cyrilzakka/clinical-trials huggingface dataset:
Islet After Kidney Transplant for Type 1 Diabetes

The purpose of this study is to determine if prolonged administration of the anti TNF (tumor necrosis factor)-Alpha agent etanercept is associated with enhanced graft survival in patients undergoing islet after kidney transplantation.


Eligibility Criteria:
Inclusion Criteria:

* Patients with type 1 diabetes mellitus, who have a stable functioning renal transplant, are taking the appropriate maintenance immunosuppression and have no severe health problems that preclude them receiving an islet transplant will be considered for inclusion.

Exclusion Criteria:

* Have a history of or findings suggestive of unstable diabetic complications (e.g. active eye disease)
* Active infections (clinically or by laboratory testing)
* History of current malignancy or suspicion of malignancy until properly investigated and excluded
* Liver or biliary abnormalities
* Unstable cardiovascular disease
* Findings to suggest immunological sensitization or those women who have the potential to get pregnant and are not using a sufficient method of contraception
Study in Healthy Volunteers of the Bioavailability of Dexpramipexole Tablets and Food Effects

To assess the bioavailability of dexpramipexole when mixed in soft food and water, and in intact tablet form in the fasted and fed states in healthy volunteers.

The effect of food on dexpramipexole bioavailability following administration of the proposed commercial formulation (capsule-shaped tablet) at the anticipated therapeutic dose (150 mg twice daily) has not been studied. Therefore, this study has been designed to evaluate the effect of a standard high-fat, high-calorie meal on dexpramipexole bioavailability following administration of a single 150 mg dose in healthy volunteers, consistent with US Food and Drug Administration (FDA) and European Medicines Agency (EMA) recommendations.

Additionally, patients with ALS can have difficulty swallowing tablets, necessitating alternative methods of administration for the drug. Therefore, this study has also been designed to evaluate the bioavailability of dexpramipexole mixed with water or crushed in soft food (applesauce).

Eligibility Criteria:
Inclusion Criteria:

* Subjects who, in the opinion of the Investigator, are healthy as determined by pre-study medical history, physical examination and 12-lead ECG.
* Adult males/females aged 18 to 55 years inclusive.
* Male subjects and female subjects of childbearing potential must practice effective contraception during the study and 90 days after their last dose of study drug.

Exclusion Criteria:

* History of malignant disease, including solid tumors and hematologic malignancies.
* History of any clinically significant endocrine, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, or other major diseases, as determined by the Investigator.
* Surgery within 90 days prior to check in.
Microcurrent Device (TIVIC Health)

The purpose of this study is to investigate whether daily use of a microcurrent neuromodulation device, which applies a small current of electricity to the forehead and maxillary region, will decrease the pain experienced by patients in the days following functional endoscopic sinus surgery (FESS). This study is a prospective randomized controlled study. Enrolled subjects will be randomized (1:1) to receive either an active neuromodulation study device or a sham device that appears identical to the active device while emitting no therapeutic microcurrent. Subjects will self-treat with the device at home and will be followed for 2 weeks after FESS.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for FESS functional nasal or endoscopic sinus surgery
* Possessing an American Society of Anesthesiologists physical status classification of I or II
* Age ≥ 18
* Possess the capacity to give informed consent
* Able to read, write and understand English or Spanish
* Able to attend follow up visits at postop days 7 and 14 Visit 1 (within 0 - day 14) and post-op Visit 2 (within 10 - 21 days)
* Postop pain VAS ≥ 5 in PACU phase II

Exclusion Criteria:

* Age \< 18
* Does not understand English or Spanish
* Does not meet inclusion criteria
* History of chronic pain
* Experiencing chronic pain requiring opioids at baseline and/or who are under the care of pain management specialists
* Neurologic disorders (including seizure disorders)
* Undergoing planned or unplanned additional procedures at the time of FESS surgery
* In custody of the state
* Prisoners
* Known to be pregnant
* Implanted cranial metallic components or devices including deep brain stimulators or cochlear implants
* Has an implanted or external worn cardiac device including pacemakers, automated implantable cardioverter defibrillator (AICD), or any other cardiac electric devices (including non-implanted devices, e.g. defibrillator vest)
VPIA Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration

This study is a prospective cohort study aiming to evaluate an improved VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia

This study trials a new Vital signs-controlled patient-assisted intravenous analgesia (VPIA) regimen using a purpose-built pump that aims to enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. The system studies the parturient's pattern of analgesic use in 15 minute epochs and titrates the demand doses and basal infusion rate to maintain a plasma level of remifentanil that is appropriate for the degree of pain felt.

The system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm which would temporarily stop the pump and step down doses accordingly when predefined critical values are reached.

Eligibility Criteria:
Inclusion Criteria:

* Patients who choose to use parenteral opioid for pain relief with informed consent
* Patients who refuse labour epidural analgesia or with contraindication to epidural analgesia (eg. thrombocytopaenia, previous thoraco-lumbar spinal instrumentation)
* Gestational age of \>= 36 weeks

Exclusion Criteria:

* Patients who are unable to understand instructions given regarding the use of patient controlled analgesia (PCA) or unable to self administer PCA boluses
* Patients with difficulty in communication due to language differences
* Patients with known hypersensitivity to remifentanil or any component of its formulation or to other fentanyl analogue
* Patients with severe respiratory disease
* Patients with history of drug dependence of recreational drug abuse
* Patients with unmanaged foetal bradycardia
Topotecan Vs. Topotecan + Etoposide Vs.Topotecan + Gemcitabine in Ovarian Cancer Therapy

Determination of total survival under Topotecan Monotherapy, Topotecan + Etoposide and Topotecan + Gemcitabine in second-line therapy in patient with recurrent ovarian cancer.

In Germany ovarian cancer belongs to the most frequently forms of cancer in the female population. The prognosis for women with a platin refractory ovarian cancer is very bad. The median survival time amounts for less a year. Especially in this palliative situation therapies regarding efficacy as well as quality of life are needed. in Germany Topotecan is approved since 1996 for patients after previous treatment with platin, the rare non-hematological side-effects making it interesting for a palliative therapy. Since best results in a chemo-therapeutical treatment are commonly obtained with the combination of two or more cytostatic agents this study tests a Topotecan Monotherapy and two Topotecan combinations. Both combination agents show efficacy alone against solid cancer using from Topotecan different mechanism resulting in different main side effects. Total survival, remission rates, time ti progression and quality of life are the main criteria investigated.

Eligibility Criteria:
Inclusion Criteria:

* Patient with recurrent ovarian cancer
* Second-line chemotherapy
* \> = 18 years of age
* ECOG \< = 2

Exclusion Criteria:

* ECOG \> 2
* Patients with more than one chemotherapy in anamneses
Inforcing Spiritual Care: Enhancing Well-Being and Competency in Psychiatric Nurses

This study was done to evaluate the effectiveness of spiritual care education program in enhancing the well-being and competency of psychiatric nurses.

After explaining the aim of the study, an official permission from the aforementioned psychiatric institutions will acquired to carry out the study. In order to prevent conflicts with regular hospital nursing shifts, the study team had arranged the instructional sessions with the head of nurses. Nursing who fulfilled the qualifying requirements and gave their verbal, informed consent was taken by the researchers. Nurses completed the self-administered data collection sheet. The self-administered questionnaire was completed in 15-20 minutes on average. The pre-test questionnaire was first given to both groups prior to the start of the educational session in order to gather data. The post-test was administered using the same pretest questionnaire.

Intervention of spiritual care education/training program For eight weeks, the intervention group participated in a spiritual care education program that aimed to improve their ability to provide spiritual care. Program orientation, an introduction to spiritual care, the concepts of spiritual care, the significance of spiritual care, the theoretical underpinnings of spirituality in mental health, practical strategies for integrating spiritual care in psychiatric nursing, reflective practice, and self-care for enhancing personal spirituality were all covered in the program's weekly two-hour sessions. Throughout the study period, the control group received no intervention and carried on with their regular nursing practice without any further instruction.

