cyrilzakka/clinical-trials huggingface dataset:
Anterior Capsulectomy vs. Repair in Direct Anterior THA

Randomized prospective study comparing the anterior capsule repair vs capsulectomy with regards to post-operative pain and range of motion outcomes in elective primary unilateral direct anterior approach THA for osteoarthritis. Visual Analog Scores (VAS) will be recorded for preoperative and postoperative months 1 and 4. Hip range of motion will be assessed by goniometer measurements and lateral hip radiographs in maximum flexion.

The purpose of the study is to compare post-operative pain control and hip range of motion between two surgical techniques (anterior capsular repair vs. anterior capsulectomy) during direct anterior total hip arthroplasty.


Eligibility Criteria:
Inclusion Criteria:

* Elective unilateral primary total hip arthroplasty Direct anterior surgical approach Osteoarthritis diagnosis 18 years of age or older

Exclusion Criteria:

* Bilateral primary total hip arthroplasty Revision hip arthroplasty Avascular necrosis of the hip Rheumatoid arthritis of the hip Younger than 18 years of age
Impact of Chronic Air Pollution on Non-cystic Fibrosis Bronchiectasis

We aim at investigation the impact of chronic air pollution exposure on non-cystic fibrosis bronchiectasis outcome.

* Patient files will be search for time of death and cause of death.
* Other variables will be collected: bacterial culture results, therapy, gender, age, etc.
* These data will be linked with pollution data: trafic load, distance to major road, etc.

Eligibility Criteria:
Inclusion Criteria:

* HRCT diagnosis of bronchiectasis
* recurrent infections or chronic sputum production
* patients between 18 and 65 years old.

Exclusion Criteria:

* Cystic Fibrosis
* Tumoral disease
* Traction bronchiectasis due to interstitial lung disease
* patients older than 65 years or younger than 18 years at recruitment
* COPD
Lateral Ridge Augmentation Using Autogenous Bone Blocks or Xenogenic Bone Block Grafts Loaded With Recombinant Human Bone Morphogenic Protein 2

Since there are no clinical studies available comparing the gold standard (autogenous bone graft plus resorbable membrane) to the promising combination of xenogenic bone graft loaded with rhBMP-2 in combination with a collagen membrane for localized ridge augmentation, the present exploratory study has been designed.

The aim of the present study is therefore to test whether or not the application of a xenogenic bone block loaded with rhBMP-2 will results in clinically, radiographically and histologically similar outcomes as the gold standard (autogenous bone block) for the regeneration of chronic ridge defects.

The investigators expect that there is no difference in bone quantity and quality between the two methods and that the use of the test treatment will be more user and patient friendly according to the patient perception/acceptance since no second surgical site will be necessary as well as cause less complications.


Eligibility Criteria:
Inclusion Criteria:

* requiring implant therapy for the reconstruction of 1 to 4 missing teeth
* revealing insufficient bone volume for implant placement (cases where less than 50% of the implant surface would be surrounded by native bone) requiring bone augmentation procedure

Exclusion Criteria:

* Medication with a contraindication for implant therapy
* Previous administration of InductOs
* Skeletal immaturity
* Any active malignancy or patient undergoing treatment for a malignancy
* An active infection at the operative site
* Persistent compartment syndrome or neurovascular residua of compartment syndrome
* Pathological fractures such as those observed in (but not limited to) Paget's disease or in metastatic bone
* Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
* Contraindications on ethical grounds,
* Pregnancy,
* Intention to become pregnant during the course of the study,
* Breast feeding,
* Treatment with other investigational products,
* Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc),
* Known or suspected non-compliance, drug or alcohol abuse,
* Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia or confusional state of the subject,
* Participation in another study with investigational drug within the 30 days preceding and during the present study,
* Previous enrolment into the current study,
* Enrolment of the investigator, his/her family members, employees and other dependent persons,
* Patients where autogenous bone cannot be harvested.
MR Imaging of Knee Osteoarthritis and Acute Knee Injuries

The purpose of this study is to use better magnetic resonance imaging (MRI) techniques to examine the knee and the bony and soft tissue changes so as to better predict the progression of osteoarthritis and acute knee injuries.

