations at the beginning and end of the process.


Eligibility Criteria:
Inclusion Criteria:

* 65 years and over,
* Having a Standardized Mini Mental Test Score of 24 and above,
* physically active (self-sustaining),

Exclusion Criteria:

* severe cardiopathy,
* uncontrolled hypertension,
* mental disorder,
* Presence of any health condition that may prevent functional autonomy test such as hearing and vision,
* have mental disorders and dementia,
* people with any unstable medical condition
Open Versus Endovascular Revascularization in Patients With End-stage Renal Disease

Treatment of patients with end-stage renal disease and critical limb ischemia still poses challenges to vascular medicine due to limited survival, comorbidities and infrapopliteal involvement of arteriosclerosis in these patients.

Most optimal vascular therapy mode has not been finally decided in these patients.

Therefore retrospective analysis of patients receiving open surgical and endovascular revascularisation was performed.

Query of internal clinical database for identification of patients (2009-2017)with end-stage renal disease and critical limb ischemia, receiving either open surgical (Group I "OR") or endovascular revascularisation (Group II "EVT").

Furthermore, retrospective comparison as to morphological criteria (lesion length, peripheral run-off, plantar arch) and comorbidities.

Prospective follow-up of identified patients by means of telephone contacts and/or clinical examination of evaluation of Long-term outcome measures (Overall survival, Amputation-free survival, wound healing)

Eligibility Criteria:
Inclusion Criteria:

* presence of end-stage renal disease
* presence of critical limb ischemia (Ankle-brachial-index \> 0.4 or presence of rest pain or ischemic ulcers or gangrene)
* revascularisation by means of Bypass or endovascular therapy

Exclusion Criteria:

* conservative Treatment
* non-atherosclerotic lesions
* coagulation disorders
A Study of HGS1029 in Subjects With Relapsed or Refractory Lymphoid Malignancies

The purpose of this study is to determine if HGS1029 is safe and well tolerated in patients with relapsed or refractory lymphoid malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed relapsed/refractory lymphoid malignancies
* Previously treated with at least 2 therapeutic regimens
* ECOG performance \< 2.
* Life expectancy of at least 3 months
* Adequate renal function
* Adequate hematologic status
* Adequate liver function
* Transfusion independent

Exclusion Criteria:

* Received other therapy (biological or drug) to treat cancer within 4 weeks prior to starting treatment with HGS1029 or who exhibit persistent clinical evidence of cancer treatment toxicity
* The use of systemic corticosteroids within 1 week of starting treatment with HGS1029
* Evidence of active bacterial, viral or fungal infection within 2 weeks before starting treatment with HGS1029
* Known HIV infection
* Positive for hepatitis B surface antigen or positive hepatitis C antibody
* Grade 2 or greater neuropathy
* Pregnant female or nursing mother
* Males or females who do not agree to use effective contraception during the study and through at least 30 days after the last dose of HGS1029
Influence of Preop Fibrinogen on Blood in Pediatric Cardiac Surgery

Fibrinogen plays an important role in the coagulation cascade. Low levels of preoperative fibrinogen have been associated in adults with higher blood and transfusion requirements during surgery. Guidelines from the European Society of Anesthesiology and Intensive Care recommends fibrinogen substitution based on viscoelastic tests in adult cardiac surgery. Cardiopulmonary bypass results in a profound hemodilution and dilution of all coagulation factors. This is especially true in children where the priming volume of the cardiopulmonary bypass circuit is much higher compared to the patient's weight than in adults. Cardiopulmonary bypass generates high levels of tissue plasminogen activator resulting in a hyperfibrinolysis, further lowering fibrinogen levels.

The aim of this retrospective study is to explore a possible relationship between preoperative fibrinogen levels and perioperative blood loss, as well as transfusion requirements in children undergoing cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* all children with cardiac surgery under cardiopulmonary bypass between 2008 and 2018
* Age \< 16 year

Exclusion Criteria:

* preoperative coagulopathy
* Jehovah's witnesses
* patients with fresh frozen plasma in the priming of the cardiopulmonary bypass circuit
Sophisticated Assessment of Disease Burden in Patients With Fabry Disease

To detect early signs of cardiac and metabolic alterations as well as to evaluate the progression of cardiac and metabolic impairments in mildly affected patients with Fabry Disease using high sensitive diagnostic methods.

Observational Study Evaluating the use of cardiac MRI with late enhancement technique, Echocardiography, 24h Holter ECG, plasma Lyso-Gb3 and urinary Gb3, to identify early signs of progressive Fabry Disease.

Eligibility Criteria:
Inclusion Criteria:

1. Women: A confirmed exonic mutation within the α-Galactosidase gene Men: A confirmed exonic mutation within the α-Galactosidas gene and/or reduced α- Galactosidase activity
2. Female patients ≥ 25 years-old and male patients ≥ 25 years-old
3. The patient has not received enzyme replacement therapy for treatment of Fabry disease
4. The patient must have voluntarily signed an Institutional Review Board (IRB)/Independent Ethics Committee (IEC)-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient
5. The patient has already mild symptoms of Fabry disease presented in at least one minor organ involvement, e.g. proteinuria 1, mild cardiac symptoms not needing treatment yet, pain attacks, gastrointestinal symptoms or history of TIA.

