cyrilzakka/clinical-trials huggingface dataset:
Transforaminal and Parasagittal Approach in Lumbar Epidural Steroid Injection

Lumbar epidural injection is used in the treatment of lumbar radicular pain. There are three different application methods: lateral parasagittal, midline interlaminar and transforaminal epidural injection. Investigator aimed to compare lateral parasagittal and transforaminal epidural injection methods. The purpose of the study is to determine which method is more efficient.

It was planned to recruit 60 participants in the study. Interlaminar epidural steroid injection will be applied to 30 patients with midline and 30 patients with lateral parasagittal approach. All patients will receive Oswestry disability index before and 2-4-12 weeks after the procedure. All patients will receive Somatization Amplification Scale (SSAS) before the treatment. The results of the patients will be compared. It will be investigated which method is more effective.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral low back pain, radiculopathy

Exclusion Criteria:

* malignancy
* past back surgery
Comparison of Tendon Repair and Physiotherapy in the Treatment of Small and Medium-sized Tears of the Rotator Cuff

The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.

Surgical treatment by tendon repair or physiotherapy are accepted treatment options for small and medium-sized rotator cuff tears, but have never been compared in randomised, controlled studies.

In this study, patients presenting clinical signs together with imaging findings (MRI and sonography) for a full-thickness rotator cuff tear will be randomly allocated to surgery (tendon repair) or physiotherapy. Outcome measuring will be performed by the Constant score, the self report section of the American Shoulder and Elbow Surgeons score (ASES), the Short Form 36 Health Survey (SF-36) and subscores for shoulder motion, pain, strength and patient satisfaction. Scores will be taken at baseline and after 6 months,1, 2, 5, 10 and 15 years by a blinded assessor. All operated shoulders will be controlled by MRI after one year. Patients with no effect from physiotherapy after at least 15 treatment sessions will be offered secondary surgical treatment, and scoring results from last follow-up before surgery will be carried forward to analysis, according to an intention to treat principle.

Eligibility Criteria:
Inclusion Criteria:

* Clinical history and imaging findings of a rotator cuff tear

Exclusion Criteria:

* Presence of other local or systemic diseases influencing on shoulder function
* History of earlier rotator cuff surgery
* Medical contraindications for surgery
Biofeedback Balance Exercises in Parkinson's Disease

The aim of this study was to evaluate the effectiveness of static posturography-assisted biofeedback exercises in PD-related balance disorder.

Parkinson's disease (PD) is a chronic, progressive, degenerative movement disorder, the incidence of which increases with age, characterized by motor and non-motor findings. Cardinal motor findings such as bradykinesia, rigidity, rest tremor, postural instability, and gait dysfunction and secondary motor symptoms additional to these such as dysarthria, and associated movements in the arms may be seen throughout the course of the disease. Progressive loss of dopaminergic neurons occurs in the basal ganglia, together with a decrease in the speed and angle of movement. Loss of postural reflexes causes balance disturbance findings such as impaired postural control, rigidity in the extremities, and akinesia.Falls, decreased mobility, disability and quality of life impairment occur as a result of balance disorder. Higher rates of falls or fall-related fractures have been reported in PD compared to the non-PD elderly population.There are several exercise applications aimed at balance improving strategies in PD. Strengthening exercises combined with conventional balance exercises, treadmill walking training, tai chi, and biofeedback have been shown to improve gait and and balance control in PD. Various publications have shown that biofeedback therapy in elderly individuals and in healthy individuals with postural disorder exhibits positive effects on balance by enhancing postural stability and reducing body tremor. The basic aim of this study was to investigate the effects of static posturography-assisted visual and auditory biofeedback therapy on balance and the risk of falls in PD. In addition, the study was intended to determine the effects of balance training on the individual's daily living activities, perceived safety level, and emotional state.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Parkinson's disease,
* Age 40 - 85

Exclusion Criteria:

* Presence of systemic or neurological disease capable of causing balance disorder,
* Postural hypotension,
* Presence of cardiovascular or musculoskeletal system disease capable of affecting locomotion,
* Presence of advanced dementia or mental disability
A Study to Evaluate the Efficacy and Safety of JKB-122 in Patients With NASH and Fibrosis

A double-blind placebo controlled randomized Phase 2 study to determine if JKB-122 compared with placebo resolves NASH on liver biopsy and improves fibrosis

This is a Phase 2 study in which JKB-122 is given once daily for 52 weeks to subjects with Nonalcoholic steatohepatitis (NASH) with Fibrosis who have biopsy reading more than NAS 4 with a fibrosis reading more than 1 and no cirrhosis. Subjects will be at least 18 years of age, either male or female.

