cyrilzakka/clinical-trials huggingface dataset:
First Human Trial of Targeting MDM2/MDMX PET Imaging

Investigation of the Radiotracer Uptake of \[68Ga\] MDM2/MDMX Peptide at Lesion Sites in Patients with Malignant Tumors, and Evaluation of the Capability of \[68Ga\] MDM2/MDMX Peptide to Detect Overexpression of MDM2/MDMX in Tumor Patients, Particularly Those with Recurrent or Advanced Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Ages 18 to 75 years, both males and females are eligible;
2. Participants must meet the following criteria for blood routine and liver/kidney function tests: Complete blood count: WBC ≥ 4.0 × 10\^9/L or neutrophils ≥ 1.5 × 10\^9/L, platelets ≥ 100 × 10\^9/L, hemoglobin ≥ 90 g/L; prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN); liver and kidney function: Total bilirubin ≤ 1.5 times the upper threshold limit (ULT), ALT/AST ≤ 2.5 ULN or ≤ 5 ULT for participants with liver metastasis, alkaline phosphatase (ALP) ≤ 2.5 ULN (if bone or liver metastases are present, ALP ≤ 4.5 ULN); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT;
3. Normal cardiac function;
4. An expected survival of ≥ 12 weeks;
5. Good follow-up compliance;
6. According to RECIST 1.1 criteria, there must be at least one measurable target lesion;
7. Women of childbearing age (15-49 years) must have a negative pregnancy test conducted within 7 days prior to enrollment; patients of childbearing potential must agree to use effective contraceptive methods to ensure they do not conceive during the study and for three months after examinations;
8. Patients recommended for PET/CT evaluation for tumor diagnosis and staging by a clinician;
9. Participants must fully understand the study and voluntarily participate, and must sign an informed consent form.

Exclusion Criteria:

1. Severe abnormalities in liver and kidney function as well as hematological parameters;
2. Patients who are planning a pregnancy;
3. Pregnant or lactating women;
4. Individuals unable to lie flat for thirty minutes;
5. Individuals who refuse to participate in this clinical study;
6. Individuals suffering from claustrophobia or other psychiatric disorders;
7. Other conditions deemed by the researchers as unsuitable for participation in the trial.
Unilateral Dual TAP (Transverses Abdominal Plane) Blok i Forbindelse Med Laparoskopisk Nyre Operation

Unilaterally Dual TAP (Transversus abdominis plane) block after radical nephrectomy, assessment of benefit and opioid reduction.

Transverses Abdominal Plane (TAP) Block is a relatively new regional technique which infiltrates local anesthetic between the internal oblique and transverse abdominis muscles and provides analgesia to the parietal peritoneum as well as the skin and muscles of the anterior abdominal wall (1). An Ultrasound-guided bilateral dual transversus abdominis plane block (Dual TAP block) had been reported by Boerglum et al (2,3), in which regional anesthesia postoperatively can be provided to the upper (Th6-Th9) and the lower (Th10-Th12) abdominal wall bilaterally using a four-point single-shot technique.

Pain has a wide spectrum of effects on the body. Inadequately controlled postoperative pain may have harmful physiologic, psychological consequences which potentially increase the morbidity and mortality (4,5). It has been recognized that inadequately treated postoperative pain may lead to chronic pain which is often misdiagnosed and neglected (6,7). Chronic postsurgical pain reported in 20% of patients, 6 months after nephrectomy (8).

Hypothesis: The use of unilaterally dual TAP block will reduce the VAS score for pain and the need of morphine postoperatively after radical nephrectomy.

Purpose: To evaluate the analgesic efficacy of unilaterally dual TAP block as an adjuvant to routine analgesic. To assess the difference in morphine usage in the first 48 hours after radical nephrectomy with or without applying of unilaterally dual TAP block.


