cyrilzakka/clinical-trials huggingface dataset:
Scorpio® Cruciate Retaining (CR) Outcomes Study

The purpose of this study is to evaluate the design and functional performance of the Scorpio® Cruciate Retaining (CR) Total Knee System.

The study design is a prospective, multi-center clinical trial. The Scorpio® Cruciate Retaining (CR) Total Knee System is to be implanted for evaluation in this study. This device system is commercially available and is intended for cemented use.

The study group will consist of a maximum of 265 cases, requiring primary total knee replacement, and diagnosed with non-inflammatory arthritis. All subjects will be implanted with a femoral component, a tibial insert, a tibial tray and a resurfaced patella. Subjects receiving bilateral total knee replacements will represent two cases. Study participants will be recruited from 5 institutions.

Subjects will be evaluated preoperatively and at follow-up intervals of 7 wks (± 2 wks), 3 months (± 3 weeks), 6 months (optional visit), 12 months (± 2 months) and annually thereafter (± 2 months). Each subject will be followed for 15 years post-implantation.

The objectives of this study are to:

1. Evaluate the effect of system component design on functional performance.
2. Evaluate the effect of system component design by comparing postoperative functional and radiographic findings with preoperative.
3. Evaluate complications and the rates in which they occur.

Eligibility Criteria:
Inclusion Criteria:

1. The subject is a male or non-pregnant female between the ages of 21-80.
2. The subject requires a primary cemented total knee replacement.
3. The subject has a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
4. The subject has intact collateral ligaments.
5. The subject has signed the IRB approved, study specific Informed Patient Consent Form.
6. The subject is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.

Exclusion Criteria:

1. Patient has inflammatory arthritis.
2. The subject is morbidly obese, \>60% over ideal body weight for frame and height.
3. The subject has a history of total or unicompartmental reconstruction of the affected joint.
4. Patient has had a high tibial osteotomy or femoral osteotomy.
5. The subject has a neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
6. The subject has a systemic or metabolic disorder leading to progressive bone deterioration.
7. The subject is immunologically suppressed, or receiving steroids in excess of normal physiological requirements.
8. The subject's bone stock is compromised by disease or infection which cannot provide adequate support and/or fixation to the prosthesis.
9. The subject has had a knee fusion to the affected joint.
10. The subject has an active or suspected latent infection in or about the knee joint.
11. The subject is a prisoner.
12. The subject is pregnant.
Genetic Factors of Idiopathic Polypoidal Vasculopathies in the ATM Gene (Ataxia Telangiectasia Mutated)

Polypoidal choriodal vasculopathy (PCV) is an ophthalmologic disease, characterized by vascular abnormalities of the walls of small choroidal vessels, reproducing the specific aspect of polyps (cluster aspect). PCV is one of the "boundary-forms" of age related macular degeneration.

These vasculopathies can be idiopathic. Following the radiotherapy treatments of active and occult-typed neovessels in Age-Related Macular Degeneration (ARMD), 10% of the patients would present typical polypoidal vasculopathic lesions. These polypoidal secondary lesions have been induced by radiotherapy treatment and may show an increased sensibility to radiation in these patients.

Such an increase of radiosensibility is noticed in ataxia telangiectasia syndrome, in relation to the ATM gene mutations. The secondary or idiopathic polypoidal vasculopathic lesions are to be brought closer to telangiectasias in Ataxia Telangiectasia. Considering the iatrogenic component of radiotherapy in the secondary forms of ataxia telangiectasia, it seems legitimate to search for predisposing variants to polypoidal vasculopathies in the ATM gene.

Considering the frequency of PCV worldwide, it seems important to identify the predisposing genetic factors of the ATM gene. These biomarkers to the pathology might enable us to offer prevention (reinforced protection against radiations, including light) and to develop therapeutics (recruitment of other kinases, ATM's partners, in the stability and cellular control of DNA).


