cyrilzakka/clinical-trials huggingface dataset:
"Peri-operative Antimicrobial Prophylaxis in Patients With Asymptomatic Bacteriuria of Enterobacteriacae ESBL+ Origin"

The aim of the study is to determine optimal safe duration of antibiotic prophylaxis in patients undergoing endourological procedures and ESWL, presenting with asymptomatic bacteriuria caused by multi-drug resistant bacterial strains. In this study we compare safety and efficacy of a one-day vs. three-day AMP (Antimicrobial Prophylaxis) in the above mentioned group of patients.

Patients with positive urine culture with Enterobacteriacae ESBL + resistance mechanism upon admission for endourological procedure or ESWL were subjected to body temperature measurement and laboratory tests: smear from the anus towards the presence of alarm pathogens, urinalysis, control urine culture, blood count, CRP (C-reactive protein), procalcitonin (PCT). After confirming the occurrence of asymptomatic bacteriuria, the patients were randomized to two groups - a one-day and three-day period lasting perioperative antibiotic prophylaxis. In both groups on the following day after the procedure (24 hours after the procedure) and after 7 days after the procedure, laboratory tests and body temperature measurements were performed.

Eligibility Criteria:
Inclusion Criteria:

* ESBL+ asymptomatic bacteriuria
* assigned for endourological procedure
* normal CRP, PCT and WBC
* patient's consent

Exclusion Criteria:

* urinary tract infection
* raised levels of CRP, PCT, WBC
* fever
* non ESBL+ bacteriuria
* inability to consent
Open-Label Posterior Juxtascleral Injections of Anecortave Acetate 15mg Dose for Long Term Use in Patients With AMD

The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Other protocol-defined exclusion criteria may apply.
Deep Learning in Classifying Bowel Obstruction Radiographs

Background: Accurate labeling of obstruction site on upright abdominal radiograph is a challenging task. The lack of ground truth leads to poor performance on supervised learning models. To address this issue, self-supervised learning (SSL) is proposed to classify normal, small bowel obstruction (SBO), and large bowel obstruction (LBO) radiographs using a few confirmed samples.

Methods: A few number of confirmed and a large number of unlabeled radiographs were categorized based on the ground truth. The SSL model was firstly trained on the unlabeled radiographs, and then fine-tuned on the confirmed radiographs. ResNet50 and VGG16 were used for the embedded base encoders, whose weights and parameters were adjusted during training process. Furthermore, it was tested on an independent dataset, compared with supervised learning models and human interpreters. Finally, the t-SNE and Grad-CAM were used to visualize the model's interpretation.


Eligibility Criteria:
Inclusion Criteria:

1. The hospital imaging system looked for plain abdominal standing films diagnosed as intestinal obstruction or normal between 2022 and 2024
2. Aged 18 to 80 years
3. The main complaint was gastrointestinal symptoms

Exclusion Criteria:

1. Image interference, fuzzy performance, difficult to distinguish
2. Non-gastrointestinal symptoms were the main complaint
3. Supine, prone, or lateral decubitus radiography
4. Paralytic obstruction, closed loop obstruction, et al
Resistance Training in the Fasted State

It is well evidenced in the literature that fasting aerobic exercise generates a series of metabolic differences when compared to exercise performed in the fed state, including the use of fats predominantly as an energy source. Consequently, increases in adaptations to aerobic training, related to health and physical performance, are observed when sessions are performed in the fasted state. In relation to resistance training, the evidence is limited. There is a lack of data in the literature regarding the effects of fasting on resistance exercises and whether this practice may reflect in losses or improvements in morphological and neuromuscular adaptations related to resistance training. Thus, the aim of the present project is to compare the effects of resistance training performed in the fasted state compared to the fed state during 12 weeks on body composition and physical performance in young adults. Thirty-four eutrophic or overweight individuals, not engaged in regular resistance exercises, aged between 20 and 40 years, will be recruited. They will be put on a standard customized diet and will perform 2 weekly sessions of resistance exercise after overnight fasting (10 to 12 hours) or in the fed state, for 12 weeks. Before, in the middle and after this period, evaluations of body composition, muscle thickness and quality, maximum dynamic strength and maximum power will be analyzed. Comparisons will be performed using Generalized Estimating Equations (GEE), adopting the factors group (2 stratifications) and time (3 stratifications). All results will be expressed as mean and standard deviation and the accepted significance level will be 5%.