Eligibility Criteria:
Inclusion Criteria:

-Any patient undergoing laparoscopic nephrectomy- -Age ranges 18-80- -Can read and understand Danish- -Able to give informed consent

Exclusion Criteria:

-History of relevant drug allergy- -Inability to understand written consent forms or give consent- -Age less than 18 or over 80- -Any conversion to open surgery-

-Patients included in ambulant nephrectomy project.
Physical Activity and Gastrointestinal Investigations

This is an observational study, which aims to compare the outcomes of ambulatory gastrointestinal investigations with physical activity using accelerometry. An ambulatory study refers to one in which the patient is monitored freely, often outside of the hospital environment. For this the investigators will use a lightweight (7.4g) tri-axial accelerometer worn behind the ear.

Hypothesis 1 There is no change in the amount or nature of physical activity taken by patients during ambulatory oesophageal pH monitoring or capsule endoscopy.

Hypothesis 2 There is no correlation between physical activity levels and speed of gastrointestinal transit.

For capsule endoscopy, the investigators are interested in how physical activity affects the speed of capsule transit through the GI tract. Capsule endoscopy involves a patient swallowing a pill which contains a camera, in order to image the parts of the bowel that a conventional endoscope cannot reach. A rapid transit may result in insufficient mucosal visualisation, which would reduce the sensitivity of the investigation.

For oesophageal pH monitoring, it is essential that the patient behaves as they would normally to produce measurements that represent a standard day. Using accelerometry, the investigators can compare the amount, and nature, of physical activity taken throughout the investigation to that of the preceding day, or week. In addition, further analysis of motion data captured will allow us to correlate specific activities and body orientation with pH readings to get a better insight into the pathophysiology of a patient's condition.

The studies will be conducted over 6-9 months in Imperial College Trust's medical outpatient service. All patients undergoing capsule endoscopy or ambulatory oesophageal monitoring will be asked to consider participating. Patients will receive the eAR sensor up to 2 days before their investigation, and will be asked to wear it until the end of their investigation (not whilst sleeping). Capsule endoscopy normally takes less than 12 hours, and pH monitoring takes between 24 and 48 hours. Participation makes no difference to the standard or type of care that they will receive, the sensor data is additional.

Eligibility Criteria:
Inclusion Criteria:

* Planned 24 hour oesophageal pH monitoring study, or capsule endoscopy

Exclusion Criteria:

1. Undergone previous capsule endoscopy or ambulatory oesophageal pH test
2. Currently a hospital in-patient
3. Severe mobility disorder (unable to walk or mobilise independently)
4. Age less than 18 or above 65
5. Physically unable to wear eAR sensor (eg. bilateral hearing aids or particularly small ears)
Effectiveness of Therapeutic Exercise Versus Manual Therapy in Patients With Chronic Neck Pain

It has been estimated that between 50% and 85% of the population will suffer neck pain along their life. Chronic nonspecific neck pain is one of the main causes of disability in the population, it represents 25% of visits to physiotherapy, and it also has a high chance of chronification. The efficacy of combining manual therapy and therapeutic exercise for the treatment of this pathology has been demonstrated a lot of times. However, no conclusive studies have been found that compare the isolated application of both treatments, thus being an important focus of action and research.

The main objective of the study is to check if the treatment with therapeutic exercise is better than manual therapy in the improvement of the disability in patients with chronic neck pain.

A randomized, controlled, monocentric, parallel and single-blind clinical trial will be carried out.

The simple will be obtained from the population over 18 years old with chronic neck pain of more than 12 weeks of evolution and will be those who meet the inclusion and exclusion criteria.

The patients will be randomly divided into 2 intervention groups, in one of the groups will be applied a manual therapy session of about 30 minutes once a week for 4 weeks. In the other group it will be delivered and explained to the patients, a home therapeutic exercise program that will be carried out on alternate days for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Nonspecific cervical pain of more than 12 weeks of evolution.
* Over 18 years.

