cyrilzakka/clinical-trials huggingface dataset:
Effects of Different Forms of Fatigue on Double-Task Performance in the Elderly

The dual task (walking and cognitive task at the same time) is increasingly used in geriatrics in protocols for detecting people who are falling and/or for highlighting cognitive disorders. However, frail elderly people tend to get tired quickly and a lack of awareness of the effects of fatigue on dual-task performance could alter the diagnosis.

There are two types of fatigue: mental fatigue and peripheral muscle fatigue. Each participant will do both types of fatigue over 2 appointments spaced by 7 days so that the subject can recover from induced fatigue. The sequence of fatigue tasks will be randomized.

At the first appointment (day 0):

1. Pre-fatigue assessment :

   * The subject must walk on 10m with round trip for 1min.
   * the subject must do the arithmetic count of 3 in 3
   * Then comes the evaluation in double task (walking and counting at once for 1min). The subject must walk on 10m with round trip for 1min by doing the arithmetic count of 3 in 3 at the same time.
2. mental fatigue task or muscle fatigue task (randomized)
3. post-fatigue assessment (the same as pre-fatigue assessment)

7 resting days

Second appointment (day 7)

1. Pre-fatigue assessment :

   * The subject must walk on 10m with round trip for 1min.
   * the subject must do the arithmetic count of 3 in 3
   * Then comes the evaluation in double task (walking and counting at once for 1min). The subject must walk on 10m with round trip for 1min by doing the arithmetic count of 3 in 3 at the same time.
2. mental fatigue task or muscle fatigue task (randomized)
3. post-fatigue assessment (the same as pre-fatigue assessment)


Eligibility Criteria:
Young group

Inclusion Criteria:

* 20 to 40 years old

Exclusion Criteria:

* psychiatric disorders
* Severe hearing or vision loss
* Motor or sensory disability that may interfere with test completion

Old group

Inclusion Criteria:

* 65 to 90 years old
* less than 3 Fried's criteria of fragility
* walking ability without technical assistance (at least 10m).

Exclusion Criteria:

* psychiatric disorders
* Severe hearing or vision loss
* Motor or sensory disability that may interfere with test completion

Old frail group

Inclusion Criteria:

* 65 to 90 years old
* 3 or more Fried's criteria of fragility
* walking ability without technical assistance (at least 10m).

Exclusion Criteria:

* psychiatric disorders
* Severe hearing or vision loss
* Motor or sensory disability that may interfere with test completion
Clinical Evaluation of Polycation-based New Dental Desensitizer on Dentin Hypersensitivity

Evaluate the safety and clinical efficacy of new dental desensitizers in the treatment of dentin sensitivity, including the relief of sensitivity symptoms and the duration of efficacy.

This is a randomized, single-blind and controlled study to include 40 patients with dentin sensitivity. The study will be a randomized controlled trial with split mouth control, with two quadrants of the same patient as test and control groups, the test group being the group using the new desensitizer and the control group being the group with the clinically used desensitizer (Gruma desensitizer). Improvement in dentin sensitivity symptoms was the primary outcome indicator observed. Dentin sensitivity was assessed by evaluating the reduction in dentin sensitivity VAS scores at immediately, 1 month, 3 months, and 6 months points after the desensitization treatment, and by evaluating the subjects' self-reported relief of sensitivity. Safety was assessed by evaluating appliance defects and adverse events at the immediately,1-, 3-, and 6-months points after the desensitization treatment.

Eligibility Criteria:
Inclusion Criteria:

* Dentin Hypersensitivity, with Vas score≥4 points and the normal pulp viability
* dentin-sensitive tooth in at least 2 different quadrants of the mouth (neck enamel dentin exposure or maxillofacial abrasion within the middle layer of dentin).
* in good overall health
* participants informed consent.

