cyrilzakka/clinical-trials huggingface dataset:
Safety Evaluation of Functional Electrical Stimulation (FES) Cycling in Intensive Care Unit Patients

Intensive care unit acquired muscle weakness (ICUAW), is a common disease which influence rehabilitation, extend mechanical ventilation and length of stay in intensive care unit, and affect quality of life at hospital discharge.

To prevent ICUAW, different strategies of early mobilization are recommended. But all cannot be applied in all ICU patients. Some of them benefit from heavy therapies like circulatory assistance or renal replacement therapy for example, that limit mobilization.

Cycloergometer is a tool that allows continuous passive mobilization in bedridden and even unconscious patients.

Neuromuscular electrical stimulation (NMES) is an alternative that helps preserve muscle mass and limit muscle atrophy.

Early bedside cycle exercise coupled with NMES is an interesting new approach where application of an electrical stimulation along specific motor nerves on each lower limb, generates muscles contractions and pedaling on cycloergometer.

The aim of this study is to evaluate safety and feasibility of this coupled technique called Functional Electrical Stimulation (FES) Cycling, in ICU patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Deeply sedated (Riker 1-2) patients, admitted in intensive care unit B of ST-Etienne hospital
* Without curare since 12 hours
* Normothermic or with a controlled fever (central temperature between 36 and 38°C)
* Without haemodynamic instability (mean arterial pressure \> 65mmHg and \< 120mmHg, systolic arterial pressure \> 90mmHg and \< 200mmHg, Norepinephrine \< 4mg/h)
* Without respiratory instability (respiratory rate \< 35/min, pulse oxymetry \> 90%, inspired oxygen fraction \< 60%, PaO2/FiO2 ratio \> 250, Peep \< 10cmH2O, with invasive mechanical ventilation)
* Without neurological instability (diastolic velocities in mean cerebral artery \> 30cm/s, mean velocities \> 50cm/s, pulsatility index \< 1.2, intracranial pressure \< 20mmhg, brain tissue oxygenation tension \> 15mmHg)
* Patient whose family has given informed and written consent to the patient's participation in the study

Exclusion Criteria:

* Pregnant woman,
* Patients with peripheral nerve damage prior to or at the time of measurement
* Curarized patients (non-efficacy of neurostimulation)
* Presence of a catheter in the stimulation zone (femoral artery or vein)
* Patients with lower limb, pelvic or spine fracture
* Patients with continuous renal replacement therapy
* Patients with circulatory assistance
* Patients with wounds in electrodes placement area
* Morbidly obesity with Ideal Body Weight \> 40kg/m2
* Patients with pacemaker
* Lower limb deep vein thrombosis without treatment
Characterization of White Blood Cells Sub-populations From Multiple Sclerosis Patients.

Multiple sclerosis (MS) is a chronic progressive neurological autoimmune disease, that gradually affects patient's quality of life. There are about 2.5 millions patients world wide, with an increasing cost Burdon. Up to date, it remains unclear who are the exact cells to initiate the disease. During the disease, the repertoire of cells expands and undergoes changes. The purpose of this study is to characterize those changes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosis of MS according to the revised criteria of McDonald or healthy volunteers
* Ability to provide written informed consent.

Exclusion Criteria:

- Active malignant disease
Application of 68GA-labeled CD73 Targeting Probe PET/CT Imaging in the Diagnosis of Breast Cancer

We plan to conduct a 68Ga-DOTA-dPNE PET/CT imaging study on breast cancer patients to observe the binding of the tracer to lesions and evaluate CD73 expression. Alongside this, we will correlate these imaging results with relevant clinical indicators to assess the effectiveness of 68Ga-DOTA-dPNE in diagnosing and guiding treatment in breast cancer patients. This study aims to predict responses to targeted therapies.


