cyrilzakka/clinical-trials huggingface dataset:
Pro-miniCHOP-like Regimen for Treatment-naive Elderly Patients

The proposed study is a prospective, single-center and open-ended study in patients over the age of 70 with treatment-naive diffuse large B-cell lymphoma (DLBCL). This study intends to explore a new treatment pattern using Pro-miniCHOP-like regimen and simultaneously evaluate its safety and efficacy for future clinical practice.

The study will start with an initial 21-days of induction therapy with combination of orelabrutinib, pomalidomide and rituximab(Pro regimen) in eligible patients, following contrast computed temography(CT) to guide the next treatment. Patients whose lesions have 25% or more reduction will next receive Pro-miniCHOP-like regimen for 6 cycles. Patients with reduction less than 25% will receive R-miniCHOP-like regimen also for 6 cycles. After that, maintenance therapy with pomalidomide for two years will be given to patients undergoing Pro-miniCHOP-like regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Histopathologically or Cytologically confirmed newly diagnosed untreated DLBCL;
2. There is at least one radiographically measurable lesion (i.e., ≥ 15mm in diameter);
3. Age ≥ 70 years;
4. Life expectancy \>3 months;
5. Patients with proper organic function (alanine aminotransferase, bilirubin, creatinine \< 3 times the upper limit of normal; cardiac ejection fraction ≥ 50%; SPO2\>90% under non-oxygenated conditions).
6. Written informed consent obtained from the subject.

Exclusion Criteria:

1. Patients with severe liver and kidney dysfunction (alanine aminotransferase, bilirubin, creatinine \> 3 times the upper limit of normal);
2. Patients with organic heart disease with clinical symptoms or cardiac dysfunction (NYHA grade ≥2);
3. Uncontrolled active infection;
4. Patients with central nervous system DLBCL;
5. A history of vascular embolism;
6. Co-existence of other tumors;
7. Systemic corticosteroid therapy is needed;
8. Any other psychological conditions that prevent patients from participating in the study or signing the informed consent form.
Study to Determine the Feasibility of Using an At-home Foot Temperature Monitoring Device (Thermidas)

This is a feasibility study, designed to assess the acceptability of At Home Temperature Monitoring (AITM) by patients at high risk of diabetes foot ulceration. The investigation hopes to identify any problems with the study design before progressing to a full-scale evaluation, and will assess the ease of use of the technology and if there are any barriers to using this.

Participants will be provided with an infrared camera and SMART phone and trained in how to use them. The participants will then be expected to capture images of both the plantar and dorsal aspects of their feet that will be sent to the research team for review. The two images will be captured once per day. The Intervention period will be 12 weeks.

If a raised temperature is identified, the participant will be offered a face to face review appointment where they will receive podiatry treatment (if required), ulcer prevention advice and more detailed thermal imaging. Patient and health care professional (HCP) questionnaires will be used at the start and end of the study period to assess quality of life impact and device ease of use.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Male or Female \>/ = 18 years of age
* Diabetes Mellitus type 1 or 2 according to WHO criteria
* independently ambulatory
* deemed high risk/ in remission via SCI diabetes foot risk stratification tool
* expected to comply with study schedule

Exclusion Criteria:

* active foot ulcer or open amputation site
* active Charcot Neuro-osteoarthropathy
* active foot infection based on PEDIS classification criteria
* amputation proximal to the Chopart joint in one or both feet
* critical limb ischaemia (according to PEDIS classification)
* severe illness that would make 6-month survival unlikely based on the clinical judgement of the physician or podiatrist
* concomitant severe physical or mental conditions that limit the ability to follow the instructions of the study, based on the clinical judgement of the physician or podiatrist
SMART Pilot Trial of Glycemic Screening Outreach

Approximately 130 million Americans have prediabetes or type 2 diabetes (T2D) but remain unscreened and/or unaware of their diagnosis. While prediabetes/T2D screening, also known as glycemic screening, is endorsed in national guidelines, there is almost no research on how to increase screening rates, or evaluations of interventions testing the effectiveness of screening promotion strategies. The American Medical Association has published prediabetes quality measures that apply to UCLA Health as well as all other health systems, specifically tracking the percentage of adult patients with risk factors for T2D due for glycemic screening for whom the screening process was initiated. However, there is no current systemic effort underway at UCLA, or most other health systems, to encourage glycemic screening. We are proposing a pilot trial of the first SMART (Sequential Multiple Assignment Randomized Trial) for glycemic screening. Our SMART experiment will provide preliminary feasibility and acceptability data for a larger, multisite trial that will provide vital guidance to optimize screening approaches for a growing number of screening-eligible patients so that they may seek earlier detection, treatment, and/or access to lifestyle programs and interventions for T2D or prediabetes.


