cyrilzakka/clinical-trials huggingface dataset:
After Hip Fracture Nailing, Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR)

Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.

Patients and methods:

For this prospective single-center clinical trial study, we recruited 60 geriatric proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. The participants were assigned to the Early-weight-bearing group (n= 30) or the Weight-bearing restriction group (n = 30). Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded.


Eligibility Criteria:
Inclusion Criteria:

* Patients with AO/OTA type 31 fractures were included, and all fractures were classified using intraoperative fluoroscopy with traction on the fracture table.

Exclusion Criteria:

* Patients with pathological fractures, neurovascular insufficiency, ipsilateral lower extremity musculoskeletal injury, multiple fractures, or high risk of falling, including frequent falling accidents within 6 months, unsteady gait, ipsilateral neuropathy, limb weakness, and urinary incontinence were excluded.
Detection of Amplification of Her2 Fluorescent in Situ Hybridization (FISH) in Breast Tissue Sections

The purpose of the study is the identification of amplification level in human breast tissue. The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classification of Her2 FISH stained tissue samples.


Eligibility Criteria:
Inclusion Criteria:

* Well stained breast tissue slides with bright Her2 signals

Exclusion Criteria:

* Very old slides that were already bleached
Effects of Blueberries on Symptoms and Underlying Mechanisms of Functional Gastrointestinal Disorders

There is extensive pre-clinical evidence for potential health effects of blueberries. These are related, but not exclusively due to their high polyphenol content. This translational, clinical, randomized, cross-over, double-blind, placebo-controlled study will investigate the effects of blueberries in freeze-dried powder form on gastrointestinal and extra-gastrointestinal symptoms and function, as well as specific potential underlying mechanisms, in patients with the overlapping functional gastrointestinal disorders, irritable bowel syndrome and functional dyspepsia.


Eligibility Criteria:
Inclusion Criteria:

* Fifty-five successive male or female patients with Functional Gastrointestinal Disorders FGID) enrolled from our Gastroenterology Group Practice (GGP) in Bern, Switzerland, classified as having either Irritable Bowel Syndrome (IBS), Functional Dyspepsia (FD) or both according to Rome 4 criteria (Drossman et al 2016; Schmulson et al. 2017)
* Age between 18 and 50 years
* Body mass index 18.5-29.9 kg/m2
* European / Caucasian ethnicity
* Able to give informed consent in German as documented by signature

Exclusion Criteria:

* Evidence of clinically significant disease, as assessed by usual clinical practice (history, blood and stool tests, imaging and endoscopy, as clinically required) and by investigator.
* Colonoscopy, antibiotics or probiotics within 2 weeks before or during the study.
* Planned dietary modifications (including polyphenol-rich fruit or vegetable smoothies, drinks or diets) or initiation of new treatments during the study period, besides the study interventions.
* Inability or contraindications to undergo the investigated intervention
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc.
Healthy Weight Management Project for Overweight and Obesity Children

Childhood obesity is a significant public health concern worldwide. In China, childhood obesity has dramatically increased as the economy has grown quickly over the past decades. Nonalcoholic fatty liver disease (NAFLD) is tightly associated with obesity, in China, the prevalence of NAFLD in obesity children is 40.0%，the main interventions for NAFLD are lifestyle interventions. Effective strategies to helping students lose weight and alleviate NAFLD through lifestyle interventions may help promote the physical and mental health of obese students.

This study aimed (1)to assess the effectiveness of the intervention compared with the usual practice in treating childhood overweight and obesity; (2) to determine the sustainability of the treatment in preventing overweight and obesity; (3) to help alleviate or reverse NAFLD in obesity children.

Children with overweight and obesity in six primary schools in Ningbo City, Zhejiang Province will be seleted and randomly divided into two groups: the treatment group and the usual practice group. The participants of the study were students in the third grade of primary school, and the treatment will last for one academic year. This treatment activity on lifestyle interventions will target the dietary and exercise factors of childhood obesity.