Eligibility Criteria:
Inclusion Criteria:

* 1: Age: ≥18 years old female, expected survival ≥12 weeks; 2: Without radiotherapy and chemotherapy, surgery or biopsy is feasible to obtain pathological diagnosis; 3: Standard Solid Tumor Response Evaluation Criteria (RECIST) version 1.1 with at least one measurable target lesion; 4: Obtain written informed consent and be able to follow up

Exclusion Criteria:

* 1: Severe liver and kidney dysfunction; 2: Women who are planning to conceive, pregnant, or breastfeeding, as well as those planning to have children during the study period, are not eligible to participate in this research. Women of childbearing potential must use effective contraception throughout the course of the study; 3: Individuals unable to lie flat for thirty minutes; 4: Suffers from claustrophobia or other mental illnesses; 5: Researchers believe that the subject has other conditions that make them unsuitable for inclusion in this study; 6: Refuses to join this clinical study.
Longitudinal Assessment of Adults With Severe Asthma

Cross-sectional study to characterize cohorts of subjects with asthma and healthy controls in terms of clinical features, physiological measurements and non-invasive measurement of biomarkers and develop phenotype handprints for adults with severe asthma


Eligibility Criteria:
General Inclusion Criteria:

1. Able to give written informed consent prior to participation in the study, which includes ability to comply with the requirements and restrictions listed in the consent form. Informed consent must be obtained prior to undertaking any study procedures.
2. Male or female subject aged 18 years or older at screening.
3. Able to complete the study and all measurements.
4. Able to read, comprehend, and write at a sufficient level to complete study related materials.
5. Subjects will be allowed to enrol in other studies while taking part on this study. However, Permission from the Scientific Board must be obtained to enrol or allow the continued participation of a subject enrolled in another study.

General Exclusion Criteria:

1. As a result of medical interview, physical examination or screening investigation the physician responsible considers the subject unfit for the study either because of the risk to the subject due to the study or the influence this may have on the study results.
2. The subject has a history of recreational drug use or other allergy, which, in the opinion of the responsible physician, contra-indicates their participation.
3. Subject is female who is pregnant or lactating or up to 6 weeks post partum or 6 weeks cessation of breast feeding. If a woman is subsequently found to have been pregnant at the time of an assessment data from that assessment will not be included in the analyses.
4. The subject has participated within 3 months of the first dose in a study using a new molecular entity, or the first dose in any other study investigating drugs or having participated within three months in a study with invasive procedures. Any U-BIOPRED assessments should be deferred until 3 months after the first dose or invasive procedure. Permission from the Scientific Board must be obtained to enroll or allow the continued participation of a subject enrolled in another study.
5. Those who, in the opinion of the investigator, have a risk of non-compliance with study procedures.
6. The subject has a recent history of incapacitating psychiatric disorders
7. History or current evidence of an upper or lower respiratory infection or symptoms (including common cold) within 2 weeks of baseline assessments (assessments should be deferred).
Validation Study of mHealth Technology in HIV to Improve Empowerment and Healthcare Utilisation: Research and Innovation to Generate Evidence for Personalised Care (EmERGE)

A large (3900 patients) cohort study, undertaken in five European sites to validate in a mHealth platform to enable self-management of HIV in patients with stable disease using a tailored HTA process, Model for Assessment of Telemedicine Applications (MAST), specifically developed for the assessment of mHealth solutions.

As site recruitment will be sequential and the recruitment period will last 18 months, a maximum follow-up of 35 Months will be undertaken. Study visits will take place at baseline defined as the time of mHealth introduction, months 6, 12, 18, 24 and 30.

Number of Study Centres: 5 Duration of Study: 35 Months Criteria for Evaluation: Usability of the mHealth platform, patient self-management and empowerment, clinical safety (virological suppression maintenance, CD4 count, laboratory parameters, adverse events and adherence), quality of life and self-economy will be assessed by questionnaires and laboratory parameters.

Routine data on patient demographics, treatment and investigations which will include viral load, CD4, haematology, biochemistry and urine sample. Patient Activation Measure, Quality of life, adherence questionnaire and economic questionnaires will be performed at baseline and at months 12 and 24. Satisfaction System Usability Scale will be evaluated at month 12 and 24.

