cyrilzakka/clinical-trials huggingface dataset:
Reading Fluency and Accommodative Lag

The purpose of this study is to determine whether special reading glasses improve children's ability to learn to read.

Many children are believed to under accommodate (have a lag of accommodation) when looking at near targets. If this occurs, the retinal image is out of focus. Children who have a lag of accommodation may have difficulty in focusing their eyes at near for long periods of time. This difficulty could reduce their ability to read fluently. Children with above average lags of accommodation will be randomly assigned to a group which receives special reading glasses or a group which does not. The groups will be assessed using a standard test for reading fluency.

Eligibility Criteria:
Inclusion Criteria:

* Children in grades 1, 2 and 3 who consent and assent to participate

Exclusion Criteria:

* Children in the special education program
* Children who are unwilling to have their eyes dilated or be tested
* Children who are unwilling to wear the glasses
Effect of Multimodal Exercise Training in Patients With Multiple Sclerosis

The study aims to examine the effects of multimodal exercise training including aerobic, strengthening and balance exercises via face-to-face and asynchronous video-based telerehabilitation on disease activity, disability level, aerobic capacity, physical activity level, balance, fatigue level and quality of life in individuals with multiple sclerosis. Therefore, this study consists of two hypotheses.

Hypotheses:

H0: Multimodal exercise training has no effect on disease activity and functional status in patients with multiple sclerosis H1: Multimodal exercise training has effects on disease activity and functional status in patients with multiple sclerosis

Multiple sclerosis (MS) is a leading cause of disability in young adults, with symptoms varying based on lesion size, location, and disease course. These symptoms often worsen over time, significantly impacting quality of life. To manage symptoms and potentially affect disease activity, patients are often directed to exercise interventions, though the impact on disease progression is still being studied. Neuroimaging, particularly magnetic resonance imaging (MRI), is commonly used to monitor MS, but MRI does not reveal brain activation levels, which is why functional MRI is recommended for a more detailed evaluation. Exercise, both face-to-face and telerehabilitation (TR), is considered an effective treatment for MS. Studies show that TR increases patient adherence and can be as effective as in-person therapy. Our study aims to assess the effects of a multimodal exercise program combining face-to-face and TR on disease activity and functional status in patients with MS (PwMS). PwMS with an Expanded Disability Status Scale (EDSS) score of 3.0 to 5.5 will be randomly assigned to either the multimodal exercise training group (Group I) or a control group (Group II). Disease activity, disability, aerobic capacity, physical activity, balance, fatigue, and quality of life will be evaluated. Group I will participate in exercise training three days a week (one day in-person, two days TR) for 12 weeks. Group II will receive no exercise during this period and will be reassessed after 12 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Being diagnosed with multiple sclerosis by a neurologist
* Volunteering to participate in the study
* Being ambulatory
* EDSS between 3.0-5.5
* Being literate
* Having internet access
* Not having participated in a standardized physiotherapy and rehabilitation program in the last 3 months

Exclusion Criteria:

* Having an orthopedic problem affecting its mobility
* Having psychiatric problems, severe cognitive impairment, or epilepsy in addition to the MS diagnosis
* Blurred vision or visual impairment
* Pregnancy
* Having had an attack or received corticosteroid treatment 3 months before participating in the study
* Having a disease affecting immunological parameters (infection, cancer, etc.)
Effectiveness of Physical Therapy on Axillary Web Syndrome After Breast Cancer Surgery

