cyrilzakka/clinical-trials huggingface dataset:
Denosumab to Prevent High-Turnover Bone Loss After Bariatric Surgery

Bariatric surgery leads to bone loss and increases fracture risk. This study evaluates whether denosumab can prevent the high-turnover bone loss that occurs after Roux-en-Y Gastric Bypass (RYGB) and sleeve gastrectomy (SG) surgery.

Bariatric surgery is a highly effective weight loss treatment, but one of the unintended side effects of these procedures is high-turnover bone loss and metabolic bone disease. Denosumab is a monoclonal antibody to RANKL that acts as a potent inhibitor of bone resorption. The investigators are conducting a randomized placebo-controlled trial to evaluate the ability of denosumab to prevent bone loss after RYGB or SG surgery in older adults. At the conclusion of the study, all participants will be given zoledronic acid.

Eligibility Criteria:
Inclusion criteria:

* Postmenopausal women who are planning RYGB or SG surgery
* Men aged ≥ 50 years who are planning RYGB or SG surgery

Exclusion criteria:

* Prior bariatric surgery
* Weight = 400 lbs (due to limitations of bone imaging equipment)
* Renal disease
* Hypercalcemia or hypocalcemia
* Hypomagnesemia
* Serum 25-OH vitamin D (25OHD) \< 20 ng/mL
* Hyperparathyroidism
* Liver disease (AST or ALT \> 2 x upper normal limit)
* HCT \< 32%
* History of malignancy (except basal cell carcinoma) in the past 1 year
* Significant cardiopulmonary disease
* Major psychiatric disease
* History of celiac disease or inflammatory bowel disease
* Excessive alcohol or substance abuse
* Paget's disease, primary hyperparathyroidism, or any other known congenital or acquired bone disease other than osteoporosis
* Current hyperthyroidism or use of levothyroxine with TSH \< 0.1 uIU/mL
* Current use of loop diuretics
* Current use or use in the past 12 months of oral bisphosphonates or DMAB
* Current use or use within the past 3 months of SERMs or calcitonin
* Current use or use within the past 3 months of estrogen
* Use of testosterone therapy if dose has changed within the last 3 months, or if dose change or discontinuation is planned in the upcoming 18 months
* Any current or previous use of teriparatide, strontium, or any parenteral bisphosphonate
* Use of oral or parenteral glucocorticoids for more than 14 days within the past 6 months
* Extensive dental work involving extraction or dental implant within the past 2 months or planned in the upcoming 18 months
* DXA BMD T-score of \< -3.0 at PA spine, total hip, or femoral neck
* Current use of anti-VEGF drug
Efficacy of Neurofeedback Training in Adults With ADHD

Neurofeedback training (NFT) has been frequently investigated as an alternative treatment for ADHD mainly in children and adolescents. However, randomized double-blind trials that include a sham-neurofeedback control group are lacking, as well as studies examining the efficacy of NFT in adult ADHD populations. The inclusion of a sham-neurofeedback group is crucial to monitor and exclude unspecific effects.

This study aims to investigate the efficacy of NFT as compared to a sham-feedback condition and a cognitive behavioral treatment in adults with persistent ADHD.

Efficacy is assessed on several outcome parameters, such as symptom severity, neuropsychological variables (e.g., attention, memory), and EEG parameters.


Eligibility Criteria:
Inclusion criteria:

* ADHD diagnosis
* sufficient knowledge of the German language

Exclusion criteria:

* psychiatric disorder(s) lifetime (bipolar disorder, schizophrenia, schizoaffective disorder, borderline personality disorder)
* neurological disorder (e.g., epilepsy)
* current substance abuse disorder
* receives psychotherapy (e.g., CBT) or medication
Effects of Complementary Therapies Delivered Via Mobile Technologies

The purpose of this study is to determine the effects of complementary therapies delivered via mobile technologies have a therapeutic effect on surgical patients' anxiety, pain, and self-efficacy in healing reports before, following, and at 10-day follow-up.

