cyrilzakka/clinical-trials huggingface dataset:
Virtual Reality-based Exercise Training in Radiotherapy Period After Breast Cancer Surgery

The main purpose of this study is to compare two different exercise approaches during the radiotherapy period in patients who have undergone breast cancer surgery.

Exercise therapies are effective methods in the treatment of complications after breast cancer surgery. The study aims to compare exercise practices with virtual reality-based exercise training during radiotherapy period after breast cancer surgery. Patients were randomly divided into 3 groups as virtual reality group, exercise group, and control group, considering the order of arrival at the clinic and the type of surgery (mastectomy and breast-conserving surgery). Patients in virtual reality group received virtual reality-based exercise training using Microsoft Xbox 360 Kinect (Redmond, WA). Patients in exercise group received an exercise program including range of motion, posture, stretching and breathing exercises. Both exercise groups participated in the exercise program for 30- 40 minutes, 3 days a week, as long as radiotherapy continued (5-6 weeks). Patients in the control group did not receive any exercise intervention as is done in the current practice. Assessment methods were applied at the beginning and at the end of the radiotherapy for all groups. Shoulder range of motion was measured using universal goniometer. Hand grip strength was measured using Jamar hand dynamometer. Shoulder proprioception was measured using Cybex (Lumex,NY,USA) isokinetic dynamometer. Upper extremity functional status, kinesiophobia, anxiety and depression level, fatigue and quality of life were evaluated with various questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Being over 18 years old
* Being literate
* Having a diagnosis of unilateral breast cancer
* Having undergone surgery for breast cancer
* Radiotherapy will be applied for breast cancer treatment.

Exclusion Criteria:

* Metastasis
* Have an active infection
* Having a cardiac or neurological disease that would prevent participation in the study
* Having uncontrolled hypertension
* Having an orthopedic disorder that prevents exercise
* Having sensory or cognitive impairments that interfere with communication
Does Perioperative Intravenous Magnesium Affect Postoperative Quality of Recovery in Craniotomy Surgery Patients?

Perioperative pain management for craniotomy patients may be challenging because the commonly used agents such as opioids, gabapentin, and dexmedetomidine also cause sedation, which can confound the neurological exam and can lead to respiratory depression and increased intracranial pressure. Preoperative intravenous magnesium boluses and infusions have previously been established as an effective, nonsedating analgesic that can reduce opioid consumption 25-30% up to 48 hours postoperatively.

However, intravenous magnesium has not seen widespread use in craniotomy patients due to concerns for interference with the neurological monitoring that commonly occurs in these cases. Intravenous magnesium given as a bolus preoperatively or as a constant infusion may avoid these problems and has never been investigated.

The goal of this study is to compare intravenous magnesium given preoperatively and intraoperatively to placebo in adult elective craniotomy patients to improve quality of recovery postoperatively, and evaluate safety and tolerability. Secondary endpoints will include evaluating for pain, sedation, agitation, blood pressure, and opioid consumption postoperatively.

The study is a prospective, randomized, controlled, and double-blinded clinical trial comparing clinical outcomes of craniotomy patients who a magnesium infusion of 15mg/kg/hr to a placebo group of patients who will receive a saline bolus and infusion of equivalent volume starting at surgical closure and continuing for 15 hours. The sample size calculations are based on an effect size 24 point increase in Quality of Recovery-40 Questionnaire scores from a previous randomized control trial featuring the same bolus and infusion regimen as this trial. Investigators, patients, and providers will be blinded. Patients over the age of 18 undergoing elective craniotomy surgery will be enrolled.

The study population will consist of patients undergoing elective craniotomy surgery. The inclusion criteria consists of patient age 18-85, ASA (American Society of Anesthesiologists) Physical Status Classification 1-3, with Glasgow Coma Scale (GCS) of 15 with adequate english comprehension. Exclusion criteria includes pregnant or nursing patients, patients with known allergies to any of the study drugs, patient's refusal, patients with a history of cirrhosis, chronic kidney disease stage 3 or higher, known history of substance abuse, neuromuscular disease or heart block.