Objective: To determine the effectiveness of physical therapy on the axillary web syndrome in improving pain, reducing swelling and increasing mobility of the shoulder. Design: randomized single-blinded controlled trial. Follow-up: five physical therapy assessments: pre-intervention; post-intervention, 3 months post-intervention, 6 months post-intervention. Participants: Eighty consecutive women diagnosed with axillary web syndrome after undergoing unilateral breast cancer surgery with ALND or SLND at the Prıíncipe de Asturias Hospital in Alcalà de Henares, Madrid (Spain). Randomization: women will be randomly assigned to two groups by EpiData 3.1 software. Interventions: Physical Therapy group: Physical Therapy composed of manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises; Control group: standard progressive active and action-assisted arm exercises. 9 physical therapy sessions.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral breast cancer;
* Breast surgery with lymphadenectomy and / or sentinel lymph node biopsy;
* Axillary web syndrome in chest and / or upper limb of the operated side;
* VAS\>3
* Consent to participate in the study;
* No contraindications for physical therapy (infection, metastasis);

Exclusion Criteria:

* Cognitive impairment;
* Visual impairment for reading;
* Lymphedema;
* Bilateral breast cancer;
* Systemic disease (metastases),
* Infection;
* Locoregional recurrence.
The Effect of Different Sedation Regimes on Cognitive Function in Lower Gastrointestinal System Endoscopy

There are different sedation regimes for lower gastrointestinal system endoscopy which can be administered by anesthesiologists and non-anesthesiologists. This study aims to compare the effects of propofol/remifentanil combination and midazolam/meperidine combination on early cognitive function following lower gastrointestinal system endoscopies.

Sedation for lower gastrointestinal system endoscopies can be administered by anesthesiologists or endoscopists and cognitive dysfunction after this procedure has not been fully investigated. The aim of this study was to investigate the effect of different sedation regimes applied by anesthesiologists or endoscopists on early cognitive dysfunction. Following ethics committee approval and written informed consent, 100 patients were randomly divided into two groups. In Group MM where drug regime was solely determined by endoscopists, 2 mg midazolam and 20mg meperidine was given intravenously and additional 1-2mg midazolam and 20mg meperidine (wtih a maximum total of 5 mg midazolam and 50 mg meperidine) was given when facial pain scale (FPS) was greater than 3. In Group RP where drug regime was solely determined by anesthesiologists, 100 mcg/kg/min propofol infusion and 1 mcg/kg remifentanil bolus was administered and additional 0,5 mcg/kg remifentanil bolus was given when FPS was greater than 3. Bispectral index (BIS) and hemodynamic monitorization was carried out throughout the procedure and BIS 60-80 with FPS\<3 was targeted. The time to Observer Assessment of Alertness/Sedation Scale (OAAS) score to reach 3 was measured after the procedure and Trieger Dot Test (TDT) and Digit Symbol Substitution Test (DSST) was repeated at 5th, 15th and 30th minutes.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18-65 years of age (ASA I-III risk groups), scheduled for elective colonoscopy

Exclusion Criteria:

* Patient refusal
* Mini mental test (MMT) score\<26
* Amsterdam Preoperative Anxiety and Information Scale (APAIS ) score \>10
* Advanced cardiopulmonary or psychiatric disease
* Chronic alcohol abuse
* Morbid obesity
* Known allergy to study drugs
A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis

This study looks at the healing rates in patients with Erosive Esophagitis (EE) when treated with either esomeprazole or lansoprazole


Eligibility Criteria:
Inclusion Criteria:

* Episodes of heartburn (described as a burning feeling, rising from the stomach or lower part of the chest up towards the neck) for 2 days or more during the last 7 days prior to baseline.
* Confirmed Erosive Esophagitis within 1 week prior to starting the study.

Exclusion Criteria:

* Any signs of gastrointestinal bleeding at the time of the starting the study.
* Any previous gastric or esophageal surgery.
* Various gastrointestinal diseases as listed in the protocol.
Hospitalization or Ambulatory Treatment of Acute Diverticulitis

The purpose of 01DIVER is to evaluate efficacy and safety of a home treatment protocol for non complicated diverticulitis compared with management in the hospital. The hypothesis is that a ambulatory treatment with oral antibiotic and progressive introduction of diet is not inferior to the conservative management in hospital in patients with acute not complicated sigmoid diverticulitis, shown by contrast enhanced CT scan. Patients are prospectively randomized to conservative antibiotic treatment either to ambulatory or to hospital treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* Diagnosis of mild diverticulitis by abdominal computerized tomography
* Signed informed consent