Patients scheduled for same-day surgery (SDS) often experience state anxiety, which may result in increased perceptions of pain and lower self-efficacy in healing. Complementary therapies (CT), such as relaxation technique, massage, guided imagery, and acupuncture have been shown to benefit patients undergoing surgery. The aim of this study was to examine the effects of audio relaxation technique (ART), music intervention (MI), nature video application with music (NVAM), and nature video application without music (NVA) delivered via mobile technologies on patients' state anxiety, pain perception, and perceived self-efficacy in healing.

Methods A randomized controlled trial (RCT) involving 105 SDS patients, who were assigned to an ART (n = 25), MI (n = 25), NVAM (n = 15), NVA (n = 16), or a control group (n = 24) were assessed for state anxiety via the State Trait Anxiety Inventory (STAI), self-reported pain using the numeric rating scale (NRS), and self-efficacy with the general self-efficacy scale (GSE) four days prior to surgery, immediately prior and following the surgical intervention, and at day five post-operative.

Eligibility Criteria:
Inclusion Criteria:

* Age range 18-75-years
* English or Icelandic speaking
* Cognitively alert and oriented to person, place, time, and situation
* Intact visual and auditory senses

Exclusion Criteria:

* History of substance abuse
* Chronic pain lasting more than six months
* Use of narcotic medication for more than six months
* Major psychiatric disorders
* Taking prescribed medications for thought disorders
* Having ophthalmology and/or auditory surgery or impairments
HFR A-equilibrium on Cardiovascular Stability

Aim of the present randomized controlled multinational trial is the comparison of a novel biofeedback system on sodium profiling applied to a endogenous hemodiafiltration therapy, with the standard (no sodium profiling) hemodiafiltration technique on the intradialytic overall and cardiovascular stability.

Online hemodiafiltration (OL-HDF) has been recently associated with better patient survival in comparison with standard hemodialysis in some large observational studies (Canaud et al, KI, 2006; Vilar et al, CJASN , 2009) supporting the hypothesis that convection can improve patients outcomes. Moreover, it has been demonstrated in randomized controlled trials (Locatelli et al, Journal American Society of Nephrology, 2010) that OL-HDF significantly reduced the frequency of intradialytic hypotension. Nonetheless, the associated comorbidities and ageing of dialysis population require further devices able to improve treatment tolerance. Among these tools, the sodium profiling and biofeedback system seem to be promising to accomplish this task. But the correct intradialytic sodium balance is still far away today to be easily achieved. The use of an automated adaptive system dialysis to the sodium profiling has been investigated in a feasibility trial (Colì et al International Journal Artificial Organs, 2003). They also investigated the impact of such a device on treatment tolerance.

The aim of this randomized multinational multicenter controlled trial is to evaluate the impact of sodium profiling applied to a endogenous hemodiafiltration technique on the intradialytic cardiovascular stability in comparison to standard no profiled endogenous hemodiafiltration.

Eligibility Criteria:
Inclusion Criteria:

* Patients with more than 30% of dialysis complicated by hypotension
* age between 18 and 85 yers
* time on dialysis greater than 6 months
* residual creatinine clearance less than 2 ml/min/1.73 m2
* native fistula or central venous catheter with blood flow rate greater than 250 ml/min

Exclusion Criteria:

* Life expectancy less than 1 year
* solid active neoplasm
* pregnancy
* major event in the previous 3 months (ictus, myocardial infarction, cachexia)
Comparison of Two Resuscitative Thoracotomy Techniques

Resuscitative thoracotomy (RT) is a life saving procedure for patients who have suffered cardiac arrest or are at significant risk of cardiac arrest following significant trauma. The procedure is ideally performed by a surgeon, but in some circumstance must be performed by non-surgical specialists such as Emergency Medicine physicians. The purpose of this study was to evaluate the optimal RT technique taught to non-surgical specialists in an educational human cadaver lab. The objective was to compare time to successful completion of two different RT techniques; (1) Left Anterolateral Thoracotomy (LAT) and (2) Modified Clamshell Thoracotomy (MCT). The investigators hypothesized that the non-surgical specialist time to successful completion for the MCT would be shorter than for the LAT.

