cyrilzakka/clinical-trials huggingface dataset:
SpineJack System Postmarket Registry

This postmarket registry is intended to prospectively collect real world data to support ongoing safety and performance of the SpineJack system.

The SpineJack System Registry will employ a prospective, multicenter, observational, consecutive enrollment design. The sample size for this Registry will include at least 400 patients treated for VCFs across approximately 10 sites. A total of 240 patients will be treated with the SpineJack system and 160 patients will be treated with other vertebral augmentation (VA) procedures, such as BKP or VP. Sites within the U.S. may include healthcare professionals (HCPs) that are surgeons, pain physicians and/or interventional radiologists.

Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older
2. Understand and sign the informed consent form (as applicable)
3. Exhibit no altered mental status or language barrier that may prevent completion of the patient reported outcome (PRO) surveys following the procedure.
4. VCF diagnosis made and/or confirmed at participating site.

Exclusion Criteria:

-
The Effects of Trunk Exercises on Upper Extremity and Respiratory Functions in DMD

The aim of this study was to investigate the effects of trunk training on trunk control, upper extremity, and pulmonary function in children with Duchenne muscular dystrophy (DMD).

26 children with DMD aged 5-16 were included in the study. They were divided into two groups (study and control). The study group exercised with the trunk-oriented exercise program and the conventional exercise program under the supervision of a physiotherapist, whereas the control group underwent the conventional exercise program under the supervision of their families at home for 8 weeks.

Trunk control, the upper extremity function and respiratory function test were assessed before and after the 8-week exercise program in this study.

This study aimed to investigate the effects of trunk training on trunk control, upper extremity, and pulmonary function in children with Duchenne muscular dystrophy.

26 children with DMD aged 5-16 were included in the study. They were divided into two groups (study and control). The study group (N=13) exercised with the trunk-oriented exercise program and the conventional exercise program under the supervision of a physiotherapist, whereas the control group (N=13) underwent the conventional exercise program under the supervision of their families at home for 8 weeks. The conventional program exercises were taught to patients and their families in the study and control groups. These exercises were performed daily for 8 weeks, twice a day, on average 45 minutes, each exercise 5-10 repetitions. The conventional exercises program formed stretching exercises, and active or active-assisted strength exercises (upper extremity, lower extremity, abdominal muscles, back muscles), and the Trunk-oriented exercises were specially adapted to the patient based on the patient's functional status and active participation in the exercises. Trunk control was assessed using the Trunk Control Measurement Scale, the upper extremity function was assessed using Performance of Upper Limb and respiratory function using the pulmonary function test before and after the 8-week exercise program in this study.

.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with Duchenne Muscle Dystrophy
* No injuries and no neurological or orthopedic surgery in the last 6 months
* No other systemic or orthopedic / neurological disorders to prevent exercise

Exclusion Criteria:

-
Blinatumomab as a Bridge to Allo-HSCT in HR BCP-ALL

To explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia

High Risk Precursor B-cell Acute Lymphoblastic Leukemia is a kind of leukemia with poor prognosis. Here, we want to explore the efficacy and safty of Blinatumomab as a bridge to Allogeneic Hematopoietic Stem Cell Transplantation in High Risk Precursor B-cell Acute Lymphoblastic Leukemia.

Eligibility Criteria:
Inclusion Criteria:

1. The patients meet the diagnostic criteria for high risk precursor B-ALL (according to the 2016 WHO classification) and are under hematologic remission.
2. ECOG score is 0-2.
3. Expecting life span is more than 6 months.
4. Patients are free from severe organ dysfunction.

