cyrilzakka/clinical-trials huggingface dataset:
Pilot Study Evaluating the Safety and Efficacy of a New Hard-on-Hard Total Hip Replacement System

The purpose of this study is to assess the early and long term safety and efficacy of the hard-on-hard total hip replacement system (R3 ODH-ODH utilization) in patients with non-inflammatory arthritis.


Eligibility Criteria:
Inclusion Criteria:

* At least 21 years old
* Skeletally mature
* Requires primary, unilateral total hip arthroplasty due to degenerative join disease
* Preoperative Harris Hip Score of less than or equal to 70
* Meets an acceptable preoperative medical clearance and is free or treated for conditions that would pose excessive operative risk
* Given consent to participate in the study
* Able to understand the purpose of the study, his/her role, and is available for follow-up

  10 year extension:
  * Subject has completed the 2 year primary study
  * Subject has signed an Independent Ethics Committee (IEC) approved Informed Consent Form agreeing to participate in the extension study after the nature, scope and possible consequences of the study have been explained in an understandable form
  * Subject is able to fully understand the purpose of the study, his/her role as a participant in the study, and plans to be available through ten years post-operative follow-up

Exclusion Criteria:

* Diagnosis with high risk of Total Hip Arthroplasty (THA) failure
* Requires bilateral THA
* Requires revision of a prior hip replacement
* Active infection or sepsis
* History of local hip infection
* Known metastatic or neoplastic disease
* Conditions that may interfere with THA survival or outcomes
* Need for structural bone grafts to support the implant
* Contralateral lower extremity condition
* Has other joint replacements or plans for other joint replacements within 2 years
* Systemic steroid therapy within 3 months prior to surgery
* Life expectancy less than 2 years
* Intra-articular therapy within 6 months of enrollment
* Female of child-bearing age not using contraception
* Inadequate bone stock to support the device
* Moderate to severe renal insufficiency
* Emotional or neurological condition that would pre-empt ability or willingness to participate in the study
* BMI \>40
* Above the knee amputation of the contralateral or ipsilateral leg
* Known allergies to the components of the devices
* Entered into another investigational study
* Is a prisoner

  10 year extension:

  • In the opinion of the surgeon, the subject's health, safety or well-being may be compromised or harmed by continuation in the extension phase or participation may not be in the subject's best interests.
Endometrial Nerve Fibers Detection in Patients With Different Gynecological Pathologies

The aim of this study is to investigate the prevelence of endometrial nerve fibers in different gynecological pathologies

The aim of this study is to investigate the prevelence of endometrial nerve fibers in different gynecological pathologies in addition to its relation to chronic pelvic pain

Eligibility Criteria:
Inclusion Criteria:

1. Age: 20-60 years of age.
2. Written and signed informed consent by the patient to participate in the study.
3. Women candidate for surgical intervention either via laparoscopy or laparotomy for different gynecological pathologies

Exclusion Criteria:

1. Suspected endometriosis.
2. Patient unwillingness to participate in the study.
3. No hormonal treatment for the last 6 months.
4. Suspected pregnancy.
Ticagrelor in Clopidogrel Resistant Patients Undergoing Chronic Hemodialysis

Clopidogrel administration is commonly prescribed in patients undergoing percutaneous coronary intervention, in patients with previous stroke and in patients under chronic hemodialysis via fistulae. Patients with chronic renal failure present lower clopidogrel response compared to those with normal renal function. Ticagrelor is a new oral direct-acting antagonist, which provides greater platelet inhibition in both clopidogrel responders and non-responders. It has also been shown that in patients with chronic kidney disease (creatinine clearance \<60 mL/min)ticagrelor achieved an absolute risk reduction of cardiovascular death, myocardial infarction, and stroke greater than that of patients with normal renal function. Clopidogrel resistant patients as assessed by VerifyNow P2Y12(Accumetrics)will be administered after informed consent ticagrelor 90 mg twice daily for 15 days. Platelet reactivity will be determined at the end of the treatment period. Bleeding events, major adverse cardiac events and any side effects until Day 15 will be reported in a descriptive manner.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years
* Chronic renal failure under haemodialysis
* Platelet reactivity under clopidogrel 75mgx1 ≥235 PRU
* Informed written consent

Exclusion Criteria:

* Recent (within 1 month) PCI or ACS
* Requirement for oral anticoagulant prior to the Day 14 visit
* PLTs\<100.000 / μL), Hct \<28%, Hct \> 52% at randomization
* Increased risk of bradycardiac events.
* Severe uncontrolled chronic obstructive pulmonary disease
* Known severe hepatic impairment
* History of gastrointestinal bleeding, genitourinary bleeding or other site abnormal bleeding within the previous 6 months.
* Other bleeding diathesis, or considered by investigator to be at high risk for bleeding
* Concomitant therapy with a strong cytochrome P-450 3A inhibitor or inducer
* Recent (\<6weeks)major surgery including CABG
* Recent (\<6weeks)stroke or any prior intracranial bleeding
Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis

The treatment of patients with intra-stent restenosis (ISR) of Bioresorbable Vascular Scaffolds (Abbott Vascular) remains a challenge. This study will assess the incidence, predisposing factors, pathophysiology and prognosis of the patient in this setting.

Treatment of patients with ISR remains a challenge. Currently both drug-eluting stents (DES) and drug-coated balloons (DCB) are considered as the strategies of choice in this setting. However, existing data about ISR of BVS are scarce (isolated cases and retrospective series with very few patients) on the incidence, predisposing factors, pathophysiology, treatment, and long-term prognosis of these patients. In this sense, a prospective Spanish registry of patients with ISR of DVB can obtain a very relevant clinical information that allows us to advance in our knowledge about this phenomenon that helps to prevent it and to treat it in the safest and most effective way possible.

Clinical events will be adjudicated by an independent Clinical Event Committee.

Eligibility Criteria:
In-stent restenosis of BVS with ischemia. Signed Informed Consent IRB approval.

INCLUSION CRITERIA:

PATIENT

* Age \> 20 and \< 85 years of age
* Angina or objective evidence of ischemia LESION
* ISR (\>50% diameter stenosis on visual assessment)
* Previous stent location known

EXCLUSION CRITERIA:

PATIENT

* Inclusion in other clinical research protocol
* Refuse to sign Informed Consent
Recombinant Human Interleukin-11 Combination Low-dose Rituximab in Immune Thrombocytopenia

The purpose of this study is to determine whether Recombinant Human Interleukin-11 (rhIL-11) Combination Low-dose Rituximab prednisone are effective and safe in the management of Steroid-Resistant/Relapsed Immune Thrombocytopenia (ITP).


Eligibility Criteria:
Inclusion Criteria:

1. Patients may be male or female, between the ages of 16 \~ 75 years old.
2. Isolated thrombocytopenia with an otherwise normal peripheral blood smear and no other causes of thrombocytopenia, morphologically normal bone marrow aspirate with normal to increased number of megakaryocytes, and absence of splenomegaly.
3. To show a platelet count ≤ 30 × 109/L, or platelet count ≥ 30 × 109/L with bleeding manifestations at the moment of the first infusion with the study product.
4. ＥＣＯＧ performance status ≤ 2.
5. Patients failed to respond to acceptable dose of steroids for 4 weeks, or relapsed. Some patients were also refractory to splenectomy.
6. Patients must be willing and able to give written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
3. Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.
4. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
5. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).
6. Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.
7. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
8. Patients who are deemed unsuitable for the study by the investigator (or coinvestigator).
Bleomycin Electrosclerotherapy Treatment of Vascular Malformations: A Feasibility Study

The aim of the BEST study is to examine the feasibility of assessing patient and clinician reported outcome of a single electrosclerotherapy treatment of vascular malformations.

* Sclerotherapy = injection of Bleomycin into vascular birthmarks to seal off abnormal vascular channels
* Electroporation = application of an electric field to vessels treated with a handheld needle electrode
* Electrosclerotherapy = a combination of Bleomycin sclerotherapy and electroporation


Eligibility Criteria:
Inclusion Criteria:

* New patients presenting with a vascular malformation suitable for Bleomycin sclerotherapy treatment
* Existing patients presenting with a poor response to treatment, performed more than 6 months ago
* Placement of a needle electrode into the vascular malformation is technically possible
* Evaluation of response to treatment is possible on photo documentation
* Patients agreeing to participate in the study
* The ability to understand written and spoken English

Exclusion Criteria:

* Patients not agreeing to participate in the study
* Pregnancy
* Breastfeeding
* Previous high systemic Bleomycin exposure (more than 3000 IU)
* Patients unable to provide written, informed consent
* Patients in which needle electrode placement is not possible
* Response to treatment not evaluable by photo documentation
* Patients unable to speak English
Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.


