cyrilzakka/clinical-trials huggingface dataset:
Optimization of the Management of Non-Traumatic Intracerebral Hemorrhage (OPT-ICH)

Intracerebral non-traumatic intraparenchymal hemorrhages (ICH) account for 15 to 20% of strokes. One third of the patients dies within the month following ICH, and survivors often experience residual disability with a high risk of recurrent ICH, other serious vascular events, and neurological complications such as epilepsy and dementia. Encouraging but preliminary data suggest a favorable trend in terms of survival rates in recent years. This is partly due to improved management of patients with ICH, which must be early (the concept of "time is brain") and carried out by expert personnel (medical and paramedical) in specialized units.

The main objectives of the study are:

* To evaluate the management of patients with ICH in the acute phase within the University Hospital of Tours by analyzing the procedures adopted in the various relevant departments (neurovascular units, neurosurgery, medical or neurosurgical intensive care, geriatrics);
* To evaluate whether the systematic implementation of a dedicated protocol (see \*) for the management of patients with ICH is associated with a reduction in mortality and disability in the short and long term.

The project consists of 2 parts:

* Retrospective, monocentric, observational study. Inclusion of all patients presenting with ICH admitted urgently to the University Hospital of Tours between 2018-2021.
* Prospective, monocentric, observational study. Inclusion of all patients presenting with ICH admitted urgently to the University Hospital of Tours.

Each patient will benefit from management according to a protocol which will include:

* Emergency MRI with contrast injection (contrast-enhanced brain CT scan if contraindicated);
* Admission to the Neurovascular Unit unless hemodynamically unstable or intubated;
* First intravenous antihypertensive injection with a goal \< 1 hour from arrival at the hospital;
* Anticoagulation reversal with a goal \< 1 hour from arrival at the hospital;
* Standard laboratory tests + coagulation study ;
* Neurosurgical consultation upon arrival at the department;
* Follow-up MRI at 24-48 hours or earlier if clinical worsening;
* Diagnostic work-up for the evaluation of hypertension-related end organ damage (Transthoracic echocardiogram, retinography , proteinuria);
* Contrast-enhanced follow-up MRI at 3-6 months;
* Neurological evaluation at 6 months and 2 years;
* When applicable a neuropsychological evaluation at 6M and 2 Y;

Eligibility Criteria:
Inclusion Criteria:

* aged over 18 years
* emergency admission to the University Hospital of Tours
* having an ICH on imaging performed upon admission (CT scan or MRI) at the University Hospital of Tours

Exclusion criteria :

- Patient who has given their opposition to the collection of their data
Evaluating an In-home Multicomponent Program to Manage Concerns About Falling in Frail Community Dwelling Older People

The main objectives of this study are:

1. an effect evaluation of an in-home multicomponent cognitive behavioural program on concerns about falling and related avoidance of activity (primary outcomes), as well as disability, fall incidents (secondary outcomes) and several additional outcomes in frail community-dwelling older people,
2. a process evaluation of the feasibility of the program, with the following main outcomes: population reached, performance according to protocol, exposure and engagement, opinion on the program of participants and facilitators, perceived benefit or achievement, and experienced barriers and potential solutions, and
3. an economical evaluation on the impact of the program on healthcare utilization and related costs.


Eligibility Criteria:
Inclusion Criteria:

* Aged 70 years or over
* At least some concerns about falling
* At least some associated avoidance of activity
* Fair or poor perceived general health
* Living independently in the community
* Written informed consent

Exclusion Criteria:

* Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)
* Language or hearing problems that impede completing an interview by telephone
* Sight problems that impede completing the intervention
* Confinement to bed
* Waiting for nursing home admission
* Permanent use of a wheelchair
Prevalence of Potentially Inappropriate Treatments

A multicenter point prevalence study in Turkish intensive care units.

