cyrilzakka/clinical-trials huggingface dataset:
Incidence of Fragility Fractures and Osteoporosis Screening in Chronic Stroke Patients

Stroke is a known risk factor for the development of osteoporosis, leading to an increased risk of falls and fractures. Several international studies have associated stroke with hip fractures, showing an odds ratio ranging between 1.5 and 4. The literature frequently indicates a lack of management for bone metabolism in patients following cerebrovascular events. This study aims to evaluate the incidence of osteoporosis and fragility fractures in patients with chronic stroke. A secondary aim is to assess whether patients have been adequately screened for bone metabolism following a cerebrovascular event. This study is designed as a prospective observational study. Patients aged over 65 years with chronic stroke are assessed at the U.O.C. of "Functional Recovery and Rehabilitation" at A.O.U.P. "P. Giaccone," Palermo. During the assessment, clinical and demographic data are collected, including details of the cerebrovascular event (location, hemorrhagic/ischemic, date), pre-event and post-event disability/autonomy (Rankin scale), presence of fractures (location and date) in the patient's medical history (pre and post-event), femoral and lumbar DEXA for osteoporosis evaluation, and DeFRA for assessing the 10-year risk of fragility fractures.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 65 years and older
* Diagnosed with chronic stroke
* Able to provide informed consent
* Willing to participate in follow-up assessments
* Stable medical condition that allows participation in the study

Exclusion Criteria:

* Patients with acute stroke
* Severe cognitive impairment that prevents informed consent
* Other major illnesses affecting bone metabolism (e.g., severe renal disease)
* Patients already undergoing treatment for osteoporosis
* Patients with conditions that contraindicate DEXA scan
Effect of Hypertonic Sodium Chloride on Urinary Biomarkers in Healthy Subjects and Patients With Chronic Kidney Disease

Patients with chronic kidney disease (CKD) have a defect in the tubular reabsorption of sodium, and therefore the ability to excrete a sodium load is diminished compared to healthy subjects.

Urinary biomarkers reflects the water- and sodium-channel activity in the kidney and may be measured after an infusion with hypertonic saline in CKD patients and healthy subjects.

The fractional sodium excretion is elevated as high as 10-20% In patients with chronic kidney disease (CKD) Changes in the sodium intake results in a slower expansion and/or reduction in extracellular fluid in CKD patients.

Urinary biomarkers reflects the kidneys transport of sodium and water in the nephron.

Changes in the sodium-and water channel activity is induced by intervention with hypertonic Saline (3.0%) The change in sodium-and water channel activity is followed by change in extracellular and intracellular fluid compartments and the plasma concentration of vasoactive hormones.

The purpose of this study is to investigate the changes in urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2), the activity of the sodium-and water channels, the extra- and intracellular fluid compartments and the plasma concentration of Vasoactive hormones in patients with CKD and in healthy subjects.

Subjects and patients are examined during one examination day. Four days prior to the examination day the subjects consume a standardized diet based on the amount of sodium and calories. On the examination day the subjects receive an infusion with hypertonic saline.

Renal function is measured by renal clearance of 51Cr-EDTA. Urinary biomarkers (u-NKCC2, u-ENaC-gamma and u-AQP2) are measured to evaluate the activity of sodium channels in the nephron and changes in fluid compartments are measured by body composition monitor.

Eligibility Criteria:
Inclusion Criteria:

1. healthy subjects

   * healthy males and females
   * age 18-70
   * BMI range 18,5-30,0 kg/m2
2. Patients with CKD

   * age 18-70
   * eGFR 15-60 ml/min
   * BMI range 18.5 - 30.0 kg/m2

Exclusion Criteria:

1. healthy subjects

   * hypertension (ie ambulatory BP \>130 mmHg systolic or/and \>80 mmHg diastolic)
   * history or clinical significant signs of heart, lung, liver, kidney, endocrine, brain or neoplastic disease.
   * alcohol abuse
   * drug abuse
   * smoking
   * pregnancy or nursing
   * blood donation within a month prior to examination
   * Medical treatment apart from oral contraception
2. Patients with chronic kidney disease

   * clinical significant signs of heart, lung, liver, endocrine, brain or neoplastic disease.
   * diabetes
   * immunosuppressive medications
   * smoking
   * alcohol abuse
   * drug abuse
   * pregnancy or nursing
Dilute Bleach Compresses for Radiation Dermatitis

This study is looking at the safety of applying dilute bleach compresses to patients receiving radiation therapy and the impact of these dilute bleach compresses on the frequency and severity of skin changes that occur during radiation therapy.

