cyrilzakka/clinical-trials huggingface dataset:
A Prospective, Open, Non-randomized Phase I/II Study of Therapeutic Angiogenesis in Diabetic Patients With Critic Ischemia of Lower Limbs While Administering Positive CD133 Mobilized With G-CSF

The primary objective is to analyze the safety and efficacy of CD133+ cells, obtained from peripheral blood in the treatment of diabetic patients with critic ischemia in lower limbs.

The secondary objectives are:

* To determine the safety of the intramuscular administration of CD133+ cells that have been mobilized from peripheral blood.
* To determine the CD133+ capacity to increase the re-vascularization at lower limbs in diabetic patients with critic ischemia in the lower limbs.
* To evaluate the patient global health condition using the notified results of the SF-36 questionnaires completed by patients

A total of up to 20 diabetic patients with critic ischemia of lower limbs will be included in the study. Patients will be administered with CD133+ cells, that previously have been obtained of their peripheral blood after mobilization with G-CSF

The study is divided in three phases:

Pre-treatment (previous 4 weeks of CD133+ cells mobilization). Treatment (cells mobilization, CD133+ transplant, 24 hours after infusion visit, 4, 12 and 24 weeks after transplant visits) Follow-up (9 and 12 months after transplant visits)

Eligibility Criteria:
Inclusion Criteria:

* According to the investigator opinion, patient is able to carry out with all the clinical trial requirements
* Patient must volunteer sign the inform consent before any study specific test, that is not part of the common patient attention, is performed. Patient must know that he/she can abandon the study at any time with no damage to his/her posterior attention
* Age 18 to 75
* A diagnosis of chronic critic ischemia of the lower limbs
* Diabetes Mellitus active
* III or IV stages (Fontaine classification): resting pain, ulcer or minor gangrene with no major amputation
* General contraindication or local inoperability or refractory/progression after previous surgical treatment, according to the investigator criteria
* If female reproductive potential, negative pregnancy test

Exclusion Criteria:

* Pregnant or currently breast feeding women
* Acute myocardial infarction within the last 3 years
* Non re-vascular unstable angina pectoris
* History of ischemia stroke within the last 3 years
* Neoplasia at the time of inclusion or Chemotherapy or Radiotherapy treatment in the last 5 years
* Chronic renal insufficiency
* G-CSF contraindication
* A non well controlled serious concomitant disease
* History of serious thrombotic episodes within the past 3 years
* Patients who have received other investigational therapy within 30 days previous to the study inclusion
* Patients currently in other clinical trial or receiving any other investigational agent
Myo-inositol and Vitamin D3 During IVF

Administration of a multicomponent dietary supplement (myo-inositol, vitamin D3, folic acid and melatonin) to women undergoing IVF procedures.

The aim of the study is to monitor the effects on the pregnancy, implantation and abortion rates.


Eligibility Criteria:
Inclusion Criteria:

* BMI (kg/m2): 18.5 - 24.9
* basal FSH on day 3 \<15 mIU/ml

Exclusion Criteria:

* presence of insulin resistance (IR)
* hyperglycaemia, hyperprolactinemia, hypothyroidism or androgen excess
* diagnosis of PCOS (according to Rotterdam ESHRE-ASRM Sponsored PCOS consensus workshop group)
* intake of hormones or drugs that can potentially influence the ovulation
* FSH\>15 on day 3
Trial of Prophylactic Manual Rotation of Persistent Occiput Posterior Presentation During the Early Second Stage of Labor to Reduce Operative Delivery: a Prospective Multicenter Randomized Control Trial

Superiority multicenter prospective randomized study on operative delivery (instrumental delivery or caesarean section) of prophylactic manual rotation in case of persistent occipital posterior presentation during the second stage of labor compared to expectant management. A 15% reduction of operative delivery (instrumental delivery or caesarean section) is attempt in the prophylactic manual rotation group.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Singleton pregnancy
* Term ≥ 37 weeks of gestation
* Early second stage of labor
* Rupture membranes
* Persistent occiput posterior position confirmed by ultrasound
* Epidural anesthesia
* Patient who agree to participate and sign consent form

