cyrilzakka/clinical-trials huggingface dataset:
Prospective Patient Registry for Radiation Oncology Techniques and Quality

This study will create a patient data registry to collect and analyze information on technology usage and outcomes among patients receiving a broad range of relatively new radiation treatments that have become standards of care in our practice. Review of this information will serve as a basis for development of better patient management plans, to inform decisions about acquisition of new technologies, to provide information about quality in our care delivery, and to create a database that will securely warehouse ongoing information about what treatments the patients we serve need most and the challenges they face in the treatment process. The information gathered is likely to not only improve our services at the University of Maryland and its community sites but to advance medical science and enhance the quality of care for cancer patients.

The purpose of this study is to create a robust and long-term patient data registry containing limited demographic, diagnostic, treatment, and follow-up data on patients at the study sites undergoing one or more of the following radiation treatments/technologies:

Brachytherapy, including High-Dose-Rate and Low-Dose-Rate Techniques/ GammaPod Therapy/ GRID Treatment/ Image-Guided Radiation Therapy/ Intensity-Modulated Radiation Therapy and Intensity-Modulated Arc Therapy/ MammoSite and SAVI Applicator/ Photodynamic Therapy/ Proton Therapy/ SIR Spheres and Radiolabeled Microsphere Therapy/ Stereotactic Radiosurgery and Stereotactic Body Radiotherapy/ Thermal Therapy (Hyperthermia)

Eligibility Criteria:
Inclusion Criteria:

* Patients who are 18 years old or older and scheduled to undergo any of the listed radiation treatment technologies at the University of Maryland Medical Center or one of its community sites as included in this protocol provided s/he consents to participate.

Exclusion Criteria:

* Patients who are incarcerated or in legal custody are not eligible for this study.
* Patients who are younger than 18 years, are cognitively impaired, or are otherwise unable to provide informed consent.
* Patients who are pregnant
Is Acute Appendicitis Still a Clinical Diagnosis?

This study aims to investigate the use of preoperative diagnostic imaging before appendectomy in Denmark and whether it has changed over time during the period from 2000-15. Secondly, the study aims to investigate regional, age and gender differences in the same setting.

Acute appendicitis is the most common cause of abdominal pain (1) and appendectomy is the most common emergency surgical procedure performed worldwide (2). During the last decades, there has been a paradigm shift in both diagnosis and treatment of appendicitis - surgical treatment has changed from open to laparoscopic appendectomy (3). Acute appendicitis has traditionally been a clinical diagnosis, but the use of preoperative diagnostic imaging has, in some countries, increased dramatically (4). The use of computed tomography (CT) before appendectomy is in the United States up to 90%, in England 13% and in Holland almost all patients undergo ultrasound and/or CT before appendectomy (1).

The use of antibiotics can be successful in the treatment of uncomplicated appendicitis verified on CT, and the use of CT has significantly lowered the negative appendectomy rate compared to clinical evaluation only (1). But the use of CT is inevitably inducing radiation and increasing lifetime risk of cancer - especially in younger patients who most frequently present with acute appendicitis (1,5). It is estimated that CT of the abdominal region can avoid 12 negative appendectomies but at the cost of one cancer death due to radiation (5). In Denmark surgery is still the only treatment for appendicitis, but how is appendicitis diagnosed? Is acute appendicitis still a clinical diagnosis?

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis for appendicitis undergoing appendectomy during the same admission during the period 2000-15

Exclusion Criteria:

* None
Use of the Modified Atkins Diet in Infantile Spasms

Infantile spasms constitute a type of catastrophic epilepsy syndrome occuring in young children. The ketogenic diet has been shown to be very effective in these children. The modified Atkins diet is a less restrictive option than the ketogenic diet, which has been effective in preliminary studies on refractory epilepsy in children, adolescents and adults. Modified Atkins diet may be of special importance in infants, as proteins are not restricted, hence no problems with growth are expected. Hence this pilot study has been planned to evaluate the efficacy and tolerability of the modified Atkins diet in infantile spasms refractory to conventional treatment (ACTH, vigabatrin, and anti-epileptic drugs).


Eligibility Criteria:
Inclusion Criteria:

1. Age: 6 months to 3 years.
2. Presence of epileptic spasms in clusters, with electroencephalographic evidence of hypsarrhythmia or its variants), having at least one cluster per day.
3. Treatment with at least corticosteroid/ ACTH or Vigabatrin and one other AED( sodium valproate, pyridoxine, topiramate, zonisamide, benzodiazepines (clobazam, clonazepam, nitrazepam).

