cyrilzakka/clinical-trials huggingface dataset:
Comparison Between Subacromial Ultrasound Guided and Systemic Steroid Injection for Frozen Shoulder

This study aim to compare the efficacy of guteal muscle injection and subacromial ultrasound guided injection to treat frozen shoulder. Firstly, in order to calculate the sample size correctly, we start the preliminary study. Besides, in order to propose clinical new technology which combines the advantages of the two therapies, improve the efficacy ratio of frozen shoulder therapy, and provide a frozen shoulder treatment plan according to health economics.

In recent years, there have been studies suggesting that small doses of corticosteroid systemic medication and joint local injection to treat shoulder sleeve disease is equivalent, frozen shoulder is clinically in addition to shoulder sleeve disease another common cause of shoulder pain disease, local injection of small dose of corticosteroid is a clinically commonly used treatment of frozen shoulder mature therapy, however, because of the risk of joint infection and other serious complications, and it's personnel experience depended and high qualification requirements, resulting in higher treatment costs. However, it has not been widely used in clinical applications and is generally used as a second-line therapy for the treatment of frozen shoulders. There are studies suggesting that joint cavity hormone injection may be mainly effective through its systemic effect, however, there is currently no random blind control study comparing small doses of hormone systemic injection with local injection of shoulder joints to freeze shoulder, if the equivalence of the two can be confirmed through such studies will greatly change the clinical treatment of frozen shoulders, with hip injection and other systemic medication will provide great health economic advantages, and can avoid the inherent risk of joint cavity injection, reduce the social cost of frozen shoulder treatment.

Eligibility Criteria:
Inclusion Criteria:

* 1. Primary frozen shoulder
* 2. Older than 18 years of age and less than 75 years of age
* 3. The SHOULDER PAIN VAS SCORE IS GREATER THAN 3 POINTS AND LASTS AT LEAST 1 MONTH AND LESS THAN 9 MONTHS
* 4. The passive activity of the side shoulder joint in at least 2 directions in the three directions of front, internal and outer rotation decreased by more than 30 degrees compared to the side shoulder joint or the normal reference value
* 5. corticosteroid injections were not given within 3 months of visit

Exclusion Criteria:

* 1. A history of trauma, osteoarthritis, tumors, etc.
* 2. Combined shoulder sleeve injury with magnetic resonance or B-mode ultrasound confirmed
* 3. There is a history of corticosteroid injections within 3 months of visit
* 4. Suffer from a partial infection of the side shoulder or other cases where there is a contraindication of shoulder injection
* 5. Both side shoulder joints become ill at the same time
* 6. The patient has not signed an informed consent form
Study of Meniscal Allografts

Total or subtotal meniscectomies in young patients are currently responsible of pain and limitation of activities. There isn't any other treatment than meniscal replacement. But there is no randomized clinical trial on meniscal allograft to validate the efficiency of this treatment.

Meniscal allograft is done through United States and Europe since the last fifteen years. Operative technique has regularly improved, especially because of new arthroscopic devices. The meniscal allografts to be used are taken from dead donors and then frozen according to all the reglementary aspects of tissue bank.

The graft has to be ordered as soon as the patient is randomized ; the sizing of the graft ordered is important depending on the gender size and height of the patient and on the measures of the tibial plateau on X Rays.

The arthroscopic procedure is done under general or loco-regional anesthesia. The graft has to be prepared with bone blocks attached to the anterior and posterior horn of the meniscal graft. These bone blocks will be fixed through bone tunnels and the meniscus itself will be sutured on the peripheral meniscus synovial rim.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 on
* Previous total or subtotal meniscectomy
* Medical insurance
* Female patients have to be under contraceptive treatment
* Sign consent form

Exclusion Criteria:

* Age \< 18 years
* Pregnant or breast-feeding woman
* Need of a simultaneous frontal osteotomy
* Inflammatory disease
* Septic background
* Psychiatric background
* Understanding difficulties or problems for follow-up
* No consent
* No medical insurance
Long-term Safety and Tolerability of Subcutaneous Administration of TEV-48125 for the Preventive Treatment of Migraine