Exclusion Criteria:

* Severe diverticulitis
* Informed consent not signed
* Suspicion of colon cancer
* Pneumoperitoneum
* Intolerance for oral feeding
* Antibiotics for diverticulitis in the last month
* Immunosuppression
* Pregnancy or lactation
* Severe (decompensated) other illness
* Psychological or social problems
Effect Of Strength Exercise on Respiratory Parameters, and Functional Capacity in Bariatric Surgery Patients

The aim of the investigator's study is to investigate whether postoperative inspiratory muscle training and resistance exercise training has an effect on functional capacity, respiratory functions, respiratory muscle strength and endurance in patients undergoing bariatric surgery.

Obesity is an important health problem that can affect the entire organ and system of the body, leading to various disorders and even death. The fact that BMI is over 40 kg / m2 is defined as morbid obesity. The most effective treatment step in morbid obesity is bariatric surgery.

The impairment of inspiratory muscle function related to obesity is associated with increased lung elastic load, excessive lengthening in the abdominal muscles, and dissolution of the diaphragm, leading to inspiratory muscle weakness and insufficiency. The decrease in its endurance is explained by the decrease of glycogen synthase activity in skeletal muscles. It was found that there was less decrease in the inspiratory muscle training patients whose MIP values were measured before bariatric surgery compared to those who could not do MIP values after surgery.

Respiratory functions due to obesity are impaired due to restrictive mass increase in chest wall, tendency to breathe in low lung volumes and the effect of fat distribution on pleural pressure. Total lung volume, expiratory reserve volume (ERV), reserve volume (RV), vital capacity (VC), functional residual capacity (FRC), FVC, and FEV1 values are low.

After bariatric surgery, patients' muscle strength decreased. In particular, there was a decrease in muscle strength in quadriceps, hamstring, biceps, triceps. The decrease in muscle strength after surgery has been associated with a decrease in muscle mass. It was stated that patients who did not exercise after surgery lost 7.6 kg of muscle, which was 29.7% of the total lost body weight. Resistance exercises performed after bariatric surgery have a positive impact on patients' muscle strength and functional capacity.

Obesity causes a decrease in functional capacity. Increased step width, reduced walking speed and step length are shown for the main reasons. Decreased inspiratory muscle strength in patients undergoing surgery causes weakness in peripheral muscles. This weakness in peripheral muscles also reduces the functional capacity of patients. Inspiratory muscle training studies increase the functional capacity.

Eligibility Criteria:
Inclusion Criteria:

* Having a body mass index (BMI) ≥40kg / m2 or
* (BMI) ≥35kg/m2 and at least one concomitant disease associated with obesity
* To participate regularly in treatment

Exclusion Criteria:

* Using assistive device while walking
* Lung infection in the past 1 month
* Chronic obstructive pulmonary disease (COPD)
* Having an orthopedic, neurological disease that will prevent him/her from exercising
* Uncontrollable hypertension
* Pregnancy
Study of Blood Lactate Levels in Patients Treated With Antipsychotics

Blood lactate levels in patients receiving typical or atypical antipsychotics have not been described in the literature.

The goal of this study is to assess the dynamics of lactate levels in the blood from typical or atypical antipsychotics not confounded by prior antipsychotic treatments, the investigators conducted a prospective study of lactate levels in patients receiving antipsychotic medication. The investigators hypothesized that 6 months of treatment with haloperidol or olanzapine would result in a change in blood lactate levels and extrapyramidal side effects.

The aim of this study was to compare the blood lactate levels in patients receiving typical or atypical antipsychotics.

Subjects included sixty patients with psychotic disorder were assigned to treatment for 6 months with haloperidol (typical antipsychotic), N=30 or olanzapine (atypical antipsychotic), N=30. Blood lactate levels, other metabolic parameters, and scores on the extrapyramidal symptom rating scale (ESRS) were assessed.