Eligibility Criteria:
Inclusion Criteria:

1. Documented HIV-1 infection
2. Aged at least 18 years old
3. Able to give informed consent
4. In possession of a smartphone, tablet, or similar technology supporting the mHealth platform
5. Stable on ART: Defined as ART should be unchanged for at least 3 months and viral load undetectable (\<50 copies/ml) for at least 6 months.
6. Clinically stable from an HIV perspective: Defined as without opportunistic infection or AIDS related cancers within the previous 12 months

Exclusion Criteria:

1. Aged less than 18 years
2. Pregnant
3. Participating in a clinical trial or receiving an investigational medication
4. Unable to comprehend the patient information sheet
5. Unable to comprehend the instructions for using the mHealth platform
6. Considered for any other reason by their regular physician to be unsuitable for study participation.
Telehealth Language Intervention for Children With Autism Ages 2-4 Years

The main goal of this intervention is to increase caregivers' use of interactive play and communication strategies to improve the child's early sentence development using telemedicine and video-based feedback.

Record was updated 11/2/2021 to include more detailed information about outcome measure time points. Specifically, secondary outcome measures will be collected more frequently over the course of the study (i.e., at baseline \[before starting intervention\], immediate follow-up \[week 12\], and long-term follow-up \[3 months after intervention\] assessments). No changes were made to outcome measures or how they are operationalized.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism spectrum disorder (ASD) and/or communication disorder
* Child speaks at least 50 single words or uses emerging word combinations
* Caregivers have Internet availability from their home

Exclusion Criteria:

* Child speaks using complex sentences
* Child is not within 2 to 4 years of age at time of enrollment
Effectiveness and Safety of New Botanical Component-LFCO- Compared With Existing TTO in Clinical Study

In an 8 week double blind randomized controlled split-face studies, we tried to compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)

Basically, this is a split face study - one side of face randomly assigned was applied with LFCO and the other side with TTO in same patients.

Screening of natural compounds for the development of anti-acne therapeutic agents has been steadily required considering various side effects of acne medications.However, previous studies have mainly focused on experimental tests without clinical trials and histopathological analysis.

To compare the clinical efficacy, safety and histopathological changes between Lactobacillus fermented Chamaecypris obtusa (LFCO) and existing tea tree oil (TTO)

Total thirty four patients were instructed to apply 5 % LFCO to the involved areas of randomly allocated side and 5 % TTO extract to the other side for 8 weeks in a double blind split-face clinical trial.

Eligibility Criteria:
Inclusion Criteria:

* age 19-45
* active acne lesions in both sides of face
* available during study periods

Exclusion Criteria:

* pregnancy, mental illness, intake of oral isotretinoin within 6 months, application of the other oral or topical acne medications, chemical peeling or light based treatments within 6 weeks.
A Family-Based Diabetes Intervention for Hispanic Adults in an Emerging Community

The aim of this study was to compare the efficacy of an intervention and an attention control group in producing changes in diabetes self-management, glycemic control (HbA1c) and health related quality of life in Hispanics with type 2 diabetes.

Hypothesis: The experimental group who receive an 8 week intervention program would show significantly greater improvements than an attention control group at 1 and 6 months after the intervention in: behavioral influences of diabetes knowledge, diabetes self-efficacy, and family support, outcomes of self-reported management of diabetes (physical activity, diet, medications, and glucose monitoring), HbA1c levels, and psychological outcomes of health-related quality of life.

A total of 186 participants and their family members were recruited, 103 in the experimental group and 83 in the attention control group.

An intervention consisted of eight weekly interactive modules, for a total of 12 hours, and based on modules from National Standards for Diabetes Self-Management Education, and the National Diabetes Education Program. Data were collected at baseline, immediately post-intervention, and at 3 and 6 month follow-up visits.

