cyrilzakka/clinical-trials huggingface dataset:
Effects of Functional Training by High Intensity Intervals in Older Adults With Mild Cognitive Impairment.

To analyze the effects of a high intensity interval functional training program (HIFT), in the cognitive and functional capacities of Colombian older adults with mild cognitive impairment.

This is a randomized clinical trial of single-blind with 2 arms (Control group and experimental group), in which a pre-treatment-postest design has been used.

The study will define two groups:

A control group (CG) that will not be submitted to treatment, which will be evaluated in the pre and post phase of the study. Participants assigned to this group will receive general advice on the positive effects of regular physical activity and will be given a guide to recommendations for promoting physical activity.

An experimental group (GE) that after an initial evaluation will undergo a physical training program based on high intensity interval functional training exercises.

Once the intervention is finished, it will be submitted to a final evaluation to see if there is a difference or not with the results obtained at the beginning.

Eligibility Criteria:
Inclusion Criteria:

* More than 60 years
* Adults with mild cognitive impairment
* Not participating in any physical exercise program
* Sufficient physical autonomy to participate in the physical activities required by the study
* Have no signs of dementia (\<26 on MoCA)
* Be able to understand instructions, programs and protocols.

Exclusion Criteria:

* Contraindications for conducting physical tests
* Diseases that limit cognitive performance and physical activity.
EMG Activation of Gluteal Musculature During Exercises With and Without Resistance

The gluteus medius (Gmed) and gluteus maximus (Gmax) muscles are important components in the treatment of many lower limb injuries. Recent studies have evaluated a myriad of exercises which activate the Gmed and Gmax, but limited research remains on exercises involving resistance and the role of the TFL. The purpose of this study is to evaluate Gmed, Gmax, and TFL percent maximal voluntary isometric contraction (%MVIC) and perceived exertion in healthy and low back pain patients while performing exercises with and without resistance. Methods: A convenience sample of healthy subjects and patients diagnosed with non-radicular low back pain will be recruited. Exclusionary criteria will include: current low back or lower extremity injury (healthy group), pregnancy, history of hip surgery, and radicular symptoms. Surface electromyography will be used to quantify the activity level of the gluteal muscles and TFL while performing a series of 8 exercises with and without Thera-Band® Resistance Tubing and Stability Trainer. The maximal voluntary isometric contraction (MVIC) will be established for each muscle group and the order of exercises performed will be randomized to minimize the effect of fatigue. Following the completion of each exercise, the patient will rate their perceived exertion level on the Thera-Band® Resistance Intensity Scale for Exercise (RISE). The EMG signals will be smoothed and rectified and analyzed using a root-mean-square algorithm. Clinical Relevance: The results of this study will allow clinicians to better prescribe exercises, proven to activate the gluteal muscles and limit the TFL involvement, in the treatment of low back pain.


Eligibility Criteria:
Inclusion Criteria:

* healthy, physically active subjects
* patients diagnosed with non-radicular low back pain
* 18-65

Exclusion Criteria:

* current low back or lower extremity injury (healthy group)
* pregnancy
* history of hip surgery
* radicular symptoms
Safety and Efficacy of Oral BT-11 in Crohn's Disease Patients With Moderate to Severe Disease

This is a phase 2, randomized, double-blind, multicenter study to assess the therapeutic efficacy, safety, and mechanisms of omilancor (BT-11) in patients with moderate to severe Crohn's Disease (CD).


Eligibility Criteria:
Key Inclusion Criteria:

1. Male and female subjects age 18 to 75 years, inclusive.
2. Diagnosis of CD for at least 6 weeks prior to screening
3. Moderate to severely active CD as defined by all of the following:

   * CDAI score of 220-450
   * PRO-2 stool frequency (SF) ≥ 4 and/or abdominal pain (AP) ≥ 2
   * SES-CD ≥ 6 ( ≥4 for isolated ileitis) scored by a blinded central reader

Key Exclusion Criteria:

1. Participant has ulcerative colitis
2. Participant is at imminent risk of ileo-colectomy
3. Prior enrolment in the current study and had received study treatment.
Open-label Pharmacokinetic Study of Iron Isomaltoside 1000 (Monofer®) Administered by 500 mg IV Bolus Injection or 1000 mg Intravenous to Patients With CKD

The purpose of this study is to assess the pharmakokinetic properties of higher doses (500 mg and 1000 mg) of Monofer® in patients suffering from Non-dialysis Dependent Chronic Kidney Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women, aged more than 18 years.
2. Weight above 50 kg.
3. Subjects diagnosed with NDD-CKD with MDRD calculated eGFR between 15-59 mL/min.
4. Hb \< 11.0 g/dL.
5. Either or both of the following iron stores indicators below target {Serum ferritin \< 100 ug/l and Transferrin saturation (TfS) \<20%}.
6. Life expectancy beyond 12 months by Principal Investigator's judgement.
7. Willingness to participate after informed consent.

Exclusion Criteria:

1. Anaemia predominantly caused by factors other than renal impairment or iron deficiency (according to Principal Investigator s' judgment).
2. Iron overload or disturbances in utilization of iron (e.g. haemochromatosis and haemosiderosis).
3. Drug hypersensitivity (i.e. previous hypersensitivity to iron dextran or iron mono- or disaccharide complexes or any excipients of the study drug).
4. Subjects with history of multiple allergies.
5. Decompensated liver cirrhosis and hepatitis (alanine aminotransferase (ALT) \> 3 times upper normal limit).
6. History of Immunocompromise and/or history of Hepatitis B and/or C
7. Active acute or chronic infections (assessed by clinical judgment), supplied with white blood cells (WBC) and C-reactive protein (CRP).
8. Rheumatoid arthritis with symptoms or signs of active joint inflammation.
9. Pregnancy and nursing (To avoid pregnancy, women have to be postmenopausal (at least 12 months must have elapsed since last menstruation), surgically sterile, or women of child bearing potential must use one of the following contraceptives during the whole study period and after the study has ended for at least 5 times plasma biological half-life of the investigational medicinal product: Contraceptive pills, intrauterine devices (IUD), contraceptive depot injections (prolonged-release gestagen), subdermal implantation, vaginal ring, and transdermal patches).
10. Extensive active bleeding necessitating blood transfusion.
11. Planned elective surgery during the study.
12. Participation in any other clinical study within 3 months prior to screening.
13. Untreated B12 or folate deficiency.
14. Other I.V. or oral iron treatment or blood transfusion within 4 weeks prior to screening visit.
15. ESA treatment within 8 weeks prior to screening visit.
16. Serum Ferritin \> 500 µg/L
17. Any other medical condition that, in the opinion of Principal Investigator, may cause the subject to be unsuitable for the completion of the study or place the subject at potential risk from being in the study or interfere with study drug evaluation. Example, Uncontrolled Hypertension, Unstable Ischemic Heart Disease or Uncontrolled Diabetes Mellitus.
Non Invasive Study of the Hepatic Fibrosis in Paediatrics by the Method of Study of Pediatric Hepatic Fibrosis

Early diagnosis of liver fibrosis is useful for the follow-up and treatment of chronic liver disease. At present, the unique validated method to evaluate the liver fibrosis in children, is the liver biopsy which is an invasive method. If the elastometry method is proved to be a good method to evaluate the fibrosis in children, a numerous liver biopsy could be avoided.

The elastometry method is proved to be efficient for the evaluation of liver fibrosis in adults. But the inter-costal space is too thin in children, and the adult probe could not be used. Recently a special probe adapted to the children have been TECHNICATED. We want to test this specific probe in children. Five French Paediatrics centres will participate to the study. We need 200 children inclusions in 2 years to have a statistically power analysis. Inclusion of each child will be in order to the need of a liver biopsy. Each children included will have an elastometry measure in the same time than the liver biopsy. The fibrosis will be staged by a trained pathologist and scored by METAVIR score witch is the reference. The elastometry measure will be realised by physician with 3 sequential measures in each child. The statistical analysis will be performed by statistician. If elastometry is proved to be an efficient method to evaluate the liver fibrosis in children, a numerous of liver biopsy could be avoided. Because elastometry is a non invasive method it could also be used as follow-up in different categories of children who needs sequential liver biopsy.