Exclusion Criteria:

1. Known or suspected inborn error of metabolism, as evidenced by: Clinical suspicion of metabolic disorder as evidenced by 2 or more of the following- a history of parental consanguinity, prior affected siblings, unexplained vomiting, intermittent worsening of symptoms, recurrent episodes of lethargy, altered sensorium, or ataxia, hepatosplenomegaly on examination And/ or 2 or more of the following biochemical abnormalities High blood ammonia (\>80mmol/L), High arterial lactate (\>2 mmol/L), metabolic acidosis (pH \<7.2), hypoglycaemia (blood sugar \<40 mg/dl), abnormal urinary aminoacidogram, presence of reducing sugars or ketones in urine, and positive results on urine neurometabolic screening tests.
2. Motivational or psychosocial issues in the family which would preclude compliance
3. Systemic illness- chronic hepatic, cardiac, renal or pulmonary disease
Adjunct VR Pain Management in Acute Brain Injury

Severe and refractory pain after acute injury is a known-risk factor for chronic opioid use disorder. In this study, the investigators will use Virtual Reality (VR) immersion as a non-pharmacological adjunct to treat pain associated with acute traumatic injuries, including traumatic brain injury. The investigators hypothesize that VR therapy will decrease pain and reduce opioid use in patients with acute traumatic injuries, including TBI.

Each participant will undergo one VR session and two control sessions. The VR session will take place in a commercially available VR environment, the Blu, and last 20-30 minutes (VR Blu). The control sessions will include a 2D-tablet based session that mimics the VR content (Tablet Blu) and a content-less placement of the VR headset (VR Blank). The order of these sessions will be randomized across participants are intended to complete all sessions.

Each participant will complete a pre-study questionnaire to elicit their prior experience with the virtual reality as well as measures of gaming addiction/engagement, boredom, and expectancy. These scales will help us determine which patient-level factors predict response to VR. Before and after each session, participants will complete validated scales of pain, nausea, and anxiety.. Pre- and Post-VR opioid use will be recorded. Basic vital signs including heart rate, blood pressure, and respiratory rate, will be recorded before and after each session to monitor autonomic response. Advanced measures of autonomic response will include heart rate variability,,and pupillometry metrics. At the conclusion of all sessions, participants will complete another questionnaire to document their subjective experience of using VR (perceived effectiveness)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Traumatic Injury (including but not limited to traumatic brain injury)
* Age greater than or equal to 18 years-old
* Endorsing at least moderate pain as defined by documentation of at least one numeric rating pain scale score of 3 or more in the last 24 hours.
* Glasgow Coma Scale of 15
* Expected to stay in the hospital for at least 12 hours after enrollment

Exclusion Criteria:

* Seizure prior to enrollment
* Pregnancy
* non-English speaking
* Known intolerance of Virtual Reality
* Patient unable to consent for themselves
RES Prepared With RECELL® Compared to Conventional Care for Healing of Donor Sites in Ages 1-16 Years

To evaluate whether the time to complete closure is superior for RECELL-treated split-thickness donor sites, compared with Control (standardized dressings only). The mean time for donor site healing will be compared between treatments.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged 1 through 16 years (inclusive) with a skin defect for which autografting is indicated.
2. The area of total injury or planned defect (excluding donor sites) is 5% to 25% Total Body Surface Area (TBSA), inclusive.
3. Two discrete donor sites of similar size (± 25%) can be created in a similar non-articulating location (excluding the scalp) with each donor site representing a minimum of 1% TBSA.
4. The patient and family member/parent/guardian are able to complete all follow-up evaluations required by the study protocol.
5. In the opinion of the Investigator, the patient and/or parent/guardian must be able to:

   1. Understand the full nature and purpose of the study, including possible risks and adverse events, and
   2. Provide informed consent/assent as appropriate for study participation.
6. The patient and/or parent/guardian agrees to abstain from any other treatment of the wound(s) for the duration of the study unless medically necessary and comply with all compulsory study procedures.
7. The patient and/or parent/guardian agrees to abstain from enrollment in any other interventional clinical trial for the duration of the study.
8. The patient and/or parent/guardian can read and understand instructions and give informed, voluntary, written consent.
9. Life expectancy greater than 52 weeks.

Exclusion Criteria:

1. Prior autograft harvest at planned study donor sites.
2. Patients with sepsis or hemodynamic instability.
3. The patient has an infection under active management or other dermatologic condition at the planned donor sites or treatment areas.
4. Patient (of reasonable age) or parent/guardian is unable to follow the protocol requirements.
5. The patient has other concurrent conditions that in the opinion of the Investigator may compromise patient safety or study objectives.
6. Patients with a known hypersensitivity to trypsin or compound sodium lactate for irrigation.
7. In post-pubescent girls, pregnant or breast-feeding (pregnancy test should be performed in accordance with local institutional requirements).
8. Enrollment in a concurrent study in which the study treatment may confound the endpoints of this study.
Tetragraph® Monitor: Tolerance of Preoperative Placement

This is a prospective, non-blinded, single arm study. The primary objective of this study is to evaluate the tolerance to preoperative placement of the adhesive sensor for the Tetragraph® Neuromuscular Transmission Monitor in pediatric-sized patients ≤ 12 years of age.