The baseline (pre-intervention) questionnaire was given simultaneously to the intervention and control groups in order to gather data at two different times. A questionnaire measuring spiritual well-being and spiritual care competency was filled out by both groups. The filled surveys were gathered by the study team. Both the intervention and control groups received the immediately post-intervention questionnaire simultaneously, right after the educational program concluded.

Eligibility Criteria:
Inclusion Criteria:

The participants of this study were 98 psychiatric nurses working in previously mentioned psychiatric settings and who fulfilled the following inclusion criteria as both male and female, had one year of experience in psychiatric care, willingness to participate in the study and provide informed consent and did not enroll in any ongoing spiritual care-related training.

Exclusion Criteria:

Nurses refused to participate Nurses not on the full duty
Efficacy, Tolerability, and Safety of NXN-462 in Patients With Post-Herpetic Neuralgia

The purpose of this study is to investigate whether NXN-462, a selective nNOS inhibitor, is effective in reducing pain levels in patients with post-herpetic neuralgia.

NXN-462 is designed to target the nitric oxide synthase system (NOS), specifically the neuronal NOS (nNOS) isoform. By design, NXN-462 is a potent inhibitor of nNOS with good affinity, and has little or no affinity for a range of G protein-coupled receptors, ion channels, and enzymes. NXN-462 is being developed as an oral therapy for the treatment of neuropathic pain syndromes, including PHN. This drug design strategy provides a new therapeutic paradigm for the treatment of chronic neuropathic pain.

Eligibility Criteria:
Inclusion Criteria:

* Male, or a non-pregnant, non-lactating female 18 years or older
* Have voluntarily provided written informed consent
* able to speak, read, write, and understand English
* clinical diagnosis of PHN for a minimum of 6 months
* pain intensity score of ≥3 on a 0-10 Numerical Rating Scale (NRS) at the Screening Visit
* generally in good health (other than PHN) at Screening

Exclusion Criteria:

* Are pregnant and/or lactating
* Diagnosis of any chronic pain syndrome that would interfere with the assessment of PHN
* evidence of multiple causes of neuropathic pain,e.g.lumbar radiculopathy in the lumbosacral area
* Have had neuroablation or neurosurgical intervention for PHN
* Have been taking opioid analgesics for \>5 days/week
* Have received nerve block or intrathecal analgesia within 6 weeks of the study
* History of significant gastrointestinal disease, liver disease, renal disease, endocrine disease, or cardiovascular disease
* clinically significant abnormal clinical laboratory test results or vital signs
* Are immunocompromised or immunosuppressed for any reason
* History of alcohol or other substance abuse (not including nicotine or tobacco) within 5 years
* Significant psychiatric disorder which requires drug treatment (except depression or anxiety treated with Selective Serotonin Re-uptake Inhibitors)
* Have received an investigational drug or have used an investigational device within 30 days of Screening.
* Have previously been randomized to this study
Safety of Liposom With Citalopram in Elderly Patients With Major Depressive Disorder

The purpose of this study is to determine if Liposom Forte will enhance the response to antidepressant therapy with citalopram in elderly patients suffering from Major Depressive Disorder (MDD).

The effects of phospholipid liposomes when associated with antidepressant drugs are very interesting. In addition to an improvement of somatic symptoms of depression, measured with the Hamilton Rate Scale for Depression, liposomes are able to reduce the latency of onset of the antidepressant activity of drugs like amitriptyline, clomipramine, and trazodone. These results indicate that phospholipids can be used as an adjuvant to antidepressant therapy, also allowing specific antidepressant drug dose reduction. Thus, the hypothesis is that combination therapy would not only lead to greater efficacy, but also to a more rapid onset of therapeutic response. The addition of Liposom Forte may be clinically important since it may ensure the use of lower citalopram doses, thereby reducing the risk of adverse events, and this may prove to be important, especially in elderly people.