Eligibility Criteria:
Inclusion Criteria:

- Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment.

Exclusion Criteria:

* Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study.
* Previous administration with Bimatoprost SR in the study eye.
A Prospective Cohort Study of Metabolic Associated Fatty Liver Disease in China

Metabolic dysfunction-associated fatty liver disease (MAFLD) is a new concept proposed in 2020. Unlike non-alcoholic fatter liver disease (NAFLD), the diagnosis of MAFLD requires the presence any of the following 3 metabolic risks, including overweight/obesity, presence of diabetes mellitus, and evidence of metabolic dysregulation. However, there are patients that have hepatic steatosis but no metabolic risk, who thus do not meet the diagnostic criteria of MAFLD. Besides, there are patients with both MAFLD and other liver diseases. The clinical features and the management of these patients remain unclear. Thus, further histopathological and clinical study is required to elucidate and compare the characteristics of MAFLD and NAFLD.

Here, in this single-center, prospective clinical study, investigators are planning to establish a long-term follow-up cohort of patients with either MAFLD or NAFLD. In order to understand the risk of developing liver-related complications and important extra-hepatic outcomes (e.g. cardiovascular disease), and also to better elucidate the risk of disease progression in "lean" NAFLD individuals without any metabolic dysregulation and MAFLD individuals with dual or multiple causes.

Ultimately, investigators aim to improve the diagnosis of MAFLD and improve patients' outcomes.

The study is divided into 2 parts:

Firstly, it contains a cross-sectional study to collect the clinical data of the patients with fatty liver. The clinical features of this population will be analysed.

Secondly, the study will collect the plasma, urine and stool samples of the patients in this cohort. And then a long-term follow-up of these patients will be carried out. Investigators wish to find out biomarkers that can detail patient stratification and predict the prognosis of the disease.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as hepatic steatosis in adults (fulfill at least one of the followings):

  1. Liver ultrasound shows liver parenchymal hyperechoic or "bright liver"
  2. Controlled attenuation-parameter (CAP) ≥248dB/m
  3. Hepatic steatosis diagnosed by CT/MRI/MRS
  4. MRI-based proton-density fat fraction (MRI-PDFF) shows liver fat content\>8%
  5. Fatty liver confirmed by liver histology.

Exclusion Criteria:

1. Diagnosed with hepatocellular carcinoma or other malignancy (in accordance with the appropriate diagnostic criteria);
2. During pregnancy;
3. Patients with history of liver transplantation;
4. Patients with serious cardiovascular and cerebrovascular events (such as acute myocardial infarction, cerebral infarction, cerebral hemorrhage, etc.).
Edoxaban Treatment in Routine Clinical Practice for Patients With Non Valvular Atrial Fibrillation

In order to understand the risks and benefits of edoxaban use in a real-world clinical setting in the Non-valvular Atrial Fibrillation (NVAF) indication, Daiichi-Sankyo proposed this post-authorization safety study (PASS) to gain insight into the safety (bleeding, liver adverse events, all-cause mortality and other drug related adverse events) of edoxaban use in patients with NVAF who were not preselected.

Patients will be from 10 different European countries and care settings (primary and secondary care and different specialties). A one-year patient recruitment period per country is planned, but it could be longer if patient recruitment numbers are not reached. Patient data will be documented at baseline (BL), one annual data documentation point during the four-year follow up (FU), and at final assessment. Patients who permanently discontinue edoxaban during the observation period will continue to be followed annually for a further two years, or until the end of the observational period (whichever comes first).

Eligibility Criteria:
Inclusion Criteria:

* NVAF-patients treated with edoxaban according to Summary of Product Characteristics (SmPC).
* Written informed consent for participation in the study (ICF).
* Not simultaneously participating in any interventional study.

Exclusion Criteria:

* None
Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test

The objective of this study is to evaluate the agreement of the test device (Preview® hCG Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult women of childbearing age.
* Who either request a pregnancy test, or require a pregnancy test for diagnostic studies or treatment.
* Signed and dated informed consent.