The study will examine the pathophysiology of bone marrow changes, relationship between trabecular bone and cartilage changes; and evaluate T1p relaxation methods and its' relating to cartilage loss. The protocol is geared towards sequences utilizing 3 Tesla magnetic resonance imaging (MRI) that will enable the measures of cartilage volume and T2. Measures cartilage volume and T2 are more established MR methods for studying osteoarthritis (OA).

All OA and Anterior cruciate ligament (ACL) subjects will undergo MR imaging of the knee joint at 3 Tesla at baseline,, and three annual follow up time points. Regions of interest will include the total tibial and femoral cartilage, and sub-division such as the medial and lateral compartments of the tibial and femoral cartilage to account for localized disease activity and progression.

Bone marrow edema size, MR spectroscopy based marrow fat/water content, and trabecular bone microarchitecture underlying the edema will be measured in the OA and ACL groups to determine whether there is any distinction between these measures in OA and in traumatic ACL injury, cross-sectionally and longitudinally, and their relation to cartilage loss and OA progression.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers will have had no previous knee symptoms or surgery
* Patients with mild arthritic symptoms and Kellgren Lawrence score of 2
* Patients with severe arthritic symptoms and Kellgren Lawrence score of 3, or 4
* Patients with acute ACL injury with associated bone contusion and bone edema
* Patients with posttraumatic knee injury or degenerative condition and will have cartilage resurfacing procedures
* Patient is willing to participate in the proposed study as evidenced by providing written informed consent.

Exclusion Criteria:

* Current use of an investigational drug
* Conditions other than OA which limit lower extremity function and mobility and/or would confound the evaluation of function (e.g., clinically significant spinal disc degeneration, painful or dysfunctional feet, peripheral vascular disease, lumbar radiculopathy or a stroke.)
* Patients with metallic fragments in the eyes, vascular clips, pacemakers, and other contraindications to MRI
Effects of Traditional Moderate Intensity Training and High Intensity Interval Training in Polycystic Ovarian Syndrome

To determine the comparative effects of traditional moderate intensity training and high intensity interval training on Anxiety, fatigue and Quality of Life in females with polycystic ovarian syndrome


Eligibility Criteria:
Inclusion Criteria:

* Participants with BMI greater than 25kg/m2
* Oligo- or anovulation/irregular cycles i.e 35 days
* Married women
* Primary infertility
* A diagnosis of polycystic ovaries based on ultrasound results

Exclusion Criteria:

* Use of psychiatric or psychotropic medications.
* Unresolved gynecological conditions i.e Cervical Dysplasia, Pelvic floor prolapse, Uterine Fibroids, Urinary Incontinence
* Diabetes, pregnancy, smoking, illness or injury that prevented or limited exercise performance and existing participation in regular physical activity
Deep Learning Algorithm for Detecting Obstructive Coronary Artery Disease Using Fundus Photographs

Artificial Intelligence, trained through model learning, can quickly perform medical image recognition and is widely used in early disease screening and assisted diagnosis. With the continuous optimization of deep learning, the application of AI has helped to discover some previously unknown associations with other systemic diseases. Artificial intelligence based on retinal fundus images can be used to detect anemia, hepatobiliary diseases, and chronic kidney disease, and to predict other systemic biomarkers. The above studies provide a theoretical basis for the application of artificial intelligence technology based on retinal fundus images to the diagnosis and prediction of cardiovascular diseases.

At present, there is still a lack of accurate, rapid, and easy-to-use diagnostic and therapeutic tools for predictive modeling of coronary heart disease risk and early screening tools in China and the world. Fundus image is gradually used as a tool for extensive screening of diseases due to its special connection with blood vessels throughout the body, as well as easy access, cheap and efficient. It is of great scientific and social significance to develop and validate a model for identification and prediction of coronary heart disease and its risk factors based on fundus images using AI deep learning algorithms, and to explore the value of AI fundus images in assisting coronary heart disease diagnosis and screening for a wide range of applications.


Eligibility Criteria:
Inclusion Criteria:

Eligible participants were ≥ 18 years of age, with clinically suspected CAD, and were scheduled for coronary angiography.