The investigators conducted a randomized crossover trial of two resuscitative thoracotomy techniques performed by Emergency Medicine (EM) physicians using a fresh human cadaver model. The purpose was to identify the ideal technique to be taught to non-surgical specialists in a training lab setting. The two techniques compared were the Left Anterolateral Thoracotomy (LAT), commonly taught to EM physicians in the United States, and the Modified Clamshell Thoracotomy (MCT) taught by London's Air Ambulance. The investigators hypothesized that the non-surgical specialists time to successful completion of the RT would be faster when performing the MCT compared to the LAT.

The investigators conducted this study at a large level 1 trauma center with an Emergency Medicine residency program and recruited Emergency Medicine residents and staff physicians to participate. Participants were trained on the MCT as performed by LAA and reviewed the LAT technique in a standardized fashion. Participants were then randomized to order of intervention, and conducted each procedure on a separate fresh human cadaver. Participants were evaluated on time to successful completion of the procedure, successful completion of procedural steps, and identification of anatomy. Cadaver specimens were examined for iatrogenic injuries. Participants then completed a standardized survey regarding each procedure.

Eligibility Criteria:
Inclusion Criteria:

* licensed physician
* emergency medicine residency trainee or graduate
* privileged provider at SAMMC

Exclusion Criteria:

- unwilling to participate
Clinical Trial for the Investigational Drug (PB-201) in Subjects With Type 2 Diabetes Mellitus

This crossover study investigates the safety, tolerability, pharmacokinetics (PK) ,pharmacodynamics (PD) effect of three dose levels of PB-201,and characterizes the PK profile of a prominent des-methyl metabolite of PB-201(WI-0800), following dosing of three dose levels of PB-201 in drug-naive Chinese adult subjects with Type 2 diabetes mellitus (T2DM) as monotherapy.

There were 7 days separating 4 treatment periods and at least 7-day washout (but not exceeding 14 days) between dosing in 4 periods with 3 dose levels of PB-201 and placebo. Three dose levels of PB-201 are: split dose regimen of 50 mg 30 minutes before morning meal plus 50 mg 30 minutes before lunch at approximately 3.5 hours after morning dose, and split dose regimen of 100 mg 30 minutes before morning meal plus 100 mg 30 minutes before lunch at approximately 3.5 hours after morning dose, and split dose regimen of 150 mg 30 minutes before morning meal plus 100 mg 30 minutes before lunch at approximately 3.5 hours after morning dose.


Eligibility Criteria:
Inclusion Criteria:

1. Glycosylated hemoglobin (HbA1c) 7.5%-11% at screening, and 7.0%-10.0% pre-randomization
2. FPG 7.0 mmol/L-11.0mmol/L at screening and pre-randomization
3. Body mass index (BMI) 18.5 and-35.0 kg/m2 at screening
4. Antidiabetics-naive within 2 months before screening

Exclusion Criteria:

1. Diagnosis of type 1 diabetes mellitus or secondary forms of diabetes
2. History of febrile illness within 5 days prior to dosing
3. Medical history of myocardial infarction, angina/unstable angina, coronary revascularization, stroke or transient ischemic attack
4. Any medical history or current clinical evidence of congestive heart failure, New York Heart Association (NYHA) Functional Classification, Classes II-IV
5. Episode(s) of hypoglycemia adverse events (HAE) of 'severe' intensity prior to screening; either:

   1. \>1 in the previous 3 months; or
   2. \>2 in the previous 6 months
Negative Pressure Therapy After Infected Mesh Removal.

Chronic mesh infection mesh is a complication with leads to a long hospital stays, reoperation and admissions through emergency department. Surgical site infection (SSI) after removal are 58-72.7% depending on the published series. New therapeutic lines are needed in order to improve outcomes after surgery such as negative pressure therapy.

The main objective is to determine the SSI differences depending on the use of negative pressure therapy after infected mesh removal.

Material and methods: multicentric, prospective, randomized and an open comparative study. Patients will be selected sequentially n=94. Each selected patient will be randomized in two groups: conventional closure of the surgical wound vs. negative pressure therapy with a 30-day follow-up.

The surgeon will not know the patient's arm of study before the operation. Once the wound will be closed, we will let know what kind of closure the patient will need. Negative pressure therapy will be the same in all patients, in order to mantain homogeneity.

We will set appointments each day while he is hospitalized, and after the discharge: at 7 (+/- 1) and 30 (+/- 5).

We will collect demographic data before and during surgery, as well as in the postoperative period, including appointments.