Intensive care units (ICU) are life-saving units for critical patients with using advanced technology. In some cases, it becomes a unit where treatment is not possible, the fatal patients are admitted and the death process is extended. Most patients with end-stage cancer, advanced-stage chronic obstructive pulmonary disease (COPD) and advanced-stage Alzheimer's disease prefer to die at home, although many often refer to emergency services at the end of their life and are then transferred to the ICU. Intensive care treatments are often very invasive and painful interventions. The patient who lives in intensive care unit is faced with many psychological distresses such as communication, isolation and fear besides physical ache. For this reason, it is necessary to make decisions (end-of-life decisions) such as forbearing intensive care treatments applied to the patients in the death process or cutting out the ones started. In the world, the goal for the end of life patients is, improving the last phase of their lives with the application of these decisions and symptom therapy, living in a peace without pain and respiratory distress. However, there is an uncertanity in these issues in our country and intensive care physicians are hesitant to make decisions about the end of life with concern about legal problems. Although it is known that these patients will not benefit most from the treatment of ICU, they are getting treatments for saving their lives in ICUs. The fact that intensive care beds are not available due to the patients who are not get beneficial treatment, brings the result of difficult finding of the beds which will benefit from the intensive care, and in fact it is a waste of intensive care resources which is very expensive. The size of the problem is not known as there is no data on the frequency of patients in our country who are in intensive care and require end-of-life care.

In this multicenter point prevalence study our aims are;

* to find out the incidence of patients in intensive care units in Turkey in the last period of life,
* to compare the resource use of end-of-life and non-end-of-life patients.

Eligibility Criteria:
Inclusion Criteria:

All patients who are over 18 years old, more than 48 hours in the intensive care unit, or expected to be hospitalized

Exclusion Criteria:

Patients under 18 years of age, less than 48 hours in the intensive care unit stay, or who are monitorized for post-operative care
AmbuLatory Pediatric Asthma CAre

The ALPACA study has a prospective randomized control interventional design, including a follow-up period to evaluate follow-up effects. The study is divided into two phases of 3 months using eHealth and observational monitoring.

The ALPACA study has a prospective randomized control interventional design, including a follow-up period to evaluate follow-up effects. The study is divided into two phases of 3 months; In the first phase subjects are randomized to either eHealth care (use of a communication portal including the weekly entry of SpO2, spirometry results and ACT) and explorative observational home-monitoring or only explorative observational home-monitoring during regular care. The second phase is to evaluate the effects of eHealth care compared to the control group after a follow-up period of 3 months, and the time to healthcare events during follow-up in both groups (survival analysis). The study makes use of an intention-to-treat analysis.

Eligibility Criteria:
Inclusion Criteria:

* Children with moderate-to-severe asthma.
* Children in the age group from 4 up to and included 11 years old.

Exclusion Criteria:

* Children living in a house without WIFI.
* Prior participation in eHealth care trial.
* Children/Parents with an inability to understand or speak Dutch.
* Children with divorced parents or other reasons that causes them to be less than 80% on the same living address.
* Children of whom family members have already participated in this trial.
* Children for whom it is not possible to perform at least one of the two discontinuous dyspnea assessment (lung function/pulse oximetry).
* Children using an inhaler that is not compatible with the FindAir smart inhaler cap, which cannot be replaced by a compatible alternative.
* Children with chronic diseases other than asthma (i.e. inflammatory bowel disease, behavioral disorders, mental retardation).
* Currently displaying COVID-19-related symptoms, namely a fever, cough and/or difficulty breathing (during inclusion).
* Having been positively tested as infected with COVID-19 in the past 14 days
Efficacy and Safety of Ivabradine on Top of Atenolol in Stable Angina Pectoris

To test whether ivabradine when given in combination with atenolol is able to improve the exercise tolerance of patients with stable angina pectoris


Eligibility Criteria:
Inclusion Criteria:

* Chronic stable angina pectoris
* Documented coronary artery disease
* Previous treatment with atenolol or other beta-blocker agent
* Exercise tolerance test positivity and stability

Exclusion Criteria:

* Heart rate \< 60 bpm
* Congestive heart failure
Optimizing Diagnosis Of Primary Aldosteronism

To optimize the confirmatory tests for primary aldosteronism.

