cyrilzakka/clinical-trials huggingface dataset:
Comorbidity Burden and Use of Concomitant Medications at CML Diagnosis

The aim of the retrospective study was to further characterize the prevalence of comorbid conditions as well as the use of concomitant medications in newly diagnosed CML patients in a real-world setting. Hematologists from ten Polish hematological tertiary care centers were asked to analyze medical records for all consecutive CML patients diagnosed with chronic phase CML between January 1st 2005 and December 31st 2014.

All three TKIs used as first line treatment of CML, (imatinib, dasatinib and nilotinib), may be associated with the so called "off-target" effects causing specific adverse events (AEs).

Interestingly, some co-morbidities may predispose towards developing these specific TKIs' "offtarget" AEs.

The aim of the retrospective study was to further characterize the prevalence of comorbid conditions as well as the use of concomitant medications in newly diagnosed CML patients in a real-world setting. Hematologists from ten Polish hematological tertiary care centers were asked to analyze medical records for all consecutive CML patients diagnosed with chronic phase CML between January 1st 2005 and December 31st 2014. Data were collected through on-line case report form of the Polish Adult Leukemia Group (PALG) Registry. Baseline patients' characteristics including sex, age, body mass index (BMI), risk group according to Sokal score, as well as comorbidities and concomitant therapies, were recorded at the time of CML diagnosis. The study was conducted in accordance with the provisions of the Declaration of Helsinki.

Eligibility Criteria:
Inclusion Criteria:

* 1) age ≥ 18 years; 2) diagnosis of chronic phase CML between January 1st 2005 and December 31st 2014.

Exclusion Criteria:

* primary diagnosis of CML in accelerated or blastic phase
Efficacy and Safety of Aluminaid Versus Hydrogel Wound Dressings

Burn injury is the result of an energy transfer that destroys the skin and adjacent tissues. Partial thickness burn wounds are painful and difficult to manage. The aim of burn treatment in partial thickness burns is to promote rapid wound healing, decrease pain, protect wound from infections, minimize scar formation and functional impairment In recent years, there are progressive development of new dressing material with a variety of option for depth adapted wound management. Many wound dressings are available for superficial and partial thickness burns. Hydrogel based wound dressing provides good biocompatibility with the skin and mucosa and promotes hydration of the wound bed.

Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium that was designed to reduce acute pain in the treatment of superficial and partical thickness burn injuries.

Up to date, no evidence regarding integrated with aluminium sheet in hydrogel based wound dressings for the use in partial thickness burns. Therefore this trials is aimed to evaluate the efficacy and safety of Aluminaid versus Hydrogel for the treatment of partial thickness burns.

This is a prospective, randomized, open label, active controlled trial that aim to evaluate the efficacy and safety of Aluminaid versus Hydrogel wound dressings in the treatment of partial thickness burns.

The study is a multi center trial in children and adults of 12 - 65 years old with partial thickness burns.

Eligibility Criteria:
Inclusion Criteria:

* Adults and children of 12 - 65 years old
* Partial thickness thermal burns of minimally 1% total body surface area (TBSA)
* Admission of less than 4 hours of burn injury
* Patients/legal guardian still have the ability to undergo examinations and give written informed consent.

Exclusion Criteria:

* Total body surface area (TBSA) of more than 20%
* Burns caused by chemicals, electricity or radiation
* Superficial and partial thickness burns located on the faces, palms, soles, genitalia, perineum and joint areas
* Superficial and partial thickness burns with compartment syndrome
* Superficial and partial thickness burns with a history of life-threatening trauma
* Had concomitant disease such as diabetes mellitus
* Signs of infected burns
* Patients with known allergies to product containing aluminium, hydrogel or a history of contact dermatitis
* Other conditions which according to the investigator's judgment are not appropriate to be included in the study.
* Treated with other agents before attend to clinic (oil, tooth paste, betadine, rivanol etc)
Use of an Oral Beta-2 Agonist in Persons With Spinal Cord Injury

The primary purpose of this study is to determine the effect of administration of the oral beta-2 adrenergic agonist, albuterol, on respiratory muscle strength in individuals with cervical (neck) and high thoracic (upper back) spinal cord injury and to compare findings with those obtained in a demographically matched group that will receive placebo. Participation in this study will involve 12 weeks of pharmacological intervention during which participants will be randomized to receive either oral albuterol 4mg twice daily or placebo. All investigators and study participants will be blinded to randomization by our research pharmacy. Participation in the study will require study subjects to come to our lab for the total of 2 visits (at baseline and after week 12), during which a series of tests will be performed to assess their respiratory muscle strength and pulmonary function.