Eligibility Criteria:
Inclusion Criteria:

* Overweight or obese

Exclusion Criteria:

* Existing type 2 diabetes, A1c drawn within past 3 years
Wearable Technologies for Sleep in Children and Adolescents

This study aims to evaluate the viability of wearable and portable technologies for sleep staging in children and adolescents. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation. Three domains of devices will be used: movement sensors, wearable EEG band and pulse oximetry.

The project will include individuals between the ages of 3 and 18 who reside in São Paulo city and undergo a polysomnography test at the Sleep Laboratory of the Children's Institute of the Hospital das Clínicas of the University of São Paulo, achieving a minimum of 85% sleep efficiency on the night of the test.

This study aims to evaluate the viability of the combined use of wearable and portable technologies for sleep staging. The results will be compared with polysomnography, in order to achieve clinical and diagnostic validation. Three domains of devices will be used:

* Movement sensors: Devices equipped with movement sensors (such as an accelerometer) able to monitor movement over the using period, converting this information in data related to the sleep-wakefulness cycle. In this category, the reference devices are the actimeters/actigraphs (ACT). Its use is recommended by the American Academy of Sleep Medicine to the diagnosis of insomnia and circadian sleep disorders, and should be used for 3 to 14 consecutive days. Other wearable devices, such as smartwatches, are also used with the same purpose, although not validated for clinical use.
* Wearable EEG band: EEG is a mandatory feature for type-1 polysomnography and a requirement for regular sleep staging. The project will utilize a wearable EEG band in combination with actigraphy and a ring oximeter to improve the estimation of sleep stages. This study will test wearable EEG bands with the following minimal specifications: dry EEG electrodes (no need for paste, gel, or other conductors), presented as a headband or stripe, a minimal sampling rate of 500Hz, noise, high and low filters, a battery lasting at least 8 hours, a maximum weight of 200g (including the whole device), and support for Bluetooth connection.
* Ring oximeter: The project will utilize a ring oximter to record the overnight blood oxygen levels, heart rates, and body movements.

Eligibility Criteria:
Inclusion Criteria:

* All genders
* 3 to 18 years olnde
* Resident in the city of São Paulo
* Candidate to perfome a polysomnography test at the Sleep Laboratory of the Children's Institute of the Hospital das Clínicas of the University of São Paulo.

Exclusion Criteria:

* Individuals with sleep efficiency lower than 85% on the night in question.
Interventional Study on the Evaluation of Functionality, Safety of a Robotic Prosthesis for Transtibial Amputations

The goal of this multicenter interventional pilot is to verify the functionality of a prosthesis for trans-tibial amputees.

The main question it aims to answer are:

* Is to verify the technical functionality, safety and reliability of the propulsive lower limb prosthesis prototype, with active ankle, so as to provide indications regarding the technical and functional developments to be implemented in the finalization of the device.
* Provide an indication of the functional effectiveness of the device and its satisfaction by patients.

Participants will perform:

* walking tests inside parallel bars on flat and/or inclined terrain;
* walking tests on treadmill;
* stair climbing/descent tests.


Eligibility Criteria:
Inclusion Criteria:

* Trans-tibial lower limb amputation;
* Medicare functional classification: Level K3-K4;
* Subjects who have worn prostheses for at least 1 year (experienced wearers);
* Use of prosthesis with energy-returning prosthetic foot.

Exclusion Criteria:

* Relevant medical comorbidities (serious neurological pathologies, cardiovascular pathologies, diabetes/hypertension not stabilized, severe sensory deficits);
* Wearers of implantable cardiac medical devices (PMK or AICD);
* Cognitive impairment (MMSE corrected for age and education \<24);
* Inability or unavailability to provide informed consent;
* Severe depressive and/or anxious symptoms.
Thermage CPT for Treatment of Facial and Neck Laxity

The purpose of this study to evaluate treatment with the Thermage CPT system for facial and neck laxity.


Eligibility Criteria:
Inclusion Criteria:

* 25 - 65 years of age
* Moderate facial and neck laxity
* Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments.
* Subject must understand the research nature of this study and sign an Institutional Review Board (IRB)-approved informed consent prior to the performance of any study specific procedure or assessment.
* Subject agrees not to undergo excluded procedures on the face and neck for the duration of study.

Exclusion Criteria:

* Subject is pregnant or breast feeding, or trying to become pregnant for three months prior to or during the study.
* Pacemaker, internal defibrillator, or other implanted electronic device
* Subject has an active localized infection in the treatment area(s) or an uncontrolled systemic infection.
* Subject has had prior cosmetic procedures on the treatment area(s) within six months of the baseline visit.
Preoperative Methylprednisolone in Endovascular Aortic Repair

The purpose of this study is to attenuate the systemic inflammatory response after Endovascular repair of abdominal aortic aneurysms, by administration of a single preoperative dosage of Methylprednisolone.