Eligibility Criteria:
Inclusion Criteria:

* patient age 18-85
* ASA (American Society of Anesthesiologists) Physical Status Classification 1-3
* Glasgow Coma Scale (GCS) of 15
* Adequate english comprehension

Exclusion Criteria:

* pregnant or nursing patients
* patients with known allergies to any of the study drugs
* patient's refusal
* patients with a history of cirrhosis
* chronic kidney disease stage 3 or higher
* known history of substance abuse
* history of neuromuscular disease
* history of heart block
Follow-up of Study AN004T to Assess the Persistence of AllerT Efficacy During the 2nd to 4th Season After Treatment

Study aiming to evaluate the efficacy of a 2-month pre-seasonal treatment with an AllerT 50 µg or 100 µg maintenance dose administered in previous study AN004T in reducing symptoms of allergic rhinoconjunctivitis during the 2nd following birch pollen season.

Multicenter, international, parallel-group follow-up study of subjects randomized and treated in Study AN004T (AllerT 100 µg, AllerT 50 µg, placebo) and followed over the 2nd, and if appropriate, the 3rd and 4th birch pollen seasons in this study (still double-blind during the 1st year, open-label in the 2nd and 3rd years).

Eligibility Criteria:
Inclusion Criteria:

1. Any subject having been randomized in the AN004T trial and had received at least one injection
2. Any subject having been informed and provided signed consent for participating in the trial and willing to follow all planned trial assessments

Exclusion Criteria:

1. Any subject having received specific immunotherapy against birch pollen or a tree pollen mix including birch pollen at any time since AN004T and before Visit 1
2. Any subject intending to travel during the birch pollen season outside of the birch pollination area for more than 7 consecutive days
3. Any subject unable or unwilling to record allergy symptoms and medications daily during the following birch pollen season using an electronic diary device
4. Any subject not covered by medical insurance
5. Any subject having received immunosuppressive medication within 4 weeks prior to inclusion, or planned to be used during the trial period
6. Any subject having received systemic or local antihistamines, oral or inhaled corticosteroids or under anti depressant medication with antihistamine effect within 2 weeks prior to inclusion
7. Any subject having used any investigational or non-registered drug, vaccine, or medical device within 4 weeks prior to inclusion, or planned to use such treatments during the trial period
Cervical Volume and Prediction of Preterm Labor

The primary aim of this research is to assess the predictive value of 3D cervical volume and 3D power Doppler indices in predicting pregnancies at risk of preterm labor.

Secondary aim: to compare 2D cervical length and 3D cervical length in coronal view for predicting preterm labour.


Eligibility Criteria:
Inclusion Criteria:

1. Age : 18-35 years old
2. Singleton pregnancy
3. Gestational age : 18-26 Ws knowing last menstrual period and history of regular mense.

Exclusion Criteria:

1. Multiple gestations (e.g., twins, triplets).
2. History of cervical surgery or cervical cerclage.
3. Known uterine anomalies that could affect cervical assessment.
4. Contraindications for transvaginal ultrasound, such as active vaginal bleeding or infection.
5. Severe fetal anomalies or conditions incompatible with life
Multicenter Study Comparing AI-Based Navicam vs. Conventional Pillcam in Small Bowel Pathology

Since its introduction in 2001, small bowel capsule endoscopy has been pivotal in diagnosing small bowel pathology due to its minimally invasive nature and high diagnostic accuracy. However, the technology has limitations, including prolonged reading times and the need for specialized endoscopists. The Navicam endoscopic capsule, leveraging artificial intelligence (AI) with ProScan™ for automated reading, promises to address these limitations by reducing reading times and enhancing diagnostic efficiency.

