cyrilzakka/clinical-trials huggingface dataset:
Steroids In Eosinophil Negative Asthma

Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.

SIENA is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ICS) will be compared with the effect of placebo and with a long-acting muscarinic antagonist (LMA).

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed asthma for at least previous 12 months.
* Able to perform reproducible spirometry.
* Baseline FEV1≥70% of predicted.
* Asthma confirmed either by:

  * Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR
  * Methacholine PC20 ≤ 16 mg/ml
* At least 1 of the following indications for chronic controller therapy:

  * Asthma Symptoms \> 2 days/week OR
  * Nocturnal Asthma Symptoms \> 2 nights/month OR
  * Short-acting beta-agonist use for symptom control \> 2 days/week
* For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.
* Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.

Exclusion Criteria:

* Chronic inhaled or oral corticosteroid therapy.
* Use of inhaled or oral corticosteroid therapy within 6 weeks.
* New allergen immunotherapy within the past 3 months or anticipated changes to an ongoing immunotherapy regimen.
* Use of omalizumab within 3 months.
* History of:

  * bladder-neck obstruction, urinary retention or benign prostatic hyperplasia
  * narrow angle glaucoma
  * significant cardiovascular disorders and arrhythmias
  * life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years
* Respiratory tract infection within past 6 weeks.
* History of smoking within the past 1 year, or \> 10 pack-years total if ≥ 18 years of age, or \> 5 pack-years total if \< 18 years of age.
* Chronic diseases or medical conditions (other than asthma) that could put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system, or immunodeficiency.
Task-oriented Arm/Hand Skill Rehabilitation and Therapy Dose Dimensions in Subacute Spinal Cord Injury Rehabilitation

The study is a multicenter longitudinal observational study. The therapy content and the therapy dosage of arm/skill training for patients with cervical spinal cord injury (SCI) will be observed for the primary objective. The aim is to get insight into the current therapy content and the current therapy dosage in arm/hand skill training, with the overall aim to optimize the arm/hand skill training. For the secondary objective, in addition to the patients with cervical SCI also, patients with paraplegia as a result of SCI are included. The aim is to assess the difference between the patient's perceived dose and the therapist's estimation of the therapy dose. This will give insight into the patient's and therapist's views on therapy dose; this information will contribute to optimizing therapy dose in exercise therapy in SCI. The third aim is a pilot study to explore the usability of evening reports in SCI rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

* Primary objective

  1. Have sustained a traumatic or non-traumatic SCI between C1 and T1.
  2. Have an AIS A, B, C or D
  3. Are older than 16 years
  4. Being able to follow standard arm/hand skill training.
  5. Patients in the subacute phase (4-30 weeks post-injury)
  6. Receiving usual care
  7. Able to understand the purpose of the study (understanding Dutch, English, French and German).
* Secondary objective

Add patients with:

1. Persons with SCI (C1-S4)
2. having an AIS A, B, C, D;
3. Are older than 16 years;
4. Patients in the subacute phase (4-30 weeks post-injury)
5. receiving standard care or more intensive care as defined by the SCI-MT trial - Therapists Physiotherapists, occupational therapists and sports therapists with at least two years of experience in SCI rehabilitation

Exclusion Criteria:

1. have any significant medical or physical condition (including pregnancy) or psychiatric illness that could prevent the person from participating in the study
2. are unable/unwilling to provide informed consent.
Outcome of Zeiss AT LARA EDOF Lens Implantation in Vitrectomized Eyes

To determine the surgical outcome and patient satisfaction in patients who underwent AT LARA lens implantation during or after vitrectomy at a relatively young age (around 55 years of age), mostly to treat (urgent) retinal detachment.

The surgical outcome is defined as the patient satisfaction determined by patient questionnaires.

* Visual quality: CatQuest questionnaire
* Near vision: NAVS questionnaire
* Glare: APPLES questionnaire

These questionnaires are standardized and validated, although no cut-off values have been determined. Hence, the results drawn from these questionnaires are descriptive only.

Eligibility Criteria:
Inclusion Criteria:

* patients that had a LARA IOL implanted in combination with vitrectomy.
* patients that had a LARA IOL implanted in during surgery for cataract secondary to vitrectomy.

Exclusion Criteria:

* Patients with a LARA IOL implanted without concomitant or earlier vitrectomy
Coagulation Parameters During Pregnancy in Amniotic Fluid

Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains coagulation activators, their role during pregnancy has not been elucidated. The current study aimed to evaluate coagulation parameters in AF during human pregnancy.

