cyrilzakka/clinical-trials huggingface dataset:
Donors After Circulatory Death Heart Trial

To evaluate the effectiveness of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.

A prospective, randomized and concurrent controlled, non-inferiority pivotal trial in which subjects who receive a DCD donor heart transplant will be compared to subjects who receive a standard criteria donor heart transplant (Standard of Care 1 \[SOC1\] and Standard of Care 2 \[SOC2\] - from both randomized and concurrent control groups), adjusting for differences in risk factors.

Eligibility Criteria:
Donor Inclusion

* Maastricht Category III DCD donor, defined as expected death after the withdrawal of life- supportive therapy (WLST)
* Donor age 18-49 years old inclusive
* Warm ischemic time (WIT) ≤ 30 mins, with warm ischemic time defined as: Time from when mean systolic blood pressure (SBP) is \< 50 mmHg or peripheral saturation \< 70% to aortic cross-clamp and administration of cold cardioplegia in the donor.

Donor Exclusion

* Previous cardiac surgery
* Known coronary artery disease
* Cardiogenic shock or myocardial infarction, or
* Sustained terminal ejection fraction (EF) of ≤ 50%, or
* Significant valve disease except for competent bicuspid aortic valve

Recipient Inclusion

* Primary heart transplant candidates
* Age ≥ 18 years old
* Signed: (1) written informed consent document; (2) authorization to use and disclose protected health information; and (3) consent to TransMedics' use of recipients' United Network for Organ Sharing (UNOS)/Organ Procurement and Transplantation Network (OPTN) data and recipients' Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) data.

Recipient Exclusion

* Prior solid organ or bone marrow transplant
* Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
* Multi-organ transplant
* Investigator unwilling to randomize to either arm.
NPWT in Patients Undergoing Surgical Procedures for Management of GI Malignancies

This randomized trial will use a Negative Pressure Wound Therapy device or standard wound closure, in participants with gastrointestinal neoplasms, to measure the rate of surgical site infections


Eligibility Criteria:
Inclusion Criteria:

* Scheduled surgical procedure for the management of gastrointestinal cancer
* Scheduled surgical procedure planned for incision that will result in wound \>5cm
* Scheduled surgical procedure planned for skin wound that will be closed by primary intention with either: Staples covered by sterile Telfa® and Tegaderm® or Medipore® OR Dermal or subcuticular sutures covered by Octil®
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Scheduled surgical procedure where wound considered dirty
* Scheduled surgical procedure for wound left for closure by secondary intention
* Emergency surgery
* Pregnancy. Pregnancy status is confirmed per protocol the day of surgery in the preoperative space by urine pregnancy test in patient younger than 65 and with intact uterus. Pregnant patient will be excluded from this study
* History or current diagnosis of any medical or psychological condition that in the Investigator's opinion, might interfere with the subject's ability to participate in the study or the inability to obtain informed consent because of psychiatric or complicating medical problems
Morphological and Metabolic Changes of Dorsal Root Ganglion and Sympathetic Ganglion in Patients With Postherpetic Neuralgia on MRI

Object: Postherpetic neuralgia (PHN) is pain that persists for 1-3 months after herpes zoster onset. It is the most common complication of herpes zoster and occurs in 15-40% of patients with herpes zoster. PHN has been suggested to be related with the lesion of doral root ganglion (DRG). However, the studies are almost limited to autopsies and animals , and the mechanism of PHN is still unclear. This study was conducted to investigate morphological and metabolic changes of DRG and sympathetic ganglion in patients with postherpetic neuralgia on MRI. Method: 30 patients diagnosed as PHN were recruited. The volume and fractional anisotropy of DRG of lesion dermatomes were measured under MRI, and compared with contralateral and adjacent DRG. The volume and fractional anisotropy of sympathetic ganglion of lesion dermatomes were also measured under MRI, and compared with contralateral and adjacent sympathetic ganglion.Then, the association between clinical phenotypes and DRG changes were analyzed.