Eligibility Criteria:
Inclusion Criteria:

1. Is male or female, 18 years to 70 years of age.
2. If female of childbearing potential, must not be pregnant or breastfeeding and either postmenopausal (no menses for previous 12 months) or using an effective method of birth control (e.g., oral contraceptives, hormonal injectable or implanted contraceptives, tubal ligation, or partner with vasectomy plus a barrier method).
3. Is diagnosed with non-alcoholic steatohepatitis (NASH) NAS \>4.0
4. Compensated liver disease with the following hematologic, biochemical, and serological criteria on entry into protocol:
5. Subjects taking lipid lowering agents should keep their dose stable during the study.
6. Stable use of insulin sensitizing agents (PPARs, SGLT2 inhibitors, or GLP-1 agonists for 6 months prior to screening liver biopsy).
7. Is capable of understanding and signing the informed consent document. If subject is unable to sign the informed consent form, then the subject's legal representative or guardian may provide written consent per local regulations.
8. Agrees to comply with protocol requirements.

Exclusion Criteria:

1. Has human immunodeficiency virus (HIV) or is hepatitis B or C positive.
2. Has history of liver cirrhosis.
3. Has glycated hemoglobin (HbA1c ) greater than 9%.
4. Binge drinking as drinking 5 or more alcoholic drinks
5. Significant alcohol consumption
6. Is being treated with any prescription narcotic drug (including transdermal delivery systems).
7. Has a known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold.
8. Has unstable and uncontrollable hypertension (\>180/110 mmHg).
9. Has received other therapies for NAFLD in the last 4 weeks prior to the screening visit (Day -7).
10. Requires concomitant use of or treatment with opioids or other excluded drugs such as hepatotoxic medications.
11. Has received other investigational agents within 30 days prior to the screening visit (Day -7).
12. Has either autoimmune or genetic liver disease.
13. Alpha- fetoprotein greater than 20 mcg/L. Has impaired renal function (i.e. serum creatinine CLcr \< 60 mL/min).
14. Subjects who gained or lost weight greater than 5 kg in the past 3 months.
15. Any form of chronic liver disease other than NASH
16. Suspected or confirmed cirrhosis. -
Development of a MID for the 1-minute Sit-to-stand Test

The purpose of this study is to determine the minimal important difference (MID) for the 1-minute-sit-to-stand-test (STST) with an anchor-based method.

In this study we develop the minimal important difference for the 1-minute sit-to-stand-test (STST) with an anchor-based method.

First step of this study is to find out the differences in the number of repetitions during 1-minute STST, 6-minute walk distance and health-related quality of life from pre to post inpatient pulmonary Rehabilitation program (3 weeks Duration) in the Schoen-Klinik Berchtesgadener Land.

In Addition, Balance tests on the Leonardo-Mechanograph will be performed and the Hospital Anxiety and Depression Scale (HADS) and Chronic Respiratory Questionnaire (CRQ) will be assessed.

For the second step we will use an anchor-based approach to estimate the MID of the STST. 6MWD and CRQ are used as anchors for which the MID has been established before.

Eligibility Criteria:
Inclusion Criteria:

* Patients with COPD (GOLD-Stage II to IV)
* Ability to stand-up and walk
* written informed consent

Exclusion Criteria:

* orthopaedic or other comorbidities that prevent patients from performing the STST, 6MWT or exercise Training
* acute exacerbation
* heart failure, acute coronary syndrome
Validity of Palpation in Detecting the Site of Lesion in Diabetic Trigger Finger Patients.

Aim of the study: 1) to determine validity of palpation in detecting the site of lesion in trigger finger patients by detecting sensitivity specificity, positive and negative predictive values. Hypothesis: Sensitivity of T.F palpation will be ≥ 0.70 and Specificity of T.F palpation will be ≥ 0.70.

