cyrilzakka/clinical-trials huggingface dataset:
Prevalence and Predictors of CCI in Patients With Acute Respiratory Failure (CCI)

Chronic Critical Illness (CCI) is a condition associated to patients surviving an acute phase of disease and respiratory failure (ARF) although remaining dependent on mechanical ventilation (MV). The prevalence and the underlying mechanisms of CCI have not been elucidated in this population.An observational prospective cohort study was undertaken at the Respiratory Intensive Care Unit (RICU) of the University Hospital of Modena (Italy) from January 2016 to January 2018. Patients mechanically ventilated with ARF in this unit were enrolled. Demographics, diagnosis, severity scores (APACHEII, SOFA, SAPSII) and clinical conditions (septic shock, infections, acute respiratory distress syndrome \[ARDS\]) were recorded on admission. Respiratory mechanics and inflammatory-metabolic blood parameters were recorded on admission and within the first seven days of stay. All these variables were tested as potential predictors of CCI through appropriate univariate and multivariate analysis.


Eligibility Criteria:
Inclusion Criteria:

* older than 18 years of age
* consecutively admitted to RICU due to acute respiratory failure (ARF) requiring mechanical ventilation.

Exclusion Criteria:

* refractory shock (death \< 24h)
* patient goals of care not consistent with aggressive management
* end stage COPD requiring home oxygen long term therapy or home non invasive ventilation support
* presence of interstitial lung disease
* history of neuromuscular disease
* chest wall deformities
* pregnancy
* chemotherapy or radiotherapy within the past 30 days
* evidence of neurologic injury on CT scan and GCS \< 8
* tracheostomy.
Additive Homeopathy in Cancer Patients

The investigators aim to investigate the validity of their previous results in a randomized prospective, placebo-controlled, double-blind, multicenter controlled evaluation of questionnaires in patients with advanced malignant tumors. The investigators plan to compare the treatment outcome (quality of life and survival) in tumor patients, receiving standard or "add-on" homeopathic treatment.

The null hypothesis is that "add-on" homeopathic treatment does not create a benefit for cancer patients. In addition the investigators evaluate survival time.

The EORTC-QLQ-C30, SF-36 as well as a VAS scale for subjective well-being will be filled out by the patients.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent
* Clinical diagnosis of advanced tumor stages of non small-cell lung carcinoma (NSCLC) IIIB, IIIC, IV.

Exclusion Criteria:

* sensitizing mutation of the EGFR gene or translocation of the ALK gene
* refusal to sign informed consent
* pregnancy
* hematological, hepatic, or renal pathology
* coronary heart disease
* history of secondary tumor
* major surgery within 4 weeks prior to study entry
* active infection and symptomatic peripheral neuropathy
* central nervous system metastases unless the metastases were treated and stable
* active autoimmune disease
* use of systemic immunosuppressive treatment
* use of systemic treatment during the previous 2 years
* active interstitial lung disease, or a history of pneumonitis for which glucocorticoids were prescribed
* previous systemic therapy for metastatic disease or previous irradiation
* use of any complementary and/or alternative therapy, including homeopathy other than the research treatment during the trial
Dynamic Ultrasonography VS MRI in the Evaluation of Meniscal Lesions in Patients With an Indication for Arthroscopy

This is a diagnostic, open-label, single-center interventional study.

This study aims to evaluate the diagnostic accuracy of dynamic ultrasonography for meniscal injuries in patients with an indication for arthroscopy, and to compare it with the study in MRI.

Patients admitted for ACL injury and indication for arthroscopy will be included in a study involving the evaluation of the diagnostic accuracy of dynamic ultrasound compared with MRI.

A total of 254 patients will be included, who after providing their signed informed consent to participate in the study, will undergo dynamic ultrasound. After giving signed consent to participate in the study, the patient will undergo the ultrasound evaluation for assessment of possible meniscal injury; Radiological examinations in the patient's possession or from the patient's medical record will be collected during or before the diagnostic investigation.

Eligibility Criteria:
Inclusion Criteria:

Patients with an indication for knee arthroscopy with:

1. Age between 18 and 60 years;
2. Unilateral involvement;
3. Presence of symptomatology such that dynamic ultrasound examination is precluded;
4. Ability and consent of patients to actively participate in the study;

Exclusion Criteria:

1. Patients unable to express consent;
2. Patients with malignant neoplasms;
3. Patients with rheumatic diseases;
4. Patients with diabetes;
5. Patients with metabolic disorders of the thyroid gland;
6. Patients abusing alcoholic beverages, drugs or medications;
7. Body Mass Index \> 35;
8. Pregnant or lactating women;
Multiple Micronutrient Supplementation (MMS) Iron Dose Acceptability Crossover Trial

This is an individually randomized cross-over trial to assess acceptability, preference, and perceived side effects of MMS formulations with 30 mg, 45 mg and 60 mg of iron.