Exclusion Criteria:

* Age \< 18 years
* Term \< 37 weeks of gestation
* Vaginal and instrumental Delivery maternal contraindication
* Antecedent of perineal injury type IV
* Sensitive perineum
* Crohn's disease with vaginal delivery contraindication
* Instrumental fetal contraindication
* Non reassuring fetal heart with impossibility of optimal maternal information
* Known fetal malformation
* Previous ceaserean section
* Non cephalic presentation
* Not affiliated to social security
A Feasibility Randomized Trial Evaluating Early vs Late Stent Removal Following Radical Cystectomy and Ileal Conduit Formation for Bladder Cancer

Bladder cancer is the 4th most common cancer in men and 5th most common type of cancer in Canada. Urothelial cancer accounts for approximately 90% of malignancies. At diagnosis, over 75% of cases are classified as non-muscle invasive (NMIBC), and with appropriate treatment, the majority of these patients achieve positive outcomes. The progression rate of NMIBC to Muscle-invasive bladder cancer (MIBC) varies between 5-50% at 5 years dependent on histopathological features such as grade, stage, presence of CIS and age (Carcinoma in Situ). The optimal treatment of MIBC (T2-T4N0M0) consists of neoadjuvant cisplatin-based chemotherapy followed by Radical cystectomy and urinary diversion (RCUD). In the last couple of decades, RCUD has also gained attention for treating patients with high-risk non-muscle invasive bladder cancer. Despite advancements in surgical techniques and the rise of minimally invasive alternatives, complications after surgery remain frequent, with morbidity rates of approximately 50%.

Several uncertainties persist in surgical practice, including the role of perioperative ureteric stenting during RCUD. Perioperative ureteric stenting is intended to minimize urinary leakage from the newly created uretero-enteric anastomosis and to prevent early obstruction caused by anastomotic swelling. However, stenting may increase the risk of urinary tract infections (UTIs) and necessitate additional follow-up for stent removal. Peng et al. conducted the most recent systematic review in 2021, demonstrating that ureteral stents in RCUD were linked to higher rates of anastomotic strictures. Their review did not provide evidence that these stents were more effective than not using stents in preventing post-diversion urinary leakage. The review underscored the scarcity of prospective randomized controlled trials examining the safety and effectiveness of stenting in this context. The sole prospective (non-randomized) study assessing stent dwell / retention time after RCUD demonstrated early stent removal (2 weeks) had decreased 90-day readmissions and UTIs.

Therefore, the investigators aimed to determine the feasibility of conducting a definitive randomized trial to evaluate patients undergoing radical cystectomy and ileal conduit formation to receive either early stent removal (5-7 days) or late stent removal (4-6 weeks).


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (18 years or older) undergoing radical cystectomy and ileal conduit formation for bladder cancer
* Able to give informed written consent to participate.

Exclusion Criteria:

* Treatment without curative intent (cT4b, salvage or palliative cystectomies);
* Patients undergoing alternative forms of urinary diversion (e.g. continent cutaneous urinary diversion or orthotopic neobladder formation)
* Patients previously received abdominal/pelvic radiotherapy
* Patients with concomitant upper urinary tract cancer
Implementation of Physical Exercise at the Workplace (IRMA08) - Healthcare Workers

The prevalence and consequences of musculoskeletal pain is considerable among healthcare workers, allegedly due to high physical work demands of healthcare work. Previous studies have shown promising results of physical exercise for relieving pain among different occupational groups, but the question remains whether such physical exercise should be performed at the workplace or in the private sphere at home. Performing physical exercise at the workplace together with colleagues may be more motivating for some employees and thus increase compliance. On the other hand, physical exercise at the workplace may be costly for the employers in terms of time spend. Thus, relevant ground exists to compare the efficacy of workplace- versus home-based training on musculoskeletal pain. This study investigates the effect of workplace-based versus home-based physical exercise on musculoskeletal pain among healthcare workers.

The main hypothesis is that physical exercise at the workplace for 10 weeks compared with physical exercise at home results in reduced musculoskeletal pain among healthcare workers.


