cyrilzakka/clinical-trials huggingface dataset:
TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study

Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. This study is a biobank and cohort study which investigates this hypothesis.

Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. To investigate this hypothesis we have detailedly phenotyped 606 renal transplant recipients who at the time of inclusion all were one year or more after transplantation, therewith providing a representation of stable outpatient renal trannsplant recipients late after renal transplantation. At the time of these baseline measurements, we also created a biobank with plasma, serum and aliquots of 24h urine collections. Beyond baseline, we have a regular update on adverse events, including all-cause mortality, cause-specific mortality, graft failure and development of new-onset diabetes after transplantation (NODAT).

Eligibility Criteria:
Inclusion Criteria:

* More than one year after renal transplantation
* History of renal transplantation

Exclusion Criteria:

* Signs of active infection
* Signs of active cardiac decompensation
* Active malignancy other than skin cancer
* Prognosis \< 1 year
Needle-X: Usability Testing of a Smartphone Application

Mobile health interventions offer a longitudinal approach to reducing the burden of substance use disorders and may stem the rise of the opioid overdose epidemic. Smartphone applications are one of the most popular mobile phone features nationally, among patients in addiction treatment, and among criminal justice involved (CJI) patients enrolled in addiction treatment. This research conducted at Bellevue Hospital's inpatient detoxification program established attitudes and self-reported behaviors favorable to theoretical smartphone applications addressing opioid use, HIV, and HCV prevention and management strategies. This study aims to assess the feasibility and usability of a smartphone application to enhance access to sterile needles, naloxone overdose kits, and addiction treatment programs in New York City.


Eligibility Criteria:
Inclusion Criteria:

* Fluent in spoken and written English;
* Meets or has previously met DSM-5 criteria for current opioid use disorder, of at least moderate severity;
* Owns or has owned a smartphone

Exclusion Criteria:

* Any patient who does not meet the inclusion criteria as above, is clinically unstable per the unit admitting physicians, refuses to participate in the study, or is cognitively impaired.
Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease

This study will investigate the efficacy of the Flutemetamol (18F) Injection PET tracer in identifying abnormal (18F) flutemetamol uptake patterns which predict the conversion from aMCI to a b-amyloid associated clinically probable Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* The subject is 60 years old or older.
* The subject meets the Petersen criteria for amnestic MCI.
* The subject has a score of less than or equal to 4 on the Modified Hachinski Ischemic Scale.
* The subject has a MMSE score of 24-30.
* The subject has a non-contrast MRI examination as part of the screening visit that excludes aMCI arising from structural causes.
* The subject and/or the subject's legally acceptable representative, if applicable, in accordance with local regulations, has signed and dated an informed consent.

Exclusion Criteria:

* The subject has any significant neurologic disease other than suspected aMCI; such as Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits, or known structural brain abnormalities.
* The subject has one or more aneurysm clips, artificial heart valves, metal implants, embedded metal fragments or pacemakers that would pose a risk during an MRI.
* The subject has major depression, bipolar disorder, as described in the DSM-IV within the past year.
* The subject has history of schizophrenia (DSM-IV criteria).
* The subject has had, within the prior 3 months, psychotic features, agitation or behavioral problems that could lead to protocol compliance issues.
Edmonton Symptom Assessment Scale: Self-Completion vs. Assisted-Completion

The goal of this research study is to learn how easy participants think it is to complete a symptom questionnaire.

If participant agrees to take part in the study, basic information about them will be collected from their medical record (such as their age, gender, ethnicity, religion, diagnosis, marital status, educational level, performance status, and any drugs they may have taken in the past or are currently taking).

Participant will also be given a list of words and asked to read them out loud. The research nurse or assistant will write down if participant pronounced the words correctly. This should take up to 7 minutes.

Participant will then be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

* If participant is enrolled in Group 1, they will complete the symptom questionnaire alone and then a research nurse or assistant will go over their answers with them.
* If participant is enrolled in Group 2, they will complete the symptom questionnaire with the help of the research nurse or assistant.

After participant has completed the symptom questionnaire, they will be asked if they preferred completing the questionnaire alone or if they preferred to have a nurse help them answer the questions. This should take about 1 minute to answer.

