cyrilzakka/clinical-trials huggingface dataset:
Copeptin for Prediction of Treatment Response in Children With Monosymptomatic Nocturnal Enuresis (MEN).

Monosymptomatic nocturnal enuresis (MEN) is a common problem in children, affecting 7-10% of all 7 year olds. MEN is often leading to psychosocial problems because of its burden and stigmatism.

The only available medical treatment option is the vasopressin analogum Desmopressin®. However, according to the literature, only one third of patients shows a good treatment response, defined as more than 90% of reduced bed wetting. Furthermore, treatment with Desmopressin® may lead to psychosocial problems, high costs and potentially dangerous side effects like water intoxication and hypertension.

Copeptin, mirroring arginine vasopressin (AVP), has been shown to be significantly lower in patients with MEN compared to controls and lower in patients with severe bed wetting compared to patients with only slight bed wetting.


Eligibility Criteria:
Inclusion Criteria:

* Children at the age between 5 and 16 years
* Diagnosis of monosymptomatic nocturnal enuresis
* Completion of uroflowmetry and bladder sonography if possible
* Completion of home recording charts of bed wetting episodes if possible
* Willingness to use Desmopressin® treatment

Exclusion Criteria:

* Children with daytime enuresis
* Children with lower urinary tract symptoms and infection
* Children with structural abnormalities of the urinary tract
* Children with chronic illness, esp. renal failure, hypertension, congenital heart disease, diabetes mellitus and diabetes insipidus.
Evaluate the Quality of Life of Patients With AMD

Age-related macular degeneration (AMD) is a major cause of deep visual acuity loss. Because of progressive deterioration of the macula, patients with AMD complain about progressive visual problems that can impair their quality of life in the physical, mental and social domains. The principal objective principal of this study is to describe the evolution of quality of life between the diagnosis of secondary atrophic AMD and at 18 months after confirmation of diagnosis.


Eligibility Criteria:
Inclusion Criteria:

- For the 2 populations studied

* Persons who have given consent to take part
* Persons aged 50 years or older
* Willing and able to attend all of the scheduled visits and evaluations
* Macular atrophy or drusen measuring at least 125μm or multiple drusens measuring at least 63μm
* Atrophic AMD diagnosed on OCT and by autofluorescence and OCT angiography by 2 independent experienced assessors
* Diagnosed for less than 3 years
* MAVC score ≥ 19 letters (Equivalent Snellen ≥ 20/400), by using a scale at an initial distance of 4m

For patients with secondary atrophic AMD

• Secondary atrophic AMD, defined by persistent atrophic AMD at 1 year after the last injection of an anti-angiogenic agent, and at least 2 years after the first injection.

Exclusion Criteria:

General criteria

* Persons without national health insurance cover
* Physical or mental disability ruling out participation
* Inability to sign the written consent form, adults under guardianship
* Any participation in a study involving an experimental drug during the previous 3 months (dietary supplements are authorised).
* Adults under guardianship

General medical history

• Uncontrolled AHT

Ophthalmological history

* Severe non-proliferative or proliferative diabetic retinopathy
* Uncontrolled glaucoma (defined as an intra-ocular pressure greater than 30mmHg despite treatment with an anti-glaucoma agent) or a history of filtration surgery
* Corneal disease that could impair vision
* Monogenic macular dystrophy or toxic maculopathy
* History of uveitis
* Amblyopia of the eye concerned
* Intraocular surgery in the 3 months preceding inclusion
* History of cornea transplantation in the studied eye
* Treatment affecting vision: chloroquine and hydroxychloroquine, phenothiazine, tamoxifen, interferon (93), external radiotherapy of the face and neck

Ophthalmological examination

* Significant cataract (LOCS III grade of 5 or above, annexe 5.) (94)
* Active infection in either eye
* Central anterior serous or active retinopathy in either eye
* Choroid neo-vascularisation
* Active serous retinal detachment
* Refractive error less than -15D or more than +10D
Mesothelioma Early Detection by VOCs

