cyrilzakka/clinical-trials huggingface dataset:
Effects of Exercise on Functional Ability in People With Dementia in Nursing Homes:a Cluster Randomised Controlled Trial

This is a cluster randomised controlled trial composed of two research arms: exercise training group (experimental group) and a social activity group (control group).

The recruitment process will be made only in NHs (Nursing Home) where the staff will have voluntarily accepted to participate in the study. We estimated to recruit 140 PWD (person with dementia) from around six-to-eight NHs (i.e., in average a minimum of 18 and a maximum of 24 PWD per NH). NHs constitute the unit of randomisation; NHs will be randomised to study groups using a 1:1 ratio (it means that all the participants living in a particular NH will participate in either the exercise training or the social activity). The randomisation will be stratified by the prevalence of dementia among NH residents; this stratification will provide homogeneity across research's arms, increasing thus the comparability among groups and producing then reliable results. Randomisation will be done by a statistician not involved in the LEDEN study. Allocation concealment will be ensured by the use opaque sealed envelopes. The randomisation list will be kept in a electronic, password-locked file matching the name of participants to their research identification number and their group allocation. Given the nature of the LEDEN intervention (exercise training, i.e., a behavioural intervention) and since the main outcome measure, i.e., participants' ability in executing ADLs, of the the study requires that the outcome assessor knows how participants cope in their daily life, LEDEN is a unblinded study

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of Alzheimer's disease, vascular or mixed dementia according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV);
* MMSE ≤ 20 (out of 30);
* living in one of the participating NHs for at least 3 months at the moment of baseline measurements (this time period will allow NH staff to have a good knowledge about the patient and about recent changes in his/her health status);
* to be able of walking at least 4 meters (with walking devices if needed but without human assistance);
* to be able to rise from a chair without help or with minimal human assistance.

Exclusion Criteria:

* Mild dementia, illustrated by a MMSE \> 20 (out of 30)
* Terminal illness with life expectancy less than 6 months;
* Diagnosis of Parkinson's disease;
* Diagnosis of dementia with Lewy bodies;
* Unstable cardiovascular condition or any other health condition that might be deteriorated by physical exercise;
* Planned transfer from the NH to another NH/home or to surgery during the 6-month period of intervention;
* Already participating in physical exercise ≥ 2 times/week in the last 2 months prior to the date of baseline assessments.
Efficacy of Intra-auricular Tranexamic Acid in Total Knee Arthroplasty

Tranexamic acid an antifibrinolytic that develops its anti-haemorrhagic action by inhibiting fibrinolytic activities of plasmin and many studies confirms its effectiveness in decreasing blood loss. The aim of this study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid in adult patients undergoing unilateral total knee replacement.

Total knee arthroplasty (TKA) is widely used as an effective treatment for end-stage osteoarthritis and other joint diseases of the knee and it improvements in surgical materials and techniques have greatly increased its effectiveness. However, TKA is an orthopaedic surgical method that has a substantial perioperative blood loss.

Classical methods for reducing blood loss and transfusion rate include the use of a pneumatic tourniquet, intraoperative cell saver, hypotensive anesthesia, application of erythropoietin, autologous blood transfusion, plugging of the femoral canal, cementing, drain clamping, navigation and minimally invasive surgery.

Tranexamic acid (TXA) an antifibrinolytic that develops its anti-haemorrhagic action by inhibiting fibrinolytic activities of plasmin has been used as an adjuvant to such measure and many studies with a level of evidence confirms its effectiveness in decreasing blood loss.

Fibrinolysis is stimulated by surgical trauma blood loss and TKA may be related to increased fibrinolytic activity. TXA inhibits fibrinolysis by blocking the lysine-binding sites of plasminogen to fibrin. Plasmin, bound to tranexamic acid, has a considerably diminished activity with respect to fibrin compared to that of free plasmin. Also, it appears from various studies that, in vivo, tranexamic acid at high doses exerts a braking activity on the activation of the complement system. So, TXA reduces bleeding in the TKA and its functional repercussion has also been confirmed in assays for various dosages and routes of administration.