The names of the study interventions involved in this study are:

* Di-Dak-Sol: dilute bleach compresses
* White petrolatum ointment

This is a planned open-label prospective clinical trial to determine the safety of applying dilute bleach compresses to pediatric patients being treated for rhabdomyosarcoma and other soft tissue and bone sarcomas with radiation therapy (RT).

This study is interested in finding out whether dilute bleach compresses are safe to apply and evaluating their impact on the frequency and severity of skin changes that occur in children who are receiving radiation therapy for cancer treatment.

This information may help treat other patients receiving radiation therapy for cancer treatment in the future.

The research study procedures include screening for eligibility and study treatment including weekly evaluations and follow up visits

Participants will receive study treatment throughout their radiation therapy and for one week after. They will be followed for one month after the completion of radiation.

It is expected that about 12 people will take part in this research study.

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Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a rhabdomyosarcoma or other sarcoma requiring RT
* 12 to 25 years of age
* Scheduled for a RT planning session (CT simulation)
* Have a scheduled RT start date within 1 to 2 weeks from the CT simulation
* Will be receiving doses of radiotherapy greater than at least 36 Gy
* Subjects may participate in other studies, including therapeutic trials.
* Ability to comply with at-home dilute Di-Dak-Sol compresses for final week of dilute Di-Dak-Sol compresses following radiation treatment.
* Ability to understand and/or the willingness of their parent or legally authorized representative to sign a written informed consent document.

Exclusion Criteria:

* Patients who are pregnant, which may result in discontinuation of RT
* Presence of inflammatory skin lesions in the radiation field that could interfere with assessment
Phase III Randomized Study of Lucinactant in Full Term Newborn Infants With Meconium Aspiration Syndrome

OBJECTIVES:

Evaluate the safety and efficacy of lucinactant administered by bronchoalveolar lavage (BAL) in the treatment of meconium aspiration syndrome (MAS) in newborn infants.

PROTOCOL OUTLINE:

This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

Arm I: Patients receive lucinactant by bronchoalveolar lavage, into the right and left lung, followed by lung drainage. Treatment repeats when patient stabilizes or every 15 minutes for 2 courses.

Arm II: Patients receive standard treatment including oxygen, conventional mechanical ventilation, sedation, paralysis, vasopressors, and alkalinization.

Patients are followed for 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of meconium aspiration syndrome (MAS)
* Continuous mechanical ventilation (CMV) at time of entry
* Enrollment within 48 hours of birth
* Gestational age of ≥ 37 weeks
* Oxygenation index of ≥ 5 and ≤ 30
* Written informed consent signed and dated by the infant's parent(s) or legal guardian(s)

Exclusion Criteria:

* Congenital anomalies likely to affect any primary or secondary endpoints
* Uncontrollable air leaks
* Hydrops fetalis
* Rupture ≥ 3 weeks of the fetal membranes
* Evidence of overwhelming bacterial infection at time of randomization
* Markedly labile persistent pulmonary hypertension at time of randomization
* Profound neurologic manifestations
* Sustained postductal SpO₂of \< 87% for ≥ 15 minutes at an FiO₂of 1.00
Chemotherapeutic Trial With Gemcitabine, Cisplatin, 5-FU and Folinic Acid in Esophageal Cancer

This multicenter open labeled phase 2 trial examines the efficacy of a combination of Gemcitabine 1000 mg/m2 (30 min), Cisplatin 30 mg/m2 (90 min), Folinic Acid 200 mg/m2 (30 min) and 5-FU 750 mg/m2 (24h CI) all given day 1,8 q D22 in patients with inoperable esophageal cancer. The combination was considered to be suitable for further evaluation with a freedom of progression rate (PR+CR+SD) of more than 60% and not be be of further interest with a rate of less than 40%. Given an alpha error of 5% and an beta error of 10% at least 66 evaluable patients were needed based on a 2-Stage Simon design with a first evaluation after 25 evaluable patients.


