cyrilzakka/clinical-trials huggingface dataset:
Long--term Outcome Analysis of Fracture--related Infections

This retrospective analysis of medical records is to identify risk factors for treatment failures in fracture-associated infections (FAI) at the University Hospital Basel.


Eligibility Criteria:
Inclusion Criteria:

* Patients with FAI

Exclusion Criteria:

* documented denial of consent
Protectivity and Safety of DTP/HB/Hib (Bio Farma) Vaccines in Infants, Batch Consistency, Multi Center Trial

The objectives of this study were to analyze the immunogenicity and reactogenicity of DTP/HB/Hib (Bio Farma) combination vaccine.

This trial was randomized, double blind, prospective intervention and multi centers. Total 600 subject (6-11 weeks of ages) followed this trial, divided into 3 groups, each group consists of 200 subjects. A number of 342 subjects were recruited in Bandung, while 258 subjects were recruited in Jakarta.

Eligibility Criteria:
Inclusion Criteria:

* Infant 6-11 week of age
* Infant born after 37-42 week of pregnancy
* Infant weighting more than 2.5 kg at birth
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
* Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial
* Mother at least graduate from elementary school
* Received Hepatitis B vaccine (Bio Farma) at birth

Exclusion Criteria:

* Child concomitantly enroll or schedule to be enroll in another trial
* Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5 Celsius on Day 0)
* Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
* History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
* Known history of congenital or acquired immunodeficiency (including HIV infection)
* Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (\>2 weeks)
* Other vaccination within the 1 month prior to inclusion with the exception of BCG and poliomyelitis
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective
* Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection
A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)

This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.

The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time.

The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.

Eligibility Criteria:
Inclusion Criteria:

1. Patients (males or females) diagnosed with unresectable locally advanced or MBC (either after a recurrence or as first diagnosis) from January 2016 onwards.
2. Patients who died are allowed to be included on the study.
3. Able and willing to provide written informed consent if they are alive.
4. Age ≥ 18 years.
5. Availability to medical records access and all data related to the disease management.

Exclusion Criteria:

None
A Study With LJPC-401 for the Treatment of Myocardial Iron Overload in Patients With Transfusion-Dependent Beta Thalassemia

This study is a Phase 2 multicenter, randomized, open-label, parallel-group study. The primary objective of the study is to evaluate the effect of LJPC-401 (synthetic human hepcidin) on iron levels in patients with transfusion-dependent beta thalassemia with myocardial iron overload.


Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 14 years of age with transfusion-dependent beta thalassemia.
* Patients must have increased iron levels in the heart as measured by magnetic resonance imaging (MRI). Two separate cardiac T2\*MRI from 6 to 35 msec; \<= 15% difference between the two.
* Patients must be receiving iron chelation therapy for a minimum of 1 year and be on a stable dose prior to study and expected to remain stable during study.
* Female patients of childbearing potential must not be pregnant, must have negative pregnancy tests, and must use an effective birth control method during the study.
* Male patients must be either surgically sterile or use an effective birth control method during the study.
* Patient must be willing and able to provide written informed consent. Parent of legal guardian to patients younger than age of majority must be willing and able to provide informed consent.

Exclusion Criteria:

* Any significant medical condition or lab abnormality that would prevent the patient from participating in the study.
* Pregnant or lactating women.
* Patients taking an immunosuppressive agent (except topical over-the-counter steroids, inhaled steroid medications, and non-steroidal anti-inflammatory drugs) or have a planned surgery (except dental surgery or simple dermatologic procedures).
* Patients participating in an unapproved investigational clinical trial within 30 days of this study.
* Patients with a disease, disability or condition which may interfere with the conduct of the study, or which would, in the opinion of the Investigator, pose an unacceptable risk to the patient.
* Patients who are unwilling or unable to comply with the study requirements.
* Patients with known hepatitis B or hepatitis C, or being treated for a positive viral load or are noncompliant with hepatitis medications.
* Known and active human immunodeficiency virus (HIV) infection.
* Patients with Child Pugh class C cirrhosis or liver failure.
* Patients with severe congestive heart failure (NYHA Class 4).
* Use of erythropoiesis stimulating agents in the past 3 months prior to study entry.
* History of allergic reaction to hepcidin or excipients.
* Contraindication to MRI scanning.
Estimation of Gestational Age by TCD