Eligibility Criteria:
Inclusion Criteria:

* parents agree and support their children's weight loss, and students and parents have informed consent;
* students in third grade aged 8 and 10 years old;
* students with childhood overweight/obesity defined according to the criteria for Chinese children and adolescents.

Exclusion Criteria:

* medical history of heart disease, hypertension, diabetes, tuberculosis, asthma, hepatitis or nephritis;
* obesity caused by endocrine diseases or side effects of drugs;
* abnormal physical development like dwarfism or gigantism;
* physical deformity such as severe scoliosis, pectus carinatum, limp, obvious O-leg or X-leg;
* inability to participate in school sport activities;
* a loss in weight by vomiting or taking drugs during the past 3 months.
Compare the Impact of Hemofilters and Hemodialyzers on Cytokine Removal During Cardiopulmonary Bypass in Pediatric Cardiac Surgery

Cardiopulmonary bypass (CPB) allowed the correction of several congenital heart diseases such as intracardiac malformations, but it is well known that this is not a harmless procedure because it can lead to a systemic inflammatory response syndrome (SIRS), with activation of complement, cytokines, coagulation, and fibrinolysis pathways.

Due to economic causes, hemofilters became less available in low-resource countries, which forced perfusionists to use hemodialyzers instead during CPB. Preliminary data showed the potential safety of using hemodialyzers instead of hemofilters in Zero-balanced ultrafiltration.

The Objectives of the study This study aims to compare impact of hemofilters and hemodialyzers on cytokine removal during cardiopulmonary bypass in pediatric cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Pediatric patients who are undergoing elective cardiothoracic surgery which cardiopulmonary bypass will be conducted.
2. Age of patients from 1 year to 15 years.
3. CPB duration more than 60 minutes.

Exclusion Criteria:

1. Pediatric patients with known signs of sepsis.
2. Pediatric patients having had previous cardiothoracic surgery.
3. Preoperative renal failure.
4. Preoperative cardiogenic shock requiring the use of inotropes.
5. Preoperative lactate concentration \&gt; 2 mmol/L.
A Study to Evaluate the Safety, Tolerability of INCB160058 in Participants With Myeloproliferative Neoplasms

This study is being conducted to assess the Safety, Tolerability, and Pharmacokinetics of INCB160058 in Participants With Myeloproliferative Neoplasms.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* MF: Intermediate-1 or higher risk PMF, post-PV MF, or post-ET MF with evidence of minimum burden of disease based on splenomegaly and previously treated with at least 1 JAK inhibitor for ≥ 12 weeks and resistant, refractory, intolerant to, or have lost response to JAK inhibitor treatment.
* PV: Confirmed diagnosis of PV and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
* ET: Confirmed diagnosis of high-risk ET as defined in the protocol and previously treated with at least 1 prior standard cytoreductive therapy and are resistant, refractory, intolerant to, or have lost response to treatment.
* Life expectancy \> 6 months.
* Willingness to undergo a pretreatment and regular on-study bone marrow biopsies and aspirations (as appropriate to disease).
* Existing documentation of JAK2V617F mutation from a qualified local laboratory.

Exclusion Criteria:

* Presence of a hematological malignancy requiring treatment, other than PMF, post-PV MF, post-ET MF, PV, or ET.
* Prior history of major bleeding or thrombosis within the 3 months prior to study enrollment.
* Participants with abnormal hematologic, hepatic, or renal function based on laboratory evaluation.
* Has undergone prior allogenic or autologous stem-cell transplantation or allogenic stem-cell transplantation is planned
* Active invasive malignancy.
* Significant concurrent, uncontrolled medical condition.
* Acute or chronic HBV, active HCV or known HIV.
* Any prior MPN-directed therapy within 5 half-lives or 28 days (whichever is shorter) before the first dose of study treatment.
* Participants undergoing treatment with G-CSF or GM-CSF, romiplostim, or eltrombopag at any time within 4 weeks before the first dose of study treatment.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
Anterior Gastropexy vs. No Anterior Gastropexy for Paraesophageal Hernia Repair

This study evaluates the effect of anterior gastropexy (one or more sutures fixing the stomach to the inner abdominal wall) on improving durability of paraesophageal hernia repair. Half of participants will receive anterior gastropexy, while the other half will not. The hypothesis is that anterior gastropexy will help to prevent paraesophageal hernias from recurring.