Eligibility Criteria:
Inclusion Criteria:

* Elective endovascular repair of an asymptomatic abdominal aortic aneurysm.
* Informed signed consent

Exclusion Criteria:

* Positive HIV status, positive hepatitis B or C status
* Immunoinflammatory disease - except topically treated skin disease and respiratory disease.
* Glaucoma
* Gastric or duodenal ulcer
* Systemic fungal infection
* Immunosuppressive treatment
* Current treatment for cancer
* Allergy towards contents of Solu-Medrol
* Alcohol consumption: Men \> 21 drinks and women \> 14 drinks weekly
* Pregnancy
* Lack of informed signed consent
* Patients where follow up is planned at other location than Rigshospitalet.
Interactions of Medicine and Exercise With Meal Timing

To analyze the effects of altering the time of ingestion of participants' habitual medication (i.e., metformin, statins, ARAII/IACE) and meals around the time of exercise training (exercise fasted or fed) on the improvement of metabolic syndrome factors (hypertension, insulin sensitivity, dyslipidemia, and obesity). There will be a preliminary study of the effects of training "time-of-day" on the primary study outcomes.

Objective: The purpose is to study in a group of adults with metabolic syndrome and obesity, the effects of altering timing between exercise training, meals, and their habitual medication on the improvement in the factors that compose the metabolic syndrome (i.e., hypertension, insulin resistance, central obesity, and dyslipidemia). The main objective is to find the most productive combination between exercise training and the timing of their habitual pharmacological treatment, and meal ingestion for lowering those factors.

Methods and design: Cross-over randomized double-blinded, pretest-posttest control group experimental design. The project will be developed in a single center with the collaboration of the regional public health system (SECAM). There will be a preliminary study of the effects of training "time-of-day" on three parallel groups of individuals.

Subjects: Will be referred by their primary care physicians to our study unit or recruited by advertisements in local media.

Up to 180 subjects, all of them with metabolic syndrome will be recruited (\>25% women).

Measurements:

Specifically, we will study if the cardiovascular and metabolic adaptations to aerobic training that result in amelioration of metabolic syndrome factors are potentiated by correct timming of training, meals, and medicine around exercise training time.

Eligibility Criteria:
Inclusion Criteria:

* Metabolic syndrome patients diagnosed according to The International diabetes federation consensus of 2009 (Alberti, et al., Circulation).

Exclusion Criteria:

* Cardiovascular disease or musculo-skeletal that prevents them from being able to perform intense exercise.

  * Respiratory failure
  * Liver o renal disease
  * Pregnancy
Pregnancy and Congenital Toxoplasmosis

The Toxoplasma gondii parasite causes toxoplasmosis. It is characterized by persistent cysts mostly localised in the brain and ocular areas. In the case of immunodeficiency, those cysts are likely to reactivate. During pregnancy, an infection exposes the foetus to a variety of consequences, from severe neurologic lesions to subclinical forms at birth. However, those forms are likely to complicate at any age to toxoplasmic retinochoroiditis, that can unpredictably recur with severe functional consequences. Pregnancy may stimulate lesions or their recurrences, putting the foetus at risk of contamination because of the release of tachyzoites in the bloodstream. The occurrence of these complications is poorly known, especially with congenital toxoplasmosis. Nevertheless, this information is essential to take care of patients, particularly women with congenital toxoplasmosis, usually worried about the consequences of a pregnancy.

As a precaution, women with congenital toxoplasmosis follow a specific ophthalmologic, and trimonthly monitoring, composed of fundus examinations during pregnancy and in postpartum. To eliminate the contamination risk, serological examinations at birth and one year later are done on their kids.

The aim of this study is to estimate the risk of toxoplasmic retinochoroiditis during pregnancy and the impact on their children. Retrospective and prospective data from the Lyon Cohort of Maternal and Congenital Toxoplasma Infections will be used.

As a result of to this study, the investigators expect to provide better information to women suffering from congenital toxoplasmosis about their own ocular safety during pregnancy, and the safety of their child(ren). The investigators seek to provide new national and international recommendations about these patients and their children's care.