Exclusion Criteria:

1. Patients are combined with severe organ dysfunction: Organ failure: Cardiac failure: ejection fraction(EF) \<30%, NYHA standard, cardiac function not Full Grade II or above; Liver and kidney insufficiency: serum total bile Erythroid ≥2mg/dl, AST or ALT≥ upper limit of normal 2.5-fold, serum creatinine (SCr) \>2.5mg/ dL or blood Creatinine clearance rate \< 30ml/min.
2. Patients are combined with infection or other complications that can not tolerate chemotherapy.
3. Patients are suffering from central nervous system/solitary extramedullary leukemia.
4. Patients are considered as tumer progression.
5. Patients has undergone allogeneic hematopoietic stem cell transplantation or underwent autologous stem cell transplantation within 6 weeks or other immunotherapy within 4 weeks.
6. Pregnant and lactating women will not be included.
Tobacco Cessation Treatment Preferences Among Veteran Smokers

There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers cite several barriers to delivering evidence-based tobacco cessation care, including insufficient time and lack of training. In addition, a large proportion of patients who begin tobacco cessation treatment do not quit. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to improve patients' ability to quit tobacco use. The purpose of this study is to demonstrate the feasibility of a larger trial, and to evaluate the acceptability of the intervention design. Thirty participants will be assigned to receive either 1) a treatment that includes personalized counseling, tobacco cessation medications, and text messaging; or 2) referral to Department of Veterans Affairs' Quitline program plus SmokefreeVET, a text messaging program.

There are significant barriers to tobacco cessation treatment for patients and providers in specialty care clinical settings. Specialty providers in general cite several prominent barriers to delivering evidence-based tobacco cessation care, including insufficient time, lack of training, a perception of low motivation in their patients, and concerns about the sensitivity of tobacco cessation discussions. In addition, a large proportion of patients who begin tobacco cessation treatment do not achieve initial abstinence. Use of healthcare technology (i.e., telehealth, electronic health record, and computerized treatment algorithms based on patient data) to personalize treatment has the potential to increase patient engagement and proactively address treatment non-response. The proposed randomized controlled trial is a two-arm experimental design to demonstrate the feasibility of a larger trial and the acceptability of the intervention design. Participants (N = 30) will be stratified by clinic and randomized to either 1) the active treatment, which includes personalized cognitive behavioral treatment, personalized smoking cessation pharmacotherapy, and test messaging support; or 2) standard of care Department of Veterans Affairs' Quitline (telehealth intervention including 5 sessions of CBT) plus SmokefreeVET (text-messaging intervention).

Eligibility Criteria:
Inclusion Criteria:

* Durham VA patient
* willing to complete study procedures
* appointment in Durham VA Infectious Disease (ID) Clinic or Durham VA Cardiology Section within the past 12 months
* currently smoking 7 times per week (cigarettes, cigars, cigarillos, hookah, etc.) and/or using 1 can of smokeless tobacco per week

Exclusion Criteria:

* participation in Aim 3 (already received the intervention)
* current hospitalization (recent hospitalization is acceptable)
* currently not using combustible or smokeless tobacco (vaping only)
* acute risk for suicide documented in the medical record
* or inability to complete study procedures
Mother - Daughter Initiative (MDI) in Cervical Cancer Prevention

The Mother-Daughter Initiative (MDI) will test the feasibility and acceptability of a strategy to deliver comprehensive cervical cancer prevention services in Thailand and the Philippines by integrating the HPV vaccine for girls ages 9-13 into already successful screening and treatment programs for mothers.


Eligibility Criteria:
Inclusion Criteria:

* Age 9-13 at first HPV vaccine dose
* Mother/legal guardian and daughter are both interested and willing to have the girl receive the HPV vaccine
* Mother/legal guardian and daughter both indicate that they would be able to return to clinic for the three vaccine doses

Exclusion Criteria:

* Girls with a known history of any allergies or severe reaction to any vaccines, food or medicine
* Pregnant adolescents will be excluded. If a girl becomes pregnant after the first dose is administered, she will not be provided with the second or third dose
* Girls with moderate or severe illnesses will be asked to postpone vaccination eg. Pneumonia.
* Girls with a weakened immune system, cancer, leukemia, AIDS or other immune system problems
* Girls with a bleeding disorder or currently taking anticoagulants
* Girls that have received any other vaccinations in the past 4 weeks
* Girls currently on steroids, such as cortisone, prednisone, or anti-cancer drug.
Predictive Blood Tests for Severe Radiation Reactions in Breast Cancer Patients

Some patients who undergo breast cancer treatment with lumpectomy followed by radiation therapy develop significant late skin and soft tissue changes, resulting in a poor cosmetic outcome. The goal of this study is to try to predict severe tissue reactions by using a combination of three of the latest blood tests, one of which we have developed ourselves.

