cyrilzakka/clinical-trials huggingface dataset:
High-dose Vitamin D3 in Pancreas Cancer

Different studies have shown that a deficiency in vitamin D (≤20ng/mL) results in higher rates in morbidity and mortality rates in cancer patients. Clinical studies investigated and demonstrated altered vitamin d tissue in pancreatic cancer. But there is no prospective study evaluating the beneficiary effects of oral supplementation of vitamin d in altered vitamin d tissue from pancreatic cancer. We want to examine the effect of a high dose vitamin D3 therapy vs. a standard base dose vitamin D3 therapy in pancreas cancer patients with a vitamin D deficiency. In case of benefit in our results we could implement vitamin D3 as a supportive standard therapy in pancreatic cancer patients.


Eligibility Criteria:
Inclusion Criteria:

both sexes

* vitamin D deficiency(≤20ng/ml)
* patients\>18 years of age
* pancreatic cancer
* surgical intervention/non-surgical intervention
* signed written informed consent

Exclusion Criteria:

* patients\<18 years of age
* pregnancy
* contraindication for oral vitamin D intake
* hypercalcemia (\> 2.65 mmol/l total calcium and/or \> 1.35 mmol/l ionized calcium at screening)
* other ongoing vitamin D conducted trial
* known kidney stones, active tuberculosis or sarcoidosis (in the last 12 months)
* metastasized pancreatic cancer
* normal vitamin D serum levels
* missing written informed consent
Standard Antibiotic Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy

Background and aim: Urinary tract infections (UTIs) are commonly seen after flexible ureteroscopy. Prevention of UTIs remains controversial. The present randomized study aimed to compare the rate of post-procedural UTI in patients subjected to the standard antibiotic prophylaxis alone versus enhanced prophylactic measures.

Patients and methods: The study included 100 patients subjected to fURS for management of ureteral and/or renal stones. Patients were equally and randomly allocated into one of the two treatment groups using randomly computer-generated allocation tables and concealed envelope technique. Treatment groups included standard antibiotic prophylaxis group and enhanced prophylaxis group. Patients in the standard antibiotic prophylaxis group IV fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively. In the enhanced prophylaxis group, patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.


Eligibility Criteria:
Inclusion Criteria:

* All patients subjected to flexible ureteroscopy for management of ureteral and/or renal stones.

Exclusion Criteria:

* Symptomatic urinary tract infection.
* Use of rigid ureteroscopy and antegrade ureteroscopy.
Effectiveness of Probiotics Prophylaxis of Urinary Tract Infections in Children

The investigators aim to assess the effectiveness of prophylaxis of urinary tract infections in children with a probiotic containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1. It is formulated a hypothesis that a 3-months course of probiotic prophylasis is more effective than placebo.

In previously published European and global guidelines, there has been no consensus among experts regarding the prophylaxis of recurrence urinary tract infections. Depending on the recommendation, the prevention of recurrence UTI should be used, not justified, or should be used in special cases. However, preparations that will be effective in preventing UTI and will not cause bacterial resistance are still sought.

106 patients aged 3 to 18 years with recurrence UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) or children with ≥1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors (congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls) will be randomly assigned to receive a 90-days prophylaxsis arm (probiotic UroLact containing Lactobacillus Rhamnosus PL1 and Lactobacillus Plantarum PM1) or a 90-days placebo arms.

The primary outcome measure will be frequencies of recurrence of UTI during the 6 months after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* recurrent UTIs (defined as: ≥2 infections in the upper urinary tract or 1 UTI in the upper urinary tract and ≥1 in the lower urinary tract or ≥3 or more UTI in the lower urinary tract in one year) OR 1 infection in the upper urinary tract and ≥1 of recurrent UTIs risk factors: congenital anomalies of the kidney and urinary tract, constipation, bladder dysfunction, myelomeningocele, sexual activity in girls
* ≥1 episode of urinary tract infection in the last 6 months

Exclusion Criteria:

* intake of probiotic preparations for ≥1 month in the last 3 months
* known allergy to the study products
* immunosuppression therapy
* disease with immune deficiency
* children with other coexisting infection, e.g. meningitis, sepsis, pneumonia, otitis
Effect of GLP-1 on Angiogenesis

GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their efficacy is documented. However, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with T2D. Few studies have properly addressed the role of GLP-1-based therapies in regulating vascular integrity and angiogenesis. The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2 and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.