This study aims to assess the diagnostic concordance and to compare the efficiency of the AI-based Navicam capsule with the conventional Pillcam SB3 in the exploration of the small bowel.

This is a prospective, multicenter, randomized, observational study involving multiple hospitals across Spain. At each site, patients will ingest both the Pillcam SB3 and Navicam capsules in a randomized order. Reading times, transit times, and diagnostic yield will be compared between the two devices. A central reading committee of experienced gastroenterologists will conduct blinded evaluations of both explorations using predefined criteria.

The primary endpoint is the diagnostic concordance between Navicam's AI-driven ProScan™ system and the conventional reading of Pillcam SB3, measured by Cohen's kappa index.

The secondary endpoints include to assess the correlation in lesion detection, video download times, gastric and small bowel transit times, total reading times, and adverse events.

The sample size is 147 patients, accounting for an expected 10% dropout rate, based on previous studies showing a diagnostic concordance kappa index of 0.6.

This study aims to establish that the AI-based Navicam capsule is at least as effective as the conventional Pillcam SB3 in diagnosing small bowel lesions, with potentially reduced reading times, thus enhancing clinical efficiency in small bowel diagnostics.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients over 18 years of age with any clinical indication to undergo a small bowel exploration using capsule endoscopy at the participating hospital.

Exclusion Criteria:

* Patients with known small bowel strictures detected by computed tomography (CT) or magnetic resonance imaging (MRI).
* Patients with a history of esophagogastric and small bowel surgery (excluding ileocecal resection).
* Patients with a clinical contraindication for small bowel capsule endoscopy.
* Hospitalized patients.
* Patients with pacemaker or Implantable Cardioverter Defibrillator (ICD).
* Patients scheduled for a MRI within 15 days after capsule endoscopy ingestion.
* Pregnant or actively breastfeeding patients.
* Patients with swallowing disorders requiring endoscopic placement of the capsule.
* Simultaneous participation in another clinical trial using any investigational drug or device.
* Concurrent life-threatening pathology or condition.
* Inability to sign the informed consent form.
Preventing Weight Gain and Unhealthy Behaviors in Children

This study will address engagement in unhealthy behaviors, low levels of self-regulation, and unhealthy weight gain for children from low-income households.

Evidence suggests that components within structured days (e.g., school days) have a positive influence on children's obesogenic behaviors (i.e., diet, sleep, physical activity, sedentary behaviors) and self-regulation. In this pilot study children will be randomized to two arms: attend a structured summer camp, not attend a camp. The investigators hypothesize that children attending the summer camp will engage in more healthy obesogenic behaviors, display higher levels of self-regulation, and subsequently will experience less weight gain than children not attending the summer camp. To test this hypothesis the following specific aims will be accomplished: Aim 1 (Primary): Compare changes in BMI z-scores and fitness among children from low-income households attending a structured summer day camp and those not attending a structured summer day camp. Aim 2 (Secondary): Compare changes in obesogenic behaviors among children attending a structured summer day camp and those not attending a structured summer day camp. Aim 3 (Exploratory): Explore changes in self-regulation and the moderating effect of these changes on primary and secondary outcomes among children attending and not attending a structured summer day camp.

Eligibility Criteria:
Inclusion Criteria:

* participants will be boys and girls that attend one of the participating schools
* indicates "yes' on an informed consent document for participation in the study

Exclusion Criteria:

* diagnosis of an intellectual disability, such as Down Syndrome, Fragile X, Fetal Alcohol and/or a physical disability, such as wheelchair use, that prevents the ability to ambulate without assistance.
* children who plan to enroll in a summer camp during the year that they participate in the study will also be excluded from the study.
* No other exclusion criteria will be used.
Whole Body Cryotherapy and Morphological and Rheological Indicators

The aim of the planned study was to evaluate the effect of repeated cryostimulation treatments on immunological, morphological, and biochemical indicators of the peripheral blood of healthy, young Men

A group of 18 healthy men aged 19-26 participated in the study. The group included a group of ten students with high physical activity and a group of eight students with moderate physical activity.