- Different parameters are used to estimate gestational age AC, HC , BPD and FL

-TCD is one of the parameters ,here we are testing its accuracy in calculating GA

Eligibility Criteria:
Inclusion Criteria:

* pregnant ladies with GA between 16 - 40 weeks

Exclusion Criteria:

* pregnant ladies with GA less than 16 weeks
Fluorescent Cholangiography in Acute Cholecystitis

Currently, there is limited scientific evidence regarding the effectiveness of fluorescent cholangiography in emergency cholecystectomy for acute cholecystitis. The primary aim of this study was to assess the efficacy of near-infrared fluorescent cholangiography to detect extrahepatic biliary anatomy in different severity degrees of acute cholecystitis.

The study aims to to evaluate the efficacy of near-infrared fluorescent cholangiography for real-time visualization of the extrahepatic biliary tree (cystic duct, common hepatic duct, cystic duct-common hepatic duct junction, common bile duct and any accessory or aberrant ducts) in emergency laparoscopic cholecystectomy before and after hepatocystic triangle dissection and in different degrees of severity of acute cholecystitis according to the American Association of Surgery for Trauma (AAST) classification, specifically distinguishing between non-gangrenous (grade I) and gangrenous or complicated (grades II-V) forms. For intra-operative fluorescent cholangiography, 2.5 mg indocyanine green (ICG) was administered intravenously 45-60 min prior to surgery, according to the recent guidelines from the International Society for Fluorescence Guided Surgery. All the operations were performed by the same team of surgeons. Near-infrared fluorescent cholangiography was performed by using Stryker's fluorescence imaging system (Stryker, Portage, Miami, USA). Near-infrared fluorescent cholangiography was performed at three defined time point during laparoscopic cholecystectomy: (i) following exposure of Calot's triangle, prior to any dissection; (ii) after partial dissection of Calot's triangle; (iii) after complete dissection of Calot's triangle, according to the "Critical View of Safety" method.

Eligibility Criteria:
Inclusion Criteria:

* patients with a clinical and radiological (abdominal ultrasound and/or computed tomography) diagnosis of acute cholecystitis based on the revised TG18 who underwent laparoscopic cholecystectomy within 24-72 hours from the onset of symptoms;
* patients with ASA score of 1-3;

Exclusion Criteria:

* patients with a known allergy to indocyanine green;
* ASA score 4-5;
* patients deemed non-operable via laparoscopic approach due to high cardio-respiratory risk;
* previous surgical interventions on the biliary tract;
* history of liver cirrhosis or severe liver disease;
* ongoing pregnancy or breastfeeding.
Head-Mounted Vibrotactile Prosthesis for Patients With Chronic Postural Instability

The goal of this project is to provide individuals that have a balance deficit with a device that will give them signals that they can feel (vibrations) in order to help them maintain a correct sense of balance and perception of place in the environment.

This proposal addresses a National Institute on Deafness and Other communication Disorders (NIDCD) research topic that emphasizes the "development of assistive devices for balance disorders". The proposed work will evaluate the assistive efficacy of such a balance prosthesis in a population of chronic imbalance patients spanning a wide range of disease etiologies.

Eligibility Criteria:
Inclusion Criteria:

* Ambulatory patients who have had chronic imbalance for at least one year, and have reached a functional performance plateau with respect to their balance adaptation.

Exclusion Criteria:

* Neurological disorders other than chronic balance disorders, as determined by medical history and neurological screening procedure.
* Any medical condition as determined by the health questionnaire that would interfere with performance on the postural stability evaluation tests.
* Peripheral neuropathies of the lower extremities.
* Subjects who are unwilling or unable to adhere to all study requirements, including completion of the training period, evaluation tests, and return to clinic for a follow-up visit.
Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients

The primary aim of this study is to compare regional amyloid burden in Parkinson's disease (PD) to normal control subjects. We hypothesize that there will be significant differences in overall amyloid burden in PD patients compared to age-matched normal controls.