Eligibility Criteria:
Inclusion Criteria:

* Men and women;
* Aged between 19 and 40 years;
* Body mass index (BMI) between 18 and 29.9 kg/m²;
* Not engaged in regular strength physical exercise (\>1 weekly session) for the last 3 months.

Exclusion Criteria:

* Smokers;
* Use of medications and/or supplements that may influence the outcomes evaluated;
* Individuals who have a chronic disease that may prevent physical exercise.
Promoting the Use of CPAP Therapy Among OSA Patients

Obstructive sleep apnea (OSA) is the most common sleep breathing disorder in the U.S. Continuous Positive Airway Pressure (CPAP) therapy is the most effective treatment for OSA. However, up to 50% of patients who accept using CPAP therapy fail to adhere to it. This study will evaluate an information systems (IS)-based solution that sends tailored, motivational, educational messages and tailored feedback messages to promote CPAP usage among noncompliant OSA patients. The primary aim of this study is to determine the efficacy of the proposed IS solution and its effect on fostering the use of CPAP therapy among OSA patients.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of OSA
* Prescribed treatment of CPAP therapy
* Possession of a mobile phone that has multimedia messaging capabilities
* Capacity to consent.

Exclusion Criteria:

* Unable to speak and read English
Ketamine and Magnesium in Erector Spinae Plane Block

In this study, it will aimed to evaluate the effect of magnesium sulfate and ketamine HCl added to local anesthetic on postoperative pain management in the ultrasound-guided erector spina plane (ESP) block in patients will undergo video-assisted thoracoscopic surgery.

Patients who will undergo lung resection with elective video-assisted thoracoscopic surgery will be included in the study. After routine monitoring, general anesthesia induction, and intubation with a double-lumen tube, patients who are placed in a lateral position will receive an ESP block at the T5 level, accompanied by ultrasonography, for postoperative analgesia.

For this purpose; Group I (control group) 0.5% bupivacaine 20 ml, Group II 0.5% bupivacaine 20 ml+150 mg MgSO4, Group III 0% ,5 bupivacaine 20 ml+2 mg/kg ketamine HCl will be administered. In all groups, the total volume will completed to 25 ml with 0.9% NaCl.

After surgery, hemodynamic values (heart rate, systolic and diastolic blood pressure), oxygen saturation, VAS scores (at rest and effort), Ramsey sedation score, patients satisfaction scores, PCA morphine consumption, additional analgesic requirements, and side effects will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* lung resection with video-assisted thoracoscopy,
* voluntarily agree to participate in the study,
* over 18 years old,
* ASA I-III

Exclusion Criteria:

* ASA\>III
* Coagulation disorders or anticoagulant agent therapy,
* Allergy or hypersensitivity to any drug to be will be used in the study,
* Epilepsy,
* High intracranial pressure,
* Unwillingness to participate in the study
* Inability to use the PCA device
App-based Motivational Interviewing and Artificial Intelligence in Diabetes Management