Whole-body cryotherapy was performed in a cryochamber located in the Malopolska Cryotherapy Centre in Krakow (Poland) in the spring of 2013 and in the winter and spring of 2014.

The temperature inside the vestibule during the procedure was about -60 ºC and in the actual chamber about -120 ºC. The concentration of oxygen in the air of the cryochamber was kept constant at 21-22% and continuously controlled by two independent oxygen probes.

The participants of the study were subjected to 24 whole-body cryotherapy treatments (one treatment three times a week for two months). Before the procedure, they were informed about how to move and breathe in the cryochamber. Each entrance to the cryochamber was preceded by a 30-second adaptation period in the vestibule at a temperature of -60 ºC. Then the subjects entered the cryochamber for three minutes. During the treatment, the men wore short trousers, woollen socks and gloves, hats or headbands to protect against freezing and clogs. Moreover, the mouths and noses of the participants were covered with surgical masks, secured with a strip of gauze. During the procedure, the subjects were in permanent eye contact with the doctor and the staff.

Eligibility Criteria:
Inclusion Criteria:

* informed consent for research;
* equal age and above 18 years of age;
* no contraindications to cryostimulation procedures;
* physically active

Exclusion Criteria:

* lack of informed consent for research
* children and adolescents under 18 years of age,
* patients with inflammatory diseases, infectious, autoimmune and cancer
Trial on the Effectiveness of Mindfulness Training for Smokers

The Mindfulness Training for Smokers study follows a randomized controlled design with 240 total participants. Both the study group and the control group will be enrolled in the Wisconsin Tobacco Quit Line and will receive four weeks of nicotine patches. The control group will receive the Quit Line intervention alone where as the study group will receive the Quit Line intervention plus the Mindfulness for Smokers Intervention. The Mindfulness for Smokers Intervention provides four weeks of instruction in mindfulness meditation followed by four weeks of participation in a weekly meditation group. The principal hypothesis for the study is that Mindfulness for Smokers plus the Quit Line will lead to significantly higher rates of smoking cessation at 6 months than the Quit Line alone.

The MTS study is funded for through a five year K23 NIH training grant. The study follows a randomized controlled design with N = 240. Both the study group and the control group will be enrolled in the Wisconsin Tobacco Quit Line, will receive four weeks of nicotine patches, and receive phone based counseling through the Quit Line. The control group n = 120 will receive the Quit Line intervention alone where as the study group n = 120 will receive the Quit Line intervention plus the Mindfulness Training for Smokers (MTS) Intervention.

Mindfulness Training for Smokers provides 4 weeks of mindfulness meditation instruction followed by entry into a MTS meditation group. The total time for the study including recruitment, intervention and participant follow-up for N = 240 will be four years. The study will recruit subjects from the Dane county region through the University of Wisconsin School of Medicine and Public Health Center for Tobacco Research and Intervention (UW-CRTI). Recruitment will take place through the television and radio advertisements (appendix). In addition, the Wisconsin Quit Line web site will provide a link to the MTS study. With this link, quit line coaches will have a brief description of the study (see appendix) and will provide contact information for the study. Finally, the MTS web site (url: www.sittoquit.org) will provide basic introductory information available to the general public.

The principal hypothesis for the study is that MTS plus Quit Line will lead to significantly higher rates of smoking cessation at 6 months than use of the Quit Line alone. Secondary hypotheses is that study group compared to controls will show significant differences in questionnaire results that test distress, depression, anxiety, attentional control, mindfulness and quality of life.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18 years or over;
2. Participants must express "high" motivation to quit smoking
3. Participants must express willingness to attend "all" meetings for 2 months.
4. Smoke 5 or more cigarettes per day

Exclusion Criteria:

1. Self report of alcohol use of 4 drinks or more a night on 4 or more nights per week.
2. Self report of using chewing tobacco, snuff or cigars in the last week.
BlueWind Medical Reprieve System for the Treatment of PNP

The current study will evaluate the safety and performance of the BlueWind Medical Reprieve System for the treatment of Chronic Painful Peripheral Neuropathy.