Exclusion Criteria:

The exclusion criteria were as follows: (i) prior percutaneous coronary intervention (PCI); (ii) prior coronary artery bypass graft (CABG); (iii) other heart disease (e.g., congenital heart disease, valvular heart disease, or macrovascular disease); (iv) inability to have photographs taken; and (v) and a diagnosis of ST-segment elevation myocardial infarction (STEMI). Prior to the coronary angiography procedure, all eligible patients provided informed consent to participate in the study and to have their photographs used for research purposes.
Variables That Are Correlated to Developing Multiple Endocrine Neoplasia (MEN) and Pancreatic Neuroendocrine Tumors (PNET)

The study aims to identify predictors of disease in patients with hyperparathyroidism (HPTH) who undergo surgery.

Researchers aim to identify somatic mutations and inherited genetic variants which may help predict the development of PNET in patients with hyperparathyroidism.

Eligibility Criteria:
Inclusion Criteria:

1. MEN1 patients who have undergone parathyroidectomy and did not develop PNET.
2. MEN1 patients who have undergone parathyroidectomy and had surgical removal of PNET.

Exclusion Criteria:

N/A
Metal Ion Serum Concentrations in Patients With Total Hip Replacements

Other research studies have shown that the levels of metals in the blood are slightly increased after patients receive a total hip replacement. We want to learn whether these elevated levels are associated with any adverse effects. We hope this study will help us identify which type of patients have elevated levels of metal in their blood.

It is suspected that the concentration of the metals chromium, cobalt and titanium in the blood will be higher in people with an all metal total hip prosthesis than in those with a plastic and metal prosthesis. To find out if this is true, we will test blood samples for the levels of metal in the blood and compare the values from 3 groups of people:

1. people with metal on metal hip replacements
2. loosening of a plastic and metal prosthesis and
3. evidence of osteoarthritis and are awaiting a total hip replacement.

Eligibility Criteria:
Inclusion Criteria:

Group 1 - unilateral hip replacement with metal on metal prosthesis, well functioning.

Group 2 - loosening of plastic and metal prosthesis Group 3 - osteoarthritis of the hip and awaiting total hip replacement

Exclusion Criteria:

* renal dysfunction
* other types of metal implants or dental prostheses
* rheumatoid arthritis
* hip infection
Safety and Efficacy of Pegylated Exenatine Injection (PB-119) in Drug-naïve T2DM Subjects

A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of 24 once-weekly subcutaneous doses of PB-119 in Drug-naïve T2DM Subjects.

The study included a maximum 2-week screening period, a 4-week single-blind introduction period, a 24-week double-blind treatment period, a 28-week open extension treatment period, and a 4-week safety follow-up period.

At the end of the single-blind entry period, eligible subjects were randomly assigned to two different administration groups in a 1:1 ratio and received a 24-week double-blind treatment.

All subjects who completed the double-blind treatment entered the open extension treatment phase.Open extension treatment with subcutaneous injection of 150μg PB-119 once a week for 28 weeks.

Safety follow-up was conducted 4 weeks after the end of treatment/completion of early exit visit in the open extension period.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 18\~75 years old;
* Confirmed T2DM patients meet the diagnostic criteria for type 2 diabetes published by WHO1999；
* 18.5 kg/m2 \< BMI \< 40.0 kg/m2 at screening;
* 7.5% ≤ HbA1c ≤ 11.0% at screening;
* 7.0% ≤ HbA1c ≤ 10.5% when the random;
* 18.5 kg/m2 \< BMI \< 40.0 kg/m2 during screening and before randomization

Exclusion Criteria:

* T1DM;
* Continuous use of insulin for more than 14 days within 1 year before screening or before randomization；
* Treatment with any dipeptidylpeptidase 4 (DPP-4) inhibitor or glucose-dependent insulin-stimulating peptide (GIP) or/and glucagon-like peptide-1 (GLP-1) receptor agonist prior to screening or randomized prior treatment；
* Screening for any of the following heart diseases within the first 6 months or before randomization；
* Patients whose hypertension was not effectively controlled during screening or before randomization (after resting ≥5 minutes, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg)；
* Serum amylase or lipase \>3×ULN or those with previous diagnosis of acute/chronic pancreatitis were screened or randomly screened；
* Screening for severe trauma or infection that may affect glycemic control within the first month or before randomization；
* A history or family history of medullary thyroid carcinoma (MTC) or multiple endocrine adenomatosis type 2 (MEN2)；
* Known to be allergic or intolerant to the study drug or metformin；
* Female subjects during pregnancy or lactation.
Biomarkers in Samples From Younger Patients With Wilms Tumor