Length of Study:

It should take about 15 minutes total to complete the study. Patient's participation on this study will end after they have completed the symptom questionnaire.

Additional Information:

Participant is taking part in this study alone. Participant's family members will not be in the room with them.

This is an investigational study.

Up to 128 participants will be enrolled in the study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of advanced cancer, including recurrent, locally advanced, or metastatic cancer
2. Patients must know their cancer diagnosis
3. Patients referred for consultation to the Supportive Care team
4. Age \>/= 18
5. Patients must be able to understand, read, write, and speak English
6. Patients have never done the ESAS before
7. Patients must sign an informed consent
8. Ability to independently complete the study as assessed by the research staff

Exclusion Criteria:

1. Patients who have clinical evidence of cognitive impairment as determined by the research staff
2. Patients who have already done the ESAS in the past.
3. Patients who are considered to be in severe physical or emotional distress based on the assessment by the research staff
4. Patients who refuse to participate in the study.
Smartwatch-supported Internet-delivered Intervention for Depression

The current study seeks to investigate the acceptance of the use of a smartwatch in an internet-delivered Cognitive Behavioural Therapy (CBT) based intervention for depression.

Eligible patients (n=70) will be invited to use the supported intervention over an 8-week period. Participants who have indicated consent will be randomised in two arms: iCBT intervention - treatment as usual (n=35) and iCBT intervention with smartwatch (n=35). Participants in the smartwatch group will be lent a smartwatch for the duration of treatment, with an app allowing them to monitor their mood in the moment, and keep track of their daily sleep and activity level. All participants will be asked to complete an acceptance questionnaire regarding the technology at three time points: before first use, at 3 weeks, and 8 weeks. This study will contribute to the growing literature on acceptance of technology supporting mental health interventions worldwide. The results may help to establish criteria for patient acceptance of the smartwatch technology as a treatment enhancer in the context of mental health interventions.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for the internet-delivered CBT intervention 'Space from Depression'
* Own a compatible mobile device (iPhone 6 or upper)

Exclusion Criteria:

* Suicidal intent/ideation; score \>2 on PHQ-9 question 9
* Psychotic illness
* Alcohol or drug misuse
* Previous diagnosis of an organic mental health disorder
* Currently in psychological treatment for depression symptoms
* Unstable medication regimens
Ritalin, Memory and Attention in MCI: a Behaviour-EEG Study

Traditionally, memory impairments in the elderly population are treated using cholinesterase inhibitors, although impairments remain after treatment. Dopamine (DA) is also involved in cognition and is especially of interest in healthy ageing because of the role in processing speed and cognitive control. To what extent dopamine treatment improves memory and attention in older impaired individuals is unknown. However, such an effect is conceivable because of the close relationship between memory and attention in aging and since improved processing speed and cognitive control may lead to improved memory.

The investigators aim to examine, in the impaired older population, whether a treatment using methylphenidate, a DA re-uptake inhibitor that enhances DA, improves attention and memory. The study will be conducted according to a cross-sectional, double-blind, placebo-controlled, 2-way cross-over design. 20 male and female patients with Mild Cognitive Impairment (MCI), amnestic type, aged above 60 years of age; 20 male and female patients with MCI, non-amnestic type, will be recruited from the Orbis Medical Centre. Participants will be treated once with 20 mg methylphenidate (MPH) and once with placebo. All medications will be administered orally with a capsule. The treatment order will be established by counterbalancing.


Eligibility Criteria:
Inclusion Criteria:

* The participant has been diagnosed with Mild Cognitive Impairment, either of the amnestic or the non-amnestic type.
* In the opinion of the investigator, the participant is capable of understanding and complying with protocol requirements.
* The participant signs and dates a written informed consent form.
* The volunteer is male or female.
* The participant is aged 60 to 80 years, inclusive, at the time of informed consent.
* The participant has a body mass index of 18.5-30, inclusive, at medical screening.
* The volunteer is healthy, i.e. absence of all exclusion criteria and has normal static binocular acuity (corrected or uncorrected) as well as normal hearing (using a whisper test during medical screening).