The BlueWind Reprieve system is a neurostimulator consisting of an Implant and external components.

The system is intended for home care use. The chronic pain treatment is achieved by an electrical stimulation of peripheral nerve fibers. The stimulation is set so that it generates paresthesia in the stimulated area (e.g. foot), reducing the pain sensation and improving the quality of life for the patient.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent.
2. Male or female aged 18 - 80.
3. Patient agrees to attend all follow-up evaluations and is willing to completely and accurately fill out pain questionnaires.
4. Diagnosis of chronic neuropathic pain due to peripheral neuropathy.
5. Documented pain attributed to neuropathy for at least 6 months.
6. Pain intensity with an average daily VAS score of at least 6, demonstrated by 2-3 ratings per day across 7 days.
7. Patient refractory to conservative treatments including pain medication, for at least 6 months.
8. Stable pain medication for at least 4 weeks prior to study enrollment.

Exclusion Criteria:

1. Previous participation in another study with any investigational drug or device within the past 90 days.
2. Any active implant (cardiac or other).
3. Any metal implant in the area of BlueWind device implantation site.
4. Current pregnancy or attempting to get pregnant (female patient).
5. Any clinically significant neurologic disorders (except PNP).
6. Any clinically significant or unstable medical or psychiatric condition that would affect the patient's ability to participate in the study.
7. Patients with severe or unstable cardiovascular, pulmonary, gastrointestinal, hematological, hepatic, renal or endocrine diseases.
8. Severe peripheral vascular disease that may cause intermittent claudication or ischemic ulcers.
Evaluation of the Levels of Pain and Discomfort Between Two Methods of Leveling and Alignment

The duration of orthodontic treatment is one of the exacerbation causes of orthodontic pain. Several methods have been suggested to reduce the duration of orthodontic treatment classified to surgical and non-surgical methods.

Researches used minimally invasive surgical methods like corticision, piezocesion, micro-osteoperforation, and piezo-puncture indicated that most of these methods can accelerate dental movement by 20 - 40% without causing additional pain as a result of using those methods. Applying corticision on the lower anterior teeth using a surgical blade and a hammer may accelerate tooth alignment during orthodontic treatment. This study consists of two groups, patients will be randomly assigned to one of these two groups.

Pain is defined as an unpleasant emotional sensory experience associated with actual or potential harm. It was mentioned as one of the most common complaints related to orthodontic treatment, and around 65-95% of patients undergoing orthodontic treatment suffer from various degrees of pain.

Corticision is one of the minimally invasive surgical procedures that is not associated with flap lifting. It was used to accelerate tooth movement in animals and case report studies. Its application on humans may aggravate their fear and anxiety towards the pain that may accompany this technique.

No study in the literature has been searched in patient perception of pain, discomfort, levels of acceptance and satisfaction accompanied corticision application, but in this study, these previous variables accompanied corticision technique have been studied on crowded lower anterior teeth cases which are one of the most common types of malocclusion.

Eligibility Criteria:
Inclusion Criteria:

1. Age range between 18 and 24 years
2. Completion permanent dentition (except third molars)
3. Mild to moderate crowding (2-6 mm according to Little's index)
4. Absence of medications intake that interferes with pain perception for at least one week before the beginning of the treatment

Exclusion Criteria:

1. Systematic diseases that could affect bone and tooth movement and no contraindication avoid oral surgery
2. Medical conditions that affect tooth movement (Corticosteroid, NSAIDs)
3. Patients had previous orthodontic treatments
4. Poor oral hygiene or concurrent periodontal disease