Exclusion Criteria:

* gastroesophageal reflux
* Dental caries, wedge defects, crowns or large fillings.
* Received dentin sensitivity desensitization treatment or used desensitization mouthwash within 1 month.
* Received systematic periodontal therapy or periodontal surgery within 3 months, ongoing orthodontic treatment, and medical treatment, including long-term use of anti-inflammatory, analgesic, and psychotropic medications.
* Pregnancy or breastfeeding.
* Participated in other clinical trials in the past 3 months.
Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome

REGENECYTE (HPC, Cord Blood, hUCB) for treatment in patients with post-COVID.

This is a two-arm, single-center, single-blind, randomized, placebo-controlled phase IIa study. A total of 30 subjects with post-COVID will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* 1. Male or female aged ≥ 18
* 2. With post-COVID syndrome
* 3. Has had a recent (within 7 days) negative SARS-CoV-2 test (an approved PCR or antigen test)
* 4. Able to provide signed informed consent (by the subject or his/her legally authorized representative)
* 5. Is willing and able to participate in all aspects of the study, including completion of subjective evaluations, attendance at scheduled clinic visits, and compliance with all protocol requirements as evidenced by providing a written informed consent

Exclusion Criteria:

* 1. Neurological disorders prior to COVID-19 diagnosis
* 2. With pre-existing terminal illness
* 3. With known immune disease
* 4. Is pregnant or breastfeeding
* 5. Is currently participating in another investigational study or has been taking any other investigational product within the last 4 weeks before screening
* 6. Has received any vaccination within 3 weeks prior to the first IP infusion
* 7. Judged by the investigator to be not suitable for study participation
* 8. Under the conditions that may increase risk of complications based on the medical judgment of the investigator and the parameters
Minimally Invasive Biomarker for Asthma Disease Severity

Can a clinical test be developed that could help manage asthma symptoms?

Project goals:

Develop a point-of-service assay to assess eosinophilic airway inflammation

Proposal Specific Aims:

1. To establish the infrastructure and test the feasibility of sputum collection in a clinical setting as a minimally invasive patient sampling process for biomarker testing
2. To transform the laboratory-based eosinophil peroxidase (EPX) ELISA detection assay into a clinic-friendly assessment that does not require sophisticated laboratory equipment

Eligibility Criteria:
Asthma subjects:

Inclusion

* Provider diagnosed asthma
* FeNO\>50 ppb
* FEV1 \> 1.0 Liter

Exclusion

* COPD by history
* Bronchiectasis by history
* Pregnant participants

Normal subjects:

Inclusion

- Age matched to asthma subjects

Exclusion

* Any eosinophil disorder by history
* Asthma by history
* Rhinitis or sinusitis by history
Study of Dose Adjustment From Levothyroxine to a New Levothyroxine Sodium Test Formulation

The purpose of this study is to investigate the effect of switching participants taking levothyroxine to a new sodium formulation.

The drug being tested in this study is a new sodium formulation of levothyroxine. Levothyroxine (L-Thyroxine Christiaens®) is used in the treatment of hypothyroidism. This study will investigate the effect of switching subjects taking levothyroxine to a new levothyroxine sodium formulation.

The results of this study will be used to provide instructions to general practitioners and endocrinologists assisting patients on levothyroxine hormone substitution in performing the switch to the new formulation.

The study will enroll approximately 90 patients. Patients receiving the same daily dose of L-Thyroxine Christiaens® during the past 6 weeks and with serum thyroid stimulating hormone (TSH) levels between 0.4-2.5 mU/L will be switched to the equivalent daily dose of the new formulation of levothyroxine. After the switch, patients will be followed up after 2 (± 2 weeks) and 4 months (± 4 weeks).

All participants will be asked to take a daily dose at the same time each day throughout the study.

This study will be conducted in Belgium. Participants will make 3 to 4 visits to the clinic.

Eligibility Criteria:
Inclusion Criteria:

1. (Near) total thyroidectomised patients.
2. Aged 18 years and older.
3. Stabilised on the same daily dose of L-Thyroxine Christiaens® during the last 6 weeks before inclusion in the study.
4. Written informed consent given.
5. Able and willing to comply with protocol requirements and to complete the study.