Paraesophageal hernias are hernias in which the stomach and/or other abdominal organs herniate through the diaphragm into the chest. This abnormal anatomy can lead to acid reflux, trouble swallowing, and shortness of breath, and can also be a risk factor for surgical emergencies involving the stomach. For these reasons, the Society of American Gastrointestinal and Endoscopic Surgeons has strongly recommended that all symptomatic paraesophageal hernias be repaired.

These repairs are technically challenging, and the best available evidence suggests that more than half of patients undergoing repair will have radiographic hernia recurrence at 5 years after surgery. There has been suggestion that use of anterior gastropexy - in which suture is used to affix the stomach to the anterior abdomen - may reduce recurrence rates. However, it is uncertain whether this data is reliable. While some surgeons use anterior gastropexy routinely because they believe it reduces recurrence, other surgeons do not use anterior gastropexy due to the concern that patients will have short-term pain at the suture site. This study aims to evaluate the effect of using anterior gastropexy on recurrence rates after paraesophageal hernia repair, compared to not using anterior gastropexy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Able to participate in follow-up
* Symptomatic paraesophageal hernia
* Paraesophageal hernia is at least 5 centimeters in height on upper GI study or endoscopy
* Elective laparoscopic paraesophageal hernia repair (must begin laparoscopic, but may convert to open surgery if needed)
* Crura must be reapproximated at time of surgery

Exclusion Criteria:

* Previous operations of the esophagus or stomach
* Emergent operation for acute gastric volvulus
* Paraesophageal hernia repair with concurrent bariatric procedure or procedure to reduce stomach volume
* Placement of gastrostomy tube
Dietary Intervention Replacing Carbohydrate With Protein and Fat Has Greater Effect on Peripheral Blood Mononuclear Cell Metabolites Than on Plasma Metabolites in Patients With Prediabetes or Type-2 Diabetes

This study examined whether dietary-induced reductions in lipoprotein-associated phospholipase A2 (Lp-PLA2) activity in peripheral blood mononuclear cells (PBMC) and plasma affected metabolic profiles in PBMCs and plasma.

Eighty nonobese patients (aged 40-70 years) with prediabetes or newly diagnosed type-2 diabetes were randomly assigned to a control group (normal diet with refined rice) or a whole-grain group (replacement of refined rice with whole-grains and legumes). This dietary intervention replaced approximately 7% of carbohydrate-derived energy with approximately 4% of protein-derived energy and approximately 3% of fat-derived energy.

Eligibility Criteria:
Inclusion Criteria:

* subjects who had IFG (100≤ fasting glucose \<126 mg/dL)
* or newly diagnosed type-2 diabetes (fasting glucose ≥126 mg/dL)

Exclusion Criteria:

* current and/or past history of cardiovascular disease including angina
* liver or kidney dysfunction
* thyroid or pituitary disease
* pregnancy or lactation
* taking medications or supplements
Joint School-Health Project of the Neapolitan Child

Unhealthy lifestyle habits during the childhood could negatively impact the health status actual and during the later stages of life.

The School represents the major Institution to implement actions aim at promoting healthy lifestyles habits.

The Joint School-Health Project of the Neapolitan Child aimed at assessing the impact of a health education programme to improve lifestyle habits during the childood. To evalute the effects of this educational programme, the dietary habits, the sleep hours, the hours spent in sedentary behaviors (tv, smartphone) and the hours of physical activity will be evaluate at the baseline and at the end of the programme.