Exclusion Criteria:

* Oncological processes.
* Pregnancy.
* Infectious diseases.
* Degenerative diseases.
* Fibromyalgia.
* Previous spinal surgeries.
* Previous traumatic events.
* Hernias and/or cervical protrusions.
* Neurological processes.
* Current treatment for cervical pain.
* Neuropathic characteristics pain.
Fifth Metatarsal Orthopedic Outcome Trial

Fractures of the shaft, distal to zone three, of the fifth metatarsal often occur after foot distortion. There is very little evidence available regarding the optimal treatment. Currently the most common treatment is prolonged cast immobilization. Operative treatment has been reported as an alternative and could promote early recovery. No comparative study has been published regarding optimal treatment

Objective: The main objective is to determine experienced pain, as measured by NRS-11 score, 3 months after intervention and compare this between the intervention and control group. Secondary objectives are functional outcome as measured by AOFAS Lesser Toe Scale, FAAM score, progress of NRS-11 score through time and PROMIS Mobility/pain interference. Furthermore, quality and duration of fracture healing will be compared between groups. The impact on daily life will be compared as measured by duration of return to work and normal footwear.

Study design: Randomised controlled clinical intervention trial

Study population: Humans with an acute shaft fracture of the fifth metatarsal bone, 18 years or older.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older at the time of study entry
* Informed consent
* Competent to participate in follow up and fill out questionnaires
* Dislocated (1mm or more on plain radiography) fracture of the shaft, distal from zone 3, of the fifth metatarsal according to the Orthopedic Trauma Association (OTA) classification 87.5.3 A-C

Exclusion Criteria:

* Open fracture
* Proximal fifth metatarsal fracture, Jones fracture
* Clinically significant or symptomatic vascular or neurologic pathology on the ipsilateral leg
* Former surgery or history of development disorder of the contralateral fifth metatarsal
* Multiple fractured metatarsals in the affected foot
* Medical history of Rheumatoid Arthritis
* Unable to undergo surgical procedure
Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy

A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Adult men and women \> 18 years
* Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months
* Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area (BSA) ≥ 10 %
* Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy

Exclusion Criteria:

* Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis
* A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough);
* White blood cell counts less than 4000/mm\^3 or more than 20000/mm\^3
* Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)
* Systemic Lupus
* Non respect of adequate wash out periods for treatments that might have an impact on the disease
* Any associated disease that could be impacted by the study treatment intake
* Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study
Combined Dexmedetomidine and Glycopyrrolate Therapy

Catheter-related bladder discomfort after transurethral resection of bladder tumor is frequent because of indwelling urinary catheter for irrigation. The mechanism of the catheter-related bladder discomfort is similar to that of overactive bladder, in which muscarinic acetylcholine receptors are stimulated. The catheter-related bladder discomfort is a well known predisposing factor for emergence delirium after general anesthesia. In this study, we aimed to compare the incidence of catheter-related bladder discomfort between dexmedetomidine only therapy and combind dexmedetomidine and glycopyrrolate therapy.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I and II
* elective transurethral resection of bladder tumor under general anesthesia

Exclusion Criteria:

* arrhythmia
* bladder outflow obstruction
* overacitve bladder
* end stage renal disease
* neurogenic bladder
* morbid obesity
* psychiatric disorder
The Innate Immune Response and Enteric Nervous System in Crohn's Disease.

The study aims to explore the relationships between inflammation, nerve changes, and the expression of interferon-stimulated proteins in inflamed and non-inflamed bowel areas from patients with Crohn's disease. Crohn's disease is a chronic inflammatory condition with complex causes and mechanisms that remain uncertain despite extensive research.

Methods and Procedures This exploratory study utilizes tissue samples from a clinical biobank at Aalborg University Hospital. The samples are paraffin-embedded blocks from which tissue sections are prepared for immunohistochemical and histological staining. The study focuses on assessing the expression of interferon-stimulated proteins through optimized immunohistochemical staining methods, ensuring reproducibility via automated machines. The protein expressions are then analyzed qualitatively and semi-quantitatively and compared with structural changes in the bowel tissues.