This research study is studying biomarkers in tissue samples from younger patients with Wilms tumor. Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. It may also help doctors predict how patients respond to treatment

PRIMARY OBJECTIVES:

I. To determine whether recruitment of tumor-associated macrophages is related to clinicopathological factors in Wilms tumor (tumor stage, presence of vascular invasion, tumor progression, and survival).

OUTLINE:

Paraffin-embedded specimens are analyzed for macrophage markers. Results of each sample are then compared with patient's tumor stage, presence of vascular invasion, tumor progression, and survival.

Eligibility Criteria:
Inclusion Criteria:

* Wilms tissue microarray samples provided by the Children's Oncology Group
Modulation of Vasoreactivity in Septic Shock: Impact of Recombinant Protein C

The purpose is to demonstrate that vasoreactivity of patients with septic shock evaluated with dose-response curve is diminished in septic shock and ameliorated by activated protein C (APC).

This amelioration is correlated to decrease of inflammation, decrease of reactive oxygen species (ROS) markers and increase of circulating catecholamines.


Eligibility Criteria:
Inclusion Criteria:

- Patients with septic shock as determined by standard criteria (including infection and severe infection)

Exclusion Criteria:

* Pregnant women
* Absence of signed informed consent. Due to gravity of medical situation of patients, inclusion will be possible after informed consent of a family member. As soon as possible, an informed consent will be obtained by patient
* Contraindication to Xigris: evolutive internal bleeding , intracranial pathology, neoplasia or brain involvement, concomitant heparin therapy \>= 15 IU/kg/h, known hemorrhagic diathesis except acute coagulopathy subsequent to sepsis, severe chronic liver disease, platelet count \< 30000 x 10\^6/L, high bleeding risk, known hypersensibility to drotrecogin alfa (activated), one of excipients or bovine thrombin
Psychosomatic Effects of Implantable Cardioverter Defibrillator With Home Monitoring Function (QUANTUM)

Quality of life (QOL) and psychological well-being of patients with implantable cardioverter-defibrillators (ICDs) are significantly influenced by the experience of shock therapies. A close therapeutic relationship between patients and physicians, resulting in short reaction times to ICD-treated arrhythmic events and, in an optimised antiarrhythmic therapy, may help the patients to deal with their situations in the best possible way.

The researchers investigate the influence of automatic remote patient monitoring on QOL, anxiety, and depression in ICD patients, and kind and frequency of (un-)scheduled patient-physician contacts. They also evaluate monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy.

Our study investigates the influence of automatic remote patient monitoring on quality of life (QOL), anxiety and depression in patients with implantable cardioverter-defibrillators (ICDs), and frequency of (un-)scheduled patient-physician contacts. The study also evaluates monitoring-induced changes in patient mobility and in patients' perceptions of ICD therapy.

The patients will receive BIOTRONIK Lexos-T or Lumos-T ICD models, with the integrated Home Monitoring capability. The latter allows wireless, everyday transfer of the essential status and therapy data from the ICD memory to a website accessible by the attending physicians. The website is managed by BIOTRONIK Home Monitoring Service Center.

Patients will be randomised into:

* Group 1: Home Monitoring is established from the outset.
* Group 2: Home Monitoring is introduced 9 months after ICD implantation.

Follow-up for both groups is 18 months.

Study Hypothesis: Home Monitoring improves the Hospital Anxiety Score in ICD patients.