GLP-1 receptor agonists are introduced in the treatment of type 2 Diabetes (T2D) and their efficacy is documented. Beside their therapeutic benefits, direct cardiovascular effects have also been reported. However, safety aspects are also important to evaluate with respect to micro and macrovascular complications associated with T2D. T2D patients treated with GLP-1 analogs may suffer from microvascular complications such as macular oedema and proliferative retinopathy, characterized by excessive retinal angiogenesis. Few studies have properly addressed the role of GLP-1-based therapies in regulating vascular integrity and angiogenesis. The role of GLP-1 on endothelial cell (EC) growth, EC integrity and angiogenesis thus needs to be characterized. Our aim is to provide the proof of concept that agonists of GLP-1 regulate angiogenesis in humans and identify the underlying mechanisms. The present project is the translational part of the ANR Angiosafe-T2D, regarding clinical safety aspects of GLP-1 receptor agonists (namely Liraglutide) on angiogenesis.

The study evaluate the impact of one-month treatment Liraglutide on both ANGPT2 and ANGLPT4 levels and endothelial circulating progenitor cells, angiogenesis biomarkers in type 2 diabetic patients.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients (ADA criteria)
* Age \> 18 years
* Obesity (BMI \>= 25 kg/m2)
* HbA1c \> 6.5 %
* Treatment with Metformin and/or secretagogues
* Effective contraception (women)

Exclusion Criteria:

* Treatment with Exenatide, Liraglutide or other incretinergic regimen (\<1 month before recruitment)
* Type 1 diabetes
* acute disease or infection
* chronic renal failure (MDRD eGFR≤50 mL/min)
* recent cardiovascular event or surgery (\<3 months)
* pancreatitis history
* anti-VEGF treatment
* untreated cancer
* immunological disorders
* pregnancy and lactation
* Vulnerable people : deprivation of Liberty safeguards
* hypersensitivity to the active substance or to any of the excipients of the investigational drug
* diabetic ketoacidosis
* heart failure stage 3 or 4 (NYHA III-IV)
* Hepatic insufficiency
* inflammatory bowel disease and gastroparesis
* No affiliation to the social security
Urokinase-Plasminogen Activator (uPA) Inhibitor WX-UK1 in Combination With Capecitabine in Advanced Malignancies

The purpose of this study is to determine the safety, tolerability, maximum tolerated dose (MTD), pharmacokinetics, and pharmacodynamics of the combination of WX-UK1 and capecitabine in patients with advanced malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed diagnosis of a non-hematologic malignancy that is either unresponsive to currently available therapies or for which there is no known effective therapy.
* Patient willing to give informed consent, understand and comply with study procedures/restrictions
* Age\>=18
* Patients must have an ECOG performance status of 0, 1, or 2
* Life expectancy of \> 12 weeks
* Negative serum pregnancy test for women of child-bearing potential and not nursing. Fertile patients must use effective contraception during and for 30 days (women) or 4 months (men) after treatment with WX-UK1.
* Measurable or non-measurable disease. Patients without clinical or radiologic evidence of disease are not eligible.
* Laboratory parameters (obtained within the screening period): WBC \>= 3 G/L, neutrophils \>= 1.5 G/L, platelets \>= 100 G/L, Hgb \>= 9 g/dL), total bilirubin \<= 1.5 x ULN, ASAT/ALAT/AP/GGT \<= 2.5 x ULN, serum creatinine \<= 2 x ULN.