Eligibility Criteria:
Inclusion Criteria:

* students aged 5-13 years of both sex;
* parents/tutor written informed consent.

Exclusion Criteria:

* lack of written informed consent;
* unwillingness to participate.
Effects of Different Parental Involvement on Anxiety and Delirium

Induction of anesthesia in surgical procedures can be a distressing process for both children and their parents. Nonpharmacological behavioral interventions, unlike sedative medications, can reduce children's anxiety without adverse effects. The effect of having both parents present during anesthesia induction on children's anxiety and parents' anxiety has not yet been documented.

This study will aim to evaluate the effect of having both parents present during anesthesia induction on children's and parental anxiety during the perioperative period.

Surgery can be very stressful for patients, especially children. Studies show that 50-75% of children experience fear and anxiety when undergoing surgery and being put under anesthesia. This anxiety can have adverse effects on their recovery, leading to more extended hospital stays, increased pain, and behavioral issues. To address this, various medical and non-medical approaches are used to ease children's fears. One such approach is allowing parents to be with their children until the anesthesia takes effect. This study aims to assess how having both parents present during this time impacts the child's anxiety levels.

The effect of parental presence on the anxiety of children and parents was studied in various studies. Whether both parents affect anxiety has not been studied yet. In this study the investigators will evaluate the anxiety of children by using mYPAS.

Eligibility Criteria:
Inclusion Criteria:

* 80 children of both sex, aged 5-12 years with ASA physical Status I-II will be enrolled

Exclusion Criteria:

* Mentally challenged
* Deaf Child
* Cerebral Palsy
* Premedicated Child
* Language Problem
* Uncooperative
* History of psychiatric disease in children or the parents
* Previous surgery or anesthesia history
Reduction of Shear Forces Using Semi-flexible Sockets on Transtibial Amputees

The purpose of this graduate student research study, is to test two different sockets for comfort and test what pressures are created by the socket during daily activities. The objective is to illustrate that semi-flexible sockets will maintain its rigidity and resist progressive shear forces from daily activity, ergo making our prosthetic system a more comfortable experience for the prosthetic user.

Subjects will immediately be prepared for a casting of their residual limb. On the second visit, subjects will return to be fitted with a definitive rigid carbon fiber socket. At this time, a questionnaire and physical assessments will determine subjects comfort and safety. The physical assessment consists of a ten minute walk on a treadmill, at a self-selected pace. A balancing test on a SMART Balance Master will also be used to assess subject safety, by utilizing the limits of stability protocol. Subjects' will be required to wear the prosthesis given to them for one week before returning for a follow-up appointment. On the third visit, the subjects' will return the first prosthesis to the investigators of the study, where an additional socket will be given to the subject for the second portion of this study. Subjects will be evaluated with a questionnaire and physical assessments to determine comfort and safety. Participants will be required to wear the prosthesis given to them for one week before returning for a follow-up appointment. During the final appointment, the subjects will return all devices given to them to an investigator of the study.

Eligibility Criteria:
Inclusion Criteria:

* Transtibial amputee with mature limb
* Minimum of 3-years of prosthetic use
* Capable of ambulating on a treadmill for ten minutes
* Minimum age of 18 years old
* Both Unilateral and Bilateral Amputees
* K-Level K2-K4

Exclusion Criteria:

* Any open wounds/ulcerations on the residual limb
* Skin allergies to silicone or latex
* Unmanaged co-morbidities such a diabetes and congestive heart failure
Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction

Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning.

The study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.

Please see above

Eligibility Criteria:
Inclusion Criteria:

* Patients more than 18 years
* STEMI \< 12 hours
* TIMI 0-1 in infarct related artery

Exclusion Criteria:

* Multivessel disease (stenoses in non-infarct related arteries \>70%)
* Cardiogenic shock
* Left main occlusions
* Lesions that cannot be treated with stents
* Previous CABG
* Pregnancy
* Severe renal insufficiency
* Previous extensive Q-wave infarction
* LBBB
A Study of ASP1585 to Evaluate the Bioequivalence Between ASP1585 Granules and ASP1585 Capsules

The purpose of this study is to assess the bioequivalence between ASP1585 granules and ASP1585 capsules after repeated oral administration of ASP1585 granules or ASP1585 capsules under open-label conditions in non-elderly healthy male subjects. In addition, the safety of these products is assessed.