Eligibility Criteria:
Inclusion Criteria:

* Chronic Spinal Cord Injury (\>1 year post-injury)
* All American Spinal Injury Association (ASIA) classifications
* High Paraplegia (level of injury T1-T6)
* Tetraplegia (level of injury C2-C8, non-ventilator dependent)

Exclusion Criteria:

* history of asthma
* uncontrolled hypertension or cardiovascular disease
* those using beta-2 adrenergic agonists
* epilepsy or seizure disorder
* hyperthyroidism
* chronic corticosteroid use
* those taking monoamine oxidase inhibitors or Tricyclic antidepressants for depression
* hypersensitivity to albuterol or any of its' delete components
* pregnancy
* use of ergogenic aids or supplements with anabolic characteristics including, but not limited to:

  * creatine monohydrate
  * anabolic steroids (e.g., testosterone)
  * growth hormone and their analogs and/or derivatives
The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs

Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.

Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.

Methods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.

The Effects of Virtual Reality and Music on Pain, Anxiety, Itching, and Vital Signs During Skin Prick Testing: A Randomized Controlled Trial ABSTRACT Aim: This study aimed to examine the effects of virtual reality and music on pain, anxiety, itching, and vital signs of children during a skin prick test and evaluation.

Background:Virtual reality and music are utilised to reduce pain, anxiety, and itching in children throughout various treatment processes.

Methods: This randomised controlled trial was divided into three groups: Virtual reality (n=30), music (n=30), and control (n=30). Anxiety was assessed before and after the skin prick test using the "State-Trait Anxiety Inventory for Children"; pain was assessed during and after the skin prick test using the "Wong-Baker Faces Pain Rating Scale"; vital signs were measured before, during, and after the skin prick test, and the itch assessment "Visual Analogue Score" was assessed at 5, 10, and fifteen minutes after the skin prick test. The study followed the CONCORT guideline.

Key words: allergy skin test, children, pain, anxiety, itching, virtual reality glasses, music.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 9-12 undergoing their initial skin test
* With no cognitive, visual, or auditory impairments
* No recent medical encounters involving pain or anxiety within the past 3 months
* Parents who volunteered for participation in this study.

Exclusion Criteria:

* Those who are not between the ages of 9 and 12 and have had a skin prick test before
* With cognitive, visual, or auditory impairments,
* Recent medical encounters involving pain or anxiety within the past 3 months,
* Parents who volunteered no for participation in this study.
To Evaluate the Efficacy and Tolerability of the Use of Vitatonus Dexa Compared to Dexamethasone in Patients With Neuralgia of Various Origins

To evaluate the efficacy and tolerability of Vitatonus Dexa compared with dexamethasone in the signs and symptoms of neuralgia of various origins.

Clinical study, randomized prospective and random in nature, with a patients diagnosed with neuralgia of diverse origin.

Patients will be include in sufficient quantity to achieve the minimum of 104 evaluable patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patients who consent to participate in the study by signing the ICF;
2. Patients of any ethnic group of both sexs aged over 18 years;
3. Patients with clinical diagnosis of neuralgia of various origins.
4. Patients who present scores on the Visual Analogue Scale (VAS) greater than or equal to 4 for PAIN.

Exclusion Criteria:

1. Patients with known hypersensitivity to lidocaine and thiamine or any component of the formula;
2. Pregnant women and nursing mothers;
3. Hypertensive or cardiac patients;
4. Patients with history of ulcers in the stomach or duodenum, diabetes mellitus or severe infections;
5. Patients who use levodopa, salicylates, colchicine, aminoglycosides, chloramphenicol, anticonvusivantes or potassium supplement.
6. Patient with a history of alcohol or use illicit drugs;
Impact of Covid-19 Restrictive Measure on Anxiety, Depression and PTSD for Relatives of ICU Patients

To limit the pandemic Covid-19 infection, the French government imposed a closure of all Intensive Care Unit (ICU). The family's visitations are prohibited during active Covid -19 pandemic in 2020 and in 2021. This restrictive visit policy could result in an increase in symptoms of anxiety, depression or post-traumatic stress disorder for relatives of ICU patients. The aim of this study is to compare symptoms of anxiety, depression or post-traumatic stress for relatives of ICU patients during Covid period with those during no Covid period (2020 and 2021) with those no Covid period (2022)

Observational multicenter study

Three groups are compared:

* no visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2020
* restrictive visitation group. Enrollment during the application of national containment measures to limit Covid pandemic in France: March to June 2021
* open visit group. Enrollment during a no Covid period without restrictive visitation: March to June 2022 The primary objective is to compare the Hospital Anxiety and Depression Scale (HADS) for relative at 3-6 months after the ICU patient discharge between the three groups The secondary objectives are
* to compare the Post-Traumatic Stress Disorder (PTSD) for relative at 3-6 months after the ICU patient discharge between the three groups
* to compare the prevalence of significant symptoms of both anxiety and depression for relative at 3-6 months after the ICU patient discharge between the three groups
* to compare the prevalence of significant PTSD-related symptoms for relative at 3-6 months after the ICU patient discharge between the three groups
* to identify the factor associated with significant symptoms of both anxiety and depression
* to identify the factor associated with significant PTSD-related symptoms

Eligibility Criteria:
Inclusion Criteria:

* Relative of patient who was admitted in ICU and treated with invasive mechanical ventilation administration during 24hours at least.

Exclusion Criteria:

* Relative who declines the enrollment
An RCT Comparing Xenograft and Allograft for Ridge Preservation

To compare the effectiveness of demineralized freeze-dried bone allograft + cross-linked collagen membrane with xenograft + non-cross-linked collagen membrane for posterior extraction socket ridge preservation.

Buccal bony wall loss is a common sequela following tooth extraction, and guided bone regeneration (GBR) is a common treatment for the regeneration of ridge form and volume preservation allowing dental implant placement. Many bone augmentation biomaterials are employed to accomplish GBR, and both the medical/ dental community and, subsequently, patients benefit from understanding whether a given GBR biomaterial might be more efficacious. To this end, a randomized, case series comparison of allograft + x-linked collagen membrane versus xenograft + non-x-linked collagen membrane would be beneficial to both the dental community and patients.

The study compares the effectiveness of demineralized freeze-dried bone allograft + x-linked collagen membrane with xenograft + non-x-linked collagen membrane for posterior region extraction socket ridge preservation.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects 18 to 70-yrs of age
2. Subject indicated for posterior tooth extraction (from 1st premolar to 1st molar) intended for implant placement, with adjacent teeth intact (for stent indexing)
3. Subjects with extraction site bony buccal dehiscences at least 1/3 the depth of socket and 1/3 the mesial-distal width of tooth socket
4. Subjects will have read, understood and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
5. Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

1. Subjects with a history of any tobacco use within the last six months.
2. Subjects with healing disorders (i.e., diabetes mellitus, cancer, HIV, bone metabolic diseases) that could compromise wound healing and/ or preclude implant surgery; or who are currently receiving or have received within two months prior to study entry, systemic corticosteroids, immunosuppressive agents, radiation therapy, and/or chemotherapy which could compromise wound healing and preclude periodontal surgery.
3. Subjects taking intramuscular or intravenous bisphosphonates.
4. Subjects who have a known allergy or sensitivity to alginate, latex, collagen or acrylic.
5. Female subjects who are pregnant or lactating, or who intend to become pregnant during the study duration
6. Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
7. Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Assessment of Liver Glucose Metabolism in Diabetic Subjects

Type 2 diabetes is associated with hepatic insulin resistance. One consequence of insulin resistance of the liver is an altered hepatic glucose metabolism. This study investigates whether the whole body (M-value) and hepatic insulin sensitivity obtained by hyperinsulinemic euglycemic clamp is influenced by a preceding intravenous glucose tolerance test (Botnia Clamp) in subjects with type 2 diabetes.

The hyperinsulinemic euglycemic clamp represents the gold standard for measuring peripheral insulin sensitivity. The insulin sensitivity is described by the M-value,which is calculated from glucose infusion rates during the last 30min of the clamp.

Glucose is metabolised in the periphery: 50% by neural tissues, 20% by splanchnic bed and liver, 15% by skeletal muscle, 5% by adipose tissue and 10% by blood cells and other tissues. Under hyperinsulinemic conditions there is a strong shift in glucose utilization: 85% skeletal muscle and 15% by neural tissues, splanchnic bed and liver, adipose tissue, blood cells and other tissues. The contribution of skeletal muscle varies with different insulin sensitivity.