Eligibility Criteria:
Inclusion Criteria:

* Men aged 20 - 50 years
* Not taking any antipsychotic medication 1 month prior to the study
* Diagnosed psychotic disorder

Exclusion Criteria:

* Female
* Tobacco use
* Diabetes mellitus
* Baseline lactate blood level over 2.0 mmol/L
Clinical Validation of the AliveCor Kardia 12L and 6L Devices

AliveCor (www.alivecor.com) has developed an ECG device (KardiaMobile) that interfaces with iOS and Android smartphones and tablets. This ECG consists of a lightweight hardware case with two metal electrodes that can snap onto the back of the phone and a software application. By holding the right finger(s) on the right electrode and the left finger(s) on the left electrode, an electrical circuit is completed and a lead-I, 30 second rhythm strip is created. KardiaMobile and a newer device, KardiaMobile 6L, were approved by FDA for ECG rhythm recording. Recently, AliveCor developed two new devices: Kardia 12L and Kardia 6L to record 12- lead and 6-lead ECGs, respectively. However, the data generated from the two new devices have not yet been validated for accuracy. The purpose of this study is to evaluate the accuracy of the ECGs recorded by AliveCor Kardia 12L and 6L devices. This will be compared to simultaneous standard of-care 12-lead ECG recordings. The ECGs will be analyzed for accuracy and statistical difference using root-mean-square error and cross correlation between the median beats.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female patients 18 years old or older
2. Ability to sit for an ECG and AliveCor Kardia 12L and Kardia 6L recordings for 20 minutes

Exclusion Criteria:

1. Any internal stimulator that would generate electrical interference with the recording system of the AliveCor Kardia 12L or Kardia 6L.
2. Open chest wounds or recent (\<30 days) surgery to the chest or abdomen.
3. Absence of any limb that would require modification of the lead set-up
PFA-100 Responsive to Effect of Energy Drinks on Platelet Function

This study evaluates the responsiveness of the Platelet Function Analyzer (PFA-100) to the effect of energy drinks on platelet function. Participants' will have blood drawn prior to and 60 minutes after ingesting 250ml of a commercially available sugar-free energy drink.

Two previous studies have demonstrated increased platelet aggregation 60 minutes after drinking a commercially available sugar-free energy drink. These studies utilized traditional platelet function studies, such as light transmission aggregometry (LTA), where platelet function is examined while adding varying concentrations of a panel of agonist to platelets. These studies are technically difficult, time intensive studies requiring specialized laboratories. They are relatively non-physiologic and do not mimic platelet response to vessel wall damage. Other tests better represent the reactions to vessel wall damage, including the PFA-100, which measures platelet aggregation and adhesion under conditions of high shear.

Overall, PFA-100 is less expensive, requires less technical skill, and is less time consuming than LTA. It has been utilized in bleeding disorders and is demonstrating promise as a marker of thrombophilia. PFA-100 has demonstrated sensitivity to drug and dietary effects. It has also shown differences in closure time between sedentary and athletic individuals PFA-100 has not been used to investigate the effect of energy drinks.

Eligibility Criteria:
Inclusion Criteria:

* a history of consuming at least one energy drink beverage in the past 6 months without adverse effects;
* engage in moderate to strenuous physical activity more than 3 days per week.

Exclusion Criteria:

* Known thromboembolic risk including protein C or S deficiency, anti-thrombin III deficiency, Factor V Leiden;
* history of thromboembolic event;
* current or previous anti-coagulation therapy, anti-platelet therapy, calcium antagonists; - current tricyclic antidepressant therapy, current selective serotonin re-uptake inhibitor therapy; antibiotic therapy; or famotidine therapy;
* acute illness;
* pregnancy;
* hemophilia;
* significant history of cardiovascular disease and/or diabetes mellitus;
* history of adverse effect of energy drinks.
* Inability to comply with pre-test dietary and activity requirements.
Movement and Behaviours Measurement Study

There are few studies that already have validated specific raw accelerometer cut-points for people over 65 years old.