There is an urgent need for better control and prevention of complications in type 2 diabetes mellitus (T2DM). Behavioural change is critical, and while literature suggests that motivational interviewing (MI) may be effective in improving glycemic control, none has explored app-based MI designed specifically for T2DM. The overall objective of this project is to determine the effectiveness of primary care model combining app-based MI and AI-powered personalised nudges delivered through a mobile application (app) for diabetes management (EMPOWER-PLUS). The project aims to evaluate the effectiveness and implementation of MI and nudges through EMPOWERPLUS to deliver diabetes management through a randomised controlled trial (RCT). This will be a 3-arm RCT with primary outcome measure being the difference in HbA1c level at week 36 between the intervention and control arms. Secondary outcome measures include cost-effectiveness, quality of life, medication adherence, diet, and physical activity. Eligible poorly controlled T2DM patients with T2DM in polyclinics will be randomized to intervention arm who will receive EMPOWER-PLUS and smartwatch wearable on top of their usual clinical care. The first control group will have access to nudges delivered through app and smartwatch wearable in addition to usual clinical care but will not receive MI. The second control group will receive usual care (no access to MI, nudges and smartwatch wearable). This study is important to improve T2DM outcomes and reduce healthcare utilization by providing scientifically evaluated and transformative primary care model. Leveraging on digital technology and artificial intelligence to drive personalised care, behavioural change and empowerment has huge potential for scale up.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21 years and above
* Have been diagnosed with diabetes (T2DM)
* Had HbA1c result of ≥ 7.5% within past 3 months
* Physically able to exercise
* Able to read and converse in English
* Able to download the Empower+ app, use the smartphone wearable tracker, and conform to the minimum smartwatch and app monitoring schedule

Exclusion Criteria:

* On bolus insulin treatment
* Require assistance with basic activities of daily living (BADL)
* Have planned major operation or surgical procedure within 9 months from the time of recruitment
* Cognitively impaired (scored \&lt; 6 on the Abbreviated Mental Test)
* Currently pregnant or lactating
* Current participants of ongoing clinical trials involving the usage of a smartphone wearable tracker or mobile health app to assist diabetes management
* Past Empower study participants who refused to participate in future Empower studies
Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis

To investigate that olanzapine can reduced side effect about nausea and vomiting in women with gynecologic cancers receiving carboplatin-based regimen by using olanzapine and placebo

A double-blind, placebo-controlled, randomized crossover trial

Eligibility Criteria:
Inclusion Criteria:

* Women with gynecological cancer receiving carboplatin-based chemotherapeutic regimen
* ECOG performance status 0-1
* Normal bone marrow, liver, and renal functions
* Can speak and write in Thai language

Exclusion Criteria:

* Women with nausea or vomiting prior to chemotherapeutic administration
* Pregnant women
* Women with active infection
* Women with bowel obstruction
* Women with symptomatic brain metastases
* Women who received dopamine receptor antagonists within 1 week before chemotherapeutic administration
* Women who received corticosteroid within 1 week before chemotherapeutic administration
* Women with past history of chemotherapy or radiotherapy
* Women with psychiatric disorders
* Women with poor controlled diabetes mellitus
* Women who received anticonvulsant medication
* Women with history of neuroleptic malignant syndrome
* Women with history of olanzapine allergy
* Women with history of lactose intolerance
Bovine Lactoferrin in Reducing Taste Disturbances in Patients With Colorectal Cancer Receiving Oxaliplatin-Based Chemotherapy

The purpose of this research study is to determine if using a lactoferrin supplement will improve taste perception. Lactoferrin is a type of protein that is naturally produced in the body and is commonly found in saliva.

PRIMARY OBJECTIVES:

I. To assess the impact of lactoferrin (bovine lactoferrin) supplementation on self-reported taste and smell disturbances in patients with colorectal cancer receiving oxaliplatin-based chemotherapy

SECONDARY OBJECTIVES:

I. To assess the impact of lactoferrin supplementation on the baseline lipid peroxidation byproducts in saliva in these patients as measured by the thiobarbituric acid-reactive substances (TBARs) assay.

II. To assess the impact of lactoferrin supplementation on the ability of these patients to generate increased lipid peroxidation byproducts when challenged with a weak iron containing solution.

III. To assess the impact of lactoferrin supplementation on self-reported general quality of life and on specific self-reported anorexia/cachexia issues in patients with established chemotherapy-induced taste disturbances.