Exclusion Criteria:

1. The patient has received ERT or investigational product(s) for any reason within 30 days prior to study entry.
2. Any contraindication for MRI-diagnosis
3. Incompatibility to MRI contrast agent (elevated serum creatinine - according to SPC of contrast medium) The patient is unable to comply with the protocol, e.g., has a clinically relevant medical condition making implementation of the protocol difficult; has an uncooperative attitude; is unable to return for study evaluations; or is otherwise unlikely to complete the study, as determined by the investigator.
4. Planned ERT within the next 24 months (nevertheless if a ERT becomes medically necessary in the observational period ERT might be introduced)
Primary Graft Dysfunction, Pronation, Bilateral Lung Transplants

Proning manoeuvre as an early treatment for acute severe hypoxic respiratory failure has been implemented recently during the COVID-19 pandemic. This method was proposed more than fifty years ago to improve gas exchange : Proning Severe ARDS (PROSEVA) trial, however, was the milestone which demonstrated mortality benefit in patients with severe ARDS. Nevertheless, few analysis were performed on the effects of the prone position after lung transplantion (LT). The aim of the study is therefore to relate LT primary graft dysfunction (PGD) pathophysiology, which occurs in postoperative setting, to prone-positioning effects on ventilation-perfusion matching, improved lung compliance and clinical outcomes of impairedorgan patients.

Lung transplant is the final stage of intervention in dramatic respiratory failure unresponsive to other medical or surgical treatments: reduced disability, improved life quality and extended life are outweighed by still high mortality and morbidity of LT, compared to other solid organs transplants. LT patient survival is undermined, above all, by PGD onset up to 72h in postoperative scenario. Acute lung injury, characterized by reperfusion and ischemia damage, evolves in pulmonary edema and severely inflammed graft status. Tipical radiological findings are bilateral spreading infiltrates, whose treatment was until some years ago mainly supportive, i.e. protective mechanical ventilation and fluid restriction. Two retrospective studies recently demonstrated favorable oxygenation response in terms of PaO2/fraction-of-inspired-oxygen (FiO2) ratio and lung compliance. Our purpose was to broaden gas-exchange results by the analysis of short-term outcomes (i.e duration of mechanical ventilation, reintubation or tracheostomy, anastomotical complications, organ rejection in 30 days, acute kindney injury development and/or filtration necessity, hospital length and mortality). Our aim is to assess through this pilot study if early pronation (realized within 24 hours from admission) has a more favorable outcome on patients developing moderate/severe PGD within the first 24 postoperative hours.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 y.o.
* First bilateral lung transplant
* PGD grade 2 or 3 within 24 hours from ICU admission Admission to ICU for post-operative monitoring after LTx
* Written informed consent obtained

Exclusion Criteria:

* Age \< 18 years old
* PGD\<2
* Single transplant
* Re-transplant
* IMV, venous-venous (V-V) or venous-arterial (V-A) extracorporeal membrane oxygenation (ECMO) before surgery
* Contraindications to prone positioning
* Refusal of consent
Impact of Online Ordering on Low-Income Adults' Food Security in Online Food Pantry Settings

The primary objectives of this study are to determine whether the transition to online ordering at a choice-based food pantry network influences food security status among low-income adults and determining whether there are differences in impact by age group.


Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or older
* have visited a food pantry that either is or is not scheduled to transition to online ordering at least once
* have capacity and willingness to provide consent
* speaks English

Exclusion Criteria:

* aged less than 18 years
* have not visited a food pantry that either is or is not scheduled to transition to online ordering at least once
* does not speak English
Cauterization of the Anterior Ethmoidal Artery by Transconjunctival Approach

The incidence of epistaxis varies from 7 to 14% in the general population and represents 30 per 100,000 emergency room admissions in adults. Most nasal bleeding is self-limiting without the need for specific medical treatment. Cauterization under local anesthesia and control of medical comorbidities (arterial hypertension and hemostasis disorders) are effective in most cases. In case of failure of cauterization or in case of more posterior epistaxis, an antero-posterior packing can be put in place for 48 hours. In case of failure or recurrence of packing removal, endoscopic sphenopalatine artery (SPA) ligation or embolization is proposed. In case of persistent epistaxis despite hemostasis of the PSA, ligation of the anterior ethmoidal artery (AEA) is recommended. This artery cannot be embolized because of the risk to the ophthalmic artery. The ligation of the AEA is most often performed via the external paracanthal approach. It can also be performed by endonasal endoscopic approach but involves the performance of an anterior ethmoidectomy, a long surgery with a significant risk of complications. Its identification by the endonasal route is complicated in the event of abundant bleeding. Moreover, its endoscopic cauterization is difficult if the artery is not procidente. The transconjunctival approach avoids a visible scar and the complications of an ethmoidectomy.

The objective of the study was to compare the efficacy of transconjunctival and external cauterization of the anterior ethmoidal artery in patients with refractory epistaxis

Eligibility Criteria:
Inclusion criteria:

* Male or female (age ≥18 years)
* Persistent epistaxis after meching
* Having required transconjunctival anterior ethmoidal artery cauterization surgery
* Subject operated at the University Hospitals of Strasbourg between 01/01/2015 and 01/05/2023
* Subject not objecting to the reuse of his/her data for scientific research purposes.

Exclusion Criteria:

- Subject who has expressed opposition to the reuse of his/her data for scientific research purposes.