Eligibility Criteria:
Inclusion Criteria:

* Any gender, adult. Age minimum limits 18.
* Infected chronic mesh.
* Signing of informed consent.

Exclusion Criteria:

* Enterocutaneous fistula or enteroatmospheric fistula.
* Infected chronic mesh related to parastomal hernia.
* Patients who will no complete the follow-up period.
* Informed consent denial.
Influence of FFR on the Clinical Outcome After Percutaneous Coronary Intervention

Fractional flow reserve (FFR) is a physiologic index for the determination of ischemia-causing coronary stenosis as well as drug eluting stent (DES) optimization, even multiple anatomic imaging parameters have been widely used in clinical practice for the assessment of optimal stent procedure. Prognostic value of post-stent FFR (FFRpost) have been rarely evaluated in patient treated with 2nd generation DES. This multicentre, prospective registry was aimed to evaluate the influence of physiologic parameters on the clinical outcome after 2nd generation DES implantation.

Patients who diagnosed obstructive coronary artery disease and treated by DES with FFR examination would be enrolled, consecutively. FFR measurement would be required at the baseline and at the end of index PCI procedure. PCI procedure would be performed upon local routine. Any available 2nd generation DES could be used. Informed consent should be obtained and protocol should be approved by each collaborator's institutional review board (IRB). Web-based electronic-case record form (CRF) system will be used for collecting data. All data will be handled and analyzed by blind fashion at independent core lab. Patient will be followed-up at each collaborator's hospital at least 2 year after index procedure. Any adverse event will be reported and addressed immediately by appropriate medical treatment to protect patient.

Eligibility Criteria:
Inclusion Criteria:

* any patient meets eligible criteria who underwent PCI with DES followed by FFR measurement at the index procedure
* patient who provide informed consent

Exclusion Criteria:

* culprit vessel of acute coronary syndrome
* failed achieving TIMI 3 flow at the end of PCI
* left ventricular ejection fraction \<30%
* graft vessel
* collateral feeder
* in-stent stenosis
* primary myocardial or valvular heart disease
* in patient whose life expectancy less than 2 years
* visible thrombus of target vessel segment
Feasibility of a Mobile Application to Support Reflection and Dialog About Strengths in People With Chronic Illness

Self-management of chronic illness can be highly demanding and people need to mobilize their personal strengths in order to live well with their condition. A mobile application was designed in collaboration with people with chronic illness and health care providers with the aims to support awareness of patients' strengths and patient-provider dialogues that include strengths. The aim of the present study is to evaluate with mixed methods the perceived usefulness and usability of the application and potential effects of the application on patients.

In this pre-post design pilot study participants will be recruited from self-management courses for people with rheumatic diseases. Before using the application participants will be asked to report their strengths in a written format. After using the mobile application to reflect on their strengths the participants will be interviewed about their experience of using the application and on the task of reflecting on their strengths. They will also be asked to fill out a questionnaire on perceived usefulness and user-friendliness. Before and after using the application the participants fill out questionnaires on emotions (Positive and Negative Affective Scale) and self-efficacy (The Arthritis Self-efficacy Scale). All interviews will be audio-taped and analyzed with a qualitative approach. Descriptive analysis will be applied for quantitative data.

Eligibility Criteria:
Setting 1:

Inclusion Criteria:

* Age of 18 years or older
* Can read and speak Norwegian language
* Diagnosed with a chronic condition
* Participating or having recently participated in a learning and mastery or an outpatient rehabilitation program

No exclusion criteria
Study of Malnutrition in Primary School Children

Study of malnutrition in primary school age children aim to asses the prevelance of malnutrition amoung the children in this age group and also ldintified the factors that affect in malnutrition between the children and the study will done in two primary school one present in rural area and another in urban area to compare the factor and the result that affect in both two different area

Study of malnutrition in primary school age children aim to asses the prevelance of malnutrition amoung the children in this age group and also ldintified the factors that affect in malnutrition between the children and the study will done in two primary school one present in rural area and another in urban area to compare the factor and the result that affect in both two different area investigators in this study will use anthropometric measurment to asses wheight and height and BMI and also collect sociodemographic data from participant for Ex father and mother education and age ,sex,place of residence,father and mother jop, mean income.

and also collect data about hygine lnformation for Ex safe and cleen drink water , presence of toilet ,wash hand before and after eating and cooking ,clean nail .