Exclusion Criteria:

* The subject has uncontrolled, clinically significant neurologic, cardiovascular, pulmonary, hepatic, renal, metabolic, gastrointestinal, or endocrine disease or other abnormality which may impact the ability of the subject to participate or potentially confound the study results.
* The volunteer has uncontrolled existing major psychiatric symptoms.
* The subject has uncontrolled hypertension.
* The volunteer has hyperthyroidism.
* The participant has known hypersensitivity to any component of the formulation of MPH or related compounds.
* The participant has glaucoma.
* The subject has a history of drug abuse (defined as any illicit drug use) or a history of alcohol abuse within 1 year prior to the first visit or is unwilling to agree to abstrain from alcohol from 24 hours prior to each test day and/or drugs throughout the study.
* The participant has any sensory or motor deficits which could reasonably be expected to affect test performance.
Proof-of-concept to Evaluate the Efficacy and Safety of Prednisone in Idiosyncratic Hepatotoxicity

This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value.

This trial´s aim is to assess if oral prednisone (compared to placebo), administered over five weeks is beneficial in terms of decreased total bilirubin (TBL): reduction of the peak of TBL at least 50% at 14 days or reduction in the time to normalisation of TBL value, and to assess if oral prednisone (compared to placebo) is safe and well tolerated in patients with acute moderate to severe DILI.

Eligibility Criteria:
Inclusion Criteria:

1. Female and male patients, aged ≥ 18 years.
2. Patients who have been diagnosed with DILI by the expert committee.
3. Patients with moderate to severe DILI (elevations of ALT or AST ≥ 5 times the Upper Limit of Normal (ULN) and serum TBL ≥ 2.5 mg/dL).
4. Patients who do not show a 15% reduction in ALT values or TBL continues to increase 5-10 days after liver damage recognition despite the withdrawal of the culprit drug.

Exclusion Criteria:

1. No clear DILI diagnosis after an expert committee DILI assessment.
2. DILI due to immune-checkpoint inhibitors.
3. Presence of active infection as evidenced by positive urine or blood culture.
4. Acute liver failure (international normalized ratio (INR) \> 1.5 and hepatic encephalopathy).
5. Model for End-Stage Liver Disease (MELD) ≥ 30.
6. Known hypersensitivity to prednisone or placebo components.
7. Pregnant or nursing mothers.
8. Co-existing infection with hepatitis C, hepatitis B, or human immunodeficiency virus (HIV).
9. Patients already receiving systemic steroids or other immunosuppressants.
10. Inability to provide informed consent.
11. Presence of clinically significant comorbid illnesses (by clinician's criteria) that might impede the completion of the study.
EUS-Guided Drainage of Refractory Malignant Ascites

This study evaluates the efficacy and safety of drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses. Patients with cancer older than 18 years with a life expectancy of less than 6 months who undergo EUS-Guided will be included in the study.

Malignant ascites is described as the presence of fluid in the abdominal cavity due to the presence of tumors. Its appearance is a predictor of worse prognosis in the evolution of malignant neoplasm and reduces the quality of life of patients.

The use of prostheses with drainage to the gastric cavity has shown good clinical results as the reduction of paracentesis evacuation needs. This achieves the reduction of hospital admissions and the improvement of the quality of life of the patient.

In order to verify the usefulness of this drainage technique, a prospective observational study has been designed. Patients with cancer over 18 years of age will be included, with a life expectancy of less than 6 months and who have undergone drainage of refractory malignant ascites through the implantation of plastic prostheses.

Participants receive the intervention in the same manner and intensity if they are not enrolled in the study.

Eligibility Criteria:
Inclusion Criteria:

* Cancer patients in terminal phase with refractory malignant ascites older 18 years of age

Exclusion Criteria:

* Patients under 18 years of age
* Patients with a life expectancy greater than 6 months
* Patients who are receiving cancer treatment for curative purposes or who suffer from a psychiatric disorder that prevents them from understanding and accepting the procedure
* Patients who do not accept to participate in the study.
Triamcinolone Levels in Cochlear Perilymph, Lateral Canal and CSF

Patients undergoing surgery of a vestibular schwannoma will be included in the study. Patients will receive triamcinolone acetonide 24h before surgery. During translabyrinthine surgery cochlear perilymph, perilymph from the semicircular canal and cerebrospinal fluid will be taken and analyzed for triamcinolone content. In patients undergoing middle fossa or retrosigmoid resection only cerebrospinal fluid will be taken and analyzed for triamcinolone acetonide level.