Exclusion Criteria:

1. History of Graves' disease or positive TSH-receptor antibodies.
2. History of thyroid cancer requiring TSH suppression.
3. Medical procedures or treatments planned that could influence the thyroid hormone state of the patients during this trial.
4. Use of levothyroxine containing medicines provided by other brands to treat hypothyroidism.
5. Pregnant or planning pregnancy. Female patients of childbearing potential need to apply highly effective methods of birth control.
6. Participation in another trial in the past 6 weeks.
7. Exclusion criteria during the study are the occurrence of any serious adverse reaction, any laboratory or clinically relevant change in patient status, any change in smoking status, use of drugs non-authorized by the physician (to avoid relevant drug interactions) and lack of patient compliance with the study drug. (OR events not considered as exclusion criteria but to be documented in the case report form, as a possible explanation for change in lab parameters and/or dose switch).
Learning Brushing Using Game Elements in Mobile Phones Apps

The study aims to compare the efficacy of using gamification for oral hygiene in children at home environment.

Subjects will be randomized into three groups:

1. The first group will receive a manual toothbrush Curaprox 5460 ultra soft, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Chomper Chums.
2. The second group will receive electric toothbrush Playbrush Smart Sonic, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Playbrush App.
3. The third group will receive electric toothbrush Playbrush Smart Sonic, Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Utoothia.

Eligibility Criteria:
Inclusion Criteria:

* Children with secondary dentition (not completed);
* Children age 10 years and above and don't have mental or physical disabilities;
* Children brushing teeth by themselves;
* Children using manual or electric toothbrush;
* Children using a mobile phone;

Exclusion Criteria:

* Children with the fixed orthodontic appliance;
* Children above 14 years;
A Study of Respiratory Muscle Strength in Patients With Late-onset Pompe Disease (LOPD)

Study 701-201 is a study in patients with late-onset Pompe disease (LOPD). The study will test respiratory muscle strength initially and again after 24 weeks in subjects treated or not treated with BMN 701 .


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to provide written informed consent, after the nature of the study has been explained, and prior to any study-related procedures
* Documented diagnosis with late-onset Pompe disease - At least 18 years of age at study entry
* Willing and able to comply with all study procedures

Exclusion Criteria:

* Requires ventilatory support while awake and in the upright position
* Concurrent disease, medical condition, or extenuating circumstance that, in the opinion of the investigator, might compromise patient well-being, study completion, or data collection
* Allergy to tools or procedures used for respiratory muscle testing
Molecular Adsorbent Recirculating System (MARS®) in Hypoxic Hepatitis

Hypoxic hepatitis (HH) is reported to be the most frequent cause of elevated aminotransferase levels in hospital. Up to 10 % of critically ill patients develop HH during the course of their intensive care unit (ICU) stay. Occurrence of HH is a life threatening event and ICU-mortality is reported to be up to 60%. Early therapeutic intervention is of central prognostic importance in patients with HH to improve the hemodynamic impairment as early as possible, to reduce hyperammonemia and hepatic encephalopathy, to avoid progression of organ failure and to improve outcome. Studies reported that Molecular Adsorbent Recirculating System (MARS®) therapy improved the hemodynamic situation in patients with acute and acute on chronic liver failure. The study hypothesis is that MARS® therapy in critically ill patients with severe HH improves hepatic hemodynamics and function and consecutively the course of the disease. 40 patients with suffering of severe HH with aminotransferase levels \> 40 times the upper limit of normal of more than 12 hours will be randomized 1:1 to MARS® therapy (n=20) or conventional therapy (n=20). 4 MARS®-sessions will be performed on three consecutive days, each for at least 12 hours. Treatment will be continued under special circumstances. The maximum duration of the treatment phase is 7 days. The primary endpoint is the difference of the indocyanine plasma disappearance rate at day 7. The expected duration of the study is 2 years.