Eligibility Criteria:
Inclusion Criteria:

* Being a woman
* Born before March 2022
* Suffering from congenital toxoplamosis

Exclusion Criteria:

* Refusal to give informed consent
* Any condition that would limit the ability of the patient to give consent
* Psychiatric cares
* To be deprived of liberty
* To be under administrative supervision
Comparison of Hydroxyethyl Starch and Crystalloid Coload Combined With Norepinephrine Infusion for Hypotension

The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Colloid fluid coload has been highly demonstrated for prevention and/or treatment of post-spinal anesthesia hypotension. In addition, there's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension is still unknown. The purpose of this study is to investigate the ED50 and ED90 for an effective 6% Hydroxyethyl starch (130/0.4) or crystalloid coload combined with prophylactic norepinephrine infusion dose for postspinal anesthesia hypotension in patients undergoing cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* Primipara or multipara
* Singleton pregnancy ≥ 37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
* Hemoglobin \< 7g/dl
* Coagulation or renal function disorders
* Known allergy to hydroxyethyl starch
* Fetal distress, or known fetal developmental anomaly
To Assess Safety, Tolerability and Physiological Effects on Structure and Function of AXA4010 in Subjects With Sickle Cell Disease

This is an open-label study to understand the safety and tolerability of AXA4010, a novel composition of amino acids in adult and adolescent subjects with sickle cell disease over 12 weeks. The study also assesses the effects of this amino acid composition on the structure and function of the vascular system. Physiological effects on structure and function will be assessed by Magnetic Resonance Imaging (MRI) to assess blood flow in the brain and kidneys and the 6-Minute walk with pulse oximetry. Changes in blood biomarkers of inflammation will also be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Willing to participate in the study and provide written informed consent
* Male and female adolescent (ages 12 to 17 inclusive) and adult (≥ 18 years of age) subjects with a prior medically documented diagnosis of sickle cell disease (SS or β0 thalassemia)
* For Cohort 2 adult subjects only, a Screening cerebral blood flow/ velocity by transcranial doppler (TCD) should be \>110 cm/sec
* Subjects must show active hemolysis at the time of screening based on each of the following parameters:

  * Lactate dehydrogenase (LDH) ≥ 2x above upper limits of normal (ULN) of the age- and gender-appropriate ranges
  * Indirect bilirubin \> 2x of the age- and gender-appropriate ULN
  * Absolute reticulocyte counts \> 2x of the age- and gender-appropriate ULN
* Able to ambulate (without assistance or walkers etc.) in a 6- minute walk test

Exclusion Criteria:

* Ten (10) or more Vascular-Occlusive Crisis (VOC)s that required hospital or emergency room (ER) visits within the past 12 months
* Any clinically significant changes abnormalities on the screening 12-lead ECG
* Estimated glomerular filtration rate \<60mL/min/1.73m2 appropriately corrected
* Hemoglobin (Hb) ≤6.0 g/dL at Screening
* Subjects on chronic transfusion regimens, or who received a transfusion within the last 2 months prior to screening
* Experienced VOC or any other sickle crises (eg acute chest syndrome, splenic sequestration, dactylitis, stroke) within the last 2 months prior to Screening
* Current or history of significant alcohol consumption
* Other poorly controlled medical conditions as judged by the Investigator
* Known sensitivity and/or history of clinically significant food intolerance/allergies to proteins (including whey, soy, casein, amino acids, etc.)
* Unable or unwilling to adhere to contraception requirements
* Any contraindications to an MRI scan for Cohort 2 only
* Any other condition that, in the opinion of the Investigator, renders the subject at risk for compliance, compromises the well-being of the subject, or hinders study completion
Effects of Mirror Therapy and Cognitive Therapeutic Exercise in Stroke Patients

This is a randomized clinical trial aimed at patients with a diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke. Its objective is to evaluate the effects of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, to achieve maximum functionality of the affected upper member,

Objective: To assess the effect at 3 months of the of the mirror therapy and cognitive therapeutic exercise, both in combination with task-oriented motor learning, applied for 30 days in the functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and quality of life in stroke patients.

Design and setting: A randomized clinical trial of three parallel groups.

Population: 152 patients with residual hemiparesis due to ischemic or hemorrhagic stroke will be included, selected by consecutive sampling at the Neurological Service and Stroke Unit of the University Hospital of Burgos (HUBU).

Measurements and intervention: Functionality of the affected upper member, cognitive performance, emotional state, performance of daily living activities and health-related quality of life will be evaluated. The intervention groups will receive a treatment based either on mirror therapy or on congnitive therapeutic exercise, both combined with task-oriented motor learning for 30 days. No additional intervention with the participants of the control group will be completed.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of residual hemiparesis due to ischemic or hemorrhagic stroke,
* Movements of the affected upper members classified between stages II and IV on the Brunnstrom Scale
* Score on the Montreal Cognitive Assessment (MOCA) scale equal to or over 26

Exclusion Criteria:

* Heminegligence
* Wernicke's aphasia
* Visual deficits (homonymous hemianopsia)