Eligibility Criteria:
Inclusion Criteria:

* Age\>=18
* Histologically proven inoperable esophageal cancer
* Karnofsky Performance status \>=60%
* Estimated life expectancy of \> 12 weeks
* Measurable disease
* No other oncologic therapy
* Measurable disease
* Adequate bone marrow function
* Geographic proximity and compliance
* Informed consent
* Negative pregnancy test and adequate contraception

Exclusion Criteria:

* Insufficient hepatic or renal function
* Elevated serum calcium
* Pregnancy/breast feeding
* Active infection
* Other malignancies
* Systemic tumour complications requiring emergency interventions
Robot-Assisted Therapy in Stroke Patients

This project consists of two parts: Robotic Rehabilitation Trials, and Study of Outcome Predictors and Clinimetric Attributes. In the first part of study, the investigators aim to (1) investigate the treatment effects of robot-assisted therapy (RAT) in patients with stroke on various outcomes, (2) test the dose-response relations by using two different intensities (higher versus lower intensity RAT), and (3) investigate the effects of the training intensity on a biomarker of oxidative stress. Treatment outcomes will encompass the spectrum of functioning including motor ability, motor control strategies, basic/extended daily functions, mobility, community reintegration, quality of life, and biomarker (8-OHdG). In the second part of study, the purposes are to define the appropriate populations for RAT and to examine the clinimetric properties of clinical measures relevant for use in robotic rehabilitation research. the investigators will identify the clinical predictors that will potentially influence the functional outcomes after interventions. Finally, the investigators will examine and compare the clinimetric properties (e.g., validity and responsiveness) of the clinical measures of rehabilitation outcome to inform selection of test instruments that may detect clinically meaningful change after rehabilitation therapy.


Eligibility Criteria:
Inclusion Criteria:

1. 3 to 24 months onset from a first-ever unilateral stroke
2. an initial UL subsection of the Fugl-Meyer Assessment score of 18 to 56 indicating moderate to severe and moderate UL movement impairment
3. no excessive spasticity in any of the joints of the affected UL (shoulder, elbow, wrist, fingers)
4. be able to follow study instructions and perform study tasks
5. without upper limb fracture within 3 months
6. lack of participation in any experimental rehabilitation or drug studies during the study period
7. willing to provide written informed consent

Exclusion Criteria:

1. subjects exhibiting physician-determined major medical problems or poor physical conditions that would interfere with participation
2. subjects with excessive pain in any joint that might limit participation
The Effect of Lidocaine Patch for Postoperative Pain

The lidocaine patch is currently only permitted for post herpetic neuralgia but the investigators want to study its effectiveness in post operative pain after inguinal herniorrhaphy

After open unilateral inguinal herniorrhaphy, patients are randomly divided into group L and group P groups. Group L attaches two lidocaine patches for 12 hours, above and below the incision site. Group P attaches two placebo patches for 12 hours, above and below the incision site. Pain scores are recorded for 30 minutes, 2 hours, 24 hours, and 1 week after surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status I - II
* Scheduled open unilateral herniorrhaphy

Exclusion Criteria:

* body mass index (BMI) \< 18.5 or ≥ 35 kg/m2
* severe renal or hepatic dysfunction
* allergy to amide-based local anesthetic agents
* taking class 1 antiarrhythmic drugs (tocainide and mexiletine, etc.)
COvera in BRAnch Registry

The purpose of the registry is to evaluate the peri-operative and short-, mid- and long-term outcomes of the Bard Covera Plus (Tempe, Arizona, USA) for the treatment of atherosclerotic aorto-iliac aneurysm in combination with a multibranched endograft


Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥18 years
* Patients who underwent/will undergo a complex aortic procedure with the use of a Covera Plus covered stent graft as a bridging stent, in the centres involved in this Registry
* Subject has consented for study participation and signed the approved Informed Consent