Eligibility Criteria:
Inclusion Criteria:

* Subjects may be enrolled if they (inclusion criteria):

  * Are males or females ≥60 years of age
  * Meet research diagnostic criteria for Parkinson's disease:
  * Diagnosis of a parkinsonian syndrome

    * Bradykinesia (slowness of initiation of voluntary movement with progressive reduction in speed and amplitude of repetitive actions)
    * At least one of the following: muscle rigidity, rest tremor, postural instability not due to visual, vestibular, cerebellar or proprioceptive causes
  * Supportive criteria for diagnosis of PD (two or more required)

    * Unilateral onset of symptoms and persistent asymmetry
    * Rest tremor present
    * Progressive illness
    * Excellent response to levodopa with dyskinesias
    * Levodopa response for 5 years or more
    * Clinical course of 10 years or more
  * Have the ability to lie flat and tolerate a 10 minute PET scan.

Exclusion Criteria:

* Subjects may not be enrolled if any of the following are present (exclusion criteria):

  * History of repeated strokes, repeated head injury, definite encephalitis
  * Use of neuroleptics at onset of symptoms
  * Sustained remission
  * Strictly unilateral feature persisting \> three years after onset
  * Significant supranuclear gaze palsy
  * Cerebellar, pyramidal and early severe autonomic findings
  * Early severe dementia suggesting a diagnosis of dementia with Lewy bodies (DLB)
  * Imaging study showing structural abnormality that could explain parkinsonism
  * Negative response to an adequate levodopa trial
  * Current clinically significant psychiatric disease that prohibits providing informed consent or participation in the study
  * Current clinically significant endocrine or metabolic disease, pulmonary,
  * Women of childbearing potential who are not two or more years post menopausal or surgically sterilized
  * Have received any investigational medications, or have participated in a trial with investigational medications within the last 30 days
Stroke Patients Receiving Chiropractic Care Post-rehabilitation

The Life University Center for Chiropractic Research is conducting a research study to better understand how 12-weeks of chiropractic care differentially affects the post-rehabilitation brain electrical patterns and body movement patterns of individuals who have experienced hemorrhagic versus ischemic stroke The study will involve visits to the Life University Center for Chiropractic Research (CCR) in midtown Atlanta. During the 12 weeks of focused care, chiropractic visits could be several times a week depending on the care plan. In addition to the chiropractic care, individuals will receive a physical examination and three follow-up assessments. The assessments in the CCR will include a non-invasive evaluation of the brain wave patterns using electroencephalography (EEG), completion of a few surveys, a balance assessment and a movement assessment. Qualified individuals will receive study treatment and care at no cost.


Eligibility Criteria:
Inclusion Criteria:

* Post stroke rehabilitation

Exclusion Criteria:

* Not experienced sub-arachnoid bleeding within the last 4 weeks, fractures or trauma to the skull, pregnancy, or progressive RA.
[18F]F-AraG PET Imaging to Visualize Tumor Infiltrating T-cell Activation in Non-small Cell Lung Cancer.

\[18F\]F-AraG is a promising tracer to image activated T-cells with positron emission tomography (PET). The aim of the ATTAIN trial is to investigate the pharmacokinetic characteristics of this novel tracer by performing a full kinetic modelling, assess test-retest (TRT) variability and to correlate the tumor tracer uptake with the pathological assessment.

The efficacy of immunotherapy and patient selection for combinatorial immunotherapy strategies would greatly improve if the tumor microenvironment (TME) could be characterized more accurately. Positron emission tomography (PET) using tracers that target immune cell subsets may provide a non-invasive means to immune profile the TME. Imaging T-cells can help in identifying 'hot' tumors, or parts of the tumor mass that have high concentrations of tumor infiltrating T-cells and also provide information on its activation.

A promising tracer to image activated T-cells is \[18F\]F-AraG. Based on the hypothesis that \[18F\]F-AraG will accumulate in activated T-cells, it is expected that \[18F\]F-AraG and PET will enable to (reproducibly) identify tumors and tumor areas with high concentrations of tumor infiltrating activated T-cells on pathological assessment. In the ATTAIN trial this \[18F\]F-AraG uptake in tumor lesions and healthy organs is explored by full kinetic modelling.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed NSCLC, a histological biopsy is mandatory.
2. Patients that are resectable upfront as per multidisciplinary tumor board evaluation.
3. Be willing and able to provide written informed consent for the trial.
4. Be above 18 years of age on day of signing informed consent.
5. Have a performance status of 0-1 on the ECOG Performance Scale at screening.