Eligibility Criteria:
Inclusion criteria :

* Children age more than 6 months and under 18 years old.
* Children with an hepatic biopsy for any fibrosis hepatitic diseases
* Clinical examination by a physician

Exclusion criteria :

* Children of less than 6 months and more than 18 years old.
* Pregnant women.
* No written informed consent
* No social security
Tumor Absorbed Dose-Response Relationship in Patients Treated With 177Lu-DOTATATE for Meningioma

The hypothesis for this study is that there is a dose-response relationship in patients treated with 177Lu-DOTATATE for meningiomas.

Dosimetry is essential for Peptide Receptor Radionuclide Therapy (PRRT) of meningiomas, to predict efficacy and dose-effect relationships at the individual level, and to move towards personalized medicine. Due to the increasing therapeutic applications of Lutathera, the European Association of Nuclear Medicine (EANM) recently issued recommendations on the dosimetry of 177Lu-labeled somatostatin analogues. Nevertheless, despite these recommendations, the evaluation of meningioma tumor dosimetry in Peptide Receptor Radionuclide Therapy studies is not systematic, which has not enabled us to clearly determine the dose delivered to the meningioma lesion in these treatments and the possible dose-response relationship in this type of treatment.

Eligibility Criteria:
Inclusion Criteria:

* patients treated for menigioma at nancy hospital
* patients who performed 3 scintigraphics exams during there treatment

Exclusion Criteria:

* patients deprived of liberty
* patient who refused to collect data retrospectively
Promotion of Thickened Feeds to Manage Newborns With Feeding Difficulties

Swallowing dysfunction and delay of oral feeding skills in premature infants significantly delay discharge from the hospital. Thickening oral formula or breast milk feeds with commercial thickeners and rice cereal has been used in some nurseries with the goal of promoting development of adequate feeding skills. The objective of this pilot study is to examine the effect of thickened feeds on premature infants with oral feeding difficulties due to dysfunction secondary to immature swallowing.

Hypotheses:

* Thickened feeds will lead to a reduction in symptoms secondary to immature swallowing in 32-40 weeks gestational age infants when compared to non-thickened feeds
* Thickened feeds will promote transition to hospital discharge.


Eligibility Criteria:
Inclusion Criteria:

1. apneas and bradycardias with oral feedings
2. oxygen desaturations with oral feedings
3. excessive coughing or gagging with oral feedings

Exclusion Criteria:

1. less than 32 weeks adjusted gestational age
2. greater than 40 weeks adjusted gestational age
Cooling Strategies for Older Adults in the Heat

The earth's climate is warming, and the number of heat waves has increased in recent years. At the same time, the number of adults over the age of 65 is growing. Humans sweat and increase blood flow to the skin to cool their body when they get hot. Older adults do not do this as well as young adults. This makes it harder to safely be in warm and/or humid conditions. It is important to learn about cooling strategies for older adults to safely be in warm and/or humid conditions.

There is compelling evidence that intermittent hand and forearm cold-water immersion effectively reduces the rise of core temperature during heat stress in older adults. However, it is still unknown if this is an effective cooling strategy for older adults. Furthermore, our laboratory has shown that folic acid supplementation improves blood flow responses in older adults. This may be beneficial to older adults during heat stress.

Subjects sign an informed consent form and undergo a medical screening prior to participation. The screening includes a physical exam, anthropometry, chemical and lipid profiles.

Subjects participate in 4 experimental trials, 2 while on folic acid supplementation and 2 while on placebo. The order of treatment (folic acid supplementation or placebo) is randomized. Participants will place their hands and forearms in cold tap water intermittently for one of the two trials for each treatment. The order of the hand and forearm immersion trial is randomized for each treatment. The trials are separated by at least five days. For each experiment, core temperature, heart rate, blood pressure, skin temperature, and sweat rate are measured. Each experimental visit will last 2 hours.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 65 and older
* English proficiency

Exclusion Criteria:

* Chron's disease, diverticulitis, or similar gastrointestinal disease
* Abnormal resting exercise electrocardiogram (ECG)
* Tobacco use
* High-risk determined by the Atherosclerotic Cardiovascular Disease (CVD) Risk Factor Assessment
* Antiepileptic or antiseizure medications
* Methotrexate
Efficacy of Semi-rigid Ureteroscopic Laser Lithotripsy in the Treatment of Proximal Ureteral Stones: a Randomized Controlled Trial

The efficacy of Ho: YAG and TFL combined with semirigid ureteroscopic treatment of proximal ureteral stones will be compared.