Patients with the following conditions were excluded: psychiatric diseases or communication disorders; contraindications to MRI;DRG radiofrequency therapy, spinal cord electrical stimulation and other direct intervention treatments for DRG were performed before examination.

Eligibility Criteria:
Inclusion Criteria:

* aged more than 18 herpes zoster in cervical, thoracic,lumbar or sacral regions agree to participate to the research

Exclusion Criteria:

* can not cooperate to MRI for mental disease contraindication for MRI treatments for DRG such as radiaofrequency therapy, spinal cord electircal stimulation were performed before examination. disagree to participate to the research
Combined Administration of Intravenous and Topical Tranexamic Acid in Total Knee Arthroplasty

This prospective randomized controlled trial was conducted To compare the efficacy of TNA in terms of total blood loss and the allogenic transfusion rate among the three study groups; intravenous alone, combined intravenous and low dose topical TNA and combined intravenous and high dose topical TNA.

To evaluate the safety of each regimen in view of deep vein thrombosis and venous thromboembolism.


Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosis of primary osteoarthritis

Exclusion Criteria:

* patients with diagnoses other than primary OA
* patients on anticoagulation therapy
* patient with chronic renal failure
* patient with CVA Hx
* Patient with seizure Hx
* Patient with severe CHF
* Patient with acquired or congenital coagulopathy
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)

To determine the relative risk of developing atopic dermatitis in infants fed a study formula based on whole goat milk compared to infants a study formula based on cow milk protein.

The study is a randomized, double-blind, parallel-group trial to study the effect of feeding infants goat milk or cow milk formula in the first year of life on the risk of allergy and other health outcomes, including growth, tolerance and quality of life in the first 5 years of life.

Eligibility Criteria:
Inclusion Criteria:

* Having obtained written informed consent (signed and dated) of the child's parent(s)/caregiver(s), indicating that the child's parent(s)/caregiver(s) has/have been informed of all pertinent aspects of the study
* Born full term (≥37 weeks +0 days and ≤ 41 weeks +6 days of gestation)
* Age at enrolment \< 3 months of age (\<90 days)
* Birth weight ≥2.5 kg and ≤4.5 kg
* Born from a singleton pregnancy
* Child's parent(s)/caregiver(s) is/are of legal age of consent
* The child's parent(s)/caregiver(s) have sufficient local language skills to understand the study information, the informed consent, and to comply with the study procedure
* The child's parent(s)/caregiver(s) is/are willing and deemed able to fulfil the requirements of the study protocol and procedures
* Mother has expressed the intention to partially (in combination with breastfeeding) or fully formula-feed

Exclusion Criteria:

* Diagnosed disorder considered to interfere with nutrition, growth or development of the immune system
* Participation of the child in any other interventional trial or participation of the mother in any intervention trial with child follow-up
* Infant has a doctor's diagnosis of atopic dermatitis or a severe widespread skin condition prior to randomization that would make the detection or assessment of atopic dermatitis difficult
* Infant has consumed an infant formula for more than 4 weeks prior to enrolment
* Cow milk allergy or intolerance
* Institutionalized infant
Therapeutic Plasmaexchange in Early Septic Shock

Sepsis is defined by the occurrence of critical organ dysfunction in the context of infection. Unfortunately, its incidence appears to be rising, and the mortality of septic shock remains extraordinary high (\> 60%). Death in sepsis arises from shock and multi organ dysfunction that are - at least in part - triggered by an inadequate response of the host's immune system to the infection. Given the injurious role of 1) this overwhelming immune response and 2) the consumption of protective plasmatic factors (e.g. vWF cleaving proteases, hemostatic factors etc.) while the disease is progressing the investigators hypothesize that early therapeutic plasma exchange (TPE) in the most severely ill individuals might improve hemodynamics, oxygenation and ultimately survival. This therapeutic strategy combines 2 major aspects in 1 procedure: 1. removal of harmful circulating molecules and 2. replacement of protective plasma proteins. The investigators designed the EXCHANGE trial to analyze in a randomized fashion the benefit of TPE as an add-on treatment to state of the art standard sepsis care. Only patients with early septic shock (\< 24 hrs) and high catecholamine doses (norepinephrine \> 0.4 ug/kg body weight/min) will be included. Those in the treatment group will receive 1 TPE within 2 hours following randomization. The primary outcome is norepinephrine dose 6 hrs after randomization. The recruitment period is 2 years and will be performed at the Hannover medical School University hospital in Germany. Secondary endpoints (including organ dysfunction as well as biochemical markers of inflammation and coagulation) will be assessed on day 1-8 and day 28 after TPE.