Exclusion Criteria:

1. Subjects with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of screening. Inhaled or topical steroids, and adrenal replacement steroid \>10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
2. Psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
3. Patient is pregnant or breastfeeding or expecting to conceive within the projected duration of the trial, starting with the screening visit through 12 weeks after the last \[18F\]F-AraG PET scan.
Orthopedic Intelligent Navigation System in the Treatment of Fresh Femoral Neck Fractures

The goal of this clinical trial is to verify the safety and effectiveness of orthopaedic surgical navigation system in the treatment of fresh femoral neck fractures.

Participants will:

* Take three cannulated compression screws by navigation system or by traditional method to treat femoral neck fractures.
* Visit the clinic 1, 3, 6, 12 months after surgery for checkups and tests.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years old, gender is not limited;
2. Patients diagnosed with femoral neck fracture;
3. Patients with indications for internal fixation of femoral neck fracture and able to tolerate surgery;
4. The subject or his legal representative is informed of the nature of the study and agrees to participate in the study.

Exclusion Criteria:

1. Participants who had participated in clinical studies of other drugs, biologics or medical devices before enrollment and did not reach the primary study endpoint time limit;
2. The patient is known to have a history of allergy to one or more implanted materials;
3. Patients determined by researchers to be physically weak or unable to tolerate surgery due to other systemic diseases;
4. Active infection of the hip joint or other parts of the body is determined by the investigator;
5. Diagnosed as metabolic bone disease, radiation bone disease, etc.;
6. Severe hip contracture deformity or severe muscle loss fused to the functional position for a long time without pain;
7. have inflammatory arthritis, such as rheumatoid arthritis, systemic lupus erythematosus arthritis, ankylosing spondylitis, etc.;
8. The patient is mentally incapable or unable to understand the requirements of participating in the study, and it is difficult to cooperate;
9. Other conditions deemed unsuitable for inclusion by the investigator.
Effect of Steroids on Thrombosis (Blood Clot Formation) and Inflammation in Patients Undergoing Hip Surgery

Studies have shown that surgery causes some reactions in your body consistent with inflammation. When the inflammation is extensive, it may affect different parts of the body including the lungs. Corticosteroids are commonly used to treat inflammation and are different from performance enhancing steroids associated with athletics. The purpose of this study is to determine the influence of low dose steroids given 3 times in a 24 hour period on thrombotic markers (markers that are associated with increased risks of clotting, a possible complication of surgery), interleukin (IL)-6 cytokine release (part of the stress response seen with surgery), and urine desmosine levels (a marker of lung injury) in a randomized placebo controlled trial patients undergoing total hip replacement.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing unilateral total hip replacement with Drs. Douglas Padgett, Thomas Sculco, or Edwin Su.
* Patients between the age of 50 and 90

Exclusion Criteria:

* Patients on steroid therapy regardless of dose or duration of treatment or those requiring stress-dose steroids preoperatively
* Patients who are smokers
* Patients who have diabetes
* Patients who are \<50 and \>90 years of age
* Patients with history of prior difficulties tolerating corticosteroids
6th Month EWL% After Sleeve Gastrectomy to Get a Better Sleep Quality

Obesity, caused by caloric intake over output, has become a global health problem. The relationship between sleep and obesity is widely discussed in the literature. Little is known regarding the compliance of sleep quality and patients' weight loss. This study aimed to review how sleep quality is affected by bariatric surgery, examine whether compliance with sleep quality can be predicted after bariatric surgery, and assess its correlation with excess weight loss.

A cross-sectional study was conducted among patients that underwent bariatric surgery (laparoscopic sleeve gastrectomy). Sleep quality was assessed using the Pittsburgh sleep quality index (PSQI) scale preoperatively and at the 6th postoperative month. Survey data were recorded and PSQI scores were calculated. A PSQI global score above 5 indicates poor sleep quality. The participants were divided into two groups good sleep quality and poor sleep quality. Descriptive statistics and Spearman correlations were applied. Logistic regression analysis was performed to predict sleep quality.

Eligibility Criteria:
Inclusion Criteria:

Patients who underwent LSG for morbid obesity after being considered suitable for bariatric surgery by multidisciplinary evaluation were included in this study. Patients with aged 18-65 years, BMI \> 40 and BMI \> 35 and comorbid disease were included.

Exclusion Criteria:

Patients treated for sleep disorders have been excluded.