Amniotic fluid embolism is a rare devastating thromboembolic event, which is probably caused by the entrance of amniotic fluid (AF) to the maternal circulation. While AF contains coagulation activators, their role during pregnancy has not been elucidated. The current study aimed to evaluate coagulation parameters in AF during human pregnancy.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing amniocentesis during 15-35 weeks of gestation.

Exclusion Criteria:

* A history of venous thromboembolism
* Systemic disease i.e.; diabetes, hypertension, hypo or hyper-thyroidism,
* Anticoagulant treatment
* Abnormal embryo
A Study of Glycemic Control in Left Ventricular Assist

The study is being conducted to understand if the hemoglobin A1c, a measurement of control of blood sugars over a 3-month time, is valid in patients with Left Ventricular Assist Devices (LVADs) in place. To understand whether it is an adequate measurement, the investigators will compare the A1c to results from a continuous glucose monitor (CGM) measurement of blood sugars. By monitoring blood sugars continuously, the investigators will also assess whether they can get better control of blood sugars with a CGM, including avoiding low blood sugars.


Eligibility Criteria:
Inclusion Criteria:

* Prior implantation of contemporary, centrifugal flow LVAD (HeartWare or HeartMate 3) at any time after 2010
* Diagnosis of type II diabetes mellitus
* Any antihyperglycemic regimen
* Greater than 3 months out from LVAD implantation
* Capable of utilizing smartphone device for LibreLink app for uploading glycemic data
* Patients may be enrolled who have preexisting CGM in place.

Exclusion Criteria:

* Type I diabetics
* Unable to return at 3 month evaluation
* Unwillingness to participate
Proactive Population Health Management of Cardiovascular Disease in Primary Care Using the PROSPERA-program.

The PROSPERA-program is a complex multilevel approach that includes training for healthcare providers, a risk assessment process, and decision support tools to help match patients with the appropriate treatment based on their care needs.

The goal of this clinical trial is to determine if the PROSPERA-program can improve the cardiovascular risk profile in patients aged 40-90 years enrolled in primary care programs for increased cardiovascular risk, such as cardiovascular disease, increased vascular risk, or diabetes.

The main question it aims to answer is:

• Does the cardiovascular risk profile improve for patients using the PROSPERA-program?

Researchers will compare the PROSPERA-program with standard cardiovascular care to see if the program enhances cardiovascular population health in primary care.

Additionally, the study will assess how well the PROSPERA-program fits into the workflow of primary care providers and supports shared decision-making.

Participants will:

* Receive a consultation with their general practitioner or practice nurse according to the PROSPERA-program.
* Have their routinely collected healthcare data used for evaluation.
* Be asked to complete a questionnaire or participate in an interview (for a subset of patients).


Eligibility Criteria:
Inclusion criteria:

* Age \> 40 years and ≤ 90 years
* Patient in a primary care practice enrolled in this study
* Included in the cardiovascular disease (CVD), increased vascular risk (IVR) or diabetes mellitus (DM) Dutch Integrated Care programs
* Additional criteria for subgroup that receives questionnaires: able to communicate in the Dutch and/or English language

Exclusion Criteria:

* Patients with Diabetes Mellitus type I
* Patients receiving palliative care
* Patients with any form of cognitive impairment diseases such as Dementia or Alzheimer
* Patients who are treated in other Integrated Care programs because of their frailty (e.g. elderly who are treated in the 'Kwetsbare Ouderen Chronische Zorgprogramma')
A Clinical Study for the Development of a Device (Lovelace) for Antepartum Fetal Monitoring

Bloomlife Lovelace FT is a non-invasive, wireless, external measurement system used to measure accelerometer and electrophysiological signals on pregnant women with a singleton pregnancy, by acquiring biopotential signals from abdominal surface electrodes.

In this study, Bloomlife Lovelace FT is used to collect the dataset needed for the development of a future product (Bloomlife Lovelace) for the monitoring of fetal heart rate, maternal heart rate and uterine activity.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman ≥ 18 years old
* Gestational age greater or equal to 24 weeks and 0 days
* Singleton pregnancy
* Ability to read and understand Dutch
* Willingness to participate in the study

Exclusion Criteria:

* Implanted pacemaker or any other implanted electrical device
* History of allergies to skin adhesives
* Irritated or lesioned skin at the Bloomlife Lovelace FT electrodes locations
* Contraindication to the use of CTG based on physician's decision (e.g. due to preterm contractions)
Continuous Glucose Monitoring Technology in the Perioperative Period During Cardiac Surgery

This is an observational study of continuous glucose monitoring technology during cardiac surgery. The investigators would like to develop data for descriptive analysis of a comparison of continuous glucose monitoring with a gold standard under the conditions of cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

* Competent adults scheduled for elective cardiac surgery.