In this study, the investigators aim to optimize the three confirmatory tests: salt loading, captopril challenge and fludrocortisone suppression, and to confirm a better choice of confirming testing for single or combined diagnosis of primary aldosteronism. Additionally, the investigators plan to collect blood and tissue samples of PA patients for genetic testing, and to proceed a long-term follow-up for further investigating the mechanism underlying PA and evaluating the cardio-cerebrovascular complications risk.

Eligibility Criteria:
Inclusion Criteria:

* With hypertension;
* With adrenal diseases

Exclusion Criteria:

* Pregnant or during lactation period;
* Under 18 yr;
* BMI ≤ 19 or ≥ 35
* With Cancer medical history
* Been through cardiovascular diseases in the past 3 months;
* Been through malignant arrhythmia, respiratory muscle paralysis or skeletal muscle paralysis caused by hypokalemia.
The Effect of Methotrexate on Sperm Quality in Men With Inflammatory Bowel Disease

Inflammatory bowel disease (IBD) is a chronic inflammatory disorder of the gastrointestinal tract which includes Crohn's disease (CD) and ulcerative colitis (UC) which peak in incidence (rate or frequency) during the reproductive years. An increasing number of young people will face challenging decisions regarding medical management of this chronic disease during a period of time when they are still completing schooling, establishing their career, and/or are building a family.

Treatment options for IBD consist of immunosuppressive therapy, such as immunomodulators (azathioprine and methotrexate). Methotrexate (MTX) is a folic acid antagonist (a substance that interferes with or inhibits the action of another). It is thought that MTX works by decreasing the inflammation in the gastrointestinal tract. MTX has been studied for many years and in used as treatment in not only IBD, but also in conditions such as rheumatoid arthritis and lupus. However, due to concerns about the safety of MTX, particularly in regards to fertility and pregnancy has limited its current use.

Participants are invited to take part in this research project to determine whether the treatment of IBD patients with MTX is associated with an increased risk for infertility. Investigators will recruit 75 male IBD patients under MTX treatment for their IBD as well as 75 healthy male controls for a total of 150 patients at the University of Wisconsin Hospital \& Clinics.


Eligibility Criteria:
Inclusion Criteria:

1. Cases: Men aged 18 to 40 years with a confirmed diagnosis of UC or CD based on endoscopy, pathology, and/or radiology AND who regularly take MTX (per oral, subcutaneous, or intramuscular) either as monotherapy or in combination with mesalamine (any except sulfasalazine), corticosteroids, anti-TNF agents, or anti-adhesion molecules for at least one month specifically for the treatment of IBD. Controls: Men aged 18 to 40 years with a confirmed diagnosis of UC or CD based on endoscopy, pathology, and/or radiology AND who do not take MTX (per oral, subcutaneous, or intramuscular) either as monotherapy or in combination with other IBD-specific drugs.
2. Individual able and willing to consent to donate their sperm to research.

Exclusion Criteria:

1. Men with previously documented problems with male reproductive health such as known hypothalamic-pituitary disorders (e.g. pituitary macroadenomas, pituitary infarction), primary hypogonadism (e.g. cryptorchidism, Klinefelter's syndrome), or disorders of sperm transport (e.g. erectile dysfunction, history of vasectomy)
2. Current use of alkylating agents, ketoconazole, sulfalsalazine, H2-receptor antagonists or spironolactone
3. Men who have undergone ileal pouch anal anastomosis within 3 months of study entry
EBUS-TBNA vs Flex 19G EBUS-TBNA

This is a prospective randomised diagnostic clinical study to determine whether the use of a new flexible sampling needle can improve the yield of endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA). Patients undergoing EBUS-TBNA for clinical reasons as deemed necessary by the managing physician or multidisciplinary team will be randomised to undergo either EBUS-TBNA or Flex 19G EBUS-TBNA. The procedure will be performed under local anaesthesia using conscious sedation or general anaesthesia according to usual practice at the trial centre. Specimens will be placed in saline and formalin and forwarded to the pathology laboratory. The specimens will be spun down to create a cell pellet which will undergo cytological and histological examination as per usual protocol at the trial centre.The pathologist, who will be blinded as to which technique was used to obtain the sample, will grade the quality, quantity, and cellularity of the specimens.