To evaluate the long-term safety and tolerability of subcutaneous (SC) administration of TEV-48125 (at 225 mg once monthly \[except for a loading dose of 675 mg for CM patients\] or at 675 mg every 3 months) for the preventive treatment of Chronic Migraine and Episodic Migraine patients


Eligibility Criteria:
Inclusion Criteria:

* Patient has a history of migraine (according to The International Classification of Headache Disorders, third edition \[beta version\] criteria) or clinical judgment suggests a migraine diagnosis
* Patient fulfills the criteria for Chronic migraine or Episodic migraine in baseline information collected during the 28 day screening period
* Not using preventive migraine medications for migraine or other medical conditions or using no more than 2 preventive migraine medication for migraine or other medical conditions if the dose and regimen have been stable for at least 2 months prior to giving informed consent.
* Patient demonstrates compliance with the electronic headache diary during the screening period by entry of headache data on a minimum of 24 of 28 days and the entered data is judged appropriate by the investigator.

Exclusion Criteria:

- Hematological, cardiac, renal, endocrine, pulmonary, gastrointestinal, genitourinary, neurologic, hepatic, or ocular disease considered clinically significant in the judgment of the investigator
Suction Drainage in the Management of Peri-operative Bleeding in Total and Unicomcompartmental Knee Arthroplasty

Although, suction drainage is routinely used in orthopedic clinical practice, there are still no precise guidelines on its use in total joint arthroplasty, particularly in total as well as unicompartmental knee arthroplasty. In fact, drain use is likely associated to an increased risk of blood transfusion due to the lack of tamponade effect, as well as a higher infection rate. Furthermore, the drain itself could interfere with knee mobilization, delaying its functional recovery. Thus, the aim of this study was to investigate the real usefulness of suction drainage in perioperative bleeding control in the management of total as well as unicompartmental knee arthroplasty.

Knee arthroplasty is currently a widespread treatment either for osteoarthritis (OA) as well as other joint disorders. Specifically, total knee arthroplasty (TKA) is commonly considered one of the most effective orthopedic procedure in the treatment of end-stage knee OA as well as various rheumatic diseases such as rheumatoid arthritis, leading to a substantial pain relief and functional improvement. Besides, unicompartmental knee arthroplasty (UKA) represents a viable alternative in the treatment of unicompartmental knee OA showing a lower morbidity. Nevertheless, since knee arthroplasty involves soft tissue dissections and numerous bone cuts, several perioperative complications can be observed. Particularly, the subsequent local hemorrhage can lead to anemia, functional limitation, nerve palsy as well as increase in wound tension resulting in healing impairment. Moreover, the local hematoma could represent a growth environment for bacteria. Although TKA usually shows a higher hemorrhage rate, some patients undergoing UKA still show the aforementioned complications. Accordingly, intraarticular suction drainage placement can likely ease the hematoma drain, leading to swelling decrease, surgical wound healing improvement as well as reduction of postoperative infections. However, despite suction drainage is routinely used in TKA as well as UKA, there are still no precise guidelines and its effectiveness remains controversial. Indeed, drain use is likely associated to an increased risk of blood transfusion due to the lack of tamponade effect, as well as a higher infection rate. Moreover, the drainage conduit could obstruct physiotherapy leading to a delayed recovery. Therefore, since fast-track program has been increasingly applied in the management of TKA and UKA, an early drainage removal is recommended. Thus, the aim of this study was to investigate the real usefulness of suction drainage in perioperative bleeding control in the management of TKA and UKA.

Eligibility Criteria:
Inclusion Criteria:

* knee osteoarthritis diagnosis
* No contraindications to antithrombotic prophylaxis
* Availability of blood tests results before surgery as well as in the first three postoperative days.
* Detailed description of clinical records

Exclusion Criteria:

* contraindications to antithrombotic prophylaxis
* anti-platelet therapy
* knee arthroplasty revision indication
STUDY OF THE EXPRESSION OF CIRCULATING AND INTRA-TUMORAL CHEMOKINES IN PATIENTS WITH PROSTATE CANCER

Multicentric, observational, prospective, non-interventional study with occasional biological sample collection (serum bank, urine bank and tumor bank)

This project is an exploratory study, based on the hypothesis of involvement of chemokines in hormonal escape of prostate cancers.