Other data will be collected from participant about dietary habits for Ex how many times eating meat, paultary ,fish in week and how many times eating vegetable,fruits ege milk in day .

This all data will be analysed by use the proper statical analysis system and finally the results will obtained

Eligibility Criteria:
Inclusion Criteria:

* healthy Children who agree the participate in study (6-12) years old .
* Both sexes.

Exclusion Criteria:

* Children below sex years or above 12 years .
* children not in primary school .
* children who refuse participate in study.
Examining a Training Program for for Acute Lymphoblastic Leukemia Childhood Cancer Survivors

Acute lymphoblastic leukemia (ALL) is the most common pediatric malignancy, with the peak incidences occurring in children two to five years of age. Children with ALL received neurotoxic chemotherapy agents for two to three years that causes decreased distal muscle strength and poor timing of muscle activation. After completion of medical treatment, ALL childhood cancer survivors (ALL CCS) are more likely to have an inactive lifestyle, resulting in life-long gross motor proficiency differences compared to their peers. ALL CCS typically do not utilize physical therapists' expertise after medical treatment has been completed. There are limited physical therapy (PT) intervention studies for ALL CCS.

We are performing a feasibility study to examine a movement based intervention that utilizes fast movements through jumping rope to improve balance, coordination, movement speed, and movement agility. The abilities to generate fast movements are required to perform functional activities and for playing sports. Participants will receive five in-person PT sessions and a home program for six weeks. The goal of this research is to determine the feasibility, acceptability, and promise of a PT program that emphasizes fast movements in ALL CCS.

Eligibility Criteria:
Inclusion Criteria:

* Children 6-17 years old
* Completed medical treatment for ALL within the past five years (1 to 60 months)
* Speak English.

Exclusion Criteria:

* Diagnosis of a neurological disorder such as cerebral palsy, Down syndrome
* Currently receiving PT services.
Nursing Students Education Virtual Reality Wound Care

This study is a randomized controlled trial aiming to determine the effect of pressure sore prevention education given to nursing students at a foundation university through virtual reality on student satisfaction, self-confidence perception and knowledge retention. The study will investigate whether virtual reality training affects student satisfaction and self-directed learning skills, differences between pre-test and post-test scores, and retention of the training. 66 nursing students will be included in the study, the experimental group will be trained with VR goggles and the control group will be provided with written material. The data obtained during the data collection process will be analyzed with the SPSS V23.0 program, descriptive statistics and appropriate parametric or nonparametric tests will be used. The measurement tools to be used include the 20-question "Knowledge Assessment Form for Pressure Ulcer Prevention" developed by Jeffries \& Rizzolo and the "Student Satisfaction and Self-Confidence in Learning Scale". Ethics committee approval, relevant permissions and participant consent will be obtained for the study and the data obtained will be stored for 5 years and then destroyed. The literature review reveals the widespread use of virtual reality in education, healthcare and other fields and the critical role of pressure sore prevention in reducing healthcare costs and improving the quality of patient care.

This study will be conducted as a pre-test post-test randomized controlled trial to determine the effect of pressure sore prevention education on student satisfaction, self-confidence perception, and knowledge retention at Ankara Medipol University Department of Nursing. Data will be collected from 70 nursing students through an online survey, the experimental group will be trained with VR goggles, while the control group will be provided with written material. Data collection will take place in five phases: pre-test, training, post-test, satisfaction and confidence assessment, and a retention test after three months. The measurement tools to be used include the 20-question "Knowledge Assessment Form for Pressure Ulcer Prevention" developed by Jeffries \& Rizzolo and the "Student Satisfaction and Confidence in Learning Scale". Data will be analyzed in SPSS V23.0 and appropriate parametric or nonparametric tests will be applied. Data will be collected between March 2025 and July 2025 and will be stored for five years and then destroyed.

Eligibility Criteria:
İnclusion Criteria

* Nursing Students,
* 2nd year nursing student

Exclusion Criteria

* not a nursing student
* 1st, 3rd or 4th year nursing student