Eligibility Criteria:
Inclusion Criteria:

* Adult caucasian patient
* Polypoidal choriodal vasculopathy
* Informed written consent

Exclusion Criteria:

* History of cephalic radiotherapy
* Absence of affiliation to social security or universal health coverage (CMU)
A One Year Trial Evaluating the Safety and Efficacy of the ALK House Dust Mite Allergy Tablet

The primary aim of this trial is to evaluate the efficacy of the ALK house dust mite tablet given once daily compared to a placebo tablet in the treatment of house dut mite allergic rhinits.

Additionally the secondary objective of the trial is to evaluate the safety and tolarability of the ALK house dust mite tablet.

Immunotherapy has been shown to provide therapeutic benefits to subjects with house dust mite induced allergy. This trial is planned to investigate if clinically relevant improvements in rhinitis symptoms and with less use of symptomatic medication can be obtained in subjects with a history of poor didease control despite of use of symptomatic medications.


Eligibility Criteria:
Inclusion Criteria:

* A history of house dust mite allergy
* Use of symptomatice medication for treatment of house dust mite allergy
* Positive skin prick test to mites
* Positive specific IgE

Exclusion Criteria:

* History of uncontrolled asthma
* Overlapping symptomatice allergies
* Previous treatment with immunotherapy
PIERS and BIS, sFIT:PIGF, Adrenomedullin

Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity and mortality worldwide.1 Standardization of antenatal and postnatal assessment and surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model of preeclampsia have been associated with reduced maternal morbidity.

Background: Pre-eclampsia, more than being proteinuric gestational hypertension alone, is a state of exaggerated systemic inflammation and remains a leading direct cause of maternal morbidity and mortality worldwide.1 Standardization of antenatal and postnatal assessment and surveillance of pre-eclampsia with protocols that recognize the systemic inflammatory model of preeclampsia have been associated with reduced maternal morbidity.2 To quantitatively asses electroencephalography (EEG) mental involvement in Pre-eclampsia is still time consuming and not always readily available. PIERS was developed and internally validate as a pre-eclampsia outcome prediction model- (Preeclampsia Integrated Estimate of RiSk) model.3 The purpose of our study was to evaluate the discriminative power of the Bispectral Index (BIS), biomarkers sFIT (soluble FMS-like Tyrosine Kinase): PIGF (Placental Growth Factor) ratio,4 and adrenomedullin mortality risk stratifier,5 to classify the degree and progression of pre-eclampsia.

Methods: In 24 patients with Eclampsia or pre-eclampsia investigators will use an artefact-free 20-min mean BIS value, as well as biomarkers sFIT (soluble FMS-like Tyrosine Kinase): PIGF (Placental Growth Factor) ratio and adrenomedullin mortality risk stratifier to classify the degree of pre-eclampsia correlated the PIERS Pre-eclampsia risk assessment PIERS percentage (http://piers.cfri.ca/PIERSCalculatorH.aspx) will be calculated from patients' clinical and laboratory findings documented in their charts, compared with 24 pregnant patients without Eclampsia or pre-eclampsia.

Eligibility Criteria:
Inclusion Criteria

1. Pregnancy at any stage (3 trimesters)
2. Eclampsia (Frank eclampsia) will be the crux of the study
3. Pre-eclampsia that is suspected will end up with Frank Eclampsia

Exclusion criteria:

1. Any neurological conditions that can alter the electroencephalography like epilepsy
2. Any medical conditions that can alter the electroencephalography like hypoglycemia
Perioperative Modification of Hemostasis During Ventricular Assist Device Implantation

Implanting a ventricular assist device (VAD) is a promising therapy for end-stage cardiac failure. However, the implantation of these devices is associated with a high risk of severe hemorrhages and massive blood product transfusion in the first 48 hours following the implantation. The primary purpose of this study is to assess the functionality of the von Willebrand Factor (vWF) which is essential for hemostasis. The hypothesis is that the high shear stress generated by these VAD expose ADAMTS13 cleaving site on the vWF. This result in a loss of high molecular weight vWF and an acquired von Willebrand syndrome.

The secondary purpose of the protocol is to assess platelet function after the implantation of VAD. Indeed, platelet function might be affected shortly after the implantation of the device.