The target population of this study is patients with proximal ureteral stones who are scheduled to undergo semirigid ureteroscopic laser lithotripsy. After enrollment, the subjects will be randomly assigned to the semirigid ureteroscopic holmium laser (Ho: YAG) lithotripsy group and the semirigid ureteroscopic thulium fiber laser (TFL) lithotripsy group for surgical treatment. The subjects will be followed up after surgery, and the collected data will be summarized and analyzed after the study.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old;
2. patients diagnosed with unilateral proximal ureteral stones ≤2cm by computed tomography (CT)/Kidney and upper bladder (KUB) radiography who required surgery;
3. patients who volunteered to participate in this study.

Exclusion Criteria:

1. Unable to give informed consent;
2. Untreated urinary tract infection;
3. Pregnant women;
4. Known anatomical abnormalities (such as urinary diversion or ureteral stenosis);
5. Urothelial tumors, transplanted kidney stones, irreversible coagulopathy;
6. The semi-rigid ureteroscope cannot reach the stone site, ureteroscopy-negative stones, and stones can be removed directly without laser lithotripsy;
7. The researchers believe that they are not suitable for participation in this study.
Determination of a Proper Needle Entry Point; Effects of Skin Compression With an Indicator on Radiation Exposure Time of Fluoroscopically Guided Transforaminal Epidural Block in Obese Patients

To evaluate the effects of skin compression with an indicator at the needle entry point on radiation exposure time of fluoroscopically guided transforaminal epidural block in obese patients


Eligibility Criteria:
Inclusion Criteria:

* Adult patients with ≥ 25 kg/m2 BMI who were scheduled for the transforaminal epidural injection

Exclusion Criteria:

* Local anesthetic allergy, coagulopathy
ODYSSEY: A Study to Investigate the Efficacy of Tradipitant in Treating Severe or Critical COVID-19 Infection

This is a randomized, double-blind placebo-controlled trial to investigate the efficacy and safety of tradipitant 85 mg orally given twice daily to treat inflammatory lung injury associated with severe or critical COVID-19 infection.

On evaluation for enrollment, participant will need to meet all inclusion and exclusion criteria. If participant consents, they will be randomized 1:1 to treatment with either tradipitant 85 mg PO BID or placebo in addition to standard of care for COVID-19 infection as per the protocol at the treating hospital. NEWS 2 will be assessed at screening and daily following randomization. Inflammatory lab markers as detailed should be collected once per day in the morning, preferably at the same time every morning. All enrolled participants will have whole blood collected for whole genome sequencing.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-90
* Confirmed laboratory COVID-19 infection by RT-PCR
* Meeting severe or critical criteria of COVID-19 infection as defined at treating hospital
* Confirmed pneumonia by chest radiograph or computed tomography
* Fever defined as temperature ≥ 36.6 °C armpit, ≥ 37.2 °C oral, or ≥ 37.8 °C rectal
* Oxygen saturation less than 92%

Exclusion Criteria:

* Recent use of illicit drugs or alcohol abuse
* Known allergy to tradipitant or other neurokinin-1 antagonists
* Pregnancy
* Known HIV, HBV, or HCV infection
* Malignant tumor, other serious systemic diseases
* Inability to provide informed consent or to have an authorized relative or designated person provide informed consent, or to comply with the protocol requirements
The Model Building and Empirical Research of Eye Health Interventions for Children

The purpose of this study is to determine whether Eye Health Intervention can obviously reduce and delay myopia onset and development and improved the awareness rate of knowledge apparently .


