cyrilzakka/clinical-trials huggingface dataset:
Clinical Outcomes of the ALPS Proximal Humerus Plating System

The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.

Specific Aims:

* Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs
* Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions
* Document revisions, complications, and adverse events

The purpose of this study is to document the performance and clinical outcomes of the A.L.P.S® Proximal Humerus Plating System.

Specific Aims:

* Conduct physical assessments measuring shoulder strength and range of motion, physician assessment of radiographs
* Obtain patient-reported outcomes regarding pain level, function capabilities, and work/leisure restrictions
* Document revisions, complications, and adverse events

Eligibility Criteria:
Inclusion Criteria:

* Patients who present with a proximal humerus fracture requiring primary or revision ORIF using A.L.P.S Proximal Humerus Plating System
* Patients who present with a proximal humerus fracture that involves the metaphysis
* 18 years or older

Exclusion Criteria:

* Patients under the age of 18
* Patients who have an infection, sepsis, or osteomyelitis
* Patients who are unwilling to take part in study, have documented psychiatric disorder that limits ability to consent and maintain follow-up, or who may have severe problems maintaining follow-up (e.g. patients who are prisoners, homeless, intellectually changed without adequate family support)
* Patients who do not speak English (do to unavailability of non-English surveys)
* Patients who have known risk factors of pathologic fractures (e.g. bone metastasis)
* Patients who have received treatment for osteoporosis (e.g. bisphosphonate) within the last 5 years or whose treatment lasted longer than 5 years
* Patients who have Type 1 diabetes
* Patients who have other bone disease (e.g. osteogenesis imperfecta, Paget's disease, thyroid disease, Vitamin D deficiency, hyperparathyroidism)
* Patients that have a history of cancer, abnormal serum calcium, or chronic steroid use
Feasibility Testing of the Alert for Atrial Fibrillation Program

The purpose of this study is to determine the psychometric properties of the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS) and to generate critical, practical knowledge about the feasibility of conducting a randomized trial to test the effect of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of Atrial Fibrillation (AF).

The purpose of the proposed research is to evaluate the psychometric properties of the Knowledge, Attitudes, and Beliefs about Atrial Fibrillation Survey (KABAFS), which is an instrument designed to tailor the delivery of the Alert for Atrial Fibrillation program. The proposed research will also test the feasibility of studying the effect of the Alert for Atrial Fibrillation program on treatment-seeking for symptoms of AF in a larger, randomized trial. This research is significant, because current research suggests that treatment seeking for AF is hindered when people do not recognize symptoms that represent AF, attribute those symptoms to alternative causes, or do not believe symptoms are serious enough to require medical evaluation. Interventions tailored to modify patient-specific knowledge, attitudes, and beliefs that hinder early treatment-seeking are critically needed in order to improve early detection of AF. The long term goal of this research is to improve health outcomes of those at risk for developing AF.

Eligibility Criteria:
Inclusion Criteria:

* 65 years of age or older
* Under the care of providers from the Department of Medicine
* English-speaking
* Community dwelling,
* Have access to and ability to communicate via a telephone
* Have one or more risks for developing AF
* Not be diagnosed with AF

Exclusion Criteria:

* Documented cognitive impairment
* Uncompensated hearing or visual deficits
* Scheduled for surgery or have undergone a surgical procedure in the last 30 days,
* Undergoing active treatment for a malignancy
* Receiving hospice care will be excluded
A Study to Assess Efficacy, Safety of KAE609 in Adult Patients With Acute Malaria Mono-infection

This study will assess efficacy, safety , tolerability and PK in uncomplicated adult malaria patients with acute P. falciparum infection after single dose with KAE609 at 75 mg, 150mg, 225mg and 300mg/day

the study is comprised of 4 sequential cohorts, in total there will be up to 48 patients enrolled in the study.

cohort 1: 6-12 patients receive 75mg single dose. cohort 2: 6-12 patients receive 150mg single dose. cohort 3: 6-12 patients receive 225mg single dose. cohort 4: 6-12 patients receive 300mg single dose. After approximately every 6 patients in any cohort have been treated with a given dose and complete the first 15 days, a safety and tolerability data review will be conducted by a Data Monitoring Committee(DMC). Consensus agreement of DMC is required to either escalate to the next dose level or expand a given cohort with an additional 6 patients in order to obtain more safety data.

Eligibility Criteria:
Inclusion Criteria:

* Male and female patients aged 20 to 60 years
* Presence of mono-infection of P. falciparum
* Weight between 40 kg to 90 kg

Exclusion Criteria:

* Patients with signs and symptoms of severe/complicated malaria
* Mixed Plasmodium infection
* Presence of other serious or chronic clinical condition requiring hospitalization.
* Severe malnutrition
* Significant chronic medical conditions which in the opinion of the investigator preclude enrollment into the study
Renal Safety Evaluation After Dotarem®-Enhanced MRI

Although there is a well documented risk of acute renal failure with the iodinated contrast agents, the implication of intravenous gadolinium-based contrast agents in nephrotoxicity remains controversial. The aim of this study was to evaluate the safety profile of gadoterate meglumine (Dotarem®) in patients with chronic renal insufficiency by evaluating the rate of patients experiencing contrast-induced nephrotoxicity following the injection of gadoterate meglumine.