Three tubes of blood will be drawn from each subject. Two members of the study team will also independently assess each subject for the degree to which various radiation-induced soft tissue changes are evident. Subjects will be put into three groups according to the severity of the soft tissue changes which are noted, and the results of the blood tests for members of each group will be analyzed to determine whether a correlation with cosmetic outcomes can be determined. If the results are promising, they will be studied further and used as the basis for future prospective clinical trials.

Eligibility Criteria:
Inclusion Criteria:

* Breast cancer treatment: lumpectomy followed by external beam XRT to breast
* Age at the time of radiotherapy treatment: 45-65 years old
* XRT dose to breast: \>/= 4500 and \</= 5200 cGy, fraction size 180 or 200 cGy
* Dose distribution: no area receiving \>/= 112% of prescribed dose
* Follow-ups: patients must be \>/= 2.5 years post-treatment

Exclusion Criteria:

* Reconstructive surgery to involved breast
IVIg Therapy for Patients With Idiopathic Cardiomyopathy and Endomyocardial Biopsy Proven High PVB19 Viral Load

Rationale: Parvovirus B19 (PVB19) persistence in the heart has been associated with progressive cardiac dysfunction and evolution to dilated cardiomyopathy.

Objective: Whether high dose of intravenous immunoglobulin (IVIg) in addition to conventional heart failure therapy achieves virus reduction, thereby resulting in improvement of cardiac function.

Study design: A interventional study of virus presence and cardiac functional capacity before and after IVIg therapy.

Study population: Patients with idiopathic cardiomyopathy and symptomatic heart failure for more than 1 year and a significant PVB19 viral load in endomyocardial biopsies (EMB) and treated with high dose of IVIg were included.

Intervention (if applicable): Patients were treated with a total dose of 2 g/kg of immune globulin administered as 0.5 g/kg IV over a period of 6 hours on each of 4 consecutive days.

Main study parameters/endpoints: EMBs: virus (PVB19, enteroviruses, adenoviruses, Epstein-Barr virus, human herpes virus-6 and cytomegalovirus), inflammation (lymphocytes an macrophages) and fibrosis. Cardiac functional capacity: NYHA classification, echocardiographic evaluation (left ventricular ejection fraction, end-systolic diameter, end-diastolic diameter).


Eligibility Criteria:
Inclusion Criteria:

* Idiopathic heart failure \<1 year.
* Optimal conventional heart failure medication \<6 months.
* PVB19 viral load \>150copies/mcg DNA in EMBs.

Exclusion Criteria:

* significant (lesions \>50% stenosis) coronary artery disease.
* significant valvular disease.
* systemic diseases such as sarcoidosis, giant cell myocarditis, hemochromatosis, or systemic autoimmune diseases.
Evaluation of Social Cognition in Patient With Type 1 or Type 2 Narcolepsy Versus Patients With Idiopathic Hypersomnia

Narcolepsy is a chronic disabling neurologic disorder mainly characterised by excessive daytime sleepiness. Type 1 narcolepsy is associated with a deficit of hypocretin in the cerebrospinal fluid responsible for the cataplexy symptom while type 2 shows a normal hypocretin level and no cataplexy. While the development of narcolepsy is independent of parental social level, narcolepsy has a significant influence on educational level, grading, social outcome, and welfare consequences. Several studies assessed global cognition efficiency, mood, and attention in narcoleptic patients but only a few specifically measured social cognition and mostly without a control group.

In a population of narcoleptics children, a severe impairment in social cognition is described for 20% of the group, contrary to 2 % for the control group. The literature also depicts some impairments in decision making, somatic and cognitive emotions responses but the emotion recognition seems to be preserved.

A better understanding of the social and cognitive aspects of narcolepsy could lead to a better treatment of the disease in its entirety, including if relevant specific cognitive behavioural therapy.

The protocol consists in a psychometric evaluation including several questionnaires in order to assess social cognition. It will be proposed to patients with type 1 or type 2 narcolepsy and patients with idiopathic hypersomnia.