Eligibility Criteria:
Inclusion Criteria:

* Body weight (at screening) ≥ 50.0 kg and \< 80.0 kg
* Body mass index (BMI) (at screening) ≥ 17.6 kg/m2 and \< 26.4 kg/m2
* Healthy, as judged by the investigator/sub-investigator based on medical history and the results of physical examination (subjective symptoms and objective findings) and all tests obtained at screening and during the period from hospital admission to immediately before study medication in 1st period.

Exclusion Criteria:

* Received or scheduled to receive any investigational drugs in other clinical trials, post-marketing studies, or clinical studies within 120 days before the screening or during the period from the screening to 1st hospitalization.
* Donated or scheduled to donate 400 mL of whole blood within 90 days before the screening or during the period from the screening to 1st hospitalization, 200 mL of whole blood within 30 days before the screening or during the period from the screening to 1st hospitalization, or blood components within 14 days before the screening or during the period from the screening to 1st hospitalization.
* Any deviation of the laboratory tests at screening or 1st hospitalization.
* A deviation from the normal range of blood pressure, pulse rate, or body temperature at screening or 1st hospitalization

  * Sitting blood pressure: Systolic blood pressure: ≥90 mmHg, ≤140 mmHg; Diastolic blood pressure: ≥40 mmHg, ≤90 mmHg
  * Sitting pulse rate; ≥40 bpm, ≤99 bpm
  * Axillary body temperature; ≥35.0°C, ≤37.0°C
* History of drug allergies
* Upper gastrointestinal disease (e.g., nausea, vomiting, and stomachache) within 7 days before 1st hospitalization
* Concurrent or previous hepatic disease (e.g., viral hepatitis, drug-induced liver injury, and hepatic impairment)
* Concurrent or previous heart disease (e.g., congestive heart failure, angina pectoris, and arrhythmia requiring treatment)
* Concurrent or previous GI disease (e.g., ileus paralytic, gastric atony, intestinal atony, colitis ulcerative, peptic ulcer and gastroesophageal reflux esophagitis; except for a history of appendicitis).
* Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis)
* Concurrent or previous renal disease (e.g., acute renal failure, glomerulonephritis, and interstitial nephritis)
* Concurrent or previous cerebrovascular disorder (e.g., cerebral infarction)
* Previous use of bixalomer
* Excessive smoking or drinking habit
A Conversion Study to Assess Safety and Efficacy of a MR4 Based Immunosuppressive Regimen in Stable Liver Recipients

Assessment of the safety and the efficacy of a tacrolimus modified release (MR4) based immunosuppressive regimen in stable liver transplant subjects converted on a 1:1 (mg:mg) basis from a Prograf® based immunosuppressive regimen.

Multicenter, open, single sequence crossover study. Subject Enrolment: Prograf® administered twice daily is replaced by Prograf as study medication, administered twice daily.

Six weeks Prograf-Treatment Phase to confirm compliance to regimen stability requirements (see Inclusion and Exclusion Criteria), and collection of data under Prograf treatment.

Conversion from Prograf (twice daily, morning \& evening dosing) total daily dose to MR4 once daily (only morning dosing) on a 1:1 (mg:mg) basis on Day 1.

Twelve weeks MR4-Treatment Phase with study assessments for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Liver transplant at least 12 months prior to enrollment.
* Prograf® dose remained unchanged for a minimum of 12 weeks prior to enrollment and tacrolimus whole blood trough level measurements were in the range of 5-15 ng/mL.

Exclusion Criteria:

* Any unstable medical condition that could interfere with the study objectives in the opinion of the investigator.