This is a two phase study, The first phase (phase 1) will identify potential biomarkers among asbestos exposed individuals with pleural mesothelioma. The second phase (phase 2), is a double blinded case-matched controlled study to determine the predictive capability, sensitivity, and specificity of these biomarkers in detecting early stage pleural mesothelioma. Biomarkers in the form of volatile organic compounds (VOC) in exhaled breath samples from subjects with either pleural mesothelioma or pleural plaques, will be evaluated. A biomarker present in serum will also be concurrently evaluated in the same cohort. The soluble serum biomarker mesothelin related peptides (SMRP), which has been posited as a biomarker for mesothelioma, will be analyzed for its relationship to the breath VOC profile.

Mesothelioma is a rare, aggressive and treatment-resistant disease and, in the United States, is caused almost exclusively by exposure to asbestos fibers. There is often a lengthy latency period of 40-50 years between exposure and disease onset. The median age of diagnosis is 65 years while the median survival time after diagnosis of pleural mesothelioma without treatment is 9 months. Symptoms, where present, may be non-specific, which further contributes to delayed diagnosis.

In this study, the volatile organic compound (VOC) profile of exhaled breath from subjects with histologically confirmed mesothelioma will be compared against case-matched control subjects with bilateral pleural plaques or bilateral pleural thickening. Putative markers will then be tested against a blinded cohort to test predictive value of the markers.

This study seeks to identify markers for mesothelioma using a non-invasive technique which samples volatile organic compounds (VOC) in the breath of test subjects (Owlstone Medical Ltd, Cambridge, England).

A comparison of the participant's VOC profile will be made with an FDA-approved, serum-based assay (Lumipulse Mesomark®, Fujirebio Diagnostics Inc., Malvern, PA) of the participant's soluble mesothelin related peptides (SMRP) to discern parameters of efficacy..

Eligibility Criteria:
Inclusion Criteria

* Male or Female over 18 years of age
* Clinical diagnosis of pleural mesothelioma or presence of pleural plaques on X-Ray
* Documented exposure to asbestos
* Must be able to provide breath sample
* Must be able to provide relevant medical information

Exclusion Criteria

* Presence of malignancies other that mesothelioma within the past 6 months
* Treatment for any malignancies other than mesothelioma within the past 6 months
* Inability to provide past clinical information
* Inability to perform breath collection procedure
* Smoking or consuming alcohol within two hours of conducting breath collection procedure
Zurich Multiple Endpoint Vitamin D Trial in Knee OA Patients

This is a 2-year double-blind randomized controlled trial in 287 community-dwelling individuals age 60 years or older undergoing uni-lateral total knee replacement due to severe OA of the knee.We compare an oral dose of 2000 IU vitamin D3 per day to 800 IU. The primary endpoints are pain and disability related to rehabilitation of the operated knee,and related to the expected high prevalence of OA in the contra-lateral knee. Secondary endpoints are change in 25(OH)D levels, muscle strength, balance, lower extremity function, the rate of falls, bone density and bone quality, bone metabolism, general pain, fall-related fractures, body composition, blood-pressure, major cardiovascular events, blood glucose-insulin levels, executive cognitive function, rate of upper respiratory tract infections / all infections, tooth loss, dental health, health care utilization, number and size of facial skin keratosis, and radiographic progression of the non-operated knee. Pain and disability will be assessed by the pain and function subscales of the Western Ontario- McMaster Universities Osteoarthritis Index (WOMAC). Randomization will be stratified by WOMAC function prior to surgery, radiological evidence for OA in the contra-lateral knee, and hospital. Clinical visits will take place at baseline (6-8 weeks after TKR), at 6, 12, 18 and 24 months of treatment. In addition, all individuals will receive a phone call every 2 month to assess adverse outcomes and compliance to treatment, supported by a hotline for immediate report of adverse events.

Statistical power: We expect more than 80% power with 200 participants completing their 24 month follow-up, and 260 participants completing their 12 month follow-up.

This is a trial with medicinal product.