Eligibility Criteria:
Inclusion Criteria:

1. Patients requiring anesthetic care and use of neuromuscular blockade
2. Age ≤ 12 years
3. ASA 1-4

Exclusion Criteria:

1. History of a peripheral neurologic or neuropathic disorder
2. Upper extremity cannot be used for TOF monitoring
3. Undergoing a surgical procedure in which neuromuscular blockade is not required
4. Patient is edematous
5. Patients with significant behavioral or neurocognitive issues which affect behavior and impact the ability to place the sensor
Investigating the Role of Motivational Interviewing in Swedish Patients Undergoing Knee Arthroplasty

Knee arthroplasty is a successful surgical treatment for end-stage osteoarthritis. Most patients are satisfied with the result, however, 10% of the patients have remained dissatisfied over the last decades despite the advantages of the surgical procedure. Previous studies suggest that rehabilitation needs to be individualized and that some patients request additional support.

Patient empowerment is a patient-centered strategy to increase, amongst other, patient engagement, participation, and motivation. Patient empowerment can be defined as a "process that helps people gain control over their own lives and increases their capacity to act on issues that they themselves define as important". One way of increasing patient empowerment is through motivational interviewing. Motivational interviewing is an evidence-based approach in which patients are supported to identify behavior changes toward their own individual goals.

The aim of this study is to investigate if motivational interviewing could increase satisfaction in patients undergoing knee arthroplasty. Furthermore, we want to examine role MI in this patient group with interviews of both MI-practitioners and patients as well as detailed investigations about the MI sessions.


Eligibility Criteria:
Inclusion Criteria:

Scheduled for primary knee arthroplasty

Exclusion Criteria:
Effects of High Intensity Laser Therapy (HILT) in Patients With Subacromial Impingement Syndrome

The aim of this study is to determine the effects of high intensity laser therapy (HILT) in patients with subacromial impingement syndrome (SIS). This study aims to compare the effects of HILT alone and HILT and therapeutic exercise combination on shoulder pain, ROM, joint position sense (JPS), muscle strength and function.The investigators hypothesized that shoulder pain, ROM, JPS, muscle strength and functionality would improve with both treatments but that HILT combined with exercise would result in better outcomes than HILT alone.

30 patients with SIS will be randomized into two groups. Pain intensity will be assessed with visual analogue scale (VAS), pain-free and normal range of motion (ROM) with goniometer, joint position sense (JPS) with inclinometer, muscle strenght with hand-held dynamometer, and shoulder functionality with Constant Murley Score (CMS) and Shoulder Pain and Disability Index (SPADI) in a pretest-posttest design. HILT Group (n=15) will receive only HILT for 10 sessions, 3 days a week on alternate days. HILT\& Exercise Group (n=15) will receive exercise treatment in addition to HILT for the same duration of time.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as SIS (≥3 positive of 5 impingement tests: Neer's sign, Hawkins and Kennedy, Empty Can, painful arc of abduction and external rotation resistance tests)
* No history of shoulder injury and/or shoulder symptoms requiring treatment other than SIS for the last 1 year
* Shoulder pain less than 7/10 of Visual Analogue Scale
* Being able to elevate the shoulder over 140 degrees

Exclusion Criteria:

* History of upper extremity fracture, shoulder surgery
* Frozen shoulder
* Full-thickness rotator cuff (RC) tear
* Shoulder instability, systemic musculoskeletal disease
* Shoulder pain with cervical spine motion,
* Having any of the contraindications of HILT.
Nutritional Supplementation in Patients With Chronic Respiratory Disease

The aim of this study is to investigate the nutritional status of patients with chronic pulmonary disease undergoing regular outpatient pulmonary rehabilitation.

Background：

Exercise limitation due to impaired respiratory function is a common problem for COPD patients, and reduced muscle mass and malnutrition can exacerbate symptoms, impacting their functional ability and quality of life. Underweight COPD patients have an increased risk of mortality and acute exacerbations. Therefore, monitoring the body composition, nutritional status, and metabolic state of COPD patients and providing adequate nutritional support are crucial aspects of COPD management.Compared to healthy older adults, COPD patients require higher protein intake. Most studies have focused on analyzing body composition, respiratory and limb muscle strength, exercise performance, physical activity, lung function, emotional perception, and self-perceived scales, with limited assessment and exploration of calorie intake. Moreover, calorie intake estimation has mostly relied on formulas, lacking personalized and accurate assessment through indirect calorimetry.

Study Design：

This study is a single-center, prospective, randomized controlled trial.