Exclusion Criteria:

* Bleeding diathesis or coagulopathy
* Patients with active systemic or cutaneous infection or inflammation
* Patients who are pregnant or lactating
* Patient younger than 18 years of age
* Patients who did not receive treatment using a Covera Plus covered stent graft.
A Research Study, Looking at How Xultophy® Works in People With Type 2 Diabetes in Local Clinical Practice in United Arab Emirates

The purpose of the study is to collect information on how Xultophy® works in patients with type 2 diabetes. The participants will get Xultophy® as prescribed to them by the study doctor. The study will last for about 26-34 weeks. The participants will be asked questions about their health and their diabetes treatment as part of their normal study doctor's appointment.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
* The decision to initiate treatment with commercially available Xultophy® has been made by the patient/Legally Acceptable Representative and the treating physician before and independently from the decision to include the patient in this study.
* Male or female, age greater than or equal to 18 years at the time of signing informed consent.
* Diagnosed with type 2 diabetes and treated with basal insulin plus or minus oral anti-diabetic drugs (OADs) or Glucagon-Like Peptide-1 Receptor Agonist (GLP-1 RA) plus or minus OADs, except Xultophy®, for at least 12 weeks prior to informed consent and initiation visit (visit 1).
* Available and documented glycosylated haemoglobin A1c (HbA1c) value less than or equal to 12 weeks prior to initiation of Xultophy® treatment.

Exclusion Criteria:

* Hypersensitivity to the active substance or to any of the excipients as specified in the Xultophy® local label.
* Previous participation in this study. Participation is defined as having given informed consent in this study.
* Female who is known pregnant, breast-feeding or intends to become pregnant.
* Treated with Xultophy® previously.
* Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.
PRAGMA (Prostate Radio Ablation Guided by Magnetic Resonance Imaging Acquisition) in Metastatic Prostate Cancer

Patients with metastatic prostate cancer can undergo MRI-guided prostate Stereotactic body radiation therapy (SBRT) without significant adverse events, similar to what has been reported for patients with localized prostate cancer. We hypothesize that prostate SBRT will be well-tolerated in metastatic prostate cancer patients, with quality of life outcomes similar to what has been reported in non-metastatic prostate cancer patients.

The MRidian ViewRay offers delivery of prostate SBRT with real-time MR guidance, which provides superior soft-tissue differentiation with excellent visualization of the prostate. This ViewRay platform offers the ideal setting for this study, that aims at precisely delivering prostate SBRT with a simultaneous integrated boost (when indicated) to visible nodules.

In this study, we hope to demonstrate the safety and feasibility of using 36.25 Gy in 5 fractions, plus a simultaneous integrated boost (when indicated), in patients with metastatic prostate cancer.

Eligibility Criteria:
Inclusion Criteria:

* Biopsy-proven diagnosis of prostate adenocarcinoma
* Age ≥ 18
* Must have biopsy-proven metastatic prostate cancer

Exclusion Criteria:

* History of prior pelvic radiation (external beam or brachytherapy)
* Inability to undergo MRI
* AUA score \>20
* For patients on systemic therapy, enrollment must be within six months of start of therapy unless exception is made by protocol PIs.
Cardiac Rehabilitation and Ongoing Physical Activity During COVID-19

The current Coronavirus Disease 2019 (COVID-19) pandemic has resulted in extraordinary public health orders of social distancing and self-isolation, leading to widespread disruption and discontinuation of cardiac rehabilitation programmes and other social opportunities for cardiovascular disease (CVD) patients to exercise. In Austria, the government initiated drastic public health measures (national lockdown) on March 16, 2020, leading to closure of all outpatient cardiac rehabilitation facilities and restriction of inpatient rehabilitation to patients with urgent medical indications only.

This study aims to explore the impact of COVID-19-related national lockdown and public health restrictions on cardiac rehabilitation patients, with respect to maintenance of physical activity for secondary CVD prevention.