Eligibility Criteria:
Inclusion Criteria:

* Age over 18 years old
* Who gave his consent to the study
* With an end-stage heart-failure
* Under surgery for a ventricular assist device implantation
* Scheduled or in emergency

Exclusion Criteria:

* Preoperative anemia less than 7 g/dL
* Subject under the protection of justice
* Subject under guardianship or curatorship
* Pregnancy
* Breastfeeding
Remote Ischemic Preconditioning in Head and Neck Cancer Reconstruction - A Randomized Controlled Trial

The purpose of the trial is to investigate, if remote ischemic preconditioning reduces the risk of complications in patients undergoing resection of head and neck cancer and immediate reconstruction with autologous free tissue transfer.

Remote ischemic preconditioning is a treatment, which is carried out by inducing brief episodes of upper arm occlusion using an inflatable tourniquet.

Blood samples will be taken during the operation and postoperatively to evaluate the effects of remote ischemic preconditioning. These blood samples will be analyzed for clotting properties and markers of inflammation.

Furthermore, effects on the blood supply of the transferred tissue flap will be measured by infrared thermography.

Effects on surgical complication rates will be obtained by clinical follow-up and patient chart review.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified or clinically suspected malignant tumor in the oral cavity, maxillae, mandible, pharynx, larynx, and/or esophagus.
* Will undergo tumor resection and immediate free flap reconstruction at Aarhus University Hospital, Denmark.
* The reconstruction is planned with a single free flap.

Exclusion Criteria:

* Arterial and/or venous thromboembolism within the last three months.
* The reconstruction is planned with more than one free flap.
Meperidine for Patients Expected to Have Poor Tolerance During Diagnostic Esophagogastroduodenoscopy.

Our pilot results showed that meperidine reduce patient discomfort during EGD (esophagogastroduodenoscopy). But many patients can tolerate EGD well without any sedative agents. So the investigators target the use of meperidine on patients expected to have poor tolerance in this study, which includ young females with high anxiety level and patients with prior poor tolerance. The investigators test the hypothesis that meperidine improves tolerance and alleviates discomfort for patients expected to have poor tolerance during diagnostic EGD.


Eligibility Criteria:
Inclusion Criteria:

* female youger than 65 years with high anxiety level
* patients with previous poor tolerance of EGD

Exclusion Criteria:

* a therapeutic EGD
* sedation with other agents
* contraindication to Buscopan (hyoscine N-butylbromide) or meperidine
* American Society of Anesthesiology (ASA) risk Class 3 or higher, renal failure
* age less than 20 years or more than 80 years
* pregnancy
* refusal to provide written informed consent. All participants signed written informed consents
Comparison of TACE Versus TACE/TACI Combination in Advanced Hepatocellular Carcinoma With Portal Vein Invasion

The aim of this study is to compare the efficacy of transarterial chemoembolization with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

Potentially curative treatments for hepatocellular carcinoma (HCC) include surgical resection, liver transplantation, and local ablative therapy.

However, HCC patients are diagnosed at advanced stages in Korea. Especially, HCCs with portal vein invasion are unresectable and they are not suitable for other curative therapies. For these patients, the optimal treatment remains largely controversial. As a palliative treatment, the benefit of transarterial chemoembolization (TACE) had been shown in patients with unresectable HCC and without portal vein invasion by several trials. In patients with main portal vein invasion, TACE is theoretically contraindicated because of the potential risk of hepatic failure resulting from ischemia after TACE. However, recent studies have revealed that TACE could safely be performed in these patients.

The aim of this study is to compare the efficacy of transarterial chemoembolization (TACE) with adriamycin to transarterial chemoembolization with adriamycin/transarterial chemoinfusion (TACI) with cisplatin combination in advanced hepatocellular carcinoma with portal vein invasion.