Eligibility Criteria:
Inclusion Criteria:

* adult patients (\>/= 18years old)
* diagnosis of type 1 or type 2 narcolepsy or idiopathic hypersomnia
* non opposition

Exclusion Criteria:

* comorbid psychiatric or neurologic disease
* patient under 18 years old
* patient under guardianship, curators or deprived of liberty, refusal of the patient
Effect of Nigella Sativa on Nonalcoholic Steatohepatitis and Steatosis

The investigators hypothesize that Nigella Sativa will have an effect on Nonalcoholic Steatohepatitis and Liver Steatosis by enhancing lipophagy in the liver tissue.


Eligibility Criteria:
Inclusion Criteria:

* Patients suffering from Steatohepatitis
* Patients suffering from Liver Steatosis

Exclusion Criteria:

* Patients suffering from viral hepatitis
* Patients with HIV infection
* Patients suffering from Wilsons Disease
Long-term Surgical Outcomes of Scaphoid Proximal Pole Fracture Nonunion

The treatment for scaphoid proximal pole nonunion remains challenging due to the poor vascularity in the proximal pole fragment, associated SL injury and the technique of fixation. Vascularized bone grafts and non-vascularized iliac bone graft have been used in patients with scaphoid proximal pole nonunion, but the indication has not been well clarified. Alternatively, we have been treating such patients with vascularized bone graft , or non-vascularized bone graft with screw or k-wire fixation with considerable success. The purpose of this study is to evaluate and analyze retrospectively the surgical efficacy of our procedure.

Scaphoid nonunion are common and operative treatment with bone graft was reported to have good result. However, the treatment for proximal pole nonunion remains controversial. There are some patterns of pathoanatomy combined with scaphoid fracture, like SL ligament tears, which could not be easily identified or treated initially. The proximal pole nonunion was near SL joint. Therefore, proximal pole nonunion may result in DISI instability. Furthermore, proximal pole nonunion was identified as a poor prognostic factor in scaphoid nonunion.

In the past 10 years, we have some different technique, like VBG, arthroscopic bone graft to achieve good results. Some studies revealed that significantly better SL stability was achieved with ARASL. We also used ARASL with BG to improve proximal pole union. However, it is not clear which method would be appropriate for proximal pole nonunion. We retrospectively investigated the functional outcome and radiological results after at least 2-year follow-up to clarify the surgical efficacy of these procedures.

Eligibility Criteria:
Inclusion Criteria:

* (1) chronic nonunion (wrist pain for more than 3 months after injury) as defined by preoperative radiographs; and (2) combined positive SL instability measured by intraoperative arthroscopy exam test; (3) Grade I SNAC.

Exclusion Criteria:

* (1) skeletally immature patients; (2) previous wrist trauma or surgery.
Adherence Degree of Kasr-Alaini Hospital Pre-anesthetic Tests to the NICE-UK Guidelines

Routine preoperative tests aim to identify asymptomatic diseases that can't be recognized by history and examination. Identification and management of these diseases is thought to help minimizing perioperative morbidity and mortality. A large number of routine screening tests increase the cost of perioperative care. Also unneeded tests may harm the patient due to overtreatment for borderline / false positive results. Therefore, the routine use of such examinations remains controversial.

The National Institute of Health and Clinical Excellence (NICE-UK) guidelines for preoperative examination are the assessment standard developed by NICE in collaboration with the National Collaboration Center for Acute Care in the UK; in order to reduce unnecessary tests by recommending which tests should be offered to people before minor and major operations.

The aim of this study is to assess the degree of adherence of the current preoperative tests at Kasr Alaini hospital to the NICE guidelines, to assess the effectiveness and usefulness of the current practice of various examinations ordered by anesthesiologists during the pre-anesthetic evaluation in patients who are intended for elective surgery in the hospital and to also evaluate the cause of delay \& its effect to predict postoperative complications.


Eligibility Criteria:
Inclusion Criteria:

* All adult patients scheduled for elective surgical operations.