Exclusion Criteria:

* Inability to consent, emergency surgery.
Evaluation of the Main Determinants of Patient Acceptability of the Bowel Cleansing Procedure, and of Success of Bowel Cleansing and Caecal Intubation

Several factors are important in achieving a successful colonoscopy, including patient acceptability of the bowel cleansing procedure and the overall quality of cleansing.

This observational study has been designed to explore the main determinants of acceptability of the bowel cleansing procedure to the patient in an Italian "real life" setting. In addition, the study is to examine the determinants of quality of bowel cleansing and describe aspects of the technical performance of the colonoscopy (time to reach the caecum and adenoma detection rate).


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent obtained prior to inclusion.
* Male and female outpatients, aged ≥ 18, treated with bowel cleansing preparation the day before undergoing routine colonoscopy at selected participating centres.

Exclusion Criteria:

* Children and adolescents aged less than 18 years. Pregnant or breastfeeding women.
* Listed contra-indications to the relevant product used for the bowel cleansing procedure.
* Patients having been submitted to a previous colonoscopy over the last five years.
* Patients who have taken laxative enemas the day preceding the colonoscopy.
Misoprostol for Management of Women With an Incomplete Miscarriage

Miscarriage is defined as the spontaneous loss of a pregnancy before 24 weeks gestation, that is, before fetal viability. The clinical signs of miscarriage are usually vaginal bleeding associated with abdominal pain and cramping. The miscarriage is named 'complete' or 'incomplete' according to whether or not tissues are retained in the uterus. If a woman has minimal bleeding but her cervix is closed, this is known as a 'threatened miscarriage. However; if the pregnancy is still inside the uterus but the cervix is open, this is described as an 'inevitable miscarriage', which it will not usually be possible to save the fetus.

the aim of the study is to evaluate 2 doses with misoprostol in Women With Incomplete First-trimester Miscarriage After Misoprostol Treatment

Eligibility Criteria:
Inclusion Criteria:

* Women with confirmed incomplete induced miscarriage, less than 12 weeks' gestation.
* No known allergy to misoprostol.
* Women who will be hemodynamically stable.
* Good access to emergency facilities

Exclusion Criteria:

* Women with signs of severe infection ( fever \> 38°)
* Women with severe vaginal bleeding
* Women are known to have allergies to prostaglandins
* Severe abdominal pain requiring immediate intervention
Strain Echocardiography During Septic Shock : an Observational Pilot Study

The mortality of septic shock remains high nowadays despite a trend toward improvement.Septic cardiomyopathy has been reported in most experimental models of sepsis shock. Its relationship with mortality is unclear. A decrease in mortality have been reported in patients with decreased left ventricular ejection fraction (LVEF), but a recent meta-analysis did not support such results. In fact, it appears that high LVEF are linked to profound vasoplegia which is associated to bad outcome.

In the other hand, alterations of Strain echocardiography, a new method allowing a more sensitive evaluation of heart function, have been associated with a worse outcome in sepsis patients. Only few studies have examined echocardiographic strain during sepsis shock in human, and its natural history was only described in pigs. Moreover, the right ventricular strain was reported only by Orde et al whereas the evolution of strain during fluid infusion have never been studied. The aim of the present study is to describe the natural history of echocardiographic strain during sepsis shock and to determine its prognosis value.


Eligibility Criteria:
Inclusion Criteria:

* Septic shock (suspected or proven infection and norepinephrine ≥ 0,25µg/kg/min)
* Inclusion within the first 24h of septic shock

Exclusion Criteria:

* Patient \< 18 year of age
* Pregnant women
* History of myocardial infarction, valvular disease, atrial fibrillation
Evaluation of Post-operative Discomforts in Children After Extraction of Temporary Teeth

This prospective observational study aim to evaluate discomforts after extraction of temporary tooth under local anesthesia. The first objective is to describe the prevalence of the post-extraction pain (PEP), post-extraction bleeding (PEB), post-extraction biting injury (PEBI) in children, and the analgesic usage. The secondary objective is to define whether it is possible to determine a profile of patients or a type of extraction's procedure predictive to PEP and administration of analgesics, PEB or PEBI.