Exclusion Criteria:

* History of hypersensitivity to the study drugs or chemically related compounds or any of the excipients
* History of or current neurological disorder, in particular an active or treated seizure disorder
* Known standard therapy for the patient's disease that is potentially curative or known to extend life expectancy.
* Carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease.
* Concurrent or prior (within 4 weeks prior to start of WX-UK1 treatment for cytotoxic chemotherapy, biological-, endocrine-, investigational- or radiotherapy and 6 weeks for nitrosoureas, mitomycin-C)
* Uncontrolled infection
* Significant cardiac disease (NYHA classification III or IV
* Contraindication to an infusion volume of 1000 ml over 2 h
* History of or current blood coagulation disorders
* History of or current bleeding disorder (including cerebral bleeding, recurrent massive nose bleeds, hematuria or unexplained bruising)
* Diabetes mellitus, if not controlled by insulin, oral anti-diabetic agents or diet alone
* Anticoagulant or thrombolytic therapy within four weeks prior to start of treatment (except heparin flush to keep a port open or coumadin 1 mg/day or ASA 100mg/d)
* Active serious illness that renders the patient unsuitable for study entry or multiple blood sampling
* Illness or condition that might alter the absorption, distribution, metabolism and elimination of WX-UK1
* Known Hepatitis B/C or HIV infection
* Contraindication to capecitabine intake as specified in the SPC such as DPD-deficiency or concomitant intake of sorivudine or sorivudine related compounds
* Known hemorrhagic brain metastasis
Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial

The purpose of this double-blinded, placebo-controlled study is to test if treatment with Botulinum toxin-A is effective in reducing chronic muscle-related pain in adults with spastic cerebral palsy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Spastic Cerebral Palsy.
* Chronic pain, related to spastic muscle. Chronic pain defined as: 1)Recurring regional pain for at least three months AND 2)Pain intensity on average for the last 24 hours ≥3 on Numerical Rating Scale.
* Signed Informed consent.

Exclusion Criteria:

* Allergy/hypersensitivity to Dysport® or any of its components.
* Pregnancy.
* Women who breastfeed their children.
* Treatment with Botulinum toxin-A within the last five months.
* If there has been dose changes in any muscle-tone altering medication within two weeks of Visit 1.
* A clear degenerative cause behind the pain as elucidated by the clinical examination (e.g. history of osteoarthritis).
* Intellectual disability and/or communication impairment that disable the individual from answering the questionnaires and giving informed consent.
Study of Thymosin Beta 4 in Patients With Venous Stasis Ulcers

The purpose of this study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 administered topically in patients with Venous Stasis ulcers

The purpose of this double-blind, placebo-controlled, dose-response study is to evaluate the safety, tolerability and effectiveness of Thymosin Beta 4 (Tβ4), administered topically, in patients with Venous Stasis (VS) ulcers. VS ulcers develop on the ankle or lower leg in patients with chronic vascular disease. In these patients, blood flow in the lower extremities is impaired, leading to edema (swelling) and mild redness and scaling of the skin that gradually progress to ulceration. Tβ4 is a synthetically-produced copy of a naturally occurring 43 amino acid peptide that has wound healing and anti-inflammatory properties and can up-regulate the expression of laminin-5.

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent Form signed by the patient
* Male or female, between 18 and 79 years of age
* At least one venous leg ulceration stable for at least 6 weeks before enrollment
* Surface area between 3 and 30 cm2

Exclusion Criteria:

* Have clinical evidence of active infection on the index ulcer
* Use of any experimental drug, or participation in any clinical study, within the 60 days before enrollment
* Use of systemic or topical steroidal therapy, immunotherapy, or cytotoxic chemotherapy within the 60 days before enrollment
* History of adverse reaction to any ingredients of the study medication
* Clinically significant neurological, cardiovascular, respiratory, hepatic, renal, metabolic and dermatologic disease other than venous ulcers
* Current or former malignancy
* Arterial disorder resulting in ulcerated ulcers
* Diabetes mellitus
* Pregnant or lactating (breastfeeding) women. A serum pregnancy test will be performed at screening for female patients of childbearing potential
Patients' and Caregivers' Views of Multidimensional Care in Amyotropic Lateral Sclerosis in Germany