Eligibility Criteria:
Inclusion Criteria:

1. Meets DSM-V criteria for major depressive disorder
2. Score of ≥ 16 in the HAM-D
3. Score of ≥ 23 on the Mini-Mental State Exam (MMSE-2)
4. Aged ≥ 65 and \< 85 years
5. Patients able to understand the study procedures and to comply with protocol requirements
6. Patients legally able to give written informed consent to the trial (signed and dated by the subject)

Exclusion Criteria:

1. Any contraindication for treatment or intolerance to Liposom Forte or citalopram
2. Congenital long QT syndrome, bradycardia, recent acute myocardial infarction, uncompensated heart failure or concomitant use of drugs that prolong the QT interval
3. History of psychiatric disorder other than major depressive disorder, including history of substance use disorder
4. Presence of psychotic symptoms, even if they are not sufficient to make diagnosis of a mental disorder
5. Severe organic disease (e.g., major surgery, metastatic cancer, stroke, delirium, severe neurological disorder, heart attack, chronic heart failure, asthma, severe cardio circulatory disorders)
6. Diabetes Mellitus type I and II
7. Acute suicidal or violent behaviour or history of suicide attempt within the year prior to study entry or current suicidal ideation
8. Treated with long acting injectable (LAI) antipsychotics within 6 months prior to study entry
9. Treated with any antipsychotics, antidepressant, food supplements or over-the-counter CNS-active medications (e.g, St. John's Wort, melatonin, Selective Serotonin Reuptake Inhibitors \[SSRIs\], Serotonin and norepinephrine reuptake inhibitors \[SNRIs\], Monoamine-Oxidase Inhibitors \[MAOIs\], or other antidepressants) within 4 weeks prior to the first administration of study medication
10. Ongoing or planned psychotherapy or other psychological treatment during the study period
The Diagnostic Value of 18F-FET PET/MRI for CNS Tumors in Children and Adolescents

To investigate the diagnostic value of 18F-FET PET/MRI instead of MRI alone, children and adolescents with tumor in brain or spinal cord are included and scanned primarily at our hybrid PET/MRI using the amino acid analog 18F-FET. The scans are performed at primary diagnosis, before radiation therapy, before and after operation, when relapse is suspected and three or six months after initiation of chemotherapy.

Background. Tumors in the brain and spinal cord are among the most common causes of death and disability by cancer in children and adolescents. MRI is used for primary diagnosis as well as follow-up but is often challenged by tissue changes caused by the treatment. The amino acid analog 18F-FET is used increasingly in adults to delineate tumor and discriminate tumor from treatment effects. A hybrid PET/MRI scanner enables the simultaneous imaging with PET and MRI, which is important in especially the younger children needing anaesthesia to cooperate to the procedure.

Aim The aim of the study is to compare diagnostics using MRI alone with 18F-FET PET/MRI (or sequential MRI and PET) in children and adolescents diagnosed with a central nervous system (CNS) tumor before the age of 18 years. The scans will be performed at primary diagnosis/before operation/biopsy, within 72 hours after operation, planning radiation therapy, evaluation of treatment effect, when relapse is suspected.

Exclusion criteria are MRI contraindications, pregnancy, or a syndrome with increased sensitivity to radiation.

The investigators wish to evaluate which cases and for which tumor types, 18F-FET PET/MRI will increase sensitivity and specificity of diagnosing CNS tumors.

Side effects The side effects are mainly the side effect from the MRI with venous puncture, the MRI contrast leading that can lead to shortlived nausea or headache, fasting for 6 hours and the radioactivity exposure of 4.2 mSv (1,4 times the early background radiation) for each scan procedure. The maximal number of scans in the project is 3, 6 or 10 depending on the diagnosis.

Data Analysis The correlation between 18F-FET uptake in tumor and tumor grading (obtained from operation/biopsy) will be investigated.

When relapse is suspected, sensitivity and specificity for recurrence/progression for MRI alone versus PET/MRI will be compared.