Eligibility Criteria:
Inclusion Criteria:

* Patients with clinical or histological diagnosis of HCC based on the guidelines of the AJCC
* Patients with advanced HCC with invasion of major branch(es) of portal vein in the arterial phase of dynamic CT or MRI
* Patients who have received previous local therapy treatments (RFA, PEI, cryoablation, surgery, resection) are eligible
* Age : 18 years to 80 years
* ECOG Performance Status of 0 to 2
* Child-Pugh class A (Child-Pugh score 5-6)
* Adequate bone marrow, liver function as assessed by the following laboratory requirements to be conducted within 7 days prior to screening:

  * WBC count \> 2,000/mm3
  * Absolute neutrophil count \> 1,000/mm3
  * Hb ≧ 8.0 g/dL
  * Platelet count ≧ 50,000 /mm3
  * Bilirubin ≦ 3 mg/dL
  * Adequate clotting function: INR \< 2.3 or \< 6sec

Exclusion Criteria:

* Child-Pugh score ≧ 7
* ECOG Performance Status ≧ 3
* Patients with chronic kidney disease or serum creatinine ≥ 1.2 mg/dL
* History of organ allograft
* Patients with uncontrolled co-morbidity which needs treatment
* Patients who have received prior systemic chemotherapy
* Patients with extrahepatic metastasis
Non-Incised Papilla Flap in Deep Supraossous Defects

The objective of this study was to assess the effectiveness of NIPSA in periodontal lesions with deep supra-alveolar defects, measuring the clinical efficacy of this flap. The non-incised papilla surgical approach (NIPSA) is a novel technique that accesses the periodontal defect from apical direction and was established with the aim of creating clinical advances compared with marginal access techniques.

The defects with a supra-alveolar components are more frequent than intrabony defects, there is very little evidence about their treatment .


Eligibility Criteria:
Inclusion Criteria:

* diagnosis of periodontal disease (periodontitis stage III and IV, grade A \[12\];
* non-smokers and former smokers who quit smoking at least 1 year previously
* previous treatment for periodontal disease using non-surgical periodontal treatment completion of step I and II of periodontal therapy
* compliance with periodontal maintenance and oral hygiene (FMPS at baseline ≤ 30%)
* active residual pockets (positive bleeding on probing; BoP) associated with intrabony defects that were not resolved with non-surgical treatment after 4-6 months of maintenance.
* periodontal lesions with probing depth (PD) \> 6 mm and supraalveolar defect (pre-diagnosis clinically (periodontal probe)

Exclusion Criteria:

* systemic disease contraindicating periodontal surgery,
* smokers, and
* third molars or teeth with incorrect
* endodontic or restorative treatment.
A Study to Learn How Different Amounts of the Study Medicine Danuglipron Are Taken up Into the Blood in Otherwise Healthy Adults With Overweight or Obesity

The purpose of this study is to learn the following about the study medicine, danuglipron, after multiple days of dosing in healthy adults who are overweight or obese:

* how the study medicine, danuglipron, is taken up into the blood
* about the safety and tolerability of danuglipron

The total number of weeks of the study is about 15 (about 4 months).


Eligibility Criteria:
Key Inclusion Criteria:

* 18 years of age or older
* Body mass index (BMI) of ≥25.0-45.4 kg/m2; and a total body weight \>50 kg (110 lb)

Key Exclusion Criteria:

* Evidence or history of any clinically significant medical conditions or laboratory abnormality
* Any condition possibly affecting drug absorption
* Known intolerance/hypersensitivity to a GLP-1R agonist
Effects of Music Intervention Combined With Progressive Muscle Relaxation in Cancer Patients

Study design A 2-arm, assessor-blinded randomised controlled trial will be conducted. The design will follow the Standard Protocol Items Recommendations for Interventional Trials (SPIRIT)

Aim: To assess the effect of MCP on anxiety, depression and QoL of BGC patients receiving chemotherapy.

Objectives

* To assess the effect of MCP on the anxiety of BGC patients receiving chemotherapy.
* To assess the effect of MCP on depression of BGC patients receiving chemotherapy.
* To assess the effect of MCP on QoL and patients' satisfaction of BGC patients receiving chemotherapy.
* To determine whether stress level, coping and coping styles mediate the intervention effect on anxiety, depression and QoL.