Exclusion Criteria:

* Minors.
* Adults who are unable to independently give consent for study.
* Known pregnancy (i.e. - patient appears obviously pregnant).
* Recent miscarriage or abortion and yet to have 2 complete menstrual cycles before study start.
* History of ectopic pregnancy, fibroids, congenital uterine anomaly that causes an irregular-shaped uterus.
* Taken any of the medications of contraceptives containing estrogen in last two weeks.
* Hemodynamically unstable.
* Moderately to severely ill-appearing or in moderate to severe pain.
* Technically not possible to obtain blood or urine from the study subject.
The Effect of OSA on Severity and Prognosis of Patients With IgAN

This study aims to investigate the influence of obstructive sleep apnea hypopnea syndrome (OSA) on the severity and prognosis of patients with IgA nephropathy (IgAN), and to evaluate the therapeutic effect of continuous positive airway pressure (CPAP) intervention in such patients. Although the study is designed as an observational cohort study, where patients self-selected whether to receive treatment rather than being assigned, there is still an intervention project, CPAP, present in the observational cohort. Through a cohort study design, scientific evidences are expected for clinical decision-making and optimize treatment strategies for patients with OSA and IgAN.


Eligibility Criteria:
Inclusion Criteria:

* Diagnostic criteria: IgA nephropathy is diagnosed based on the pathological results of renal biopsy and/or clinical manifestations (such as hematuria, proteinuria, abnormal renal function, etc.), in accordance with the internationally recognized diagnostic criteria for IgA nephropathy. Obstructive sleep apnea-hypopnea syndrome (OSAHS) is confirmed through overnight polysomnography (PSG) with an apnea-hypopnea index (AHI) of ≥5 events per hour, primarily consisting of obstructive events.
* Age and gender: Participants must be ≥18 years old, with no gender restrictions (as both OSAHS and IgA nephropathy do not show significant gender predisposition).
* Informed consent: Participants are required to voluntarily sign a written informed consent form, acknowledging and agreeing to participate in the study, including all its contents and potential risks.

Exclusion Criteria:

* Other sleep-related breathing disorders: Participants with mixed sleep apnea, central sleep apnea, or severe snoring with an AHI index of \<5 events per hour will be excluded to ensure that the study population is limited to patients with OSAHS.
* Severe internal medical conditions: Patients with severe cardiopulmonary dysfunction, malignancy, severe liver disease, mental disorders, or other severe internal medical conditions that may significantly affect sleep or the progression of kidney disease will be excluded.
* Recent surgery or medication: Individuals who have undergone surgery within the past 3 months that may affect sleep or kidney function, or who are currently using medications that may significantly interfere with sleep or the assessment of kidney disease (such as corticosteroids, immunosuppressants, novel antipsychotics, etc.) will be excluded.
* Pregnant women.
* Inability to cooperate with the study: Patients who are unable to complete the study procedures (including polysomnography, follow-up, etc.) due to cognitive impairment, language communication difficulties, remote residence, or other reasons will be excluded.
Efficacy and Mechanisms of Psychosocial Treatments for Panic Disorder

The aim of the present study is to a) determine the comparative efficacy of the brief capnometry-assisted respiratory therapy (CART) and standard cognitive behavioural therapy (CBT), and b) to determine moderators and mediators.

With the data collected from the study, the investigators will test the following hypotheses: (a) CART will be as effective in treating PD/A as CBT, albeit in shorter time, b) patients with greater respiratory dysregulations, especially hyperventilation, at pretreatment will benefit more from CART, whereas patients with greater cognitive dysregulation will benefit more from CBT. CART, but not CBT, will result in reversal of hyperventilation.


Eligibility Criteria:
Inclusion Criteria:

1. A current DSM-IV (Diagnostic and Statistical Manual IV) diagnosis of panic disorder with or without agoraphobia that is designated by the patient as the most important source of current distress
2. Patients must be willing to engage in exposure to fearful situations and sensations.

Exclusion Criteria:

Diagnostic Exclusion Criteria:

1) A history of bipolar disorder, psychosis or delusional disorders (as evaluated by the SCID-IV-L (Structured Clinical Interview for the DSM IV) screening questions), substance abuse or dependence or alcohol abuse or dependence (other than nicotine in the last 3 months)

Medical exclusion factors:

1. Patients with severe unstable medical illness, clinically significant laboratory findings, or serious medical illness for which hospitalization may be likely within the next three months
2. Patients with a history of seizures, angina, myocardial infarction, congestive heart failure, clinically significant arrhythmias, transient ischemic attacks, cerebrovascular accidents, diabetes mellitus, significant asthma, emphysema, or chronic obstructive pulmonary disease