Eligibility Criteria:
Inclusion Criteria:

* presence of severe hypoxic hepatitis with aminotransferase levels \> 40 times the upper limit of normal
* duration of hypoxic hepatitis more than 12 hours
* age \>/= 18 years

Exclusion Criteria:

* age \< 18 years
* pregnancy
* DNR - order
* liver cirrhosis
* Cardiopulmonary resuscitation with unknown neurological outcome and/or hypoxic brain damage
* Expected survival of less than 24 hours
Imaging Techniques in Body Magnetic Resonance Imaging "MRI"

Any patient already receiving a scheduled MR scan of the body for any clinical indication will be eligible for this program.

If patients agree to participate in this program, it would require only a slightly longer examination time. This time would vary according to the body area/organ being visualized but would not exceed 30 minutes over the length of the clinical examination. Volunteers are eligible if they are willing to undergo an MR examination.

Patients would not be required to make any additional visits beyond their clinically-indicated visits. The study duration would vary according to the body area/organ visualized but would not exceed 30 minutes over the length of the clinical examination. Volunteers would be required to keep one study appointment to include one MR imaging examination.

There will be no interruption to the standard care given to patients who participate in this trial since the clinical portion of their examination will be completed prior to the study portion of the exam.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female clinically scheduled to undergo MR Imaging at Johns Hopkins Medical Institutions

Exclusion Criteria:

* Contraindications to MR Imaging
PEEP Resuscitation Trial

Each year, almost 3 million newborn babies die within their first month of life, often as a consequence of labour complications. Approximately 5% of newborns will not start breathing at birth and need immediate help. The optimal ventilation strategy with liquid-filled lungs has not been determined. Animal studies suggest that assisted ventilation with positive end expiratory pressure (PEEP) improves the aeration of liquid-filled lungs leading to more rapid recovery. However, no large human clinical studies have investigated the clinical responses to assisted ventilation with PEEP in asphyxiated newborns.

Laerdal Global Health has developed a PEEP valve which has been tested and shown to provide reliable end-expiratory pressures in a manikin model, even with a high mask leak. Whether this PEEP valve provides reliable PEEP in vivo and whether this translates to clinical beneficial outcomes remains to be proven.

The aim is to study whether lung aeration can be improved by adding a device for positive end expiratory pressure (PEEP) to better distend the airways in neonates more than 28 weeks gestation.

Eligibility Criteria:
Inclusion Criteria:

* Neonates who need assisted bag/mask ventilation after birth due to failure to initiate breathing the first 60 seconds after birth.

Exclusion Criteria:

* Babies with major deformities not deemed to be viable.
* Missing parental consent
Effect of Fluid Management Guided by Pulse Pressure Variation Vs Central Venous Pressure on Lung Water Assessed by Lung Ultrasound During Liver Transplantation

the aim in this study to assess the effect of fluid management in patient undergoing orthotopic liver transplantation either by using pulse pressure variation or by central venous pressure. we will assess the impact of fluid management by either methods on oxygenation and extra vascular lung water visualized by lung ultrasound.

After induction of anesthesia lung ultrasound will be performed and arterial blood gases (ABG) will be taken.

All patients in both groups will receive maintenance fluid in the form of crystalloids (ringer acetate) 4 ml/kg/H. Then fluid boluses will be given according to each group:

Group c (cvp): will receive 250 ml albumin 5% boluses to maintain CVP around 5 cmH2o Group P (ppv): will receive 250 ml albumin 5% boluses to maintain PPV below 13% as detected from invasive blood pressure monitor.