Eligibility Criteria:
Inclusion Criteria:

* Histological preparations (tissue samples) from patients with Crohn's disease who have undergone bowel resection at Aalborg University Hospital in the period from 2012 to 2023.

Exclusion Criteria:

* If the tissue material does not include the ileocecal region.
* If the pathology report does not indicate that there is tissue material from both inflamed and non-inflamed areas.
* If the patient has registered a prohibition against research in the Tissue Utilization Registry.
* The selection of cases starts with the most recent (by date) and stops when 25 suitable cases are found.
Using Novel Behavioral Approaches to Improve Long-Term Weight Loss Outcomes

This project is a randomized controlled trial to compare the efficacy of two interventions- one based on Acceptance and Commitment Therapy (ACT) and one based on Self-Regulation (SR)- and a control group (called weight loss only (WLO)) on 24-month weight loss outcomes. All participants will first participate in an initial 4-month standard behavioral weight loss program. Participants will be randomized into 1 of 3 groups and receive a 3-part workshop; the ACT workshop will teach ACT skills including acceptance and mindfulness techniques designed to promote behavior change and health behavior persistence consistent with one's core values. The SR program will focus on self-regulation, regular weighing, and modeling behavior on successful maintainers. The WLO group will receive a control workshop focused on cooking demonstrations and general nutrition topics.The primary outcome is weight loss at 24 months. The secondary outcome is change in psychological flexibility, a critical component of ACT interventions and a potential innovative mediating mechanism. Primary Hypothesis: At 24 months, the ACT group will show significantly greater weight loss as compared to the SR and WLO groups.


Eligibility Criteria:
Inclusion Criteria:

* BMI 27.5-40
* Age 30-65

Exclusion Criteria:

* currently participating in a weight loss program
* pregnant or planning to become pregnant
* medical condition that would preclude physical activity
* terminal illness
* plans to relocate
* history of substance abuse or psychological problems that are judged by the investigators to be likely to interfere with study participation
Screen to Save: NCI Colorectal Cancer Outreach & Screening Initiative

The purpose of this study is to provide educational materials and information regarding colorectal cancer (CRC), CRC screenings, and United States Preventive Services Task Force's (USPSTF) screening recommendations. USPSTF recommends screening for colorectal cancer starting at age 45 years and continuing until age 75 years.


Eligibility Criteria:
Inclusion Criteria:

* Between 45 and 75 years of age
* Spanish or English speaking
* Able to provide informed consent
* Reside in the Tampa Bay area (namely Hillsborough, Pinellas, Polk or Pasco county)

Exclusion Criteria:

* Does not meet inclusion criteria
THalidomide on Left ventricUlar Morphology aND Function in congEstive heaRt Failure

Several studies have shown that inflammation and matrix degradation have pathogenic effects on the myocardium by influencing heart contractility, inducing hypertrophy, degrading the matrix, or enhancing fibrosis, thus contributing to the continuous myocardial remodeling process.

The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of congestive heart failure (CHF).

Previous, small investigations have shown an improvement in left ventricular ejection fraction and a favorable cardiac remodeling during thalidomide therapy.

Purpose

Several studies have shown that inflammation and matrix degradation have pathogenic effects on the myocardium by influencing heart contractility, inducing hypertrophy, degrading the matrix, or enhancing fibrosis, thus contributing to the continuous myocardial remodeling process.

The sedative and antinausea drug thalidomide has been shown to have both anti-inflammatory and antioncogenic properties that could be of benefit in case of congestive heart failure (CHF).

Previous, small investigations have shown an improvement in left ventricular ejection fraction and a favorable cardiac remodeling during thalidomide therapy.