Eligibility Criteria:
Inclusion Criteria:

* Attending first ANC visit at the study clinic
* Pregnant women ≤ 15 weeks of gestation
* Aged ≥ 18 years
* Intending to stay in Dar es Salaam for the duration of study
* Provides informed consent

Exclusion Criteria:

* Severe anemia (defined as Hb \<8.5 g/dL per Tanzania standard of care)
* Sickle cell disease (SS and SC) and hemoglobin C disease (CC) as tested by HemoTypeSC
* Concurrent participation in other nutritional supplementation trial
Wearable Movement Sensors for Assessing Motor Impairments and Dyskinesias in Parkinson Disease

The purpose of this study is to measure motor fluctuations and dyskinesias in patients with Parkinson's disease using movement sensors (accelerometers and gyroscopes) to determine if this is a feasible measure to use in addition to self report, and eventually the goal will be to replace self report with a more reliable measure such as movement sensors.

Patients with Parkinson disease and motor fluctuations will wear movement sensors during their regular clinic visit with the principal investigator. The visit will be videotaped and medication status (ON without dyskinesia, ON with dyskinesia, or OFF) will be independently rated from review of the video.

Eligibility Criteria:
Inclusion Criteria:

* Participants who will be included in the study have probable or definite idiopathic PD (CAPSIT criteria (23)), Hoehn \& Yahr stage 2-4;
* One or more of the following PD-associated motor impairments experienced in the week prior to enrollment (based on history and/or examination): motor fluctuations (end of dose wearing off with hypokinesia and/or levodopa-induced choreiform dyskinesias), tremor, freezing of gait, or frequent falls (≥ 1 per week).

Exclusion Criteria:

* Neurological disorders (other than PD) or orthopedic deficits that, in the investigator's judgement, contribute substantially to impaired movement (e.g. stroke with motor sequelae;
* Essential tremor;
* Severe osteoarthritis);
* Cognitive impairment sufficiently severe to interfere with informed consent.
Building Better Bones in Children

Calcium is important for healthy bone growth in children. Poor bone growth and development during childhood can lead to osteoporosis later in life. This study will evaluate a nutrition education program designed to increase the amount of calcium children receive. The study will determine whether the program will result in long-term dietary changes and healthier bones in children.

Increased calcium intake is effective in increasing bone mineral density in children, but the effect disappears when calcium supplements are discontinued. Increased dietary calcium from daily food sources may have a greater impact on bone density than that achieved by calcium supplements. However, studies have not yet demonstrated sustained achievement of increased calcium from food sources. In addition, the effects of baseline calcium intake, bone density, and puberty status may influence bone response to increased dietary calcium. This study will develop, implement, and evaluate a Behavioral Modification-Nutrition Education (BM-NE) Intervention Program designed to promote sustained increases in dietary calcium. The study will quantify the impact of increased dietary calcium on bone density during growth and development and will determine whether the presence of risk factors for low bone density influences compliance with the program.

Participants will be recruited into two groups: a group of healthy children with no known risk factors for low bone density (i.e., no known chronic disease or previous oral steroid exposure), and a group of healthy children with potential risk factors for low bone density (previous fracture from usual childhood activities, daily dietary calcium refusal, lactose intolerance, family history of osteoporosis). Children with and without risk factors will be randomly assigned to participate in an intensive BM-NE intervention group or a usual care group that will receive counseling on bone health. The BM-NE Program will consist of five group sessions for parents and children over 6 weeks. The program will use individualized plans to increase children's calcium intake to 1500 mg per day.

Children will be followed for 3 years. Primary outcome measures will include daily calcium intake and bone mineral density. Data on height, weight, sexual and skeletal maturation, and physical activity will also be collected.

Eligibility Criteria:
Inclusion Criteria

* Height or weight above the third percentile for age
* Normal weight (\< 130% of desirable body weight)
* English speaking

Exclusion Criteria

* Significant health condition
* Medication known to affect growth (e.g., thyroxin, growth hormone, steroid medication)
* Ritalin or Adderall medication
* Significant developmental or delay impairment (e.g., autism, cerebral palsy, mental retardation)
Androgenetic Alopecia in Fabry Disease

The purpose of this study is to assess whether patients with the classic form of Fabry disease have significantly less androgenic alopecia (male pattern baldness).

Objectives: To test the hypothesis that adult males with classic form of Fabry disease have a significantly lower incidence of androgenic alopecia than matched controls.

Study Population: 120 patients aged 20-64 with Fabry disease that have GLA mutations or alpha-galactosidase A activity associated with no residual enzyme activity and non-Fabry male controls of the same age range and the same number of non-Fabry controls.