Eligibility Criteria:
Inclusion Criteria:

1. Scheduled for EBUS-TBNA as part of clinical care
2. Lymph nodes larger than 10mm in diameter
3. Age \> 18 years
4. written informed consent

Exclusion Criteria:

1. Contraindication to needle biopsy (e.g. coagulopathy, anticoagulation, thrombocytopenia)
2. Inability to obtain informed consent
Early Glue Saphenous Vein Ablation With Compression Versus Compression Alone in the Healing of the Venous Ulcer

The study evaluates the effects of early endovenous glue ablation on ulcer healing in patients with chronic venous ulceration. Half the patients are randomized to receive early endovenous ablation (within 2 weeks) and a half to standard care

To get the venous leg ulcer to heal, the current best treatment is to wear a multi-component compression bandage, with which about 60% of these ulcers will heal within 24 weeks. There is evidence that treatment of the varicose veins by surgery will prevent the ulcer from returning after it has healed. Recent studies have suggested that newer techniques of treating varicose veins, such as sclerotherapy, laser or radiofrequency in an outpatient setting may help the ulcers to heal more quickly and reduce the chance of the ulcer recurrence. The aim of this study is to see whether early treatment of varicose veins using endovenous glue embolization helps with healing.

Eligibility Criteria:
Inclusion Criteria:

* Current leg ulceration of greater than 6 weeks, but less than 6 months duration
* Able to give informed consent to participate in the study after reading the patient information documentation
* Patient age \> 18 years
* Ankle Brachial Pressure Index (ABPI) ≥ 0.8
* Superficial venous disease on colour duplex assessment deemed to be significant enough to warrant ablation by the treating clinician (either primary or recurrent venous reflux)

Exclusion Criteria:

* Presence of deep venous occlusive disease or other conditions precluding superficial venous intervention
* Patients who are unable to tolerate any multilayer compression bandaging / stockings will be excluded.
* The inability of the patient to receive the prompt endovenous intervention
* Pregnancy (female participants of reproductive age will be eligible for inclusion in the study, subject to a negative pregnancy test prior to randomisation)
Portico and Navitor India Clinical Trial

The objective of this clinical trial is to collect data on procedural safety and device performance of the Portico and Navitor devices and FlexNav delivery system to treat patients with severe aortic stenosis in the Indian population.

The objective of this Phase IV clinical trial is to characterize the procedural safety and device performance of the Portico valve, the Navitor Valve, the FlexNav delivery system and FlexNav or Navitor loading system to treat patients with severe aortic stenosis.

Eligibility Criteria:
Inclusion Criteria:

1. Subject must provide written informed consent prior to any clinical investigation-related procedure.
2. Are \>60 years of age in host country, have severe symptomatic (NYHA class ≥ II) aortic stenosis (AS), at high or extreme surgical risk and have been identified as a candidate for a Portico or Navitor valve implant.
3. Subjects must have a Society of Thoracic Surgeons (STS) score of ≥7% OR documented heart team agreement of high or extreme risk for surgical aortic valve replacement due to frailty or co-morbidities not captured by the STS score.

Exclusion Criteria:

1. Have tested positive for the Corona Virus Disease 2019 (COVID-19) virus at any time AND currently have residual signs or symptoms associated with the COVID-19 virus (eg. evidence of thrombosis, damaged/inflamed heart muscle, damaged/inflamed lung tissue, etc.)
2. Have sepsis, including active endocarditis
3. Have any evidence of left ventricular or atrial thrombus
4. Have vascular conditions (i.e. caliber, stenosis, tortuosity, or severe calcification) that make insertion and endovascular access to the aortic valve improbable
5. Have a non-calcified aortic annulus
6. Have congenital bicuspid or unicuspid leaflet configuration
7. Are unable to tolerate antiplatelet/anticoagulant therapy
8. Are pregnant at the time of signing informed consent
9. Are currently participating in a drug or device study that may impact this study (unless prior sponsor approval for co-enrollment is granted)
Computer-Assisted Tailored Cue-card Health [CATCH] Study

