cyrilzakka/clinical-trials huggingface dataset:
Assisted Device for Freezing in Parkinson Disease

Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients. Our objective is to adapt and extend FOG detectors in order to include other associated gait pattern changes, like festination.Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.

Freezing of gait (FOG) is a particular and troublesome symptom occurring in some Parkinsonian patients .This brief, episodic absence or marked reduction of forward progression of the feet despite the intention to walk is associated to a fall risk. Automatized FOG episode detection would allow systematic assessment of patient state and objective evaluation of the clinical effects of treatments. Techniques have been proposed in the literature to identify FOG episodes based on the frequency properties of inertial sensor signals. Our objective here is to adapt and extend these FOG detectors in order to include other associated gait pattern changes, like festination. The proposed approach is based on a single wireless inertial sensor placed on the patient's lower limbs. Based freezing detectors are not sufficient to detect all FOG and festination episodes. Stride length and cadence are valuable inputs to anticipate the occurrence of upcoming FOG events. The investigators have developed a solution based on a minimal number of embedded sensors and detection algorithms for future real-time applications. It is well known that auditory rhythmic stimulation or visuals marks on the ground would improve dramatically gait in patients with FOG. This sensibility to cueing leads some teams to develop some mobility aid devices rhythmic. Our purpose is to develop a wearable assistant which would trigger the most appropriate cueing aid just before occurrence of the freezing episode.

Eligibility Criteria:
Inclusion Criteria:

* troublesome freezing

Exclusion Criteria:

* dementia
Effect of High Protein Diet on Cardiovascular Diseases Risk Factors Among Overweight and Obese Children

The investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.

Background: Studies regarding the effects of high protein (HP) diet on cardiovascular (CVD) risk factors have reported contradictory results.

Objective: In present study, the investigators aimed to determine the effects of HP diet on CVD risk factors among overweight and obese children.

Design: In this randomized controlled trial, the investigators recruited 50 overweight and obese women, aged 6-11years into HP or control energy restricted diets for 10 weeks (protein, carbohydrate, fat: 25%, 45%, 30% vs. 15%, 55%, 30%, respectively). Total protein amount, divided to animal and plant sources in 50%-50% and animal sources distributed (half/half) between meats and dairy products. Fasting blood samples, lipid profile, systolic and diastolic blood pressure and anthropometric measurements were measured based on the standard guidelines.

Eligibility Criteria:
Inclusion Criteria:

* BMI \> 85th age of 6-11 years
* no history of chronic diseases
* no taken medications

Exclusion Criteria:

* do not prescribe their diet
* mental retardation
Ultrasound Guided Percutaneous Tracheostomy

Use of the ultrasound before, during and after percutaneous tracheostomy allows us great advantages; anatomy of the pre and paratracheal region and displaying potential aberrant vessels, and so the needle and dilator to move away from risk areas and ensure the prevention of possible vascular complications. Measuring the distance from the skin into the trachea can be done and this allows us to choose the average size tracheostomy tube.

The aim of this study, In the process of applying percutaneous tracheostomy, to compare the reliability of the traditional landmark method, ultrasound-guided long axis in plane application and ultrasound-guided short axis out of plane application.


Eligibility Criteria:
Inclusion Criteria:

* hospitalized patients in intensive care
* the decision to open percutaneous tracheostomy
* over 18 years

Exclusion Criteria:

* under 18 years
* Patients with high or unstable intracranial pressure
* Patients with severe coagulation disorders
* Patients attached collar
* hemodynamically unstable patients, despite the use of high doses of vasoactive drugs
* patients with infections in tracheostomy area
Iron Deficiency in Patients With Heart Failure and Reduced and Mildly Reduced Ejection Fraction

A significant percentage of patients with heart failure and reduced ejection fraction (HFrEF) or mildly reduced ejection fraction (HFmrEF) have iron deficiency who are symptomatic. This is independently associated with bad quality of life, low functional capacity, lower quality of, life and increased mortality. The prevalence of iron deficiency in HFrEF and HFmrEF patients in Jordan has not been studied in the past.