Purpose

The primary objective of this study is to carry out a double-blind, randomized, placebo-controlled study to assess the effects of oral thalidomide on left ventricular morphology and function in patients with CHF

Eligibility Criteria:
Inclusion Criteria:

* Left ventricular ejection fraction \< 50%
* Signs and symptoms of stable CHF
* NYHA III or IV functional class

Exclusion Criteria:

* Women of child bearing potential patients must demonstrate a negative pregnancy test performed within 24 hours before CT
* Clinical instability
Real-world Elecsys® GAAD Implementation and Validation to Improve Surveillance and Early Detection of HCC

Patients with liver cirrhosis are at high risk of developing hepatocellular carcinoma (HCC) which implies significant mortality. At present current surveillance methods detect hepatocellular carcinomas at a late stage resulting in few treatment options for patients and, in the majority of cases, premature death.

The goal of this study is to implement Elecsys® GAAD in real-world hepatocellular carcinoma surveillance for those with liver cirrhosis.

The main questions it aims to answer are:

* Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway increase early detection of HCC?
* Does the introduction of the Elecsys® GAAD algorithm to the surveillance pathway reduce false positive tests and unnecessary confirmatory investigations?
* Does the new surveillance pathway improve adherence?

Researchers will compare Elecsys® GAAD with standard of care tests to see if it results in earlier detection of hepatocellular carcinoma and will explore potential improvements to the surveillance pathway.


Eligibility Criteria:
Inclusion Criteria:

• Patients with known liver cirrhosis referred into or already under hepatocellular carcinoma surveillance

Exclusion Criteria:

* Pregnancy/breast-feeding.
* Patients who do not have liver cirrhosis
* Patients who already have hepatocellular carcinoma
* Any patient who is unable to understand, retain and weigh information to make an informed decision, will be excluded from the study. The investigators will use every opportunity, including tele-interpretation services to minimise this from happening.
Safety and Tolerability Ultra-high-caloric Food Supplements in Amyotrophic Lateral Sclerosis (ALS)

The LIPCAL-ALS study (NCT02306590) has provided preliminary evidence that a high-caloric nutrition might prolong survival in fast-progressing ALS patients. Since increasing the amount of calories of the intervention might possibly increase the beneficial effect, the investigators seek to investigate whether an ultra-high caloric diet (UHCD), featuring the double amount of calories compared to LIPCAL-ALS, will be well tolerated by ALS patients and may serve as an intervention for a potential LIPCALII study. For this purpose, the investigators will compare two different UHCDs (one fat-rich and one carbohydrate-rich) with regard to safety and tolerability over a time frame of 4 weeks. A third group will receive the original diet from LIPCAL, and a fourth group will receive no intervention (control group).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Amyotrophic Lateral Sclerosis (ALS) according to the revised version of the El Escorial criteria (Ludolph et al. 2015)
* Slope of ALS Functional Rating Scale Revised (ALSFRS-R) of \>0.25 points per month at baseline visit based on the formula (48 - score at baseline visit) / (time between date of first symptom and baseline visit)
* stable on standard therapy riluzole (100 mg/day) for at least 4 weeks
* capable of thoroughly understanding all information given and giving full informed consent according to good clinical practice (GCP)

Exclusion Criteria:

* already taking any dietary supplements
* participation in another clinical trial within the preceding 8 weeks
* tracheostomy or assisted ventilation of any type which exceeds 23 hours per day
* pregnancy or breast-feeding females
Vitamin K2 Supplementation and Arterial Stiffness in the Renal Transplant Population (The KING Trial)

This study is a single arm, single center clinical trial that aims to evaluate the effect of 8 weeks of vitamin K2 replacement (360 mcg/day) on the progression of arterial stiffness in stable renal transplant patients.


Eligibility Criteria:
Inclusion Criteria:

* Functional renal graft
* Stable renal function for at least 3 months prior to enrollment

Exclusion Criteria:

* History of thrombotic events
* Diagnosed coagulopathy
* Cardiovascular event in the past month prior to enrollment
* Current or planned pregnancy
* Lactation
* Soy allergy
* Concomitant or recent (past 6 months) use of supplements that contain vitamin K
* Warfarin treatment
* Known intestinal malabsorption or hypomotility syndromes