Eligibility Criteria:
Inclusion Criteria for participants:

1. Community-dwelling
2. Self-identification as Hispanic
3. Age 18 years or older
4. Self-identification as having a medical diagnosis of type 2 diabetes
5. An adult family member willing to participate in the study.
6. Must be able to speak either English or Spanish

Inclusion criteria for family members/relatives are:

1. Family member is over 18
2. Reside in the same household as the participant with diabetes
3. Must be able to speak either English or Spanish

Exclusion Criteria:

We will exclude Hispanic adults and family members who are:

1. diagnosed with type 1 diabetes
2. report prior (within the past year) or current participation in other diabetes self-management intervention programs
3. cognitively impaired (not oriented to time, place, or person, or with known dementia)
4. Pregnant at the time of T1 (baseline) data collection
Detection of Oncogenic Tumor Mutations in the Urine and Blood of Lung and Colorectal Cancer Patients

The purpose of this study is to see whether gene mutations can be found in the urine or blood of lung cancer patients and urine of colorectal cancer patients. Gene mutations are when DNA in a gene is damaged in a way that changes the genetic message carried by that gene. Gene mutations can sometimes cause lung cancers. These gene mutations are only found in lung and colorectal cancer cells, not the normal cells in your body. All lung cancer tumors and colorectal cancer tumors are now tested for different gene mutations as their presence affects lung cancer treatment. Tumor samples obtained from a biopsy or surgery are typically tested for these gene mutations.


Eligibility Criteria:
Inclusion Criteria:

Lung cancer:

For patients participating in Part A (initial testing) and Part B (serial testing):

* Patients must have a diagnosis of stage IV lung adenocarcinoma undergoing systemic therapy.
* Patients must have had or intend to have EGFR mutation testing (specifically including exon 19 deletions and L858R) performed on their tumor with results available from a CLIA certified laboratory.
* ≥ 18 years of age

Specific to patients participating in Part B (serial testing):

* Patients must be planning to receive cancer care at Memorial-Sloan Kettering.
* Patients must have a confirmed EGFR mutant lung cancer (exon 19 deletions and L858R) with molecular testing results available from a CLIA certified laboratory.
* Must be within 3 months of their diagnosis of metastatic lung cancer.
* Treatment plan should include an EGFR tyrosine kinase inhibitor, but may concurrently be on a therapeutic protocol.

Colorectal Cancer:

For patients participating in Part A (initial testing) and Part B (serial testing):

* Patients must have a diagnosis of stage IV colorectal adenocarcinoma undergoing systemic therapy or have recently progressed on therapy including anti-EGFR based therapy.
* Patients must have had or intend to have RAS/RAF mutation testing on their tumor with results available from a CLIA certified laboratory. For the patients who recently progressed on anti-EGFR must have tumor tissue molecular analyses preformed (prior to enrolling or a plan to test it at the time of enrollment).
* \>18 years of age

Specific to patients participating in Part B (serial testing):

* Patients must be planning to receive cancer care at Memorial-Sloan Kettering.
* Patients must have a confirmed RAS/RAF mutant colorectal cancer with molecular testing results available from a CLIA certified laboratory.
* Must be within 3 months of their diagnosis of metastatic colorectal cancer.

Exclusion Criteria:

lung cancer and colorectal cancer

* Comorbidities that would prohibit or make serial urine collection difficult or impossible
A Study Of The Effect Of PF-04802540 On Sleep Measures

The purpose of this study is to determine if PF-04802540 decreases REM sleep.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female (nonchildbearing potential) subjects between the ages of 18 and 55 years, inclusive
* Body Mass Index (BMI) between 18 to 32 kg/m2, inclusive, and a total body weight \>45 kg (99 lbs)
* Non-users of nicotine

Exclusion Criteria:

* Evidence or history of clinically significant medical illness
* A history of seizures, including childhood febrile seizures
* Any condition possibly affecting drug absorption
Hypo-pressive Abdominal Exercise on Inspiratory Muscle Strength, Diaphragm Thickness and Pain in Chronic Nonspecific Low Back Pain