The prevalence of chronic heart failure among the industrialized countries is 1-3%, and can exceed 30% in the elderly population. As the population ages, there is an increase in the number of co-morbidities among heart failure patients. These comorbidities are associated with an increase in major adverse cardiac events (MACE), cost, and complexity of care. Iron deficiency is one of the most common comorbidities occurring in patients with heart failure. Its prevalence can be as high as 59%, even if patients are non-anemic\[4\]. Iron deficiency in heart failure can lead to an impaired exercise capacity, a decreased quality of life and an increased risk of hospitalizations and mortality regardless of anemia. The relationship between the severity of iron deficiency and the prognosis is a linear one, with increased severity being associated with increased mortality.

Intravenous iron treatment has been shown to improve the quality of life, with an increased exercise capacity and a reduced risk for hospitalizations. The prevalence of iron deficiency in HFrEF and HFmrEF patients in Middle Eastern population has not been studied. We suspect a higher prevalence compared to Western populations especially in women.

Eligibility Criteria:
Inclusion Criteria:

* Heart failure patients with ejection fraction \<59% (including those with with reduced ejection fraction of ≤40%, or mildly reduced EF (41-49%)) within the last 2 years.
* NYHA class II-IV.
* Able and willing to provide oral informed consent.

Exclusion Criteria:

* Age\<18 years.
* Acute coronary syndrome.
* Known cases of iron overload (e.g. hemochromatosis); known cases of anemia due to other causes.
* Oral or intravenous iron supplements within the previous 3 months; erythropoietin stimulating agents or blood transfusion within the last 6 months.
* Active clinically relevant bleeding in the investigator's opinion.
* Patients with chronic inflammatory conditions (e.g. rheumatoid arthritis; Crohn's disease, etc.); active infection; and decompensated liver disease.
Efficacy and Safety of M281 in Adults With Warm Autoimmune Hemolytic Anemia

The main purpose of this study is to evaluate the efficacy and safety of M281 in participants with warm autoimmune hemolytic anemia (wAIHA).

The study consists of a 24-week double-blind, placebo control period, a 144-week open-label extension period and follow-up period of 8 weeks after last study drug administration. Eligible participants will be randomized to placebo or nipocalimab (2 dose levels) during the double-blind period and nipocalimab (2 dose levels) during the open-label extension period.

Eligibility Criteria:
Inclusion criteria:

* Participants greater than or equal to (\>=)18 years of age
* Have been diagnosed with warm autoimmune hemolytic anemia (wAIHA) for at least 3 months, and are currently receiving treatment for wAIHA or have previously received treatment for wAIHA (treatment-naive participants are not eligible)
* Participants must be able to understand and voluntarily provide written informed consent to participate in the study and comply with all study procedures

Exclusion criteria:

* Participants must not be pregnant or breastfeeding
* Participants must not have other clinically relevant abnormalities currently or in their history that the Investigator would deem them ineligible to participate
* Have been diagnosed with cold antibody autoimmune hemolytic anemia (AIHA), cold agglutinin syndrome, mixed type (that is, warm and cold) AIHA, or paroxysmal cold hemoglobinuria
Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices

Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12 mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed consent.


Eligibility Criteria:
Inclusion Criteria:

1. Acute on Chronic Liver Failure as per APASL (Asian Pacific Association of Study of Liver Disease) criteria.
2. 18-75 years
3. HVPG ≥ 12 + No/Small Esophageal varices

Exclusion Criteria:

1. Bradycardia (HR \< 60/ min)
2. Hypotension
3. Asthma
4. LVF
5. AKI (Acute Kidney Injury), (S.creat \>1.5)
6. Refractory ascites
7. SBP (Spontaneous Bacterial Peritonitis)
8. Pregnancy or Lactation
9. Past history of EVL or EST
10. Significant cardio - pulmonary co-morbidity
11. PVT
12. Presence of grades 3-4 hepatic encephalopathy (HE)
13. Patients going for liver transplant in next 12 weeks
14. No consent
Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Immunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)

the aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV


Eligibility Criteria:
Inclusion criteria:

1. Chronic hepatitis C (HCV) genotype 1 infection
2. Chronic Human Immunodeficiency Virus (HIV) -1 infection
3. HCV treatment naive or HCV treatment experienced but only relapsers
4. Age 18 to 70 years
5. Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART)
6. Karnofsky score \>70
7. HCV viral load \>1.000 IU/mL

Exclusion criteria:

1. HCV infection of mixed genotype (1/2, 1/3, 1/4)
2. Evidence of acute or chronic liver due to chronic HCV infection
3. Hepatitis B virus (HBV) infection with presence of HBs-Ag
4. Active malignancy or history or malignancy within the last 5 years
5. Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment.
6. Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy, esophageal variceal bleeding, and/or laboratory values that add up to \>/= 7 points according tho the Child-Turcotte-Pugh classification
7. Hemoglobin \</=11g/dL for women and \</= 12 g/dL for men
8. Patients with stable cardiac disease and Hemoglobin \<12g/dL
9. Known hypersensitivity to any ingredient of the study drugs
Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures

This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Primary surgical treatment of tibia fracture using intramedullary nailing
* Closed fractures: Tscherne Type C1, C2 and C3
* Open fractures: Gustilo Grade I, II and IIIa

Exclusion Criteria:

* Open growth plate on X-rays
* Known chronic endocrine or metabolic disease including diabetes and severe obesity defined as body mass index (BMI)1 \> 32.0
* Severe head injury defined as patients who are stuporous or comatose with pupillary enlargement or asymmetry
* Critically ill patients defined as patients in need of mechanical ventilation (except during surgical procedures) or circulatory support (defined as use of inotropic drugs)
Study Of the Safety of Locally Manufactured 123I-metaiodobenzylguanidine(MIBG) in Routine Clinical Use

Assessing 123 Iodine MIBG produced locally for safety while being used in clinical practice to help in patient management decisions.

We will be assessing for adverse reactions of patients injected with locally manufactured 123 Iodine MIBG. With monitoring of blood pressure and heart rate following injection and any potential immediate side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients with potential Adrenergic pathology

Exclusion Criteria:

* Pregnant or breast feeding females
* Hypersensitivity to MIBG
The Use of 5-ALA in Paediatric Patients With High Grade Brain Tumours

The aim of the study is to examine the safety and feasibility of using 5-ALA in children who have MRI scans showing an aggressive looking brain tumour. It will also study if 5-ALA can help the surgeon achieve maximal tumour removal and discriminate between normal brain tissue and tumour.

Patients will be between 3-18 years (inclusive) and all patients will receive 5-ALA 3-6 hours prior to resection surgery.


Eligibility Criteria:
Inclusion Criteria:

* Magnetic Resonance Imaging confirmation of diagnosis consistent with either: primary presentation of high grade brain tumour OR patient relapsing with previously confirmed ependymoma or high-grade glial tumour
* Tumours will be either intrinsic supratentorial or infratentorial / posterior fossa, non-brainstem, tumours
* Patient is appropriate for maximal safe resection of tumour, based on Investigator and Multidisciplinary Team judgement
* 3 - 18 years inclusive
* Adequate liver and kidney function

  * creatinine - less than one and a half times the upper limit of normal.
  * haemoglobin above the lower limit of normal
  * Alanine transferase or Aspartate transferase less than twice the upper limit of normal (if both performed, then both results must be lower than twice the upper limit of normal
  * bilirubin lower than one and a half times the upper limit of normal
* Normal Coagulation profile

  o Prothombin Time, Activated Partial Prothombin Time and Thrombin Time all within normal limits
* Urine porphyrin - Test to be completed and sent for analysis
* Blood pressure lower than or equal to the upper limit of normal
* Negative pregnancy test in women of childbearing potential\*
* Informed Consent \*A positive pregnancy test that is suspected to be due to the location of the tumour is to be queried with the TMG prior to registration of the patient