Eligibility Criteria:
Inclusion Criteria:

* Unilateral knee replacement due to knee osteoarthritis
* Age 60+ years
* German language skills
* community dwelling

Exclusion Criteria:

* Bi-lateral knee replacement or hip replacement planned in the trial period, or in the previous 6 months
* Chronic steroid intake
* Serum calcium corrected for serum albumin \> 2.6 mmol/l
* GFR \< 30 ml/min
* Severe visual or hearing impairment
* Inflammatory arthritis
* Malabsorption
* High alcohol intake
* Sarcoidosis, primary hyperparathyroidism
* History of kidney stones, lymphoma
* Chemotherapy for cancer in the previous 12 months
* Hemiplegia
* Morbus Parkinson
* Unable to walk 3 meters prior to surgery
* Bisphosphonate, parathyroid hormone , fluoride or calcitonine therapy in the last 6 months
* Zolendronate in the last year
* M. Paget (Ostitis deformans)
* Vitamin D3 intake more than 800IU/d over more than 1 month
* stay on a sunny location for more than 6 weeks per year
* heart failure
Cognitive Behavior Therapy (CBT) and Psychological Status and Immune Function

To explore the effect of CBT on psychological status of colorectal cancer patients undergoing chemotherapy. To explore the effect of CBT on immune function of colorectal cancer patients undergoing chemotherapy.

Cancer patients undergoing chemotherapy are often subjected to considerable psychological stress. CBT is considered as one of the effective methods to relieve stress. CBT is effective in alleviating depression and anxiety, but the effect of CBT on cognitive and immune function in patients with colorectal cancer undergoing chemotherapy remains uninvestigated.

Eligibility Criteria:
Inclusion Criteria:

1.18≤age≤75; 2.Being scheduled to undergo colorectal cancer surgery; 3.Being able to complete all the assessment.

Exclusion Criteria:

1. Having a history of tumor, mental disorders(including dementia), brain trauma or other cerebral diseases;
2. Having severe depression and anxiety currently;
3. Having alcohol dependence or other substance dependence;
4. Having serious physical illness;
5. Participating in other clinical studies.
Use of Fetoscopy in Missed Abortion

The purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as a powerful diagnostic tool to provide better counseling for couples having experienced pregnancy loss.


Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with missed abortion during the first trimester of pregnancy

Exclusion Criteria:

* Women diagnosed with missed abortion after the first trimester of pregnancy
* Any contraindication for hysteroscopy
Safety and Antiviral Activity Study of Clevudine 30 mg QD in Patients With HBeAg(-) Chronic HBV

The purpose of this study is to determine safety and efficacy of 30mg daily dose of clevudine (L-FMAU) at 24 weeks of treatment in chronic HBV infected patients with HBeAg negative


Eligibility Criteria:
Inclusion Criteria:

1. Patients who were between 18 and 60, inclusive
2. Patients with HBV DNA levels 1 x 105 copies/mL within 30 days of baseline.
3. Patients who were documented to be HBsAg positive for \> 6 months (documentation of positive HBsAg for the previous 6 months included previous laboratory reports showing HBsAg positive at least 6 month ago OR lab results showing IgM anti-HBc negative and IgG anti-HBc positive at screening).
4. Patients who were HBeAg negative and HBeAb positive.
5. Patients with ALT levels which were in the range of ≥1.2 and \< 15 times the upper limit of normal (ULN) and bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), a serum albumin level of at least 3.5 g/dL.
6. Women of childbearing potential with a negative serum (β-HCG) pregnancy test taken within 14 days of starting therapy.
7. Patients who were able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy.
2. Patients previously treated with lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection. Previous treatment with interferon that had ended less than 6 months prior to the screening visit.
3. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy.
4. Patients coinfected with HCV, HDV or HIV.
5. Patients with clinical evidence of liver mass or with alfa-fetoprotein \> 50 ng/mL
6. Patients who were pregnant or breast-feeding.
7. Patients who were unwilling to use an "effective" method of contraception during the treatment period and for up to 3 months after cessation of therapy. For males, condoms should be used. Females had to be surgically sterile (via hysterectomy or bilateral tubal ligation) or post-menopausal or using at least medically acceptable barrier method of contraception (i.e. IUD, barrier methods with spermicide or abstinence)
8. Patients with a clinically relevant history of abuse of alcohol or drugs.
9. Patients with a significant gastrointestinal, renal, hepatic (decompensated), broncho-pulmonary, biliary diseases except asymptomatic GB stone, neurological, cardiovascular, oncologic or allergic disease. The patient with a benign tumor was excluded if judged by an investigator that the continuation of study would be interfered by benign tumor.
10. Patients with creatinine clearance less than 60mL/min as estimated by the following formula:

(140-age in years) (body weight \[kg\])/(72) (serum creatinine \[mg/dL\]) \[Note: multiply estimates by 0.85 for women\]
Using Immersive Virtual Reality to Treat Complex Regional Pain Syndrome in Adults

This study is designed to test if the use of virtual reality (VR) can improve chronic pain related to CRPS. One way is to use virtual reality. Virtual reality involves looking into a set of goggles and interacting with a computer-simulated world. The use of VR has been shown to be an effective treatment for other pain conditions (Hoffman et al., 2019) and is inexpensive and noninvasive.

Participants will "go into" simple fun pain distracting virtual reality worlds (no previous video game experience needed) that encourages physical movement of the injured limb (e.g., their injured hand). They will also learn some simple daily 10 minute stress reduction, mood lifting mindfulness skills in VR and will receive audio instructions to focus their attention on the sights and sounds, and controlled breathing (Flores et al., 2019).

Eligibility Criteria:
Inclusion Criteria

* adults (18+)
* confirmed diagnosis of either CRPS I or CRPS II of one or both upper limbs (as defined by the Budapest Criteria)
* average pain score in the affected CRPS limb(s) greater than or equal to 3 out of 10
* on a stable treatment plan for 4 weeks prior to the VR intervention phase
* ability to wear a VR head-mounted display
* ability to speak and read English
* ability to provide informed consent.

Exclusion Criteria:

* personal history of severe motion sickness
* severe systemic disease that is a constant threat to life (ASA class IV+)
* prisoners.
Total Intravenous Anesthesia (TIVA)/Sevoflurane Initiated Intravenous Anesthesia (SIIVA) in Pediatric Patients

Because Propofol is the primary "anesthetic agent," and inhalational agents remain in trace quantities at the end of the procedure Sevoflurane initiated intravenous anesthesia (SIIVA) or not present at all Total intravenous anesthesia (TIVA) it is likely that different criteria may be predictive of extubation success in these patients compared to inhalational anesthesia.

This is because these anesthetic regimens have different pharmacologic mechanisms of actions, and therefore interact with central nervous system in different ways leading to potentially the need for different extubation criteria in patients receiving TIVA or SIIVA. Additionally, intravenous agents likely have less of an effect on airway reflexes and ventilation at light levels of anesthesia. This study is proposing an observational study to examine the predictive value of various extubation criteria in the setting of SIIVA and TIVA.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients \<10 years of age
* Undergoing elective or emergency surgery with planned airway instrumentation with an endotracheal tube (ETT)
* Patients having general anesthesia with a planned SIIVA or TIVA technique
* Patients with an end tidal agent concentration of Sevoflurane\<0.1% at the time of emergence and extubation
* following sevoflurane induction to place IV

Exclusion Criteria:

* History of home oxygen use or ventilator dependence
* Patients with cyanotic congenital heart disease
* Patients undergoing anesthesia for imaging procedures alone
* Patients intended to be managed with supraglottic airway
* Patients having an anesthesia time \< 30 minutes
* Monitored Anesthesia Care (not general anesthesia)
* Patients with contraindication to receiving Propofol (i.e. mitochondrial myopathy)
The Use of Intrathecal Morphine in the Management of Acute Pain Following Decompressive Lumbar Spinal Surgery

The primary aim of this study is to assess the impact of intrathecal morphine on post-operative pain following instrumented fusion for degenerative lumbar spine disease. Secondary objectives of this study aim to assess side effects, overall narcotic use and duration of hospital stay following administration of intrathecal morphine.