Exclusion Criteria:

* Patients operated upon an emergency basis.
* Pregnant females.
* Patients scheduled for cardio-thoracic and neurosurgical procedures.
Comparision of Two Different Feeding Method in Preterms

achievement of optimal postnatal growth by adequate enteral nutrition in critically ill preterm infants is a challenge of NICU. signs like abdominal distension, reflux, vomiting, nec is a factors of discontinuing fedding in preterm. this factors plays a role in decisions about which method of gavage feeding is adopted. we compare two different feeding method to achive less fedding tolerence.

\<1750 gr, \<33 gw infants will enroll study. exckusion criteria: major congenital anomalies major gis anomalies

The study infants are enrolled within 24 hours of birth and sequently randomized to either intermitten feeding (IF) and bolus feeding (BF). Intermittent feeding is defined as delivering enteral nutrition and generally giving 60 min and 2 hours no feeding. this circle repeats 8 times in 24 hours. Bolus feeding is the amount of nutrition put into the syringe was kept 10 cm above the baby and the fluidity was obtained by gravity through the orogastric tube. The data of the patients such as feeding intolerance (gastric residual volume more than %50 of the previous feeding volume, gastric regurgitation, abdominal distension and/or emesis ), whether there is a week-by-week feeding intolerance were noted, NEC, time to reached birth weight, time to achieved full enteral feeding, every 5 minutes during feeding, saturation, respiratory rate and heart rates will record.

Eligibility Criteria:
Inclusion Criteria:

* \<1750 gr preterm infants
* \<33 gw
* admitted to our nicu in first day of life

Exclusion Criteria:

major congenital anomalies gis anomalies septic shock exitus in 3 days of life

-
Renal Denervation in Hypertension

The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the effectiveness and costs of renal denervation in addition to standardized medical treatment compared to medical treatment alone in subjects with resistant hypertension. Bilateral renal denervation will be performed using the Symplicity Catheter - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.

The DENER-HTN study is a, multicenter, prospective, open, randomized, controlled study of the efficacy and cost-effectiveness of renal denervation plus standardized optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment alone in patients with proven resistant hypertension. Patients with essential resistant hypertension will first enter a 4-week run-in period during which they will receive a standardized triple combination therapy (diuretic+ ACE inhibitor+ CCB at maximal dose). After 4 weeks of standardized triple therapy patients will be randomized to renal denervation + optimal antihypertensive treatment compared to standardized optimal antihypertensive treatment if daytime ambulatory BP remains ≥ 135 and/or 85 mmHg. Bilateral renal denervation will be performed using the Symplicity Catheter (Medtronic ®) - a percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery. Study amendment: Extended follow-up of 48 months for all randomized patients.

Eligibility Criteria:
Inclusion Criteria:

* Individual is more than 18 and less than 75 years old at time of randomization
* Essential hypertension diagnosed during a complete work-up within the past 2 years
* Office blood pressure ≥140 and/or 90 mmHg despite a stable medication regimen including full tolerated doses of 3 or more anti-hypertensive medications of different classes, including a diuretic
* 2 functional kidneys sizing ≥ 90 mm; eGFR ≥ 40 mL/min/1.73m² (MDRD formula)
* Suitable renal anatomy compatible with the endovascular denervation procedure
* Signed Informed consent
* Confirmed resistant hypertension defined by diurnal ambulatory blood pressure measurement ≥ 135 and/or 85 mmHg after 4 week standardized triple antihypertensive treatment

Exclusion Criteria:

* Patients with an estimated glomerular filtration rate (eGFR) of less than 40 mL/min/1.73 m2
* Patients with secondary hypertension
* Kaliemia ≥ 6mmol/L
* Patient with single functioning kidney
* Patient with contrast media allergy
* Patient with any implantable device incompatible with radiofrequency energy delivery
* Patient with contra-indication to the anti-hypertensive standardized medication regimen
* Patient with transient or fixed cerebral ischemia within 3 months before inclusion
* Patient with myocardial infarction, unstable angina pectoris, coronary bypass or percutaneous angioplasty within 3 months before inclusion
* Patient with type 1 diabetes mellitus
* Patient with malignancy within the 5 past years
* Patient with atrial fibrillation and/or a brachial circumference of ≥ 42cm