Exclusion Criteria:

* Patients with low grade tumours (either radiological or histological diagnosis)
* Patient is appropriate for biopsy only, based on Investigator and MDT judgement
* Known history (including family history) of porphyria
* Hypersensitivity to the active substance or to porphyrins
* History of light sensitivity reactions
* Pregnant or breastfeeding women
The Effect of Immediate Versus Delayed Debriefing on Basic Life Support Competence In Undergraduate Nursing Students.

The goal of this clinical trial is to find out if immediate (hot) or delayed (cold) debriefing is better for undergraduate nursing students during Basic Life Support (BLS) training.

The study aims to:

* Identify the effect of hot versus cold debriefing in BLS training for nursing students.
* Identify which debriefing method students prefer.

Researchers will compare the two debriefing methods. Participants will:

* Be randomly assigned (by flipping a coin) to either hot or cold debriefing.
* Take part in a simulation about Basic Life Support.

This RCT aimed to identify the efficacy of cold versus hot debriefing in BLS training for undergraduate nursing students\&#39; BLS competence and to assess the impact of hot and cold debriefing nursing students\&#39; debriefing experience.

Specific Aims/Hypothesis Specific aim 1: Identify the efficacy of cold versus hot debriefing in BLS training for undergraduate nursing students\&#39; BLS competence.

Hypothesis 1a: In both cold and hot debriefing groups, there is a significant difference in the BLS competence of undergraduate nursing students between pre-intervention and post-intervention.

Hypothesis 1b: Undergraduate nursing students who receive cold debriefing will show greater BLS competence than those who receive hot debriefing. Our approach to testing the aim is to conduct an experimental design study.

Specific aim 2: Assess the impact of hot and cold debriefing on undergraduate nursing students\&#39; debriefing experience.

Hypothesis 2: Undergraduate nursing students who receive cold debriefing will show greater debriefing experience scores than those who receive hot debriefing.

Eligibility Criteria:
Inclusion Criteria:

* Junior or senior nursing students (i.e., in their third or fourth year of the BSN degree).

Exclusion Criteria:

* Nursing students who are not junior or senior.
Investigation of Risk Factors Encountered by Operating Room Nurses

Operating Room Nurses (ORN) are exposed to a lot of risks related to the working environment. There is a limited number of studies describing the risks faced by ADs in the work environment.

Aims: In this study, we aimed to determine the risk factors faced by AHs in operating rooms.

Background: Operating Room Nurses (AH) are exposed to a lot of risks related to the working environment. There is a limited number of studies describing the risks faced by ADs in the work environment.

Aims: In this study, we aimed to determine the risk factors faced by AHs in operating rooms.

Study Design: This is a prospective descriptive study. Methods: The study was carried out with the operating room nurses working in the operating rooms of six hospitals affiliated to the General Secretariat of the Gaziantep Provincial Public Hospitals Association between September 2019 and February 2023.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer nurse
* Being an operating room nurse

Exclusion Criteria:

• Nurses working outside the operating room
Trial of Outpatient Immunotherapy With Rituximab and Aldesleukin (IL-2) vs. Rituximab Alone for Non-Hodgkin's Lymphoma

The purpose of this research study is to find out if treatment with rituximab in combination with aldesleukin (compared to rituximab alone) decreases the risk of cancer returning, as well as determining what other effects (good and bad) this drug combination has on NHL. Rituximab and aldesleukin are not approved in combination by the Food and Drug Administration (FDA) for the treatment of non-Hodgkins lymphoma; however, Rituximab is approved for use by itself to treat NHL.