IV. To assess the incidence of vitamin D deficiency in patients with oxaliplatin-based therapy induced taste changes

OUTLINE:

Patients receive bovine lactoferrin orally (PO) (rinse or tablet) thrice daily (TID) for 1 month. Treatment continues in the absence of unacceptable toxicity.

After completion of study treatment, patients are followed up at 2 and 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have histologically or cytologically confirmed colorectal carcinoma
* There are no restrictions on the amount or types of prior therapy
* Eligible patients must be receiving ongoing chemotherapy with an oxaliplatin containing-regimen which is planned to continue for at least one month following enrollment in this trial
* Any dose or schedule of oxaliplatin administration is allowed as long as patients have self-reported taste disturbance that has either:

  * 1) developed since the initiation of oxaliplatin-based therapy, or
  * 2) a pre-existing, treatment-induced taste disturbance has subjectively worsened since initiating oxaliplatin-based therapy
* Patients must have normal baseline self-reported taste perception prior to the development of colorectal carcinoma
* Life expectancy of \>= 3 months
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Patients with a subjective history of an extreme dry mouth syndrome that prevents them from producing adequate amounts of saliva (approximately 2 mL in 15-20 min)
* Patients known to be human immunodeficiency virus (HIV)-positive
* Patients with any of the following conditions: untreated gastrointestinal reflux disease; untreated diabetes mellitus; active thrush; active oral infection; active mucositis
* Patients who are known to be pregnant or who are breastfeeding are excluded
Improving Gait Performance in Individuals With Spinal Cord Injuries: an Intervention Using Robotic Exoskeletons

The purpose of this study is to investigate whether robotic exoskeleton training can improve walking performance after SCI as compared to conventional physical therapy.


Eligibility Criteria:
Inclusion Criteria:

* Motor Incomplete spinal cord injury, as classified by American Spinal Injury Association guidelines, above the lumbar level (T12 and above).
* Able to independently stand for two minutes with or without an assistive device and with or without orthoses distal to the knee.
* Male or non-pregnant woman
* ≥ 18-years of age
* At least 6 months after injury
* Height between 5'2" and 6'2" (150-188 cm)
* Weight ≤ 220 pounds (100 kg)
* Ability to perform informed consent

Exclusion Criteria:

* Presence of clinical signs of lower motor neuron injury
* History of severe neurologic injuries other than SCI (MS, CP, ALS, TBI, CVA, etc.)
* Severe comorbidities: active infections, heart, lung, or circulatory conditions, pressure ulcers.
* Documented severe osteoporosis affecting the hip and spine
* Severe spasticity in the lower extremities (Modified Ashworth ≥ 3) or uncontrolled clonus
* Unstable spine
* Unhealed limb or pelvic fractures
* Skin issues that would prevent wearing the device
* Range of motion restrictions that would prevent subject from achieving a normal, reciprocal gait pattern, or would restrict a subject from completing normal sit to stand or stand to sit transitions.
* Upper extremity strength deficits that limit ability to balance with a front rolling walker or crutches.
* Heterotopic ossification that resists functional range of motion in lower extremities
* Contractures (\>15 degrees at the hips or \>20 degrees at the knees)
* Psychiatric or cognitive comorbidities resulting in motor planning or impulsivity concerns
* Colostomy
* Have received any physical therapy intervention within 3 months prior to enrolment in the study
* Non-English speaking
Vitamin D and Type 2 Diabetes Study

The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism.