It will be analysed if the addition of PET influences the diagnosis/chosen treatment. A major impact of 6% will be regarded significant.

The prognostic value of 18F-FET uptake after treatment will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Suspicion of newly diagnosed CNS tumor, recurrence or radiation therapy planning
* age \<18 years at first CT/MRI suggesting CNS tumor
* written informed consent from parents (age \< 18 years) or the patient (age \>18 years)

Exclusion Criteria:

* contraindications for MRI (e.g. metal implants)
* pregnancy
* known syndrome with increased sensitivity to radiation (e.g. Gorlin or Ataxia Telangiectasia
Postoperative Therapy After Interposition Arthroplasty in CMC1

In this randomized controlled trial the investigators want to investigate whether early versus late mobilisation after surgery in the first carpometacarpal joint (CMC1) leads to a faster recovery of hand function. The investigators also want to explore patients' satisfaction with the two different treatment regimes. The participants in the control group will receive the standard treatment at Diakonhjemmet hospital: immobilisation of the thumb in a splint for six weeks. The participants in the intervention group will use a soft splint for six weeks, but will be instructed to remove the splint daily to perform exercises for the thumb. A total of 70 patients will be included in the study.


Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis in CMC1 diagnosed by radiography and a surgeon.
* Planned surgery(interposition arthroplasty) in CMC1
* Ability to communicate in Norwegian

Exclusion Criteria:

* Surgery involving other joints of the hand in addition to CMC1.
* Previous surgery of the same thumb.
* Other diseases og injuries that could influence hand function.
* Mental or cognitive deficit.
Erector Spinae Plane Versus Transversus Abdominis Plane Block for Pain Control

The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS.

The present stratified randomized study aimed to compare the analgesic efficacy and safety profile of ESPB and TAPB used for postoperative pain management in obese and morbidly obese women undergoing CS. The present study will include ASA I-II women scheduled for elective CS under intrathecal anesthesia. Patients will be excluded if they had local infection, bleeding disorder or known allergy to any of the study medications. This study defines obesity as body mass index (BMI) ≥ 30 kg/m2 while morbid obesity is defined as BMI ≥ 40 kg/m2 assessed in the last pre-pregnancy visit (Sagi-Dain et al., 2021). The study will include normal weight women (n=86), obese women (n=86) and morbidly obese women (n=86).

Eligibility Criteria:
Inclusion Criteria:

* ASA I-II women scheduled for elective CS under intrathecal anesthesia.

Exclusion Criteria:

* had local infection, bleeding disorder or known allergy to any of the study medications
Is Perfusion Index an Indicator of Block Success in Ultrasound-guided Infraclavicular Brachial Plexus Block

The infraclavicular nerve block, which is frequently preferred in upper extremity surgeries, provides additional advantages such as reduction in opioid consumption by providing analgesic effect in the postoperative period as welll. The success of peripheral nerve blocks is usually assessed by subjective feedback from the patient, and patient cooperation is needed. The aim of this study is to assess whether the perfusion index level, which can be measured noninvasively, can be a predictor of the infraclavicular block success.

Thirty patients who were operated on for carpal tunnel syndrome under infraclavicular brachial plexus block were included in our study. After the procedure, at 10-minute intervals, the sensory block was assessed by a pinprick test, and the motor block was assessed by the ability to flex the hand and the forearm. In addition, PI and skin temperature were measured 0-10-20-30 minutes after the block and at postoperative 2, 4, and 6 hours. 30 minutes after the measurements, the surgical procedure was allowed to begin in patients with successful block.

Eligibility Criteria:
Inclusion Criteria:

* Ages of 18-75
* Patients who will diagnose with carpal tunnel syndrome by electroneuromyography (ENMG), and will undergo unilateral surgery under elective conditions
* ASA I-II-III patients

Exclusion Criteria:

* Patients who will refuse this method
* Neurological deficits,
* Diabetes mellitus,
* Local anesthetic allergy,
* Morbidly obese,
* Peripheral vascular disease, coronary artery disease, or coagulopathy