Trigger finger (T.F) is a disorder characterized by snapping or locking of a finger. Painful popping or clicking sound is elicited by flexion and extension of the involved digit. It is a multifactorial disease . The common mechanism of triggering is that there is a mismatch of diameter between flexors tendons and the annular pulley (retinacular sheath) of the finger. A1 pulley is the most common site of pathology; hence some authors define T.F generally as a disease of A1 pulley . Many case reports revealed that A2 or A3 pulley is a site of triggering . Others revealed that flexor retinaculum or palmar aponeurosis is the site of pathology. In some cases, after intraoperatively surgeons release A1 pulley they found still triggering and found the triggering at other site . So clinician should examine all possible sites of affection before any topical procedures application or surgery, hence our question is in T.F patients is palpation valid in detecting the site of lesion? Design and Setting: the investigator propose a case control clinical trial to enroll TF patients (cases) and non TF diabetic patients (control) to detect sensitivity specificity, positive and negative predictive values for finger palpation. The study will be conducted in physical therapy outpatient clinic and radiology department at Alahrar teaching hospital, Zagazig, Egypt.

Procedures: Patients will be referred by orthopedist who knows inclusion and exclusion criteria, he will refer 31 cases (patients who agree to participate in this study). Diabetic patients without Tf (155) will by refereed from outpatient clinics (control). Physical therapist will assess patients to detect site of pathology (A1, A2, A3, A4, A5, midpalm or wrist) then patients will be refereed to radiologist who will detect site of pathology by sonography.

Eligibility Criteria:
Inclusion Criteria:

1 - Diabetic patients will be included to this study if they have TF (cases) as clinically evaluated and refereed by orthopedist and diabetic patients not complaining of TF(control).

Exclusion Criteria:

1. patients with complete locked finger.
2. Ages below 18 y is .
3. Patients with any other hand pathology .
A Retrospective Review of Malignant Liver Tumors

This study will review the treatment and outcomes of patients having primary and metastatic hepatic malignancies. Patients treated with surgical resection, percutaneous radiofrequency ablation (RFA), and transarterial chemoembolization (TACE) will be compared with patients not receiving these treatments. Tumor recurrence and survival data will be compared to the published literature to determine the efficacy of current treatment strategies in this patient population.

Subjects will be identified by diagnosis and procedure codes from a university surgical practice and the St. John Medical Center Cancer Registry. Data will be obtained by review of both the clinic and hospital charts. In addition we plan to review and utilize liver tumor treatment and outcomes data from a national database. Treatment decisions, in cases managed by the primary investigator, were made on a clinical basis, often in collaboration with an interventional radiologist. Of the patients managed by the principal investigator, all procedures were undertaken after an informed consent process. Subjects were not exposed to risk beyond that posed by the recommended treatment. All treatments were within the scope of standard medical care. The primary investigator has no knowledge of the treatments chosen for the patients he did not manage. The subject's referring physician may be contacted to obtain follow-up data on the subject. The follow-up data will include: is the patient alive with disease; alive without disease, alive unknown; dead free of disease; dead with disease; dead unknown.

Eligibility Criteria:
Inclusion Criteria:

* Patients with primary or metastatic hepatic malignancies

Exclusion Criteria:

* Patients not diagnosed with primary or metastatic hepatic malignancies
A Prospective, Multi-center, Single Arm Study Evaluating the Express™ Renal Premounted Stent System in the Treatment of Atherosclerotic Lesions in the Aortorenal Ostium.

The purpose of this study is to demonstrate superior 9-month binary restenosis rate of the Express™ Renal Premounted Stent System as compared to an Objective Performance Criterion representative of PTRA, for atherosclerotic lesions in the aortorenal ostium.