The two main objectives are:

* To describe the variations in expression of chemokines in serum and urine level in patients with prostate cancer
* And to study the disease stage and intra-prostatic concentrations of chemokines based on serum and urine concentrations of chemokines before treatment initiation.

These estimates can be used in future trials set up for the management of prostate cancer

Eligibility Criteria:
Inclusion Criteria:

* Patients with a localized or metastatic prostate adenocarcinoma for which a new treatment will be implemented (hormone therapy for single biological relapse or relapses and metastatic hormone-sensitive) or chemotherapy (for biological relapses and / or metastatic hormone-resistant)
* Patients with a detectable PSA (Prostate-Specific Antigen)
* Patients who signed an informed consent
* Patients over 18 years
* Patients belonging to the social security scheme

Exclusion Criteria:

* Active Hepatitis B or C virus
* HIV positive
* Patients who have received prior chemotherapy
* Patients with a second neoplasia treated in the last 5 years
Purpose of This Study is to Evaluate the Safety and Efficacy of One, Two, or Three iStents for the Reduction of Intraocular Pressure in Open-angle Glaucoma Subjects

The purpose of this study is to evaluate the safety and efficacy of the iStent medical device that is implanted into the eye and designed to reduce eye pressure in patients with your condition.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with primary open-angle glaucoma (POAG)
* Subject on two topical hypotensive medications

Exclusion Criteria:

* Traumatic, uveitic, neovascular, or angle closure glaucoma
* Fellow eye already enrolled
Virtual Reality Helmet to Test for Problems With Memory

The purpose of this research study is to compare a virtual reality display device with the standard neuropsychological evaluation for detecting mild cognitive impairment (problems with memory, concentration, reaction time, etc.).

Since many individuals with mild cognitive impairment (MCI) appear to function normally, MCI may often be recognizable through testing in advance of any changes noticed by family members or caregivers. Early and frequent testing can therefore trigger an earlier diagnosis, which may increase the effectiveness of currently available medications used to delay onset of Alzheimer's symptoms. Primary care and geriatric physicians currently lack the necessary tools required for quick and accurate MCI screening in the doctor's office environment. The current industry-standard is a battery of pen \& paper neuropsychological tests that require 1.5 hours in a quiet room with a neuropsychologist.

Comparison: virtual reality display device compared to the standard neuropsychological evaluation for detecting mild cognitive impairment (problems with memory, concentration, reaction time, etc.).

Eligibility Criteria:
Inclusion Criteria:

* 65 yrs of age and older
* MMSE of 18 or greater or mini-cog of 4 or greater
* Ability to read
* Informed consent given

Exclusion Criteria:

* Visual, hearing or physical impairment that would limit ability to use the virtual reality helmet or control device
* Non-English speaking
Initial Staging of Lobular Breast Carcinoma: Head to Head Comparison of 68Ga-FAPI-46 and 18F-FDG PET/CT

Lobular Breast cancer staging with 18F-fluorodeoxyglucose positron emission tomography (18F-FDG PET) is not optimal due to the poor accumulation of 18F-FDG in the tumour. Through better sensitivity (and specificity), 68Ga-FAPI-46-46 PET should provide a more accurate staging of lobular breast cancer than 18F-FDG PET.

Research hypothesis : Through better sensitivity (and specificity), 68Ga-FAPI-46-46 PET should provide a more accurate staging of lobular breast cancer than 18F-FDG PET. Participants with lobular breast carcinoma will then undergo 18F-FDG and 68Ga-FAPI-46 PET scan.

Primary objective of the study is to compare the sensitivity of 68Ga-FAPI-46 with the sensitivity of 18F-FDG in the detection of lobular breast carcinoma lesions, measured by positron emission tomography (PET). These results will be compared with the histological data collected before or during surgery (conventional histological data and immunohistochemical labeling of FAPα on the sample obtained), clinical follow-up and any results of additional examinations carried out within the usual clinical follow-up of the patients.