The investigators hope to demonstrate a potential benefit of an additive treatment approach to improve the outcome of patients suffering from septic shock.


Eligibility Criteria:
Inclusion Criteria:

* Onset of septic shock within less than 24 hrs
* Norepinephrine dose of ≥ 0.4 ug/kg/min bodyweight (target mean arterial pressure ≥ 65 mmHg) ≥ 30 min

Exclusion Criteria:

* Age\<18 years and \> 80 years
* Pregnancy
* Known history of transfusion reactions
Pilot Study Describing the Early Evolution of the Sexual Function of Patients Receiving Adjuvant Hormone Therapy for Breast Cancer

The 2014-2019 cancer plan emphasizes the need to "reduce the impact of cancer on personal life".

The impact of cancer on sexuality is multifactorial: fatigue, anxiety, impaired body image, chemotherapy treatment.

None of these studies specifically assessed the early impact on the quality of sexual life of patients.

The purpose of this study is to describe to describe the early evolution of the quality of sexual life of patients receiving adjuvant hormone therapy for breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* Female gender
* Histologically proven non-metastatic breast cancer
* Indication of adjuvant hormone therapy
* Patient able to understand a newsletter and to agree to participate

Exclusion Criteria:

* Age under 18 years
* Pregnant woman
* Adjuvant chemotherapy
* Patient followed for heavy psychiatric pathology (requiring guardianship or trusteeship)
* Persons protected or deprived of their liberty
* Male
General Practitioners (GP) Involvement in Colorectal Cancer (CRC) Screening

Screening for ColoRectal Cancer (CRC) is widely recommended because of compelling evidence that it reduces mortality from CRC and that it's cost-effective. In France, there is a national CRC screening programme inviting people aged 50-74 years by mail to consult their General Practitioner (GP) for a free on charge Faecal Occult Blood test deliverance every two years. Participation is a key factor for the screening programs success. High levels of screening uptake and the continued participation to regular screening must be achieved and maintained in the targeted population if the enormous potential of CRC screening is to be realised. Screening rates of various international programs vary widely (20-52%) and the participation is insufficient in the most settings. Therefore, a better understanding of facilitating and hindering factors of patient participation can guide interventions to improve CRC screening rates. They include patients and physicians' factors. One issue is about GPs practice. GP involvement has been shown to improve the participation in the CRC screening. This study aims to assess the effectiveness of an intervention targeting GPs to increase patient participation in the CRC screening. Volunteer GPs will be randomly assigned to either the intervention group or to usual care (control group) and they will be followed one year. The intervention consists in providing every four months to the experimental group a list of their patients who are eligible but did not proceed yet to the screening. In both groups, patient participation in the screening will be measured at the end of the study.


Eligibility Criteria:
Inclusion Criteria:

1. General Practitioner (GP)

   * exercising in the Val de Marne (French department of the suburb of Paris)
   * volunteered to participate at the study
2. Patient

   * living in the Val de Marne (French department of the suburb of Paris)
   * having declared a 'preferred GP' exercising in the Val de Marne to the main statutory health insurance scheme ("régime général")
   * being eligible for colorectal cancer screening (aged 50 to 74 years, not excluded and having not proceed yet to the screening)
   * having consulted his 'preferred GP', whatever the reason, during the study period

Exclusion Criteria:
A First Human Dose Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects Being Overweight or With Obesity.