This study will draw from proven interventions to refine and pilot test a cue card driven computer-assisted intervention, along with HIV/STI testing, that will be tailored to each participant's demographic characteristics, risk behaviors, and biological test results. The specific aims of the proposed study are:

1. To refine a cue card driven computer-assisted risk reduction intervention that will be tailored to each participant's demographic characteristics (e.g., gender, ethnicity), risk behaviors, and biological test results (HIV, hepatitis B and C, syphilis and herpes).
2. To pilot test the tailored intervention's effects on sexual risk behaviors (e.g., frequency of unprotected sex, condom use), drug use during sex and injection risk behaviors (e.g., direct syringe sharing, indirect sharing practices) using a two-group randomized design that compares the tailored intervention with a delayed treatment control condition.
3. To assess the feasibility and acceptability of the tailored intervention in a rural setting.


Eligibility Criteria:
Inclusion Criteria:

The sample of 120 will be drawn from the Raleigh-Durham, NC metro area with the following targets:

* 40 MSM (at least 12 African American, 12 non-Hispanic white and 12 Hispanic) - eligibility includes unprotected sex with another male in the past 30 days
* 40 sex workers (at least 6 male and 6 female of each race/ethnicity) - eligibility includes unprotected sex within the last 30 days and exchange of sex for money or drugs within the past 30 days
* 40 drug users who are not sex workers or MSM (at least 2 males and 2 females of each race/ethnicity) - eligibility includes use of methamphetamine, crack or powder cocaine, or heroin in the past 30 days and unprotected intercourse and/or syringe sharing in the past 30 days.

Additional eligibility criteria include the following:

* be 18 years of age or older
* self-identify as male or female
* self-identify as African American, non-Hispanic white or Hispanic
* not currently be in or seeking substance use treatment
* speak and understand written English proficiently
* be a resident of Wake, Durham, Orange, Johnston or Chatham counties, with no plans to move in the next 3 months
Impact of Early Mobility on Post-Surgery Recovery in Patients Undergoing Oncologic Surgeries

This trial studies the impact of early mobility tracked with a 3-dimensional (3D) motion tracking technology (XSENS) on post-surgery recovery in patients undergoing oncologic surgeries. Xsens uses wireless measurements which could be used in clinical settings to objectively measure movement patterns (the joint range of movement and the distance of movement) during functional activities. Post-surgery mobility tracking may help doctors to identify the minimum required level of mobility after inpatient oncologic surgeries to enhance early post-surgery recovery and decrease early post-surgery complications.

PRIMARY OBJECTIVES:

I. To investigate objectively using evidence based randomized controlled trial the impact of early mobility (first day after the surgery) after any inpatient oncologic procedures on early recovery of postoperative course.

II. Try to find out the minimum level of postoperative mobility that needed for early postoperative course recovery by objective assessment of range of movement for each participant using 3D motion tracking system (Xsens).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients walk one to two laps around the ward twice per day, and have mobility tracked with Xsens over 5-10 minutes, until discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.

ARM II: Patients walk for minimum 30 minutes per day and mobility is tracked with Xsens over 5-10 minutes up to discharge from hospital. Patients also mobilize (walk out of the bed) on first day post-surgery under supervision and assistant of attending nurse in the floor if the clinical situation allows.

After completion of study, patients are followed up for 30 days post discharge.

Eligibility Criteria:
Inclusion Criteria:

* Ambulant inpatient with a stay of \>= 2 days after any inpatient oncologic surgery
* Eastern Cooperative Oncology Group (ECOG) scale of performance status of less than 3
* American Society of Anesthesiologist score (ASA) 3 or less
* Participants who do not engage in regular exercise regimen before the surgery (other than regular occupational physical therapy)
* Participant or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria:

* Patients with altered mental status
* Patients with psychiatric illness
* ECOG scale performance status 3 or more
* ASA score of 4
* Participants who engage in regular exercise regimen before surgery (at least one session per week)
* Patients with restricted movement due to other diseases
* Patients who require continuous monitoring