Preoperatively, HADS (Hospital Anxiety and Depression Scale), Questionnaire on Type D personality (DS 14), and SF-12 Questionnaire will be applied. At follow-up visits every 3 months, HADS, SF-12 Questionnaire, Shock Sensation Questionnaire, number of shocks since preceding follow-up visit, and medications (cardiovascular drugs, psychopharmacological drugs and barbiturates) will be evaluated. Home Monitoring ICD Impact Questionnaire will be collected at the final 18-month follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Indication for ICD implantation either as primary or secondary prevention
* Patient informed consent

Exclusion Criteria:

* ICD replacement indication
* Indication for cardiac resynchronisation therapy
* Inability to fully understand psychosomatic questionnaires, especially cognitive impairment or German language deficits
* Co-morbidities with a resulting life expectancy of less than one year
* Psychosomatic disease (requiring psychiatric therapy)
* Age \<18 years
* Patients who are already enrolled in another study
Effect of Oral TXA on Buttock Bruising Post CCH Injections in Adult Females

This is an open-label, randomized, multiple dose IIR study to evaluate the effect of Lysteda™ on bruising following QWO™ injections to the buttocks in female subjects presenting with moderate to severe cellulite.

Following determination of eligibility based on inclusion/exclusion assessment, the subjects will be randomized to either Cohort A, Cohort B, or Cohort C, based on order of enrollment. Each Cohort will receive 3 Qwo™ treatments spaced 21 days apart, with 1300 mg of Lysteda™ TID PO at one, two, or all three treatments of Qwo™. Cohort A will be given tranexamic acid at the first treatment, Cohort B at the first and second treatment, and Cohort C at all three treatments. All buttock CCH injections will follow the on-label injection protocol.

Subjects will participate in the study for 65 days total, with an additional screening period of 14 days. There will be a total of 11 visits (Screening, Day 1, Day 4, Day 14, Day 22, Day 26, Day 36, Day 43, Day 47, Day 57, Day 65).


Eligibility Criteria:
Inclusion .

* Female \> 18 and \< 55 years of age.
* At the screening visit, have buttocks with moderate to severe cellulite based on the CR-PCSS.
* Be willing and able to comply with all protocol required visits and assessments.
* Be willing to apply sunscreen to the treatment areas before each exposure to the sun for the duration of the study.
* Is willing to refrain from exercise for 24 hours following each treatment.
* Be adequately informed and understand the nature and risks of the study.

Exclusion.

* Has a history of hypersensitivity or allergy to collagenase of any other excipient of CCH.
* At the screening visit, has none, almost none, or mild cellulite.
* At the screening visit, per the investigator, has cellulite that would require less than 6 injections per buttock, or more than 12 injections per buttock.
* Is pregnant and/or is breast-feeding or plans to become pregnant and/or to breast-feed during the course of the study, or 28 days after the last treatment.
* Is currently undergoing hormone replacement therapy or has undergone hormone replacement therapy in the past 6 months.
* Has a coagulation disorder which requires anticoagulant or antiplatelet medication during the study, or has taken anticoagulant or antiplatelet medication within 14 days before injections.
* Is currently taking oral contraceptive pills.
* Is currently a smoker, or has smoked within the last year prior to screening.
* Has a history of scarring due to keloids or abnormal wound healing.
* Has received previous treatment with CCH for cellulite, or any other cellulite treatment.
* Subject has any history of anemia or taking iron pills.
Assessments of Thrombus Formation in TAVI

Transcatheter aortic valve implantation (TAVI) is well established, and can improve clinical outcomes of patients with severe aortic valve stenosis (AS) who are inoperable or have high surgical risk. Although the rates of periprocedural bleeding events are lower in TAVI compared to those in surgical aortic valve replacement, those in TAVI still remains high. In addition, current guideline recommended the dual antiplatelet (DAPT), clopidogrel plus aspirin, for a 3- to 6-month period after TAVI, however no evidences supports this approach. The antithrombotic regimen in patients undergoing TAVI is needed to be established.

To establish the antithrombotic regimen in patients undergoing TAVI,

1. the investigators assess the changes in platelet thrombus formation and white thrombus formation in patients undergoing TAVI measured by Total Thrombus Formation Analysis System (T-TAS).
2. the investigators analyze plasma microRNAs, and shear stress by using computational fluid dynamics (CFD) to clarify the mechanistic factors regarding those changes.


Eligibility Criteria:
Inclusion Criteria:

* twenty years and older
* with the informed consent of the patient or support person in case of disability at baseline (patient intubated and ventilated)

Exclusion Criteria:

* withdrawn the informed consent
* patients with trans-apical approach
* critical illness condition (severe infectious disease, cancer, severe bleeding disorder)
* transition to the surgical AVR