The progressive loss of physical functioning resulting from ALS leads also to high psychosocial burden for those affected, and organizational challenges related to medical care and aids. A multidimensional and -professional care is advised in order to meet the complex requirements of this disease. In Germany, medical care structures may not fulfil these high requirements, since non-medical services such as psychological support or social counselling are not regularly included in care procedures for ALS patients. Specialised palliative care is not a standard and still commonly restricted to the last weeks of life. Additionally, it is well known that caregivers of ALS patients are highly burdened, but there is a lack of support services for them.

By means of a cross-sectional, multicentre survey, we aim to investigate patients' and caregivers' perception of medical care for ALS, provided in Germany - with particular regard to psychosocial and palliative aspects. The extent to which physical, psychological, social, spiritual, practical and informational needs are subjectively met will be assessed and correlations with mental wellbeing, subjective quality of life, attitudes towards life-sustaining measures and physician-assisted suicide, as well as caregiver burden will be examined.

Currently, study planning (questionnaires and ethical approval) is already completed and recruitment was started. The study aims to recruit 500 participants from nationwide ALS-centres. Cooperating ALS-centres will be recruited via the German Network for Motoneuron Diseases (MND-Net), of which our centre is a member. It is intended to provide data-based starting points on how care of ALS patients and their caregivers can be improved in Germany, in line with their needs.


Eligibility Criteria:
Inclusion Criteria:

* patients with at least "possible ALS" according to El-Escorial-criteria
* at least 18 years old
* no impairments of behaviour or mental performance relevant to everyday life that limits the ability to make judgments or give consent (e.g. as part of a comorbid FTD)

Exclusion Criteria:

* impairments of behaviour or mental performance relevant to everyday life that limits the ability to make judgments or give consent (e.g. as part of a comorbid FTD)
Impact of Teacher Training and the Introduction of Early Adjustments on the Developmental Trajectory of Children at Risk of SLLD in Pre-school.

The high incidence of neurodevelopmental disorders, including specific language and learning disorders, and their profund impact on the schooling of the children concerned remains a major public health concern. Early identification and intervention are a valuable tool for improving these problems. The developmental trajectory of children could be improved by knowledge enhancement, identification and strategies to support the teachers through the involvement of health professionals in the classroom

PRISME - TSLA is a clinical trial developing experiment project for the intervention arm involving teacher training, the implementation of identification grids, follow-up observations in classroom of identified pupils, and the development of special arrangments. For the control arm, the teachers work with standard procedures of the French national education policy.

Eligibility Criteria:
Inclusion Criteria:

* In a school with at least 3 classes of primary school age children.
* At least 5 years old on 31/12/2023.
* Whose 2 parents have given their consent.
* Have received age-appropriate explanations about the study and have not refused to take part.

Exclusion Criteria:

* In a school with at least 3 classes of primary school age children.
* At least 5 years old on 31/12/2023.
* Whose 2 parents have given their consent.
* Have received age-appropriate explanations about the study and have not refused to take part.
Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden

The purpose of the study is to determine whether treatment with BMS-914392 is safe, well tolerated and associated with a reduction of atrial fibrillation burden in patients with paroxysmal atrial fibrillation and permanent pacemaker.


Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal atrial fibrillation (AF)
* Programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
* 1-50% AF burden on pacemaker interrogation at screening.
* Women of childbearing potential (WOCBP) and men must be using an acceptable method of contraception to avoid pregnancy.