Eligibility Criteria:
Inclusion Criteria:

* Eligible for PTRA and stenting.
* One or more of the following: (1-3)
* Hypertension
* Recurrent "flash" pulmonary edema out of proportion to any impairment of left ventricular function
* Renal Dysfunction
* Single, de novo, or restenotic (from prior PTRA) atherosclerotic lesion in the ostium of the renal artery
* Lesion involving the aortorenal ostium or the leading edge of the stenosis is located within 5 mm of the opacified aortic lumen
* Renal Artery Stenosis: bilateral renal artery stenosis (one stent for one lesion in each renal artery) or unilateral renal artery stenosis, including a solitary functioning kidney

Exclusion Criteria:

* Any previous or planned, surgery or percutaneous intervention ≤30 days prior to or after index procedure
* Advanced renal disease: serum creatinine \> 3.0 mg/dl
* End stage renal disease requiring dialysis; or previously diagnosed ephrosclerosis
* Recent vascular event ≤30 days pre-procedure (i.e. acute coronary syndrome, decompensated heart failure, transient ischemic attack or stroke.)
* Documented allergy or reaction to iodinated contrast media, including laryngeal edema, convulsions, profound hypotension,unresponsiveness, cardiopulmonary arrest, and clinically manifest arrhythmias (a mild allergy to contrast media that can be pretreated with medication is acceptable)
* Documented allergy to heparin, acetylsalicylic acid (ASA) or clopidogrel
* NYHA Class IV
* Bleeding diathesis
* Thrombocytopenia (platelets \< 100,000/mm3)
* Renal atrophy (renal length ≤ 8 cm determined by renal ultrasound)
* Patients requiring immunosuppressive therapy
* Renal allograft
* Stenosis location in a vascular graft or in a transplant artery Angiographic Exclusion
* Total occlusions
* Thrombus containing lesion
* Prior treatment of target lesion with stent (in-stent restenosis)
* More than one (1) lesion in target vessel
* Non-atherosclerotic stenosis (fibromuscular dysplasia)
* Excessive vessel tortuosity
* Lesion involving a side-branch
* Lesion in accessory renal artery
* Abdominal aortic aneurysm \> 3.5 cm
* Perforated vessels evidenced by extravasation of contrast media
Human Immunodeficiency Virus (HIV)and Chronic Obstructive Pulmonary Disease (COPD)

Highly active antiretroviral therapy (HAART) has considerably improved survival of HIV-infected patients. Opportunist diseases and cancers linked to immunodepression have largely regressed. Challenge is now the management of cardio-vascular diseases, nephrologic, neurologic, osteo-articular diseases, chronic hepatitis and cancer no linked to immunodepression. All this comorbidities are more reported in HIV-infected patients than in general non-HIV infected patients. Those are directly linked to the effect of chronic HIV-infection on ageing, metabolic effects of HAART, and way of life characterising this population.

Chronic obstructive pulmonary disease (COPD) results from tobacco consumption. Bronchial chronic infection, immunity, and ageing are also involved in the physiopathology of COPD. This disease has never been evaluated in a large prospective cohort of HIV-infected patients whereas there is a known increase of tobacco consumption and pulmonary infection in this population regardless to the general population.

Characterisation of COPD disease in HIV patients will allow us to make an hypothetic epidemiological link between HIV- HAART and COPD independently of tobacco consumption, and to study different physiopathologic hypothesis evocated in COPD genesis, like an accelerate pulmonary ageing.

The management of HIV is mainly represented by its commorbidities (cardio-vascular disease, nephrologic, neurologic, osteo-articular disease, chronic hepatitis and cancer no linked to immunodepression). COPD prevalence has never been studied in HIV population. In consequence, there is no guideline about the screening, treatment or follow-up of COPD in HIV patients. However this population seems particularly at risk to develop COPD because of high tobacco consumption and accelerate ageing. Thus, we need an epidemiologic study to understand the prevalence of COPD in HIV population in order to organize a specific screening and follow-up. This is supported by an improvement of COPD if early managed. On top of that, COPD screening will increase awareness of HIV patients on the problematic of tobacco consumption.