125 children in range of 2-15 years indicated for tooth extractions will be included in this study.

Informed consent will be obtained from all individual participants included in this study.

Immediately after extraction and until the following day, parents will be asked to assess the post-operative discomforts and to administrate paracetamol (acetaminophen) as soon as the child expressed a pain score ≥2 evaluated on the faces pain scale-revised (FPS-R).

A structured form is designed to obtained information regarding the patient's age, gender, socioeconomic level, and cooperation of the child before and during anesthesia or extraction, influence of accompanying person, number of previous extraction, dental hygiene. Moreover, details about the type of extraction; the indication of extraction (tooth decay, orthodontic treatment, obstacle, infection and traumatism), the type of tooth (incisor-canine or molar), the degree of root resorption, number of doses of local anesthetic, and presence of preexisting or per-operative pain are also collected.

Eligibility Criteria:
Inclusion Criteria:

* children in range of 2-15 years indicated for tooth extractions under local anesthesia.

Exclusion Criteria:

* patient under analgesic the day of the appointment or under non steroidal anti-inflammatory agents through 8 days before the extraction;
* contraindication to paracetamol/acetaminophen;
* incomplete mental health;
* extraction under sedation (including nitrous oxide/oxygen) and under general anesthesia.
* extractions of permanent tooth;

Child was also excluded from the study if parents could not be reached by phone within 32 hours after extraction and if the parents don't speak French.
Effect of Device Guided Breathing on Sleeplessness (2BRT01)

The current study is designed to evaluate the effect of device guided breathing (DGB) on sleeplessness. Healthy subjects with mild to moderate sleeplessness that wish to improve their sleep quality will be included in this study. The subjects will receive a belt type breathing sensor, download the app on their smartphone, and will be required to perform DGB at their home setting for 2 weeks after a baseline period.

Sleeplessness, defined as difficulty in falling asleep or maintaining sleep, is prevalent in about one third of the US population. Sleeplessness was found to have negative impact on the quality of life and daily functionality and in its chronic form, was also found to frequently lead to sympathetic over-activity. Stress is an important factor in triggering and exacerbating sleeplessness and its symptoms.

Current methods for alleviating the problem include drugs, modification of sleep habits (also delivered via smartphones), cognitive behavior therapy that includes relaxation techniques such as mindfulness, meditation, and diaphragmatic breathing.

Breathing pattern modification, as done by Device Guided Breathing (DGB) was found to affect beneficially the cardiovascular system. DGB guides its user in reducing breathing rate gradually from normal values (12-20 breaths/min) to slow rates (4-6 breaths/min) while increasing the relative duration of the exhalation phase. This is done by composing in real time musical tones from monitored respiration data with which the user synchronizes breathing

Breathing pattern modification, as done by DGB was originally implemented in a device called RESPeRATE that was cleared by the FDA for treating hypertension and stress and its use was supported by multiple clinical trials. However, the direct effect of DGB on sleeplessness has not yet been investigated,

DGB was recently implemented in a mobile system that consists of a Bluetooth enabled belt-type breathing sensor and an iOS mobile application ('App'). The App accumulates continuously breathing-related data and performance measure. The accumulated data are sent to an icloud-based server.

The current study is a single center, prospective, randomized, waiting-list-controlled (WLC) clinical trial designed to evaluate the effect of DGB on sleeplessness using the mobile DGB2 system.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy with mild to moderate sleeplessness
2. Male or Female, Age 18-65
3. Has ipod/ipad or smartphone compatible with the system used in the study
4. Has access to internet and email
5. Knowledge of English to the level of understanding the App and the sleep-monitor interface.

Exclusion Criteria:

1. Known sleep or respiration disorder
2. A serious systemic disease
3. Pittsburg Insomnia Rating Scale (PIRS_2) \<2
4. Pregnant
MirvasO Soolantra Association In the Treatment of Moderate to Severe rosaCea.

The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe rosacea.


Eligibility Criteria:
Main Inclusion Criteria:

1. Male or female subjects age 18 years or older;
2. Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face;
3. Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment \[CEA\]);
4. Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment \[IGA\]);
5. Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
6. Female subjects of childbearing potential must practice a highly effective method of contraception during the study;
7. Females subjects of non-childbearing potential;

Main Exclusion Criteria:

1. Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;
2. Subjects with more than 2 nodules of rosacea on the face;
3. Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;
4. Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;