Methods：

COPD patients who meet the inclusion criteria will be enrolled and randomly assigned to either the nutritional supplementation intervention group (experimental group) or the standard pulmonary rehabilitation group (control group). The experimental group will receive personalized dietary guidelines based on indirect calorimetry assessment by a nutritionist, while the control group will undergo routine pulmonary rehabilitation without dietary intervention. The study will follow up for a duration of 12 weeks, collecting data on cardiopulmonary physiological parameters, body composition, muscle strength, exercise performance, and indirect calorimetry assessment. Additionally, we will calculate the differences in recommended calorie intake between formula estimation and indirect calorimetry.

Effect：

We anticipate that indirect calorimetry will yield different results for calorie estimation compared to weight estimation and the Harris-Benedict equation. The nutritional supplementation intervention is expected to lead to improved changes in body composition, enhanced exercise performance and muscle strength, as well as better cardiopulmonary physiological parameters and self-perceived ratings.

Key words：

Chronic obstructive pulmonary disease, pulmonary rehabilitation, nutritional supplementation, indirect calorimetry

Eligibility Criteria:
Inclusion Criteria:

* Age between 45 and 80 years
* A written informed consent
* Pre-COPD or COPD stages I-IV as per the 2023 GOLD guidelines
* Recieved pulmonary rehabilitation at least three months
* Unwilling to nutritional outpatient assessment

Exclusion Criteria:

* Diagnosed with neuromuscular diseases
* Emergency room visits or hospitalizations for exacerbation of respiratory disease within three months
* Inability to cooperate with cardiopulmonary exercise testing
* Significant malnutrition or low BMI
RIPC on Activity, Fatigue and Gait in MS

This study evaluates whether Remote Ischaemic Preconditioning (RIPC) can improve activity, gait and fatigue in people with Multiple Sclerosis. Half the participants will receive RIPC, the other half will receive a sham treatment.

Regular physical activity has been shown to improve physical fitness, fatigue, quality of life, and reduce the progression of disability in people with multiple sclerosis (MS). However, people with MS are less physically active than others. This is partly due to poor exercise tolerance and fatigue.

Remote Ischemic preconditioning (RIPC) is the exposure of a limb to brief periods of circulatory occlusion and reperfusion by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg), to protect organs against ischaemic injury. RIPC has been shown to improve exercise performance and delay fatigue in athletes. However, there is little to no research examining the effect of RIPC on walking or exercise performance in MS patients. The aim of this trial is to assess whether RIPC can improve activity, gait and reduce fatigue in people with MS.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of MS as per the McDonald's criteria
* Sufficient cognitive ability and understanding of the English language to give informed consent and complete study questionnaires
* Ability to walk for 6 minutes without rest
* Resting Systolic BP of more than 100mmHg
* Resting Systolic BP of less than 170mmHg

Exclusion Criteria:

* Cognitive difficulties or insufficient English to allow understanding of consent and study questionnaires
* Inability to walk
* Other systemic illness affecting exercise tolerance
* Resting Systolic BP of less than 100mmHg
* Resting systolic BP of 170mmHg or more
BIBR 1048 Dose Range Finding Study in Prevention of Venous Thromboembolism in Patients With Primary Elective Total Hip or Knee Replacement Surgery

The primary objective of this study is to establish the dose-response relationship with regard to efficacy and safety of BIBR 1048 (50 mg bis in die(b.i.d), 150 mg b.i.d, 225 mg b.i.d. and 300 mg quaque die(q.d) ) in preventing venous thromboembolism(VTE) in patients undergoing primary elective total hip and knee replacement.


Eligibility Criteria:
Inclusion criteria

1. Patients scheduled to undergo a primary elective total hip or knee replacement.
2. Male of female being 18 years or older.
3. Patients weighing at least 40 kg.
4. Written informed consent for study participation.

Exclusion criteria

1. Bleeding diathesis, constitutional or acquired coagulation disorders.
2. Major surgery or trauma(e.g., hip fracture) within the last 3 months.
3. Cardiovascular disease
4. Any history of haemorrhagic stroke, intracranial or intraocular bleeding or cerebral ischaemic attacks lasting more than 24 hours and / or with cardiovascular pathological findings.
5. Deep vein thrombosis(DVT), gastrointestinal or pulmonary bleeding, gastric or duodenal ulcer within the last year.
6. History of or acute intracranial disease
7. Liver disease
8. Renal disease
9. Use of long-term anticoagulants or antiplatelet drugs within 7 days prior to hip/knee replacement operation.
10. Pre-menopausal women who are not surgically steriles, are nursing and are of child-bearing potential and are not practising acceptable methods of birth control
11. Known allergy to contrast media
12. Thrombocytopenia
13. Allergy against heparin.
14. Active malignant disease or current cytostatic treatment.
15. Treatment with an investigational drug in the past month.
16. Leg amputee
17. Known alcohol or drug abuse