Patients with renal insufficiency not requiring hemodialysis and scheduled to undergo a contrast enhanced MRI or unenhanced MRI examination to specify a diagnosis, were selected for inclusion. Two groups of patients were defined on the basis of the planned imaging procedure selected to obtain a diagnosis: those undergoing a Dotarem®-enhanced MRI and those undergoing an unenhanced MRI.

A clinically significant increase in serum creatinine levels after the contrast-enhanced MRI exam was used as an indication of contrast induced nephrotoxicity. A blood test was performed 24h before the MRI in order to evaluate baseline creatinine values. 72h after the exam, a second blood test was performed. An increase in creatinemia above 25% from baseline levels was defined as a contrast-induced nephrotoxic reaction. The primary endpoint of the study assessed the percentage of patients presenting a contrast-induced nephrotoxic reaction in order to show a non inferiority of enhanced as compared to non-enhanced MRI exams.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, \> or equal 18 years ;
* Patient with a known stable renal insufficiency ;
* Patient scheduled to undergo an MRI examination to specify a diagnosis ;
* Patient able to understand and provide written informed consent to participate in the trial ;

Exclusion Criteria:

* Patient with a contra-indication to MRI ;
* Patient who has a diagnosis of an hemodynamic instability or acute myocardial infarction within 15 days prior the inclusion ;
* Patient who needs hemodialysis ;
* Patient with known allergy to gadolinium chelates ;
* Patient receiving medications known to be nephrotoxic or to cause increases in serum creatinine level within 2 weeks before the inclusion ;
* Patients planned to either undergo surgery or receive chemotherapy ;
* Any condition which, based on the investigator's clinical judgement, would prevent the patient from completing all trial assessments and visits ;
* Patient under guardianship and/or inability or unwillingness to cooperate with the requirements of this trial ;
* Patient with newly discovered unstable diabetes.
Pico-Salax Versus Poly-Ethylene Glycol for Bowel Cleanout Before Colonoscopy in Children

The purpose of this trial is to compare patient's satisfaction from Pico-Salax with the standard of care, Poly-Ethylene Glycol and electrolyte solution, for bowel cleanout before colonoscopy in children, and to compare effectiveness.

Good bowel cleanout before colonoscopy is commonly associated with significant discomfort that children do not tolerate well. Many pediatric centers in North America use Poly-Ethylene Glycol and electrolyte solution (PEG-ELS, Golytely®) for bowel lavage administered in a large volume, often causing nausea, vomiting and bloating. This is often poorly tolerated by children who usually require the insertion of a nasogastric tube and a day admission. Recently, Pico-Salax was approved in Canada for bowel cleanout in children. It is administered in two divided doses, each in one cup of water; it is palatable and does not have to be given in hospital. However, no controlled study in children compared it with the current standard of care. Our preliminary experience and previous literature suggest that it is effective and well tolerated. We propose to study whether colon cleanout for colonoscopy with Pico-Salax is better tolerated than Golytely in children, by a single blinded randomized controlled trial. Positive results of this study will facilitate a better tolerated regimen for bowel clean out in children.

Eligibility Criteria:
Inclusion Criteria:

* Children between 4 and 18 years of age
* Undergoing full elective ambulatory colonoscopy

Exclusion Criteria:

* Evidence of bowel obstruction, prior partial or total colectomy and significant renal failure (GFR\<50 mls/min/1.73 m2)
* Second dose of Pico-Salax will not be given to children with blood pressure less than the tenth percentile or pulse rate \>90th% of normal reference value for age, or in children with a clinical need for bolus IV fluids decided by the clinical fellow
McGrath Videolaryngoscopy and Direct Laryngoscopy Rapid Sequence Intubation

The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.

The study aims to conduct a multicenter international trial to enroll a maximum of 800 consenting adults who fall under the American Society of Anesthesiologists (ASA) physical status 1-3 category and require elective non-cardiac surgery necessitating endotracheal intubation with rapid sequence induction for general anesthesia. The study seeks to compare the efficacy of conventional direct laryngoscopy using a Macintosh blade with the McGrath videolaryngoscope for rapid sequence endotracheal intubation.

Eligibility Criteria:
Inclusion Criteria:

* Elective surgery requiring oral endotracheal intubation for general anesthesia;
* Anticipated extubation in the operating room;
* American Society of Anesthesiologists (ASA) physical status 2-3;
* Age between 18 and 99 years;
* Body Mass index ≥ 40 kg/m2.