Design: This is a cross-sectional study comparing the prevalence of androgenic alopecia in two groups of subjects.

Outcome Measures: The levels of the outcome will be no androgenic alopecia and frontal only androgenetic alopecia opposed to vertex only and frontal and vertex androgenetic alopecia.

Eligibility Criteria:
Inclusion Criteria:

* Male patients with Fabry disease age 20-64 years old.
* Healthy male controls age 20-64 years old
* GLA gene mutations associated with the classic form of Fabry disease or having alpha-galactosidase A activity that is essentially zero
* Patients who freely agree to participate in this study and understand the nature, risks and benefits of this study and give their written informed consent.
Pharmacoscopy-guided Clinical Standard-of-care in R/r AML

With an overall survival of below 12 months, the outcome of relapsed/refractory AML (RR AML) is poor, making it a critical challenge to identify effective therapies at this stage. The RAPID-01 trial aims to show for the first time in a randomized and controlled clinical trial that Pharmacoscopy (PCY), a functional precision medicine platform, helps improve clinical standard-of-care treatment selection for patients suffering from relapsed/refractory AML.


Eligibility Criteria:
Inclusion criteria

* Patient with refractory or relapsed AML according to ELN2022 criteria.
* Age 18-70 years.
* Considered to be eligible for intensive chemotherapy.
* Written informed consent.

Exclusion criteria

* Acute promyelocytic leukemia (APL) with PML-RARA or one of the other pathognomonic variant fusion genes/chromosome translocations.
* Blast crisis after chronic myeloid leukemia (CML).
* Considered not eligible for intensive chemotherapy.
* Condition of the patient does not allow to wait for PCY results (patient requires immediate treatment).
* PCY not working / patient sample did not pass the QC steps of PCY.
* Any other serious underlying medical, psychiatric, psychological, familial or geographical condition, which in the judgment of the principal investigator may interfere with the project or affect patient compliance.
* Legal incompetence or Subjects lacking capacity to provide informed consent.
* Participation in a clinical trial with an investigational drug within the 30 days preceding and during the present investigation.
The Reliability and Validity of the Figure of 8 Walk Test and Double Task Figure of 8 Walk Test in Persons With Stroke

The validity of the dual-task F8W test in predicting falls in older adults has been confirmed. As far as we know, there are no studies evaluating the validity and reliability of the dual-task F8W test in stroke patients. Therefore, the aim of the study is to evaluate the validity and reliability of the F8W and dual-task F8W test in stroke patients.

Recently, the validity and reliability of assessment tools in which two tasks are performed simultaneously have been investigated. Although the utility of dual-task assessments in assessing falls in neurological diseases is uncertain, the reliability of dual-task assessments involving walking has shown quite good results. Stroke survivors have decreases in one or both (locomotor and cognitive) performances while walking and simultaneously performing a cognitive task. The tasks selected in dual-task evaluations may affect dual-task interactions, therefore, tasks that are compatible with daily living activities should be used in dual-task evaluations. A previous study confirmed the validity of the dual-task F8W test in predicting falls in older adults. Because of this reaason, stroke patients aged 50 and over will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

* Being 50 years of age and older,
* Having only one unilateral stroke at least 6 months prior to the study,
* Being medically stable,
* Being able to walk at least 10 meters with a cane or independently,
* Getting 24 points or more from the Standardized Mini-Mental Test',
* Being to be able to perform the cognitive task (subtraction) to be given during the evaluations.

Exclusion Criteria:

* The presence of additional orthopedic, neurological or cardiovascular diseases that may affect balance and walking,
* Uncorrected vision and hearing problems.
Artificial Intelligence Screening on Patients With Primary Angle Closure Glaucoma

The Tomey CASIA (Tomey Corporation, Nagoya, Japan) is a novel rapid imaging device that captures high-quality imaging of the entire anterior chamber of the eye over detailed imaging of a single section. In this prospective study, we want to investigate and compare the anatomical structure of the drainage angle of the eye in patients with different types glaucoma using Tomey machine. This study gives us a better understanding of the predictability, validity and accuracy of Tomey machine in the diagnosis of different types of glaucoma. Moreover, the data collected here will be used to create an artificial intelligence (AI) platform to screen certain type of glaucoma.