In the literature, efficacy of intra-articular TXA has also been confirmed, but what is the right dosage is now unclear.

The aim of this study was to observe postoperative bleeding with combined intravenous and per - os administration with two intra - articular doses (1 g and 2 g) of tranexamic acid (Sanofi-Aventis® Gentilly, France).

Eligibility Criteria:
Inclusion Criteria:

- Adult patients undergoing unilateral total knee replacement

Exclusion Criteria:

* Absence of consent
* Tranexamic acid allergy
* Coagulopathy (preoperative platelet count \<150,000 / mm3, INR \[international normalized ratio\]\> 1.4, or prolonged partial thromboplastin time\> 1.4 times normal),
* History of arterial or venous thromboembolic disease (cerebrovascular accident, deep vein thrombosis or pulmonary thromboembolism),
* Hematological disorder (a hematopoietic, hemorrhagic or thrombogenic disease),
* Retinopathy (severe limitation of the field of vision and / or color distortion),
* Refusal to receive blood products
* Pregnancy
* History of convulsions
* Participation in another clinical trial.
Trial of Kuvan in Lesch-Nyhan Disease

To assess the possibility that treatment with Kuvan (a form of tetrahydrobiopterin) will lessen the abnormal behavior and/or neurology commonly found in Lesch-Nyhan disease (LND); to assess biochemical changes as measured in blood and urine.

Lesch-Nyhan disease (LND) is an X-linked disorder of purine metabolism which results from mutation in the gene for the enzyme hypoxanthineguanine phosphoribosyltransferase (HPRT); patients have hyperuricemia, gout, urinary tract calculi, and nephropathy which are effectively treated with allopurinol. There is also a syndrome of dystonia, chorea and athetosis, as well as involuntary self mutilative biting and aggression toward their caretakers, for which there is no treatment.

Kuvan™ is a form of tetrahydrobiopterin (BH4), and is approved to help lower the blood levels of phenylalanine in people who have phenylketonuria (PKU). LND patients have been found to have decreased BH4 in the spinal fluid and brain; BH4 is a precursor of dopamine, which has an effect on behavior. In an earlier study Dr Nyhan found that treatment of LND with 5-hydroxytryptophan and carbidopa abolished the self-injurious behavior but was uniformly transient.

This is a single site open-label protocol for eight subjects age 4 years and older with Lesch-Nyhan Disease documented by deficiency of HPRT.

The study involves three study visits to San Diego and one study visit done locally. The first visit will last 13 days, the following visits are single day visits at week 4 and week 8, and the local study visit is a brief outpatient visit at week 6. Physical and neurological exams, videotaping of the patient's interactions with the study staff, and blood and urine collection for laboratory analyses will be performed at each San Diego visit. A family member or caregiver will be asked to complete a short assessment form and report any illness or medication changes. In addition, the study staff will have weekly telephone contact with the family to discuss any behavioral changes or study drug issues.

If the patient's self injurious behavior becomes worse after starting Kuvan the drug will be discontinued and the patient will be followed until the behavior returns to baseline.

Eligibility Criteria:
Inclusion Criteria:

1. Ages 4 years and older
2. Must have documented evidence of HPRT deficiency.
3. Be on a stable treatment regimen for 30 days or more
4. Willing and able to travel to San Diego for the study visits
5. Have a local neurologist or physician familiar with the patient or experienced in managing behavioral/neuromuscular disorders and willing to assist with study procedures and adverse events if necessary

Exclusion Criteria:

1. Concurrent enrollment in an investigational drug study
2. Currently taking levodopa
3. Elevated liver enzymes
4. Renal or liver impairment or disease
5. Inability to comply with required study procedures
Development and Validation of Deep Neural Networks for Blinking Identification and Classification

Primary objective of this study is the development and validation of a system of deep neural networks which automatically detects and classifies blinks as "complete" or "incomplete" in image sequences.