Eligibility Criteria:
Inclusion Criteria:

* healthcare worker
* female
* age 18-67

Exclusion Criteria:

* life threatening disease
* pregnancy
Characterizing Follicles From Auto-transplanted Ovarian Tissue

The aim of the project is to characterize the hormonal conditions in egg follicles in women who, prior to fertility treatment, have had autotransplanted frozen ovarian tissue for the purpose of fertility preservation.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 18 years or older
* Has had frozen and later autotransplanted ovarian tissue for fertility preservation purposes
* Included in fertility treatment with eff retrieval at the Fertility Clinic Regional Hospital Skive
* Is willing and able to give informed consent

Exclusion Criteria:

- Patients undergoing fertility treatment but have not received autotransplanted ovarian tissue for fertility preservation purposes
Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.

This is a prospective randomized controlled trail to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not. A hundred forty-six patients with clinically localized and histological confirmed prostate cancer will be enrolled. Continence recovery is defined in the present study as declared urinary continence (absence of incontinence episodes) in the physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF, IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the secondary objective will be assessed by SHIM questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* Histological confirmation of prostate cancer
* Localized or locally advanced prostate cancer
* Informed consent signed

Exclusion Criteria:

* Presence of urinary incontinence prior to the procedure
* Previous radiation therapy of the prostate or pelvis
* Presence of any prostatic surgery prior to the procedure
* Prior medical history of psychiatric diseases or drug addiction
* Any condition that contraindicates a radical prostatectomy
Short-term Efficacy of Intravitreal Afilibercept Depending on Subtypes of Polypoidal Choroidal Vasculopathy: Polypoidal Choroidal Neovascularization or Idiopathic Choroidal Vasculopathy

To compare the short-term effect of intravitreal aflibercept injection between two subtypes of polypoidal choroidal vasculopathy

The subjects were classified into two subtypes (type 1 and type 2 polypoidal choroidal vasculopathy) based on the presence or the absence of both of a feeder and a draining vessels on indocyanine green angiography. All received intravitreal injection of aflibercept (2.0 mg) at baseline and months 1, 2 and 4.

Eligibility Criteria:
Inclusion Criteria:

1. symptomatic typical PCV accompanying branch vascular network involving subfoveal area
2. signed informed consent; and
3. over 6 months follow-up period after enrollment.

Exclusion Criteria:

1. retinal diseases other than PCV
2. extrafoveal PCV not involving subfoveal area
3. massive subretinal hemorrhage blocking polypoidal lesion on ICGA
4. severe media opacity such as senile cataract
5. previous history of intravitreal injection
6. previous intraocular surgery history except cataract surgery which was done more than 3 months.
BreEStim for Motor Recovery in Chronic Stroke With Moderate Impairment (Pilot).

The overall goal is to investigate the effectiveness of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) on finger flexor spasticity reduction and hand function improvement in chronic stroke with moderate impairment.


Eligibility Criteria:
Inclusion criteria:

* has post stroke ≥ 6 months , medically stable;
* Unilateral, single stroke (no restriction on type (ischemic or hemorrhagic) or volume (large or small) of stroke);
* MAS score ≥ 1, i.e., detectable finger flexor hypertonia;

Exclusion criteria include:

* Patients with visual deficit/neglect; hearing or cognitive impairment;
* Patients with history of pulmonary disease (Asthma, chronic obstruction pulmonary disease, COPD);
* Patients that are currently adjusting tone alternating medications (e.g., baclofen), or
* Patients received botulinum toxin injection to the arm/fingers \<4 months, or phenol injections \< 2 years;
* Patients with a pacemaker;
* Women who are pregnant.
Improving Outpatient Endometrial Biopsy Results

Pipelle is the most commonly used outpatient endometrial biopsy device. Pipelle endometrial biopsy can diagnose 90% of endometrial cancer cases. Pipelle endometrial biopsy is one of the first-line diagnostic procedures for women presenting with abnormal peri- and post-menopausal vaginal bleeding.

Insufficient samples are obtained in 5-23% of cases. In Adan Hospital, a retrospective analysis of all outpatient endometrial samples sent to the histopathology department from April- to October 2024 study showed an insufficient sample percentage of 32% This may be attributed to factors such as patients, equipment, and physicians.