Eligibility Criteria:
Inclusion Criteria:

* primary 1-3 grade students

Exclusion Criteria:

* ocular inflammation
* eye injury
* dysgnosia
Non Invasive Ventilation on Peripheral Muscle Function and Aerobic Performance

Background: Non-invasive ventilation (NIV) reduces respiratory load and demands on peripheral muscles. Methods: This study aims to evaluate the acute effects of bi-level NIV on peripheral muscle function during isokinetic exercise and aerobic performance in chronic obstructive pulmonary disease (COPD) patients. This is a pilot crossover study performed with a non-probabilistic sample of 14 moderate to very severe COPD patients. Procedures carried out in two days. Dyspnea, quality of life, lung function, respiratory muscle strength, functional capacity (6-minute walk test - 6MWT), and isokinetic assessment of the quadriceps were assessed. Blood samples (lactate, lactate dehydrogenase, and creatine kinase concentration) were also collected. Right after, NIV was performed for 30 minutes (bi-level or placebo, according to randomization) followed by new blood sample collection, 6MWT, and isokinetic dynamometer tests. Before and after evaluations, the subjective perception of dyspnea and fatigue in the lower limbs was quantified. After a wash-out period of seven days, participants returned, and all assessments were performed again.


Eligibility Criteria:
Inclusion Criteria:

* Clinically stable COPD patients (diagnosed according to the Global Initiative for Obstructive Lung Disease), of both sexes, without exacerbation or changes in medication for at least one month before the study, and no dyspnea during daily activities (grades 2, 3, and 4 of the Medical Research Council - MRC scale) were included.

Exclusion Criteria:

* Those with a diagnosis of neoplasia, orthopedic or neurological conditions affecting exercise capacity, peripheral arterial obstructive disease, heart failure, kidney or liver disease, did not adapt, or failed to complete the study procedures, were excluded.
Comparison of Compact 3T, Conventional 3T, and 7T Scanners Using Task Based and Resting State fMRI

Comparison of 3 MRI scanners.

Comparing the strengths and weaknesses of 3 different MRI scanners in their performance of a functional MRI (an MRI that shows which areas in the brain are active during some sort of task).

Eligibility Criteria:
Inclusion Criteria:

1) Men and Women aged 18-55

Exclusion Criteria:

1. Patients with safety contraindications to MRI scanning at 3T.
2. Patients unable to adequately perform the fMRI task due to physical, neurological, or cognitive disability.
3. Patients that demonstrate 3 mm or greater translational head motion during scanning of the fMRI rhyming task data sets.
4. Pregnant women.
5. Patients that have implanted medical devices or other safety contraindications for a 7T or 3T MRI exam.
Comparison of a Pain Pump Versus Injectable Medication for Analgesia in Knee Arthroscopy

Hypothesis: Ropivacaine, morphine and ketorolac injected after knee arthroscopy is as effective as this solution plus ropivacaine administered intra-articularly for twenty-four hours.

Three groups were assigned random patients, each group provided a different method of pain medication in order to determine the effectiveness of each treatment.

Arthroscopic knee patients were randomized to 1 of 3 groups. A) 30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour; B) an identical solution plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour; C) an identical solution and no pain pump. Pain level, the amount of pain medication used and time to discharge were recorded. Clinical and radiographic evaluation was performed at nine months after surgery.

Eligibility Criteria:
Inclusion Criteria: All subjects who underwent:

* knee arthroscopy + synovectomy
* knee arthroscopy + partial or complete meniscectomy
* knee arthroscopy + chondroplasty
* knee arthroscopy + microfracture
* knee arthroscopy + autologous osteoarticular transplantation

Exclusion Criteria:

* A surgical procedure that required an incision other then an arthroscopic portal
* A surgical procedure within the same joint within ninety days
* A acute or chronic knee infection
* Any diagnosis of complex regional pain syndrome
* A known allergy to one of the study drugs
* A documented history of narcotic use
* A score of less than two standard deviation on the SF-12 mental component
* Any major systemic or cardiac illness (heart failure, uncontrolled angina, bifascicular blocks, renal insufficiency, or liver disease)
* Under the age of eighteen years