This method is based on iris and sclera segmentation in both eyes from the acquired images, using state of the art deep learning encoder-decoder neural architectures (DLED). The sequence of the segmented frames is post-processed to calculate the distance between the eyelids of each eye (palpebral fissure) and the corresponding iris diameter. Theses quantities are temporally filtered and their fraction is subject to adaptive thresholding to identify blinks and determine their type, independently for each eye. The two DLEDs were trained with manually segmented images and the post-process was parameterized using a 4-minute video. After DLED training, the proposed system was tested on 8 different subjects, each one with a 4-10-minute video. Several metrics of blink detection and classification accuracy were calculated against the ground truth, which was generated by 3 independent experts, whose conflicts were resolved by a senior expert. Two independent blink identifications are assumed to be in agreement, if and only if there is sufficient temporal overlapping and the type of blink is the same between the DLED system and the ground truth.

Eligibility Criteria:
Inclusion Criteria

* Uncorrected Distance Visual Acuity above 6/12

Exclusion Criteria:

* corneal opacities
* age-related macular degeneration
* diagnosis of psychiatric diseases
* former eyelid surgery
Arthroscopic Trochleaplasty in Chronic Relapsing Patellar Dislocations: A Follow-up Study

This study aims to evaluate the long-term clinical outcomes of arthroscopic trochleoplasty in patients treated for chronic recurrent patellar dislocations. The primary objective is to assess the effectiveness of the procedure in reducing the need for re-operations and preventing recurrent instability. Secondary objectives include evaluating postoperative complications, patellofemoral pain, functional outcomes using the Kujala Anterior Knee Pain Scale (AKPS), and quality of life measured by EQ-5D-5L. This retrospective cohort study will analyze data from patient records and structured telephone interviews conducted at least one year post-surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 years and older.
* Underwent arthroscopic trochleoplasty for chronic recurrent patellar dislocations.
* Surgery performed between 2015 and 2023.
* Availability of follow-up data and consent for participation.

Exclusion Criteria:

* Concurrent knee surgeries unrelated to trochleoplasty.
* Previous surgeries on the same knee.
* Other significant orthopedic conditions affecting the knee.
* Lack of follow-up data or consent.
Association Between Cell-free Nucleic Acid in Blood, Urine and Microbiome in Stool With Pancreatobiliary Cancer

Based on the cell free nucleic acid analysis information of blood samples, the results of microbiome and metabolite analysis of stool and urine samples of pancreatic cancer and bile duct cancer patients, the clinical correlations of them with primary cancer are evaluated. And based on these information, biomarkers for diagnosis, treatment, and prognosis of pancreatic and bile duct cancer are explored.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with pancreatic cancer through histological or radiologic examination and before treatment begins
* Patients diagnosed with biliary tract cancer (cholangiocarcinoma, gallbladder cancer) through histological or radiologic examination and before treatment begins
* Patients aged 18 or older who voluntarily agrees to participate in the study and is willing to understand and comply with the subsequent treatment procedures and sample collection schedule

Exclusion Criteria:

* Where the subject himself/herself refuses to fill out the consent form or is unable to fill out the consent form
* In the case where the sample storage conditions suggested by the reagent manufacturer are not satisfied
* Only samples that can cause errors when determining results are acquired:

  * Heat treated specimen

    * Incompletely coagulated serum and bacterial samples ③ Samples with particulate matter elements (e.g., fibroblasts, red blood cells) remaining in the sample

      ④ Specimens previously frozen and stored with blood clots that have confirmed an increase in non-specific reactivity in which samples appear to have denatured during storage

      ⑤ Sample from deceased patient

      ⑥ A patient specimen with a malignancy of ohter site

      ⑦ Sample from vulnerable persons such as pregnant women, minors, etc
Study of the Progression of Bacterial Conjunctivitis Symptoms Upon Antibiotic Treatment