Based on our literature review, we expect a significant improvement in pain scores and functional status and minimal side effects with the use of intrathecal morphine. With improved pain and function we would also expect shorter hospital stays in those patients receiving intrathecal morphine.

Adult patients (\>18 yrs or older) undergoing instrumented fusion for degenerative lumbar spine disease will be recruited and randomized to receive one of two treatments. The first group will receive an injection of morphine (200mcg) into the intrathecal space at the time of the operation. The second group will receive a saline injection. The pharmacy will prepare the aforementioned injections and deliver them to the operating room to ensure all parties are blinded. Both groups will then have a standardized analgesic regimen (including PCA morphine and parenteral analgesics) available to them in the post-operative period. Each group will be followed at regular intervals post-operatively. At each follow-up, visual analogue pain scores, side effects and narcotic use will be assessed. Patients will also have a daily functional assessment which will dictate the time of discharge. Hospital stay will be measured from time of admission to time where patient no longer requires acute hospital care based on the functional assessment.

Eligibility Criteria:
Inclusion Criteria:

* age 18yrs or older
* elective surgery for instrumented fusion of the lumbar spine for stenosis (\< 5 levels)
* with back and/or leg pain
* patients who meet ASA class 1 or 2

Exclusion Criteria:

* Patients unable to speak english
* known allergies to morphine or other opioids
* spinal surgery other than lumbar spine surgery
* history of severe respiratory illness including COPD and asthma
* history of obstructive sleep apnea
* pregnancy
* lumbar procedures performed in minimally invasive fashion
* patients lacking mental capacity to use PCA
* patients on sustained release narcotics
* patients undergoing revision of previous instrumented lumbar spine surgery
* patients with psychiatric disorders.
Which Factors Are Relevant for Treatment Outcome in Dialectical Behaviour Therapy for Borderline Personality Disorder?

The objective of this project is to investigate factors that contribute to the success and lack of success in DBT among individuals with BPD and a history of self-harm in a clinical psychiatric setting.

1. Do certain personality factors and identity disturbance predict the treatment outcome of DBT in individuals with BPD?
2. Do changes in identity disturbance, self-hate, or emotion regulation mediate the treatment outcome of DBT in individuals with BPD?
3. Do specific personality profiles moderate the treatment outcomes of DBT for individuals with BPD?
4. When does the primary treatment effect occur, and does this effect persist after a 12-month follow-up period?

Borderline Personality Disorder (BPD) is a complex and enduring mental health condition characterized by a range of symptoms. The consequences of BPD are severe, causing individual suffering, impairments in daily functioning, and increased mortality rates. Dialectical behavior therapy (DBT) is one of the most widely used treatment models for BPD and self-harm. DBT has demonstrated positive outcomes but not all individuals benefit equally from this therapy, highlighting the need for further exploration. Specifically, there is a knowledge gap regarding what predicts positive treatment response. Research exploring this topic, has highlighted the potential significance of emotion regulation, personality profiles, self-concept, and identity disturbance in understanding the outcomes of individuals with BPD.

The primary objective of this research project is to investigate the factors that contribute to the success and lack of success in DBT.

All individuals referred to DBT-treatment in the Adult psychiatric clinic in Lund will be offered participation in the study. All study participants receive the same treatment as those who chose not to participate. Measures will commence after treatment contracts have been negotiated and the treatment will continue up to a maximum treatment length of one year.

Data will be retrieved from databases, medical records as well as collected as self-report forms. Self-report measures will be conducted every three months, at end of treatment and at follow up 12 months after end of treatment. Data from registries and charts will be collected at time of consent and at follow up 12 months after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Borderline personality disorder as defined by the DSM-V (assessed with SCID or uquivalent).
* Self-harm over the past 12 months
* Offered DBT at the Lund adult psychiatric clinic

Exclusion Criteria:

* Unable to read or communicate in Swedish