We now want to investigate whether there is a difference in tissue-specific insulin sensitivity measured from a Botnia clamp (intravenous glucose tolerance test (ivGTT) and following clamp) and a single hyperinsulinemic euglycemic clamp? After a 60min ivGTT blood glucose levels in type 2 diabetic subjects are still elevated compared to baseline. High blood glucose levels can influence several parameters and may also affect insulin sensitivity. Until now, it is not proven, that the clamp preceding ivGTT does not have a significant influence on the M-value.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed type 2 diabetes (during the last 12 months)or non-diabetic subjects

Exclusion Criteria:

* severe chronic diseases
* hepatitis B, C oder HIV infection
* malignancies
* immune suppressive therapy
* psychiatric illnesses
* drug or alcohol abuse
* anemia
* renal dysfunction
Dynamic Preload Indicators in Sitting Position

Intraoperative optimization of cardiac output using goal directed fluid challenge is associated with better outcome. Dynamic preload dependence indicators are well validated during surgery in supine position. Positioning from supine to sitting position under anesthesia is responsible of several hemodynamic changes. Predictability and cut-off values of dynamic preload dependence indicators during surgery in sitting position are unknown. The objective of this prospective study is to evaluate ability of three dynamic preload dependence indicators, i.e. PPV (Pulse Pressure Variation), SVV (Stroke Volume Variation) and PVI (Plethysmographic Variability Index), during neurosurgery in sitting position.

The primary objective is to determine PPV, SVV and PVI thresholds for which patients respond to fluid challenge in sitting position.

The secondary objectives are to determine variations of PPV, SVV and PVI measures before and after positioning in sitting position, and to compare these values to each other.

Eligibility Criteria:
Inclusion Criteria:

* neurosurgery in sitting position
* age \> 18

Exclusion Criteria:

* arrhythmias
* severe heart failure
* severe lung disease
* contraindications to esophageal Doppler monitoring probe insertion (i.e. esophageal weakness)
* renal failure
Study on the Effect of a Physical Training Structured Program After a Pulmonary Thromboembolism

Exercise training, as the core component of a Pulmonary Rehabilitation program, may help restore arterial blood flow in the lungs of patients who had suffered Pulmonary Embolism (PE), stimulating and promoting vasodilator effects, repairing the damaged endothelium and recruiting new blood vessels and also inducing a net fibrinolytic balance. Besides, exercise training could have a positive effect on quality of life of these patients.

An experimental multicenter study is proposed , randomized according to parallel assignation and blinded to third ones to evaluate the effect of a 10-weeks structured exercise-based intervention protocol on the restoration of lung blood flow after an acute PE.

Main objective is to compare the efficacy and safety in terms of quantitative measures from lung scintigraphy, of lung perfusion versus usual care in patients with PE. Additionally the study is aimed to identify bio-markers of response to treatment (mRNAs, MPs and proteomic approach) and to analyze the effects of training on exercise capacity, quality of life parameters and anxiety depression scores.

Eligibility Criteria:
Inclusion Criteria:

Patients 18 years or older at PE diagnosis PE diagnosis confirmed by imaging tests according guidelines Patients under correct anticoagulant treatment Persistent Lung Perfusion Defects at one month after PE diagnosis. Signed Consent Inform

Exclusion Criteria:

Incidental or silent PE Pregnant or puerperal woman Life expectancy less than 6 months Severe comorbidities (NYHA 4 in severe heart failure; COPD, gold D; severe psychiatric illness) Any disability for physical exercise according to their doctors

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Recovery Management Intervention in China

The purpose of the study is to develop and pilot-test a Recovery Management Intervention (RMI) program for heroin addicts released from compulsory rehabilitation in China.

The project has the following specific aims:

Primary aims:

Aim 1. To engage key stakeholders in the local communities involved in supporting the transition of heroin addicts released from compulsory rehabilitation to the community; Aim 2. To identify potential barriers for participating in MMT in China; Aim 3. To develop and deliver educational/training materials on HIV risks, relapse prevention, and MMT; Aim 4. To adapt and develop the Recovery Management Intervention (RMI) program for heroin addicts released from compulsory rehabilitation in China; Aim 5. To conduct a pilot trial and obtain preliminary outcome data associated with RMI, relative to enhanced standard care.

Secondary aim:

Aim 6. To explore predictors of relapse and HIV/AIDS risk behaviors.

It is hypothesized that the intervention will reduce drug use relapse and the negative consequences associated with relapse, including HIV risk behaviors


Eligibility Criteria:
Inclusion Criteria:The study population will be drawn from all adult patients at participating compulsory rehabilitation facilities who:

1. have been incarcerated for at least one year and would have been eligible for MMT at the time of incarceration,
2. have at least 1 month remaining before release,
3. met the DSM-IV criteria for heroin dependence at the time of incarceration,
4. are willing to enroll in methadone maintenance treatment, and
5. are Shanghai residents who reside in the areas of Shanghai targeted by the study.

Exclusion Criteria: Individuals diagnosed with severe mental illness will not be eligible to participate.