The primary objective of this study is to investigate the initial antibiotic effects in the treatment of bacterial conjunctivitis symptoms in subjects one year of age and older.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis in one or both eyes of bacterial conjunctivitis based on:

   * symptoms less than or equal to 24 hours prior to first visit
   * rating \> or equal to 1 for bulbar conjunctival injection
   * must have a rating \> 1 for conjunctival discharge / exudate in at least one eye (the same eye as bulbar conjunctival injection ) at Visit 1, and
2. Must experience some matting in the affected eye(s).
3. 1 year of age or older, of any race and either sex
4. Able to understand and sign an informed consent that has been approved by an Institutional Review Board; or if the subject is a minor, the informed consent must be signed and understood by the subjects legally authorized representative (parent or guardian). Assent to participate should be obtained from subjects 6 years of age or older unless not allowed by local regulation.
5. Must agree to comply with study visit schedule, photographs and other study requirements. If subject is a minor, the parent or guardian must agree to ensure compliance.

Exclusion Criteria:

1. Cannot have had bacterial conjunctivitis as reported by subject (or parent if subject is a minor) for \> 24 hours.
2. Any current lid disease on clinical examination.
3. Known or suspected allergy or hypersensitivity to fluoroquinolones.
4. Suspected fungal, viral (e.g. Herpes simplex) or Acanthamoeba infection, based on clinical observation.
5. Any systemic or ocular disease or disorder, complicating factors or structural abnormality that would negatively affect the conduct or outcome of the study (e.g., hepatitis, acute or chronic renal insufficiency).
6. Use of topical ocular medications during the study period.
7. Antibiotics (systemic or topical) may not be used within 7 day of visit 1 or anytime after this visit for the duration of the study.
8. Women of childbearing potential not using reliable means of birth control.
9. Women who are pregnant or lactating.
10. Enrollment of more than one person per household at the same time.
11. Enrollment of the investigator or his or her staff, family members of the investigator, family members of the investigator's staff, or individuals living in the households of these individuals.
12. Participation in any investigational drug or device study within 30 days of entering this study.
Knee Arthroplasty Rehabilitation Outcomes Study

The objective of the KAROS study is to compare rehabilitation outcomes between 3 proposed protocols and a current standard of care protocol for the purpose of identifying better practice for outpatient rehabilitation among patients with single total knee replacement. The 3 advanced protocols involve use of an anti-gravity treadmill and/or the patterned electrical neuromuscular stimulation (PENS). Both medical modalities have been cleared by the FDA to be used in medical rehabilitation, including total knee replacement.


Eligibility Criteria:
Inclusion Criteria:

* Patients who undergo an elective single total knee arthroplasty and initiate their outpatient rehabilitation therapy within 3 weeks after surgery.
* Patients who are 40 years old or older.
* Patients who weight less than 320 lb to accommodate the weight limit to use the anti-gravity treadmill.

Exclusion Criteria:

* Patients who had any lower extremity joint replacement less than 1 year prior the current total knee replacement.
* Patients who are pregnant or may be pregnant.
* Patients who have a medical history of neurologic disorders.
* Patients who have received more than 2 weeks of other formats of rehabilitation prior their outpatient rehabilitation program.
* Patients who received any cancer treatment in the past year prior the current surgery.
* Patients who have uncontrolled cardiovascular hypertension.
* Patients who have cardiac demand pacemakers and/or implanted defibrillators.
Eplerenone, Aflibercept and Topical Nepafenac Serous Foveal Deta Chment in Central Serous Chorioretinopathy

describing the influence of; combined Eplerenone, intravitreal Aflibercept, and topical Nepafenac; on serous foveal detachment in eyes with CSCR

Retrospective Review of records of eyes with Central serous chorioretinopathy (CSCR) that have been treated in the period between 2015 and 2021

After checking inclusion and exclusion criteria; we will enroll all cases that have been treated by the combination of eplerenone, intravitreal aflibercept and topical nepafenac.