Exclusion Criteria:

* Persistent or permanent AF.
* AF Burden \<1% or \> 50%.
* Current or history of neurological diseases and mental disorders.
* Ejection Fraction \< 45%.
* Severe mitral or aortic valve dysfunction.
* TIA (Transient Ischemic Attack) within last 12 months.
* Acute coronary syndrome in the last 2 months.
* Previous AF ablation.
* Cardioversion in last 3 months.
* Current kidney or liver disease, or current cancer.
* History of neurological and mental disorders.
* Major surgery within 4 weeks of first dose (cardiac surgery within 4 months).
* Screening lab test results outside of allowed limits per protocol.
* QTcF \> 450 msec.
Single Shot Versus Continuous Adductor Canal Block in Patients Undergoing Total Knee Arthroplasty

Adductor canal block (ACB) has emerged as an option for postoperative regional analgesia in patients undergoing total knee arthroplasty (TKA).

Various approaches to the performance of peripheral nerve blocks for postoperative pain control in patients undergoing TKA have been described in the literature. These approaches include lumbar plexus block, femoral nerve block (FNB), with or without a sciatic nerve block, and most recently the ACB. FNB is a commonly used modality for postoperative analgesia after TKA. It is considered by some as the gold standard or the cornerstone of postoperative analgesia after TKA. However, FNB reduces quadriceps muscle strength essential for mobilization and active contribution in any physical rehabilitation program. Quadriceps weakness places the patients at risk of falling. which may be detrimental to postoperative recovery. The ACB has recently emerged as an appealing alternative to FNB as it is predominately a sensory nerve block of a more distal branch of the femoral nerve ( the saphenous nerve).

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled for primary total knee arthroplasty with
* American Society of Anesthesiologists (ASA) physical status I -III,
* mentally competent and able to give consent for enrollment in the study.

Exclusion Criteria:

1. Patient younger than 18 years old or older than 70 years old
2. Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone, and any of the drugs included in the multimodal perioperative pain protocol.
3. Revision surgeries were excluded.
4. Impaired kidney functions and patients with coagulopathy were also excluded.
5. Chronic pain syndromes and patients with chronic opioid use defined as the use of regular daily doses of systemic narcotics for the past 6 months prior to the surgery.
6. BMI of 40 or more
7. Pregnancy (positive urine pregnancy test result in Preop area on the morning of surgery)
Social Media Use in Adolescents Admitted to a Psychiatric Unit

We will investigate the association between social media use and depression in adolescents admitted to a psychiatric unit and continue to follow their progress after discharge in outpatient clinic services. We expect improvement in their depressive symptoms by modifying social media use and adding a mental health app to further encourage the positive effects of social media.


Eligibility Criteria:
Inclusion Criteria:

* Participants admitted to inpatient psychiatric unit
* Kaiser insured participants between 13-17 years of age with parental consent
* positive for social media use
* English speaking

Exclusion Criteria:

* pregnant
* non English speaking
A Study Of TeleGenetics Versus Usual Care To Increase Access To Cancer Genetic Services

The goal of this research is to evaluate the relative advantage of remote counseling over usual care in community health practices without access to genetic services. We will evaluate ability of remote telemedicine, referred to going forward as TeleGenetic services (phone or videoconferencing), to increase uptake of genetic testing and identification of genetic carriers compared to usual care. Secondly, we will evaluate the advantages of videoconferencing over telephone for delivery of remote genetic services and the short-term and longitudinal outcomes of TeleGenetic services in socio-demographically diverse patients in community practices.


Eligibility Criteria:
Inclusion Criteria:

1. Eligible participants will include adult men and women (aged 18 and older) who can understand and communicate in English
2. meet National Comprehensive Cancer Network® criteria for cancer genetic testing for breast, ovarian or colorectal cancers
3. have insurance coverage for genetic testing.

Exclusion Criteria:

1. Under 18 years old - professional guidelines do not recommend genetic testing for cancer risk in minors.
2. Does not speak English.
3. Does not have insurance.