The purpose of this study will be to assess the effects of an 8-week hypo-pressive abdominal exercise program on Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability in patients with non-specific chronic low back pain. A randomized clinical trial will be carried out. A total sample of 40 patients with non-specific chronic low back pain will be recruited and divided into 2 groups including an experimental group (n=20) which will receive an 8-week hypo-pressive abdominal exercise program and a control group (n=20) which will not receive any training program. Inspiratory muscle strength, diaphragm thickness, pressure pain threshold and disability will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic non-specific low back pain

Exclusion Criteria:

* Congenital diseases
* Rheumatic or neuro-muscular diseases
* Respiratory conditions
* Surgery
* Pregnancy
Open Label Treatment of Severe Tactile Defensiveness With Intrathecal Baclofen

The purpose of this study is to determine if intrathecal administration of baclofen can reduce symptoms of severe tactile defensiveness and autism spectrum disorder.

The purpose of this study is to determine if intrathecal administration of baclofen can reduce symptoms of severe tactile defensiveness and autism spectrum disorder.

Some people with autism spectrum disorder do not like to be touched. This is referred to as tactile defensiveness. Baclofen is a drug approved for treatment of spasticity in patients with conditions such as cerebral palsy, spinal cord injury and traumatic brain injury. Intrathecal means that baclofen is administered by injection into the spinal canal. In this study, each patient will undergo a trial administration of intrathecal baclofen and the effect of intrathecal baclofen on symptoms of tactile defensiveness and autism spectrum disorder will be evaluated.

Each patient will have three visits in connection with the study. First, there will be a screening visit in which the investigators determine if the patient is eligible to participate in the study. To participate, each patient must have autism spectrum disorder, severe tactile defensiveness, and meet other listed criteria. At the second visit, each patient will undergo the intrathecal baclofen trial procedure. The procedure used is the standard procedure to determine if intrathecal baclofen is effective for treatment of spasticity. In this study however, instead of evaluating the effect of intrathecal baclofen on spasticity, the investigators will evaluate the effect of intrathecal baclofen on symptoms of tactile defensiveness and autism spectrum disorder. The trial procedure and evaluation will require about one day. At the third visit, the follow up visit, the investigators will evaluate and discuss the patient's response to the treatment.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of autism prior to study entry
2. Exhibits these specific symptoms of autism:

   * Tactile Defensiveness
   * Increased sensitivity to sensory stimulation
3. Patients must be scored as "Always" for "Reacts emotionally or aggressively to touch" on a modified Short Sensory Profile Questionnaire. Additionally, patients must score "Always" or "Frequently" in the other categories of a modified Short Sensory Profile Questionnaire

Exclusion Criteria:

1. Allergy to baclofen or compounds with similar structure
2. Unable to be evaluated by the chosen efficacy measures
3. Any condition that in the opinion of the principal investigator will place the patient at increased risk of adverse events or preclude completion of the study
4. Concomitant use of any medication that in the opinion of the principal investigator is contraindicated with intrathecal baclofen administration
5. Females of child-bearing potential who have a positive urine pregnancy test at visit 2
Extracorporeal Membrane Oxygenation in Coronavirus Disease (COVID-19), Influenza and ARDS of Other Ethiologies

A comparison of clinical characteristics and outcomes of patients on extracorporeal membrane oxygenation (ECMO) in COVID-19, influenza and ARDS of other ethiologies

All ARDS patients on extracorporeal membrane oxygenation (ECMO) during January 1st 2016 and January 10th 2022 in University Medical Center Ljubljana were included and their clinical characteristics and outcomes were studied according to ARDS ethiology: COVID-19, influenza and other ethiologies.

Eligibility Criteria:
Inclusion Criteria:

* Patient with acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO)
* 18 years or older

Exclusion Criteria:

* Patient not eligible for ECMO treatment per institutional guidelines (terminal illness, palliative care)