Exclusion Criteria:

* Refusal of participation by attending anesthesiologist;
* Indicated rapid sequence induction for any reason including, but not limited to high risk of aspiration
* Indicated fiberoptic awake intubation.
Monday is Fasting Day - Non-Randomized Trial on Intermittent Fasting

The aim of this pilot study is to evaluate the effects of one regular fasting day per week over a total period of 8 weeks compared to a normal-eating habits among healthy volunteers.

Participants in the intervention group receive an initial group training for fasting. Then all participants will observe one fixed fasting day per week (monday) over a total period of eight weeks.

Participants in the control group receive an initial group training for healthy diet according to current German guidelines (DGE). Moreover, they will receive the same offer as in the intervention group at the end of the 8-week study period. Until then the control group participants follow a regular healthy diet.

Eligibility Criteria:
Inclusion Criteria:

* age 18 -65 yrs
* written informed consent

Exclusion Criteria:

* severe chronic comorbidity
* eating disorders
* pregnancy
* planed pregnancy
* simultaneous participation in other trials
ESG vs LSG: Short-term Nutritional Outcomes

To assess endoscopic sleeve gastroplasty in comparison to laparoscopic sleeve gastrectomy before and 3 months after the procedure in terms of multiple nutrition-related factors, quality of life, weight and other related parameters.

This will be a short-term prospective cohort study, single-center study (NewYou clinical center - Riyadh). A total of 15 endoscopic sleeve gastroplasty patients will be matched with 15 laparoscopic sleeve gastrectomy patients by age, gender and BMI. Total sample size is 30 patients. Sample size was selected based on literature, considering the sample will be surgical patients and based on booked patients in the clinic. A multidisciplinary team will provide post-procedure care (including post-surgery diet stages protocol given by the center).

Eligibility Criteria:
Inclusion Criteria:

* Adult (≥ 18 years old)
* Willingness and ability to participate
* Males and females
* Non-pregnant

Exclusion Criteria:

* Children (\<18 years old)
* Pregnant
The Effects of Mediterranean Diet on Remission, Lipid Profile, Weight and Body Composition in Children and Adolescents With Newly Diagnosed Type 1 Diabetes

Nutritional therapy has a major role in diabetes care, achieving and maintaining metabolic control: normal glucose homeostasis, normal lipid profile, normal blood pressure and desirable weight. Controlled nutritional diet, as introduced by the professional committees aims at achieving better general health condition.

There is a growing body of evidence showing that Mediterranean diet has a major role in prevention of diabetes sequelae in type 2 diabetes patients. Hitherto, the effects of Mediterranean diet on patients with type 1 diabetes has not been studied, with the exception of one Italian study.

Six months after education to consume Mediterranean diet in a cohort of 96 children with type 1 diabetes the authors observed decreased fat and cholesterol consumption, increased dietary fiber consumption, lower LDL cholesterol levels and better HDL to LDL cholesterol ratio.

The proposed study is aimed to assess the impact of Mediterranean nutrition compared to the accepted nutritional guidelines, in newly diagnosed type 1 children and adolescents on lipid profile, metabolic control, C peptide, daily insulin dose, Inflammatory parameters, endothelial function and anthropometric parameters 12 months following diagnosis.

The study designed as a two parallel arms, randomized, single center, intervention study.

Patients enrolled to the study will be randomly assigned, to one of the following groups in a 1:1 ratio. Interventional Arm: Patients assigned to the interventional arm will receive nutritional instructions of Mediterranean diet and Control Group: Patients assigned to the interventional arm will receive regular nutritional instructions in accordance with the accepted nutritional guidelines


Eligibility Criteria:
Inclusion Criteria:

* Parents/guardian are willing and able to sign an informed consent form
* Age 5-18 years
* Diagnosis with type 1 diabetes for up to 2 months prior to screening
* Peak C peptide \> o.2 pmol/mL

Exclusion Criteria:

* The patient has any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator might interfere with patient's compliance or ability to complete the study
* Any concomitant disease that might impact body composition, physical activity level and/or eating habits
* Active celiac disease, hashimoto thyroiditis or uncontrolled Graves' disease
* Down syndrome, Turner, inflammatory bowel disease
* Patients treated with antipsychotic drugs, steroids, or other drugs that might affect body weight and appetite.
* Patient who suffers from eating disorders
* Patients participating in other device or drug studies
The Power of Touch. Non-Invasive C-Tactile Stimulation for Chronic Osteoarthritis Pain

Osteoarthritis (OA) is a degenerative disease with a prevalence of up to 30% among adults over 45 years old. Moreover, elderly people over 60 years are more prone to develop a chronification of pain symptomatology. Chronic pain in OA enormously restricts patients' ability to perform their daily activities, eliciting psychological distress and mood alterations, and producing massive socioeconomic consequences. For these reasons, any non-invasive drug-free treatment that decreases chronic pain in OA requires serious evaluation.