The study poses three research questions, which will be addressed in a mixed-methods study with sequential quantitative-qualitative (QUANT-QUAL) design:

1. What was the impact of the COVID-19-related lockdown on patients' physical activity and physical fitness levels? (QUANT stage)
2. What was the patient experience of the closure of group-based cardiac rehabilitation training due to COVID-19 public health restrictions? (QUAL stage)
3. Which insights and learning points may be drawn from patients' experiences during COVID-19 public health restrictions with respect to the provision of home-based digital support for physical activity? (QUAL stage)

The study will recruit a cohort of up to 40 cardiac rehabilitation patients from one outpatient cardiac rehabilitation centre in Salzburg, Austria, whose rehabilitation programme was interrupted by COVID-19 public health orders, including "lockdown".

Patients will undergo re-assessment of physical fitness in cycle ergometry test and re-assessment of cardiovascular risk profile. This will be compared with patients' most recent available test results from before the COVID-19 lockdown (i.e. prior to mid-March 2020) from patient records. Additionally, patients will take part in a semi-structured qualitative interview in which they will be invited to reflect on their personal experiences during the COVID-19 lockdown and thereafter.


Eligibility Criteria:
Inclusion Criteria:

* Adults (18 years and over)
* Cardiovascular disease (CVD)
* Currently enrolled in outpatient cardiac rehabilitation training at the study site
* Informed consent

Exclusion Criteria:

* Contraindications for cardiopulmonary exercise testing
* Pathologies limiting exercise performance
* Pregnancy or breastfeeding
* Limited German language
Predictive Clinical and Biological Parameters in Gynecological Cancer

Research of predictive clinical and biological factors in breast cancer : genomic, proteomic, mutation


Eligibility Criteria:
Inclusion Criteria:

* gynecological cancer suspicion
* age \> 18
* signed informed consent

Exclusion Criteria:

- emergency

Exclusion criteria after histological exam Any diagnosis that is not a gynecological cancer (ovarian, cervix, endometrium).
Evaluation of the Luteolytic Effect of a Gonadotropin Releasing Hormone (GnRH) Agonist After the Administration of Human Chorionic Gonadotropin (hCG) in the Initial Follicular Phase a Its Influence on the Prognosis of in Vitro Fertilization Treatment

This study was designed to evaluate the ability of gonadotropin releasing hormone (GnRh) agonist to prevent the rise of progesterone during controlled ovarian stimulation for in vitro fertilization (IVF) after the administration of human Chorionic Gonadotropin (hCG) on the first day of menses.

The aim of this study is to evaluate the efficacy of a GnRH agonist in preventing the functional rescue of corpus luteum in women submitted to controlled ovarian stimulation with administration of hCG on the first day of menses and to evaluate its effect on pregnancy rate and ovarian steroidogenesis.

Eligibility Criteria:
Inclusion Criteria:

* age \>21 and \< 38 years old
* polycystic ovarian syndrome
* risk for ovarian hyperstimulation syndrome

Exclusion Criteria:

* recurrent abortion
* endometriosis
* more than 3 IVF failures
* use of oral contraceptive pills in the preceding 3 months
* low response to gonadotropins
SENSIMED Triggerfish Discomfort During IOP Monitoring

Evaluation of the wearing discomfort (safety and tolerability) involved during IOP monitoring with the SENISMED Triggerfish, a sensor embedded in a telemetric contact lens


Eligibility Criteria:
Inclusion Criteria:

* Patient is able to comply with the study procedure
* Patient is 18-80 years old
* Healthy subject or glaucoma patient
* Patient has consented to be in the trial and signed informed consent is available before any study related procedures are carried out
* Cylinder refraction of no more than +/- 2 diopters in the study eye
* Visual acuity of 20/80 or better in the study eye
* Ability of subject to understand the character and individual consequences of the study
* For women with childbearing potential, adequate contraception

Exclusion Criteria:

* Subjects wearing contact lenses within the last two years
* Subjects with contraindications for wearing contact lenses
* History of refractive surgery
* History of intraocular surgery in the last three months
* Severe dry eye syndrome
* Keratoconus or other corneal abnormalities
* Conjunctival or intraocular inflammation
* Pregnancy and lactation
* Simultaneous participation in other clinical trials