Eligibility Criteria:
Inclusion criteria:

* HIV seropositivity
* Age \> 18 years
* Written aggreeing
* Affiliated or profit of a social coverage

Non inclusion criteria:

* Age \< 18 years old
* Actual infectious pneumonia
* COPD exacerbation last 2 months \*
* Recent (less than 1 month) myocardial infarction
* Thoracic or abdominal pain
* Enable to answer question secondary to mental deficienty\*\*
* Physic or mental incapacity to realise COPD-6 or spirometery
* Urinary incontinency with effort
* Prisoner
* Refuse of consent or incapacity to give his consent
The Effect of Intervention With Potassium and/ or Magnesium-enriched Salt on Neurological Performance of Stroke Patients

Cerebrovascular disease is the second leading cause of death in Taiwan. Although stroke incidence and mortality decline steadily in Taiwan, its impact on medical cost, quality of life and neurological deficits remains extraordinary. Stroke incidence and mortality are also rising in the developed countries presumably due to a world-wide increase in prevalence of obesity and metabolic syndrome. Negative associations have been observed between high blood pressure, hyperglycemia and two major dietary cations in vegetables and dairy products: potassium and magnesium. Mean levels of dietary potassium and magnesium intake in Taiwan are much lower than those of dietary reference intake. Short term supplementation studies have demonstrated their effects in reducing blood pressure and degree of insulin resistance. However, long-term studies on cardiovascular events are lacking. Our previous long-term intervention trial in elderly veteran home showed a 41% reduction in cardiovascular mortality by simply switching regular cooking salt to potassium-enriched salt in kitchens. The investigators have previously observed an annual reduction of medical cost around $ 15,000 NT in the aforementioned veteran home trial. A multi-centered randomized controlled trial was carried out with three arms: (1) regular salt (Na salt), (2) potassium-enriched salt (K salt), and (3) potassium and magnesium-enriched salt (K/Mg salt). The objectives of this study was to investigate whether potassium and magnesium-enriched salt would improve the neurological performance of the stroke patients.The investigators anticipate to observe beneficial effect from consuming potassium and magnesium enriched salt for neurological improvement in stroke patients.


Eligibility Criteria:
Inclusion Criteria:

1. hospitalization within 1 month due to cerebral infarction or hemorrhage;
2. a modified Rankin Score of 4 or less at the time of discharge;
3. an age of 45 or older; and
4. an agreement to prepare foods with salt provided by the project.

Exclusion Criteria:

1. patients with poor kidney function (glomerular filtration rate\<60 ml/min), secondary hypertension, cancer, or liver diseases;
2. patients with eating disorders;
3. patients taking K-sparing medicines;
4. or patients using salt substitutes.
Study of a Single Subcutaneous Dose of Pozelimab Produced From Two Different Manufacturing Processes in Healthy Adult Participants

The primary objective of the study is to compare the pharmacokinetic(PK) profile of pozelimab produced by the original manufacturing process (Process A) compared to a second manufacturing process (Process B)

The secondary objectives of the study are:

* Assess the safety and tolerability of a single SC dose of pozelimab produced by the 2 manufacturing processes
* Assess the immunogenicity of pozelimab produced by the 2 manufacturing processes


Eligibility Criteria:
Key Inclusion Criteria:

* Has a body weight of 55 kg to 100 kg and a body mass index between 18 kg/m2 and 30 kg/m2 inclusive at the screening visit
* Judged to be in good health based on medical history, physical examination, vital signs measurements, and ECG performed at screening and/or prior to administration of initial dose of study drug
* Is in good health based on laboratory safety testing obtained at the screening visit. NOTE: Subject with a history of Gilbert's disease can be enrolled in the study
* Willing to undergo vaccination against N meningitidis unless subjects have documentation of completed series of vaccinations within the past 2 years of the screening visit
* Must have two negative COVID-19 tests within 7 days prior to study drug administration as defined in the protocol

Key Exclusion Criteria:

* History of clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as assessed by the investigator
* Hospitalization (\>24 h) for any reason within 90 days of the screening visit
* Has a confirmed positive drug test result at the screening visit and/or prior to enrollment; and/or a history of recreational drug use (eg, marijuana) and/or drug or alcohol abuse within a year prior to the screening visit
* Is positive for HIV, hepatitis B, or hepatitis C antibody as defined in the protocol
* Known or suspected COVID-19 disease
* History of tuberculosis, systemic fungal diseases, or meningococcal infection
* Known allergy or intolerance to penicillin class antibiotics or macrolides; any contraindication to azrithromycin per local prescribing information

Note: Other protocol-defined Inclusion/ Exclusion criteria apply