Comparison of primary tumor and metastases uptake of 68Ga-FAPI-46 with the uptake of 18F-FDG, radiomic study of 68Ga-FAPI-46 PET and comparative radiomic study of 68Ga-FAPI-46 PET and 18F-FDG PET and comparison of the specificity of 68Ga-FAPI-46 with the specificity of 18F-FDG after a 12-month follow-up will also be performed as secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years
* ECOG from 0 to 2
* Histological diagnosis of Lobular Carcinoma of the breast based on a breast biopsy
* Patient naïve to any treatment for lobular breast carcinoma
* Women of childbearing age should have an adequate method of contraception
* Patient having voluntarily accepted to participate in the study and signed the informed consent
* Minimum tumor stage IIA
* Sufficient histological material in the biopsy or the surgical specimen, if the biopsy is insufficient

Exclusion Criteria:

* PET scan contraindications: severe claustrophobia, unbalanced diabetes during 18F-FDG PET scans (fasting capillary blood sugar ≥ 11 mmol)
* Hormone therapy started
* 18F-FDG PET scan \> 21 days
* Pregnant women, parturients and nursing mothers
* Persons deprived of liberty by a judicial or administrative decision
* Persons admitted to a health or social establishment for purposes other than research
* Adults who are the subject of a legal protection measure or who are unable to express their consent
Prevalence of Non-adherence to Medication Among Patients on Chronic Hemodialysis

Background:

Non-adherence to medication among patients on chronic hemodialysis compromises treatment effects and results in increased morbidity, mortality and extensive costs to the healthcare system. To our knowledge, no studies have investigated the prevalence of non-adherence among Danish hemodialysis patients using a validated measure of non-adherence.

Aim:

The primary aim of this study was to investigate the prevalence of non-adherence among Danish patients on chronic hemodialysis measured by self-report.

Our second aim was to explore patients' beliefs about medicines and potential associations between beliefs and non-adherence to medication.

Our third aim was to explore the prevalence and severity of physical and emotional symptoms and potential associations with non-adherence to medication.

Design:

A multi-centre cross-sectional study according to the STROBE statement will be conducted from May 2019 - April 2021. The study will take place in the outpatient hemodialysis centres at three large University Hospitals in the Capital Region of Denmark.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of end stage kidney disease
* Must have received hemodialysis treatment ≥3 month at a hospital-based outpatient hemodialysis Centre
* Must be able to understand and speak Danish

Exclusion Criteria:

* cognitive impairment
* no current medication prescriptions
Pharmacokinetic Study of Perampanel in Chinese Healthy Subjects

This study will be conducted to evaluate the pharmacokinetics of perampanel following single and multiple oral doses in Chinese healthy male and female participants.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following criteria to be included in this study:

* Chinese healthy adult volunteers (males and females)
* Non-smoking, male or female age ≥18 years and ≤45 years old at the time of obtaining written consent. To be considered non-smokers, participants must have discontinued smoking from screening before first dosing.
* Participants with a Body Mass Index ≥18.5 and \<24.5 kilograms per meters squared at screening
* Participants who undergo screening within 3 weeks before study treatment and are confirmed to be eligible by the investigator

Exclusion Criteria:

Participants who meet any of the following criteria will be excluded from this study:

* Participants who weigh less than 50 kilograms
* Females who are breastfeeding or pregnant at Screening or Baseline
* Females of childbearing potential
* Clinically significant illness that requires medical treatment within 8 weeks or a clinically significant infection that requires medical treatment within 4 weeks before first dosing
* Evidence of disease that may influence the outcome of the study within 4 weeks before first dosing
* Any history of gastrointestinal surgery that may affect pharmacokinetic profiles of perampanel at Screening
* Any clinically abnormal symptom or organ impairment found by medical history at Screening, and physical examinations, vital signs, electrocardiogram (ECG) finding, or laboratory test results that require medical treatment at Screening
* A prolonged QT/corrected QT (QTc) interval (QTc interval for heart rate using Fredericia's formula \>450 milliseconds) as demonstrated by a repeated ECG at Screening or Baseline
Long-term Outcome of Punctate Inner Choroidopathy or Multifocal Choroiditis With Active Choroidal Neovascularization Managed With Anti-vascular Endothelial Growth Factor

To evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial factor treatment.