Trial Investigating Safety, Tolerability and Pharmacokinetics for Single Doses of NNC9204-1177 in Subjects being Overweight or with Obesity


Eligibility Criteria:
Inclusion Criteria:

* Male, aged 18-55 years (both inclusive) at the time of signing informed consent
* Body mass index (BMI) between 25.0 and 34.9 kg/m\^2 (both inclusive) at screening

Exclusion Criteria:

* Any disorder which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol
* Subjects, aged at least 40 years, with an estimated 10-year atherosclerotic cardiovascular disease (ASCVD) (as described in the American College of Cardiology and the American Heart Association Prevention Guideline) risk above or equal to 5%
* Male subjects who are not sexually abstinent or surgically sterilised (vasectomy) and are sexually active with female partner(s) who are not using a highly effective method of contraception (such as condom with spermicide) combined with a highly effective method of contraception for their non-pregnant female partner(s) (Pearl Index below 1%, such as implants, injectables, oral contraceptives, intrauterine devices, diaphragm or cervical cap+spermicide), and/or intend to donate sperm in the period from screening until 3 months following administration of the investigational medical product
Current Trends and Future Perspectives Regarding Elective Rotations

Surgical resident elective rotation abroad give different opportunity such experience a different teaching and training, acquire more and new operative experience, experience living and working in a different cultural environment. Furthermore, the growing process of globalization that involves the nations themselves in different sectors, should also lead to a homogeneity of training on a global level, in order to be able to guarantee adequate assistance to different types of patients at the same time, and the possibility for doctors themselves of working abroad. the objective of the study is to provide the first overview of what is the current Italian scenario concerning abroad elective rotations during surgical training


Eligibility Criteria:
Inclusion Criteria:

* working as short-term supernumerary registrars in a foreign surgical department during the academic year 2017-2018

Exclusion Criteria:

* Surgeons/residents who have not been abroad for training
11ß-HSD1 and Metabolic Syndrome

The purpose of this study is to determine whether the insulin sensitizing effects of rosiglitazone were accompanied by changes in 11ß-HSD1 expression and activity in different tissues. Furthermore the metabolic and hormonal effects of PPAR gamma stimulation by rosiglitazone will be analysed in several tissues.

The PPARgamma agonist rosiglitazone (R) increases insulin sensitivity, which is comparable to the effects of a reduction in 11ß-hydroxysteroid dehydrogenase type 1 (11β-HSD1) activity in animal models. We therefore aimed to investigate whether rosiglitazone-induced insulin sensitivity is associated with changes in 11β-HSD1 activity in different tissues in subjects suffering from impaired glucose tolerance. Furthermore the metabolic and hormonal effects of PPAR gamma stimulation by rosiglitazone will be analysed in those tissue samples.

Eligibility Criteria:
Inclusion Criteria:

* Impaired glucose tolerance

Exclusion Criteria:

* Treatment with insulin
* Orally taken antidiabetic medication, glucocorticoids or vitamin K-antagonists
* Heart failure
* Impaired hepatic or renal function
* Anaemia
* Disturbed coagulation
* Any other endocrine disorder
Anxiety With Cancer in the Elderly (ACE): A Cognitive-behavioral Intervention

The purpose of this study is to examine the feasibility and acceptability of and patient adherence to a telephone-administered cognitive-behavioral therapy intervention for anxiety in older adults (65 years and older) with cancer and their primary informal caregiver. This study will also examine whether the intervention has a clinically significant impact on patient anxiety (primary outcome) and depression, distress, and quality of life (secondary outcomes).