Hypothesis

* The participants receiving MCP will have a significantly lower level of anxiety compared to the control group.
* The participants receiving MCP will have a significantly lower level of depression compared to the control group.
* The participants receiving MCP will have significantly higher QoL scores and levels of satisfaction with care service compared to the control group.
* Stress level, coping will mediate the intervention on target outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Women with breast or gynaecological cancer are 18 years of age or older, and are independent legally to sign the consent form.
* Living with family and having an adult family member agree to participate in the meeting part of the program.
* Had been informed the cancer diagnosis
* Have Karnofsky score (Mor et al., 1984) ≥ 80 ( to be able to self-practice MCP)
* Can communicate, read and write in Vietnamese
* Have a device such as a smartphone, MP3 to keep the audio file (to self-practice MCP at home)
* Consent to join the study

Exclusion Criteria:

* The patients cannot understand the study procedures
* Have mental health illness, deafness, blindness
* Have not been aware of their cancer or the purpose of chemotherapy
* Be participating in other studies related to psychological issues
* Be receiving anxiety or depression treatment.
* Be participating in relaxation therapy such as yoga, meditation, mindfulness, PMR...
* Have a potential treatment (eg. surgery) or personal plans that will prevent them from practising daily during the 6 weeks of the intervention.
Mandibular Stability and Dentofacial Deformity

The present study intends to clarify whether there is positional mandibular stability in patients to be submitted to orthognathic surgery. In case of any instability exists, it is needed to understand if this could be related to a particular type of dentofacial deformity or could have any short-term or long-term influence on outcomes of the orthognathic surgery.

Treatment of skeletal discrepancy nowadays is mainly performed by combination of clinical and surgical procedures in which orthodontics intends to align the teeth according to their respective alveolar bone and the surgical procedure - orthognathic surgery - realign the jaws in an adequate position among themselves and related to the rest of the craniofacial skeleton. Orthognathic surgery has developed throughout the years technically as well as regarding fixation devices for the operated segments, providing prediction of results with a low complication incidence. A debate point is related to the possible instability of the mandibular position as a reference for surgical planning due to its articulation with the temporal fossa, the temporomandibular joint. However, studies have shown that not always the mandible position obtained for the articulator reflects the position observed in subjects after induction of general anesthesia. Since there is no evidence that indicates that any alteration of the position of the mandible could influence the outcomes of a orthognathic surgery nor any relationship of a certain type of dentofacial deformity that would be beneficiated by an specific order of surgery or skeletal reference (maxilla or mandible), the present study intends to clarify some of these questions.

Eligibility Criteria:
Inclusion Criteria:

* Dentofacial Deformity candidate to orthognathic surgery;
* Systemically capable to be submitted to the orthognathic surgery.

Exclusion Criteria:

* Patient's health condition is not stable enough to guarantee uneventful outcome;
* Required data unable to be achieved;
* Patient not agreeing to participate to the study.
Open Label Study of Ceftobiprole to Evaluate Pharmacokinetics in Adults Hospitalized in the ICU

The purpose of this research study is to measure the levels of ceftobiprole in the blood and urine during and after administration of four doses of ceftobiprole. Safety of the drug will also be evaluated.

Patients will receive an intravenous dose of ceftobiprole infused over 4 hours. Multiple blood samples will be obtained to determine the concentration of ceftobiprole in the plasma. Pharmacokinetic parameters such as clearance and volume of distribution will be calculated. 1000mg every 8hours or every 12 hours

Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Between 18 and 75 years of age inclusive
* BMI 18 - 35 inclusive
* Albumin \< 3.3 g/dL or clinical evidence of edema
* Negative Pregnancy test
* Expected survival of at least 7 days

Exclusion Criteria:

* Known drug allergy (including penicillin, cephalosporin, carbapenems, or other beta-lactams)
* Renal impairment (CrCl \< 50 mL/min) or dialysis
* History of seizures
* ALT or AST \> 5 times upper normal limit
* Sustained shock, unresponsive to sympathomimetics
* Conditions that may have jeopardized adherence to the protocol (NYHA Class 4 cardiac disease, \>15% total body burn or significant third degree burn)