The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine if vitamin D supplementation works to delay the onset of type 2 diabetes in people at risk for the disease and to gain a better understand how vitamin D affects glucose (sugar) metabolism. Researchers at US sites will enroll people with pre-diabetes (people who have higher than normal blood glucose level but not high enough to meet the diagnosis of diabetes). The study will enroll participants over approximately 2 years and participants will be followed for approximately 3 years. Participants will receive either Vitamin D or a placebo by chance. Participants will take 1 pill a day for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

1. Pre-diabetes ("at increased risk for diabetes") defined by meeting 2-out-of-3 of the following glycemic criteria at the baseline visit:

   1. Fasting plasma glucose (FPG) 100-125 mg/dL
   2. 2-hour plasma glucose (2hPG) 140-199 mg/dL
   3. Hemoglobin A1c (HbA1c) 5.7-6.4%
2. Age ≥ 30 years .(≥25 years for people of the following races: American-Indian, Alaska Native, Native Hawaiian or Other Pacific Islander).
3. Body Mass Index ≥ 24.0 (22.5 for Asians) and ≤ 42.0 kg/m2
4. Provision of signed and dated written informed consent prior to any study procedures.

Major Exclusion Criteria:

1. Diabetes based on either of the following criteria:

   1. History (past 1 year) of hypoglycemic pharmacotherapy (oral or injectable medication approved by the FDA for type 2 diabetes), used for any condition (e.g. pre-diabetes, diabetes, polycystic ovarian syndrome.
   2. Meeting the diagnosis criteria for diabetes
2. History (past 3 years) of hyperparathyroidism, nephrolithiasis or hypercalcemia.
3. Pregnancy (past 1 year by report or positive pregnancy test at screening), intent to become pregnant in the next 4 years or unprotected intercourse. History of gestational diabetes is not an exclusion criterion.
4. Currently breastfeeding.
The Effects of Dehydration on the Performance of Judoka

Dehydration is a common phenomenon in judo that can lead to negative performance such as a decline in strength, a decline in anaerobic performance, a reduced body fluid balance, glycogen depletion and worsened psychological parameters. Therefore, we want to simulate several judo combats and look at the performances whether they change during a competition day. We also want to see if the results are different in a dehydrated versus euhydrated state.


Eligibility Criteria:
Inclusion Criteria:

* judoka
* minimum 18 years
* men and women
* only dehydration: sauna, warm bath, sweat suit

Exclusion Criteria:

* injured
* sick
* not underaged (18 years)
Functional Capacity and Quality of Life Following Septal Myectomy in Patients With HCM

Investigators aim to assess changes in exercise capacity and quality of life after septal myectomy in patient with hypertrophic cardiomyopathy.

The objective of this study is to examine change in quality of life and functional capacity as respectively measured by, Quality of Life Questionnaires and six-minute walk test distance, following septal myectomy in patients with obstructive hypertrophic cardiomyopathy, as compared to prior to surgery.

Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo septal myectomy.
* Established diagnosis of obstructive HCM defined as:

LVH Thickness ≥15mm left ventricular outflow tract gradient ≥50mmHg

Exclusion Criteria:

* Prior septal myectomy or alcohol septal ablation
* Prior myocardial infarction
* Uncontrolled arrhythmias including ventricular tachycardia and atrial fibrillation
* Uncontrolled hypertension
* Angiographically documented coronary stenosis \>50%, if available at time of screening
* Inability to provide informed consent
* Inability to walk without assistive devices
* Peripheral artery disease with claudication
CREATE-1: A Study to Assess the Efficacy and Safety of AXS-02 in Patients With CRPS-1

This is a randomized, double-blind, placebo-controlled, 24-week study to evaluate the efficacy and safety of AXS-02 in patients with CRPS-I.


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female of at least 18 years of age
* Recently confirmed diagnosis of CRPS-1 (Budapest criteria)
* Average pain intensity score of ≥ 5 (based on an 11-point scale \[0 - 10\])
* Willing and able to provide written informed consent

Key Exclusion Criteria:

* Received chronic opioid therapy within 4 weeks
* Received a sympathetic nerve block within 3 weeks
* Active litigation or a pending workers' compensation decision
* Any other clinically significant medical or pain condition (eg, Parkinson's disease, cognitive impairment, or fibromyalgia) or clinical laboratory abnormality that would in the investigator's judgment interfere with the subject's ability to participate in the study