To evaluate the long-term outcome of active choroidal neovascularization (CNV) in punctate inner choroidopathy (PIC) or multifocal choroiditis (MFC) after anti-vascular endothelial factor treatment.

The age, sex, best corrected visual acuity (BCVA) in Snellen chart, and refractive status for each patient were recorded. All patients had thorough clinical examinations, including slit lamp biomicroscopy, indirect ophthalmoloscopy, and spectral domain optical coherence tomography during each visit. Fundus photography, fluorescein angiography, and indocyanine angiography were performed on all patients. OCT angiography was performed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients were punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization.
2. Follow up over 4 years.

Exclusion Criteria:

1. Patients were not punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization
2. Patients were punctate inner choroidopathy or multifocal choroiditis with active choroidal neovascularization but loss follow over 1 year.
N-acetylcysteine in Non-Acetaminophen Pediatric Acute Liver Failure

We have completed patient enrollment in the the double blind, randomized, placebo-controlled trial of intravenous (IV) N-acetylcysteine (NAC) vs. placebo for the treatment of non-acetaminophen ALF. The purpose of this study is to examine the safety and efficacy of intravenous NAC in children with ALF for whom no antidote or other specific treatment is available. Inclusion in the NAC Study required enrollment in the Pediatric Acute Liver Failure (PALF) Study Registry.

The Pediatric Acute Liver Failure (PALF) Study Group to identify, characterize, and develop management strategies for infants, children and adolescents who present with acute liver failure. The PALF study group includes 20 sites (17 in the United States, 2 in the United Kingdom, and 1 in Canada). The primary objective of the Pediatric Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with ALF, including information derived from biospecimens.

Patients enrolled in the PALF study registry were able to enroll in the NAC study providing they met the additional required inclusion/exclusion criteria.

Eligibility Criteria:
Inclusion Criteria:

* Meet entry criteria for and be enrolled in the Pediatric Acute Liver Failure prospective database.
* Able to be evaluated and initiate treatment within the first 24 hours of hospitalization
* Patients transferred from referring hospitals to the study site may be considered for enrollment, provided that no other treatment protocol has begun, and that no liver support device (BAL, extracorporeal liver assist device, transgenic pig perfusion) has been used or is contemplated.
* Use of fresh frozen plasma infusions will not disqualify patients from participation.

Exclusion Criteria:

* older than 18 years of age
* pregnancy
* ALF that is secondary to acute acetaminophen toxicity, mushroom poisoning, or a known malignancy.
* Patients who exhibit signs of cerebral herniation, have intractable arterial hypotension, require inotropic drugs, or demonstrate signs of sepsis (temperature ≥ 39.5o C or bacteremia) at the time of enrollment
* No exclusion will be made on the basis of race, ethnic group or gender.
* Criteria for inclusion of females and minorities will be those established in the NIH guidelines
Protocol for Women at Increased Risk of Developing Breast Cancer

A pilot study to assess the effects of six months of letrozole on breast tissue risk markers in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer.

A pilot study of letrozole in postmenopausal women on hormone replacement therapy at high risk of developing breast cancer. Subjects will have hyperplasia with atypia (or borderline Epithelial Hyperplasia/Atypical Hyperplasia) and evidence of Estrogen Receptor expression by random periareolar fine needle aspiration and baseline serum estradiol levels less than or equal to 150 pg/ml. The feasibility of performing RT-qPCR on breast specimens for aromatase expression will also be done at baseline.

Eligibility Criteria:
Inclusion Criteria:

* evidence of hyperplasia with/without atypia upon random periareolar fine needle aspiration of breast
* on hormone replacement therapy
* postmenopausal
* increased risk of developing breast cancer based on personal or family history
* never have taken aromatase inhibitors or selective estrogen receptor modulators in last six months
* women who have a high risk of breast cancer
* older than 18 years

Exclusion Criteria:

* anticoagulants
* marked breast tenderness
* pregnant or within twelve months of breast feeding/childbirth