Eligibility Criteria:
INCLUSION CRITERIA:

A patient will be eligible for inclusion in this study if s/he meets all of the following criteria:

* Has previously undergone BEAC or BEAM autologus SCT with PBSC rescue for any stage aggressive B-cell NHL, including transformed indolent NHL or mantle cell lymphoma according to REAL classification - only B-cell lymphomas are permitted.
* ECOG performance status 0-1.
* Previously histological documented CD20 +NHL.
* Is greater than 18 years of age.
* Is 30-100 days from autologous peripheral blood stem cell transplant.
* Must meet laboratory values (see protocol for values): Absolute neutrophils, hemoglobin and platelets.
* Has a negative serum pregnancy test within 7 days prior to trial registration (only for female patients of childbearing potential).
* If fertile, patient (male or female) has agreed to use physician-approved method of birth control to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.
* Has signed a Patient Informed Consent Form.
* Has signed a Patient Authorization Form (HIPAA).

EXCLUSION CRITERIA:

Patients will be taken off treatment if any of the following occur:

* ECOG PS \>2.
* A history of hypersensitivity to study drugs, or any component thereof, or anaphylactic history to murine protein.
* Manifested cardiac complications during transplant, including arrthymias, congestive heart failure, angina, or myocardial infarct, or had a decreased LVEF to \<45% prior to transplant
* On systemic corticosteroids.
* Diffusion capacity \<60% (corrected) and has decreased 30% or more following transplant
* Documented disease progression (See Section 10.1.6 for definition).
* Active infection, and/or is known to be seropositive for hepatitis B, hepatitis C, or HIV
* Pericardial effusion, pleural effusions, or ascites.
* A history of very aggressive NHL, such as Burkitt's or atypical Burkitt's lymphoma
* Receiving concurrent immunotherapy or rituximab therapy.
* Previously received a solid organ transplant.
* History of CNS involvement.
* A serious uncontrolled intercurrent medical or psychiatric illness, including serious infection
* A history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs.
* A pregnant or nursing woman.
* Unable to comply with requirements of study.
Stereotactic Radiosurgery for Patients With Hepatic Metastases.

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with liver metastases.

OBJECTIVES:

* To determine the maximum tolerated dose of fractionated stereotactic radiosurgery in patients with hepatic metastases.
* To determine the dose-limiting toxicity of stereotactic radiosurgery in these patients.
* To assess the tumor response in these patients.

OUTLINE: This is a multicenter study.

Patients receive 3-5 fractions of stereotactic radiosurgery over 14 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 9-13 patients receive escalating doses of stereotactic radiosurgery until 60 Gy is reached or the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which \> 33% of patients experience dose-limiting toxicity.

After completion of study therapy, patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed primary cancer

  * Stage IV primary disease with up to five liver metastases that are visualized on CT scan, MRI of the abdomen, or positron-emission tomography

    * No liver metastases secondary to germ cell tumor or hematologic malignancy
    * Other sites of metastases allowed
* No malignant ascites
* The cumulative total dose of radiotherapy to ≥ 2/3 of the liver and surrounding normal tissues, including the esophagus, stomach, and small bowel, must be ≤ 15 Gy
* Percutaneous or laparoscopic biopsy of the metastasis and placement of 3-5 fiducials required if undergoing Cyberknife for treatment delivery

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Life expectancy ≥ 3 months
* Albumin ≥ 3 g/dL
* Alkaline phosphatase \< 1.5 times upper limit of normal (ULN)
* AST and ALT \< 1.5 times ULN
* Total bilirubin \< 1.5 times ULN
* Prothrombin time \< 1.5 times ULN
* Hemoglobin \> 10 g/dL
* Platelet count \> 100,000/mm³
* ANC \> 1,000/mm³
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No history of diagnosed inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
* No active peptic ulcer disease
* No hepato-renal syndrome

PRIOR CONCURRENT THERAPY:

* Prior systemic therapy allowed provided complete blood cell counts have recovered
* No other concurrent antineoplastic treatment