For all patients in both groups: blood transfusion will be indicated with decreased HB% level below 7 mg/dl in arterial blood gases. Other blood product (FFP, platelets and cryoprecipitate) transfusion will be guided by lab results and clinical status of patient. Plasma will be transfused if INR \> 1.5 and platelets will be transfused if count \< 50, 000

Lung ultrasound will be performed to diagnose EVLW. A Philips C5 ultrasound system (frequency 5Hz; Philips Medical Systems, Suresnes, France) with an ordinary echo probe will be used. Chest ultrasound will be performed using the 12 regions method. Intercostals spaces on each side will be examined anteriorly (midclavicular line), laterally (anterior axillary line) and posteriorly (posterior axillary line) Four ultrasound aeration patterns a. Normal aeration (N): 0 score ; line sliding sign associated with respiratory movement or less than 3 B lines ; b. Moderate loss of lung aeration: score 1 ; a clear number of multiple visible B-lines with horizontal spacing between adjacent B lines ≤ 7 mm (B7 lines) c. Severe loss of lung aeration: score 2; multiple B lines fused together that were difficult to count with horizontal spacing between adjacent B lines ≤ 3 mm (B3 lines); and d. Pulmonary consolidation: score 3; hyperechoic lung tissue, accompanied by dynamic air bronchogram.

The final LUS of the patient was the sum of each regional ultrasound score (ranging from 0 to 36).

Eligibility Criteria:
Inclusion Criteria:

1. ASA physical status II- IV
2. Child C (end stage liver disease) ESLD patient.
3. Age (18- 70) years
4. Patients undergoing orthotopic liver transplantation.

Exclusion Criteria:

1. Parents' refusal.
2. Patients with chronic pulmonary disease ( Asthma, obstructive lung disease or restrictive lung diseases)
3. Patient with impaired diastolic function more than grade I.
Turkish Adaptation and Psychometric Properties of Fugl-Meyer Assessment in Acute Stroke Patients

The aim of this methodological study is to adapt the Fugl-Meyer assessment to Turkish culture and to test its validity and reliability in acute phase stroke patients.

According to the definition of the World Health Organization, stroke is a clinical syndrome that causes rapid focal (or global) cerebral function loss for no apparent reason other than vascular causes, and symptoms persist for more than 24 hours or lead to death.

To effectively manage the post-stroke processes and establish an effective treatment plan, a comprehensive assessment is necessary. One of the most common motor problems following a stroke is hemiplegia, which makes it challenging for the patient to perform activities of daily living and ambulation. Understanding the mechanisms of motor control and motor learning, which are vital components of stroke rehabilitation, necessitates the assessment of motor function. For evaluating motor function in stroke patients, there are numerous outcome measures available. The Fugl-Meyer Assessment (FMA) stands out when comparison of these assessments in terms of clinical and psychometric values. There is no official FMA version that has been translated into Turkish, even though Fugl-Meyer assessment is used in numerous research in Turkey. The aim of this study is to adapt the Fugl-Meyer assessment to Turkish culture and to test its validity and reliability in acute stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who diagnosed with stroke
* Less than 1 month passed after onset of stroke
* Upper and lower extremity motor involvement between Brunnstrom stages 2 and 5
* Voluntarily accepting to participate in this research

Exclusion Criteria:

* Visual and hearing impairment
* Upper or lower extremity amputation
* Significant cognitive impairment (Mini Mental State Test Score \< 18)
* Mental disorders affecting daily life functioning
* Global aphasia
* Other unstable conditions that may affect participation
Serum MIF in Acute Kidney Injury

Acute kidney injury (AKI) is a common complication in critical care patients. Currently no parameters are available for early prognosis of AKI. Macrophage migration inhibitory factor (MIF) has been associated with AKI in clinical studies. The aim of this study is to evaluate the time course of MIF concentrations in patients with AKI.


Eligibility Criteria:
Exclusion Criteria:

* Age \< 18 years and \> 80 years
* Patients with chronic dialysis
* Patients with continuous hemodialysis, hemofiltration or hemodiafiltration within 4 weeks prior to the study
* Patients with an expected length of ICU stay shorter than 3 days
* Patients with a low probability of surviving the first 2 days after ICU admission
* Pregnancy and nursing