Patients ≥18 years old from ophthalmic clinics with or without glaucoma were enrolled to this respective observational clinical study. However, patients with any history of eye surgery (except cataract surgery) including laser procedure were excluded. The investigators will review patients' medical chart and update any medical history in your medical record. If new scans are needed, investigators will do them at the time of patients' current visit and it will require about 30 mins. CASIA SS-OCT (CASIA 2) is a non-contact scan of the front of the eye with higher resolution and provides deeper, wider and three- dimensional views. It is the newest scan machine. It is not FDA-approved but is approved in many other countries including Japan for patient use. We may perform the scan in the light and dark condition. We may also perform the routine scan to capture images of the anterior part of the eye for comparison purpose. The results of the scanned data will be among patients' medical records. Age, sex and ethnicity within your medical records will also be used for the analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patient with or without glaucoma

Exclusion Criteria:

* Patients with any history of eye surgery (except cataract surgery) including laser procedure.
* Age \< =18 years
Comparison of Programmable and Non-programmable CSF Shunts Among Adult Hydrocephalus Patients With Different Etiologies

Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.

Relatively high revision rates up to 32% of CSF shunting operations remained an unsolved problem for neurosurgeons. The cause of revisions were diverse, including overdrainage/underdrainage, shunting system obstruction, infection or technical skill related. Programmable valve (PV) has been shown as a solution to the high revision rate in pediatric hydrocephalus patients, but it remains controversial among adults. This study is to compare the overall revision rate, revision cause, and revision-free survival between PV and non-programmable valve (NPV) in adult patients with different hydrocephalus etiologies.

The investigators reviewed the chart of all patients with hydrocephalus receiving index ventricular CSF shunt operations conducted at a single institution in northern Taiwan from January 2017 to December 2017. Patients included in the study were followed up for at least five years. Statistical tests including independent t-test, Chi-square test and Fisher's exact test were used for comparative analysis, and Kaplan-Meier curve using log-rank test was performed to compare the revision-free survival between the PV and NPV groups

Eligibility Criteria:
Inclusion Criteria:

* received shunting operations at Chang Gung Medical Foundation, Linkou Branch from 2017/01/01\~2017/12/31

Exclusion Criteria:

* Patients who received index ventricular CSF shunt at other hospitals,
* Patients who received index ventricular CSF shunt before January 1st 2017,
* Patients who were younger than 18
Drug Eluting Balloon in peripherAl inTErvention for Below-The-Knee Arteries With Freeway and Lutonix

The aim of this study is to compare in patients with critical limb ischemia the efficacy of angioplasty with different paclitaxel-eluting balloon devices for below-the-knee lesions in terms of restenosis.

Two devices will be evaluated: the Lutonix and the Freeway paclitaxel eluting balloons. A post-hoc analysis will compare the results with the historical data from DEBATE-BTK (NCT01558505).

Eligibility Criteria:
Inclusion Criteria:

* age\>18 years
* angiographic stenosis\>50% or occlusion of one below-knee vessel

Exclusion Criteria:

* allergy to Paclitaxel
* contraindication for combined antiplatelet treatment
* life expectancy \<1 year
* hypersensitivity or contraindication to one of the study drugs
* lack of consent
* need for amputation
Feasibility Study on the Characterization of the Immune Profile of Young Patients After Treatment for Breast Cancer

This study aim to determine kinetic of post treatment recovery/variation of a panel of innate and adaptative immune system cells and molecules.

The results should allow to determine the optimal post treatment immunomonitoring timing and panel to be used for future studies.

There is a complexe interaction between tumor cells ans host immunity. Immunity system (IS) is clearly involved in cancer developement control, and it is suggested that it could participate to the response to anti cancer treatment.

There is however no validated immunomonitoring strategy to allow a reliable patient's immune status along time, and particularly after treatment.There are scarce existing information on immunologic reconstitution profile recovery after treatment.

This study aim to perform immunomonitoring in young patients with cancer to describe kinetic of recovery/variation of a panel of innate and adaptative immune system cells and molecules, selected by their potential relevance according to literature.

The concerned population are young women (˂40 yo) with breast cancer.

There will be 2 patients cohorts A or "End of treatment" : patients recruited at the end of treatment (study cohort) B or "Diagnosis" : Patients recruited at diagnosis (reference values)

This study should contribute to give sufficient data to determine the pertinent timing and cells/molecules panel to evaluate immunity profiling after treatment.

These results could be used for further studies.

Eligibility Criteria:
Inclusion Criteria:

* Women with Breast cancer at initial diagnosis OR at the end of treatment
* Chemotherapy planned or performed in the treatment plan
* Patient not opposed to participate to the present study
* Affiliated to a French social security scheme.

Exclusion Criteria:

* metastatic breast cancer
* pregnant or breastfeeding woman
* Treatment with monoclonal antibodies or immunotherapy
* Immunosuppressive therapy
* Thymus irradiation
* Chronic infection in progress
* Inborn or acquired disease (other than breast cancer) impacting the immune system (SAA, Lupus...)
* Subject under guardianship or deprived of liberty