This study aims to investigate the effectiveness of noninvasive interoceptive stimulation (affective touch) in treating chronic pain associated with osteoarthritis (OA).

This study aims to investigate the effectiveness of noninvasive interoceptive stimulation (affective touch) in treating chronic pain associated with osteoarthritis (OA).

The current study aims to assess the long-term analgesic efficacy of interoceptive tactile stimulation in patients suffering from chronic moderate-to-severe osteoarthritis (OA) pain. The study will be a randomized, double-blind, sham-controlled crossover trial involving 60 OA patients with moderate-to-severe chronic pain. Patients will be randomly assigned to the treatment or control group and received interoceptive (affective touch) or control stimulation two days a week for 12 weeks. Patient will then undergo to a 4-week washout period, after that they will be assigned to the crossover treatment for another 12 weeks. The study will measure changes in pain and physical function, heart rate variability, as well as inflammatory and anti-inflammatory cytokines and medication intake, assessed at baseline, and at the end of each crossover phase. Follow-up measures will be assessed 4 weeks after the end of each crossover phase. Intermediate outcomes for pain and physical function, heart rate variability and medication intake will also be assessed after 4 and 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* osteoarthritis patients
* Age 45-90
* Diagnosis of OA ACR criteria
* Moderate-to-severe OA chronic pain.

Exclusion Criteria:

* other joint diseases
* trauma, or pain condition
* fibromyalgia
* BMI\>39 kg/m2.
Therapeutic Education Consultations With Diabetic Patients Treated With Intensified Insulin Therapy

Diabetes is a chronic condition that affects around 8% of the French population, and is associated with severe complications. Maintaining a constant blood glucose level of between 0.7 and 1.80 g/l is the day-to-day objective of diabetic patients.Insulin can be administered by injection via syringes or pens, or by insulin pumps and patients can perform self-monitoring of blood glucose.

All these actions can be the subject of therapeutic education, which involves a range of tools, including dedicated individual consultations carried out by state-qualified nurses.

The aim of the study is to evaluate the benefit of therapeutic education consultations conducted by nurses in addition to medical consultations, on the follow-up of diabetic patients, insulin pump carriers or treated with multiple injections, in terms of glycemic control, quality of life and medical complications. The objective of the study is to evaluate whether the therapeutic education consultations conducted by nurses can improve the care of the diabetic patient.


Eligibility Criteria:
Inclusion Criteria:

* Woman or man aged 18 to 75
* Diabetic patient type 1 or 2 insulin-dependent
* Patient treated with multi-injections or insulin pump
* Patient equipped with FreeStyle Libre flash glucose monitoring system
* Glycemic imbalance with HBA1c \> 8
* Patient living at home

Exclusion Criteria:

* Recent discovery (\< 6 months) of diabetes
* Major intellectual disability
* Social isolation
* IMC \> 35
* Pregnant women
Efficacy of Endoscopic Ultrasound Guided Liver Biopsy Using Dynamic Wet Technique

Endoscopic ultrasound-guided liver biopsy (EUS-LB) can overcome many shortcomings of percutaneous liver biopsy and TJLB. Targeted and non-targeted liver biopsies can be done through this biopsy. It can be done in patients with international normalized ratio (INR) up to 2. It has less tissue fragmentation compared with TJLB.

Needle entering the liver can be viewed in real-time (intrahepatic vessels and bile duct can be spared from injury) (Sharma et al., 2023). Both lobes of the liver can be accessed. It provides minimal patient discomfort. EUS-LB can access liver lesions that may not be safely accessible by routine US or computed tomography (tenBerge et al., 2002). It provides better results in obese individuals compared with percutaneous liver biopsy. It is safe in pregnant females requiring liver biopsy (Khare et al., 2024). Despite these advantages, EUS-LB is largely limited to tertiary care centers and its use is not yet widespread. This may be because, since its inception, numerous variations in needle shape, needle size, and, most notably, sampling techniques have been adopted.

However, no consensus protocol for acquisition has been recognized, leading to poor procedural standardization and wide ranges of reported outcomes in sample quality and diagnostic yield. As such, there is a substantial need for a uniform technique that will safely maximize diagnostic performance with minimal needle passes (Khare et al., 2024).


Eligibility Criteria:
Inclusion Criteria:

* The participants of the study were adults in need of liver biopsy for the evaluation of Altered liver function test

Exclusion Criteria:

* Using anti-platelets or anticoagulants within the last 5days
* Inability to provide informed consent
* Moderate-to-gross ascites
* Child C cirrhosis
* INR more than 2.01
* Platelet count less than 50,000/µL3