This project aims to improve the endometrial biopsy results by Identifying these factors in the Adan hospital setting, Implementing measures to modify these factors, and finally re-auditing the endometrial biopsy results after six months.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing outpatient endometrial biopsy in the specified time interval (11/2024- 4/2025) will be included.

Exclusion Criteria:

* Could not obtain the sample due to patient physicals, anxiety (patient decline), cervical stenosis, or severe bleeding
The Acute Effect of Exercise on Appetite Appetite-regulating Hormones and Inflammation in Children

This study describes the effect of acute high intensity exercise at 70% VO2peak on inflammation, stress, appetite hormones and appetite in lean and obese children and adolescents.

In summary, exercise does induce a variety of metabolic mechanisms on a central and peripheral level, related to appetite other than solely gut peptides. The literature points towards a rather loose coupling when it comes to high intensity exercise and the suppression of food intake, without a clear explanation of the cause of exercise induced anorexia. This study is aimed to investigate high-intensity exercise and its effects on appetite and satiety hormones, inflammation, stress and eating behaviors on appetite and food intake.

The objective of the current study is to investigate the factors contributing to exercise-induced anorexia in lean and obese children, and maximize its translation into post-exercise suppression of food intake and promotion of negative energy balance particularly in obese children. It is hypothesized that high-intensity exercise would promote a greater suppression of food intake through suppression of appetite ratings via physiological mechanisms depending on stress and inflammation rather than gut peptides.

Eligibility Criteria:
Inclusion Criteria:

* 11 normal weight and 11 obese boys will be recruited for the study. Lean and obese boys aged 10-18 years, born full-term and with a normal body weight at birth, will be included in the study

Exclusion Criteria:

* Dieters and individuals with lactose intolerance, allergies to milk and dairy products and gastrointestinal problems will be excluded from the study.
Pre-operative Aqueous Antiseptic Skin Solutions in Open Fractures

The prevention of infection is the single most important goal influencing peri-operative care of patients with open fractures. Standard practice in the management of open fractures includes sterile technique and pre-operative skin preparation with an antiseptic solution. The available solutions kill bacteria and decrease the quantity of native skin flora, thereby decreasing surgical site infection (SSI). While there is extensive guidance on specific procedures for prophylactic antibiotic use and standards for sterile technique, the evidence regarding the choice of antiseptic skin preparation solution is very limited for open fracture surgery.


Eligibility Criteria:
The inclusion criteria are:

1. Patients 18 years of age or older.
2. Open fracture of the appendicular skeleton.
3. Received or will receive definitive fracture treatment with a surgical implant(s) (e.g., internal fixation, external fixation, joint prosthesis, etc.).
4. Open fracture wound management that includes formal surgical debridement within 72 hours of their injury.
5. Will have all planned fracture care surgeries performed by a participating surgeon or delegate.
6. Informed consent obtained.
7. Patient enrolled within 3 weeks of their fracture.

The exclusion criteria are:

1. Patients that did not or will not receive the allocated pre-operative surgical preparation solution due to a medical contraindication.
2. Received previous surgical debridement or management of their open fracture at a non-participating hospital or clinic.
3. Open fracture managed outside of the participating orthopaedic service (e.g., hand fracture managed by plastic surgeon).
4. Chronic or acute infection at or near the fracture site at the time of initial fracture surgery.
5. Burns at the fracture site.
6. Incarceration.
7. Expected injury survival of less than 90 days.
8. Terminal illness with expected survival less than 90 days.
9. Previous enrollment in a PREP-IT trial.
10. Currently enrolled in a study that does not permit co-enrollment.
11. Unable to obtain informed consent due to language barriers.
12. Likely problems, in the judgment of study personnel, with maintaining follow-up with the patient.
13. Excluded due to sampling strategy.
Bioarray for the Serological Assessment of Immunity Against Vaccine-preventable Infections

Recent observations in Germany revealed above-average high proportions of refugees affected by infectious diseases of public health significance. Scrutiny of the vaccination status showed sizeable presence of seronegative subjects, with conspicuously higher prevalence among children and adolescents, thus indicating urgent necessity of i) rapid identification of carriers of vaccine-preventable diseases and ii) adjustment of protection against such infections to European Standards. Rapid immune status check needs comprehensive diagnostic tool permitting simultaneous assessment of seropositivity. Validation of such tools requires comparisons of the immune status of subjects with known vaccination history with that of migrants with incomplete or missing health and vaccination records.