The purpose of the present study is to validate raw accelerometer cut points for general people over 65 years old and specific raw accelerometer cut points based on the functional status of older adults over 65 years old.

The study will be carried out with an observational approach. Participants will be divided into 4 groups. First of them will be made grouping all subjects and the rest divided according to their functional status. They will perform different-intensity physical activities while wearing accelerometers attached to their body and wearing a portable gas analyser too. Their intensity will be assessed based on their own Rest Metabolic Rate (RMR). Energy expenditure and accelerations will be matched and, based on that, sedentary behaviour, light physical activity and moderate-to-vigorous physical activity cut-points will be derived.

Knowledge on health implications of sedentary time and physical activity has been substantially improved in the last decades with accelerometer-based estimations. The popularity of these devices is partially explained by the capacity of objectively recording physical behaviors (e.g., sleep, sedentary time, physical activity...) during the whole day. The so-called "cut-point" approach is behind most of the research on physical activity with accelerometers. Cut-points provide metrics that are easy to understand, to translate to the public and to replicate by researchers in different settings. Usually, the minimum requirement is to use cut-points adapted to the age-group of the population of interest.

Under this paradigm, cut-points have been developed in all age-groups and with a variate set to data collection and processing protocols. However, some scenarios lack of available cut-points to implement, being older adults (\> 65 years) the population with less alternatives of cut-points to use. In this sense, studies with older adults choose cut-points developed in younger adults to classify physical activity intensities. Biomechanical and physiological differences between adults and older adults advise against using this strategy. Therefore, relative energy expenditure and functional status should be considered for future cut-points design. Moreover, must be also awarded that hardly any previous cut-points validation protocols have been performed in a free-living setting. For this reason, more studies following these designs seems necessary to improve cut-points population's validity. Missing all mentioned factors could lead to physical activity and sedentary behavior patterns misclassification in this population.

Eligibility Criteria:
Inclusion Criteria:

* 65 years and older
* Non-institutionalized
* Physical function assessment (SPPB\>3)

Exclusion Criteria:

* Have started an exercise program.
* Mini-Mental Score \< 18.
* Presenting any physical activity contraindication.
Efficacy and Safety of Intravenous Acetaminophen Over 48 Hrs for the Treatment of Post-op Pain After Gynecologic Surgery

This study will be investigating the efficacy and safety administration of multiple doses of intravenous (IV) acetaminophen (IVAPAP) in the 48 hour period following Gynecologic Surgery.

The research hypothesis is that IV Acetaminophen will provide greater reduction in pain intensity and greater pain relief for moderate and severe pain as compared to placebo in the 48 hours following surgery.

Eligibility Criteria:
Inclusion Criteria:

* Undergo gynecologic surgery using standard abdominal approach such as midline or Pfannenstiel incision
* 18-75 years of age
* Body Mass Index (BMI) between 19-45
* American Society of Anesthesiologists (ASA) risk class of I, II, III
* Not have received neuraxial (spinal or epidural) opioid analgesics prior to or during surgery
* Moderate to Severe pain at rest

Exclusion Criteria:

* Requires any additional surgical procedures either related or unrelated to gynecologic surgery during same hospitalization
* Procedures involving only minimal incisions such as laparotomy, laparoscopy, supraumbilical or Maylard incisions
* Has know hypersensitivity to opioids, acetaminophen, or the excipients of IV acetaminophen
* Known history of alcohol or drug abuse or misuse
* Has impaired liver function Aspartate transaminase(AST), Alanine aminotransferase(ALT), bilirubin greater than or equal to 2 times upper limit of normal
* Has significant medical disease(s), or conditions that may contraindicate participation in the study
* Has participated in another clinical trial within 30 days of surgery