Investigators collected and recorded the following data:

* Age
* Gender
* Systemic hypertension (present or not)
* Smoking (Yes / No)
* Best corrected visual acuity (BCVA) (baseline, final)
* Central macular thickness (CMT) (baseline, final)
* Serous detachment Height (SDH) (baseline, final)
* Duration of Follow-up ( in months)

Eligibility Criteria:
Inclusion Criteria:

* CSCR eyes treated by combination of Eplerenone, Aflibercept and Nepafenac.

Exclusion Criteria:

* • CSCR treated by other modalities

  * CSCR treated by just 1 or 2 components of :Eplerenone, Aflibercept and Nepafenac
Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients

Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual drugs. Thus this study is carried out to determine the efficacy and safety of combination of tenofovir plus telbivudine (two most potent nucleos(t)ide analogues)versus monotherapy with either drug alone. This is a 104 week open labelled, prospective, randomized, multicentric study. The patient will receive either tenofovir, telbivudine or the combination of two drugs. After completion of 24 weeks, the non-responders (ie HBV-DNA \> 300 copies/ ml) will be switched to combination arm and will continue receiving tenofovir plus telbivudine for 104 weeks.


Eligibility Criteria:
Inclusion Criteria:

* HBeAg negative at screening
* Documented chronic Hepatitis B
* Treatment naive
* Compensated liver disease

Exclusion Criteria:

* Chronic Hepatitis B with Child Pugh B \& C
* HBeAg positive
* Decompensated liver disease
Safety of Airway Clearance in Non-hospitalized Infants With Acute Viral Bronchiolitis

Bronchiolitis is a disease that can occur in a mild form and moderate, and often does not require hospitalization. The technique of prolonged slow expiration followed by cough caused in children not hospitalized with mild and moderate bronchiolitis can improve clinical severity

Once each patient legal guardians has signed the informed consent document and it has been verified that the inclusion criteria are met, it will be assigned the same identification number (ID) that is related to its Clinical History (CH) by simple coding; custody of the file with the relationship of each ID with its CH will be the responsibility of the principal investigator.

Before starting the treatment protocol, a blind evaluator treats the was assigned the patient classifies the child according to the initial score of clinical severity proposed by Wang, in addition to the measurement of SO2 and heart rate measured through a pulse oximeter.

The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. The physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.

Care must be taken during the maneuvers of maintaining a position of the infant in supine decubitus in 30 degrees of slope, to avoid episodes of gastroesophageal reflux and decrease the risk of vomiting.

They are considered as criteria of cessation of the physiotherapeutic intervention, alterations abrupt of the respiratory rhythm (brady or tachypnea), stare, ocular revulsion, hiccups or hypertonia and changes in skin color (pallor or cyanosis). In addition to these clinical manifestations, it establishes that if the father or legal guardian demands it, the application of the protocol would be terminated.

In order to evaluate the immediate effect of the protocol, which is established as the effect evaluated 10 minutes immediately after the intervention was applied, the doctor again performs a measurement of SO2, heart rate and respiratory rate, and classify again according to the criteria of Wang's clinical severity scale and anotate any adverse event. At 20 minutes the same medical evaluator performs the same assessment.

Eligibility Criteria:
Inclusion Criteria:

Patients must meet the following inclusion criteria:

* Have an age between 2 months and 12 months.
* Have medical diagnosis of first episode of BQ of maximum 48 hours of evolution.
* Not previously received respiratory physiotherapy since its diagnosis.
* Have the informed consent signed by the child's legal guardians.

Exclusion Criteria:

The exclusion criteria are:

* Acute BQ with score\> 9 according to the Wang clinical scale.
* Pathology associated cardiac, neurological or traumatic.
* Previous hospitalizations for wheezing.
* Medical diagnosis of recurrent sibilant.