Patients between 18 and 90 years undergoing surgery of a vestibular schwannoma will be included in the study. Patients will be offered an application of triamcinolone acetonide intratympanically on the day before surgery.

During surgery samples will be taken to define how much triamcinolone acetonide enters into the perilymphatic fluid, the perilymph of the semicircular canals and CSF.

Patients undergoing translabyrinthine surgery will undergoing labyrinthectomy during which samples of the semicircular canal can be taken. During translabyrinthine surgery nerve monitoring will be carried out using an intracochlear electrode. Before inserting the electrode perilymph of the cochlea can be taken. Immediately after opening the dura cerebrospinal fluid will be taken. Patients undergoing middle fossa or retrosigmoid resection of the vestibular schwannoma will not undergo sampling of the perilymph. In these patients cerebrospinal fluid will be taken to determine triamcinolone acetonide levels.

Eligibility Criteria:
Inclusion Criteria:

* Patients between 18 and 90 years undergoing a surgery of the cerebellopontine angle due to vestibular schwannoma and who are willing to participate in the study

Exclusion Criteria:

* Patients younger than 18 years Patients who receive cortison regularly or receive cortison i.v. or p.o. preoperatively Patients with contraindications against the administration of VolonâA
A Single-blind RCT to Investigate the Effect of a Novel Herbal Patch for the Treatment of PF

Disorders and injuries of tendons and ligaments are some of the most diagnosed musculoskeletal (MS) disorders clinically. Nearly half of the 33 million MS disorders reported in the United States each year are tendon and ligament injuries. Although most of such injuries are non-fatal, they are severely debilitating, resulting in significant reduction in patient's quality of life, loss of productivity, and considerable costs to the healthcare system.

Among all tendon and ligament disorders and injuries, tendon and ligament overuse disorders are the most common and incapacitating ones. Tendinopathy is a painful tendon overuse disorder, which increases with population aging. It has been estimated that about 30% of consultations for MS complaints in a general practice were related to tendinopathy. The affected tendon is presented with local tenderness, swelling and pain, causing physical disability of the affected individual. The affected tendon degenerates and finally ruptures. Common sites of tendinopathy include supraspinatus, common wrist extensor, flexor tendon, patellar tendon, and Achilles tendon. The outcomes of both conservative treatments and surgeries are not satisfactory, with recurrent pain and tendon retear after surgery.

Plantar fasciitis is a chronic painful, degenerative condition of the plantar fascia. It is caused by repetitive traumas at its origin on the calcaneus. Plantar fascia is a thick, ribbon-like fibrous ligament that connects the medial calcaneal tubercle to the heads of the metatarsal bones. It contributes to the support of the foot arch by acting as a tie-rod, where it undergoes tension when the foot bears weight. Therefore, although plantar fascia is anatomically defined as a ligament, it functions similar to a tendon.

This study aims to conduct a randomized controlled study to test the efficacy of CDAM patch for the treatment of plantar fasciitis in patients.


Eligibility Criteria:
Inclusion Criteria:

* Male and female with age 18-65
* Unilateral or bilateral
* Heel pain for more than 6 weeks' duration
* VAS score ≥ 5
* Signed informed consent.

Exclusion Criteria:

* Known chronic disease or receiving long-term medications affecting bone metabolism including BPs
* Contraindication to alendronate therapy such as poor dental fitness
* ACL injury less than 6 weeks
* Injury on duty cases
* Patients who have undergone arthroscopy or open surgery in the index knee in the last 12 months
* Other associated injuries (fractures and other ligament involvement such as neurovascular bundles injury)
* Chondral lesion with concomitant intervention
* Presence of X-ray features of osteoarthritis including decrease in joint space, presence of osteophytes and subchondral cysts
* Neurological deficit
* Pregnant or breastfeeding
* Inability to give informed consent