The current massive inflow of refugees and migrants poses urgent necessity of i) rapid identification of carriers of communicable diseases and ii) adjustment of protection against vaccine-preventable infections to European standards. While universal vaccination is supposed to ensure the intended degree of protection, targeted vaccination on the basis of previous assessment of the immune status (seropositivity) was repeatedly shown to be a cost-efficient alternative. Currently, the broad use of immune status assessment prior to targeted vaccination is impeded by the necessity to apply separate seropositivity detection assays for each individual condition. This drawback can be overcome by the introduction of a comprehensive diagnostic tool permitting simultaneous assessment of seropositivity for several vaccine-preventable infections.

The objective of the present study consists in compilation of an array of sera from

* subjects with known history of immunization against vaccine-preventable infections for which vaccines are routinely available (measles, mumps, rubella, varicella, tetanus, pertussis, poliomyelitis, diphtheria, meningococcal infection) and
* new migrants/refugees without reliable vaccination records and undefined immune status to be subsequently used for the validation of a multi-pronged diagnostic tool for seropositivity detection

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Signed informed consent

Exclusion Criteria:

* Acute infectious condition
* Glucocorticoid medication above 0.3 mg/kg Prednisolone equivalent over the preceding 30 days
* Treatment with recognized T cell immunosuppressant or nucleoside analogues during the preceding 90 days
Sleep Disturbance in Lung Cancer Patients.

The aim of this study is to 1-evaluate subjectively by questionnaires and objectively by ambulatory actigraphy the quality of sleep in patients with newly diagnosed lung cancer; 2- to correlate sleep quality index with quality of life, daytime alertness, Performans status and lung cancer staging at diagnosis.


Eligibility Criteria:
Inclusion Criteria:

Newly diagnosed lung cancer age \> 18 yrs Performans status \< 3 Informed consent Life expectancy \> 5 months

Exclusion Criteria:

Psychiatric disease Performans status \> 2 Known sleep disorder
Attention Bias Modification for Transdiagnostic Anxiety

This project seeks to identify neural mechanisms underlying the tendency for anxious individuals to pay more attention to threatening information than to other types of information. A computerized treatment designed to train individuals to reduce their attention towards threat will be tested, with a focus on understanding the aspects of brain function that predict response to the treatment. This work could ultimately lead to the ability to treat anxiety more effectively by directly targeting the aspects of brain function that are altered in a given patient.


Eligibility Criteria:
Inclusion Criteria:

* Participants will:

  1. be between the ages of 18 and 55 years,
  2. score \>45 on the Spielberger State-Trait Anxiety Inventory-trait form.
  3. score \>=75th percentile on the World Health Organization Disability Assessment Schedule 2.0

Exclusion Criteria:

1. Current medication or Cognitive-Behavioral Therapy for anxiety or depression;
2. Failure to meet standard Magnetic Resonance Imaging (MRI) inclusion criteria: those who have cardiac pacemakers, neural pacemakers, surgical clips in the brain or blood vessels, surgically implanted metal plates, screws or pins, cochlear implants, Intrauterine Devices, metal braces, or other metal objects in their body, especially in the eye. If the subject has any metal or implants in the body they must be deemed safe by the MRI Research Center's safety screening procedure prior to enrollment. Dental fillings do not present a problem. Plastic or removable dental appliances do not require exclusion. Pregnancy, determined by pregnancy tests on females.
3. currently suicidal or at risk for harm to self or others,
4. visual disturbance (\<20/40 as per the Snellen test, corrective lenses allowed)
5. \<6th grade reading level as per the Wide Range Achievement Test
6. presence of bipolar, psychotic, autism spectrum, substance dependence, or primary depressive disorder
7. positive urine drug test