This study is a single arm pre-post evaluation of a six-session telephone-administered cognitive-behavioral therapy (CBT) intervention for anxiety in older adults with cancer and their primary informal (unpaid) caregiver. The primary purposes of this study are to evaluate the feasibility of the intervention and study procedures, acceptability of the intervention to older adults with cancer and their primary informal caregiver, and patient and caregiver adherence to the intervention. The secondary purpose is to examine changes in patient and caregiver anxiety, depression, distress, and quality of life pre to post intervention to determine whether the intervention has a clinically significant impact on these outcomes. Anxiety is the primary outcome; depression, distress, and quality of life are secondary outcomes. Patients will be 65 years of age or older and will be recruited from the myeloma, lung, lymphoma, gynecologic, and gastrointestinal cancer clinics at a single institution. Study measures will be administered by telephone prior to initiating the intervention (pre-intervention) and following intervention completion (post-intervention).

Eligibility Criteria:
Inclusion Criteria:

1. Patient age 65 years or older
2. Diagnosis of cancer
3. Patient and/or caregiver score of 8 or higher on the anxiety subscale of the Hospital Anxiety and Depression Scale
4. A primary informal caregiver who is willing and able to participate
5. Patient and caregiver are able to communicate over the telephone
6. Caregiver is age 21 years or older.

Exclusion Criteria:

1. Patient or caregiver is not fluent in English
2. Patient or caregiver is too weak or cognitively impaired to participate in the intervention
3. Patient or caregiver has received CBT since the patient's cancer diagnosis
4. Patient or caregiver has an active major psychiatric condition such as schizophrenia
5. Patient only experiences anxiety in the context of a specific medical procedure
6. Patient or caregiver endorses active suicidal ideation
FIND Stroke Recovery - A Longitudinal Study

Stroke survivors frequently suffer disabilities including motor and cognitive problems, impairments in speech and vision, depression, and several other disabilities that worsen their quality of life. Some will recover fully after stroke and others will have permanent impairments. Few studies show trajectories of recovery in different domains after stroke, hence recovery time-lines are not fully known. Also, the whole range of mechanisms leading to recovery are not precisely known (1). To monitor those mechanisms one can utilize biomarkers.

In parallel to the studies of recovery, studies on time series of biomarkers after stroke are limited (2). Hence, a crucial first step to increase knowledge on biomarkers of stroke recovery is to gain a better understanding of the time course of both stroke recovery and biomarker patterns. Biomarkers can later be used for outcome predictions after stroke.

BACKGROUND

Stroke survivors frequently suffer disabilities including motor and cognitive problems, impairments in speech and vision, depression, and several other disabilities that worsen their quality of life. Some will recover fully after stroke and others will have permanent impairements. Few studies show trajectories of recovery in different domains after stroke, hence recovery time-lines are not fully known. Also, the whole range of mechanisms leading to recovery are not precisely known (1). To monitor those mechanisms one can utilize biomarkers.

In parallel to the studies of recovery, studies on time series of biomarkers after stroke are limited (2). Hence, a crucial first step to increase knowledge on biomarkers of stroke recovery is to gain a better understanding of the time course of both stroke recovery and biomarker patterns. Biomarkers can later be used for outcome predictions after stroke.

WORK PLAN

AIM Determine temporal profiles describing the speed, order, and degree of recovery in neurological and cognitive functions in various domains with simultaneous profiling of changes in blood biomarker concentrations, in the acute, subacute phases and long-term of stroke. Determine individual and interindividual variations in recovery in the different domains.

Informed consent Written informed consent will be obtained from all willing participants or their next-of-kin.

Eligibility Criteria:
Investigators enrol patients presenting with first-ever ischemic stroke or intracerebral haemorrhage admitted to the stroke units at the Sahlgrenska University Hospital in Gothenburg, Sweden.

The inclusion criteria are:

• first-ever acute ischemic stroke; or intracerebral hemorrhage.

The exclusion criteria are:

* pre-stroke mRS score of ≥3;
* severe neurodegenerative disease, cerebral neoplasm or terminal illness; and
* patients considered unlikely to be able to participate in or to understand and/or comply with study procedures during follow-up visits at the hospital.