cyrilzakka/clinical-trials huggingface dataset:
A Comparison of Two Surgical Techniques Using the Unity Knee™ Total Knee System

A comparison of two Unity Knee™ tissue-balancing techniques by analysing the results from X-rays and patient questionnaires.


Eligibility Criteria:
Inclusion Criteria:

* Subjects suitable for the Unity Knee™ Total Knee System according to the product "Instructions for use"
* Over 18 years old
* Male and female subjects who are skeletally mature
* Subjects who have a smartphone (iOS or Android) with internet connection via mobile Internet data or Wi-Fi connection
* Subjects able to understand what is expected of them and be able to comply with the study protocol requirements

Exclusion Criteria:

* Any subject listed for a revision total knee replacement or conversion of a unicondylar replacement to a total knee replacement on the operative knee
* Any subject with fixed flexion contracture greater than 20 degrees
* Any subject with varus/valgus deformity greater than 15 degrees
* Any subject with confirmed osteoarthritis or other pathologies affecting the contralateral knee that is anticipated to require surgery within 12 months
* Any subjects with contralateral knee replacement that is anticipated to require revision surgery within 12 months
* Any subject whose prospects for a recovery to independent mobility would be compromised by known co-existent, medical problems
* Any subject with a known sensitivity to device material
* Any subject who is pregnant
* Any subject currently a prisoner
* Any subject known to be a drug or alcohol abuser, or have a psychological disorder that could affect follow-up care or treatment outcomes
* Any subject currently involved in any personal injury litigation, medical-legal or worker's compensations claims
* Any subject unable to read and understand English
Inebilizumab in Acute Neuromyelitis Optica Spectrum Disorders

This study is aimed to observe the effectiveness and safety of inebilizumab in the acute phase of neuromyelitis optica spectrum disorders.

This is a a multicentric, prospective, real word study of inebilizumab in NMOSD acute attack compared with oral immunosuppressant. A total of 50 patients will be enrolled at approximately 10 centers around China.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age ≥ 18 years with anti-AQP4-IgG seropositive NMOSD as defined by 2015 NMOSD diagnostic criteria by IPND (International Panel for NMO Diagnosis); 2. In the acute phase of NMOSD (definition of acute phase: new neurological symptoms or aggravation of existing symptoms within 30 days before screening, lasting at least 24 hours without with fever); 3. Patients who plan to receive or are receiving intravenous methylprednisolone therapy; 4. Expanded disability status scale (EDSS) score ≤ 8 and ≥ 2.5 during the screening period; 5. Able and willing to give written informed consent; 6. Women of childbearing potential who agree to use adequate contraception during the study.

Exclusion Criteria:

* 1. Lactating and pregnant females; 2. Participate in other interventional studies within 30 days before screening or within 5 half-lives of the investigational agent before enrollment; 3. Combined with severe mental disorders and other conditions and unable to cooperate with follow-up; 4. History of malignancies; 5. Received plasma exchange, immunoadsorption or intravenous immunoglobulin therapy within 1 month before screening; 6. Patients with negative hepatitis B surface antibody (HBsAg) and positive hepatitis B core antibody (HBcAb), or HBsAg-positive virus carriers, or patients with active tuberculosis or positive tuberculosis screening without appropriate treatment history; 7. Other situations that researchers think are not suitable to participate in this study.
The ECOVITA Study - Validation of LUS Score in SARS-CoV-2 Disease, i.e COVID-19

Lung Ultrasound (LUS) has been revealing an extremely useful tool to identify and monitor complications from Sars-COV-2 disease. Recently, a research group has proposed a score, named LUS Score, able to optimize the use of this diagnostic technique. LUS Score is computed analyzing chest posterior and lateral spaces, considering the number of artefacts generated by the inflammed interstitium (B lines), the characteristics of the pleural line and the presence or not of consolidation areas.

The comparison between LUS and chest tomography (CT), the current gold standard for the diagnosis of interstitial pneumonia by COVID-19, has confirmed from the preliminary data, the reliability of such technique. Hence, the validation on a really large sample size of the ultrasound tool performed by dedicated personnel with high expertise, may allow the validation both in the clinical practice and in emergency and ordinary wards.


Eligibility Criteria:
Inclusion Criteria:

* men and women;
* confirmed COVID19 diagnosis after nasal-oropharyngeal swab;
* any symptom at hospitalization
* any therapy
* any pre-existing comorbidity

Exclusion Criteria:

* pregnant women
* healthy subjects with other respiratory diseases different from COVID-19
Caudal Analgesia & Anticoagulated Patient

Caudal analgesia is an effective intervention for lumbosacral pain. Some chronic pain patients take anticoagulants for vasculopathy treatment. Anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. Caudal analgesia may be safe and effective in anticoagulated chronic pain patients.

Quantitative analysis of prospective clinical data. Evaluation of caudal analgesia efficacy and safety in anticoagulated chronic pain patients. Analysis of outcome, and complications.

Caudal analgesia is an effective interventional therapy for chronic lumbosacral pain. Some chronic pain patients take anticoagulants for vasculopathy treatment. Anticoagulation limits the use of caudal analgesia because of the risk of epidural bleeding. Anticoagulation may be discontinued briefly, to allow caudal injection. Interruption of anticoagulation may be difficult and dangerous for some high-risk patients. Caudal analgesia may be safe and effective in anticoagulated chronic pain patients.

Quantitative analysis of prospective clinical data. An evaluation of caudal analgesia safety in anticoagulated chronic pain patients. An analysis of treatment outcome, and complications.

Eligibility Criteria:
Inclusion Criteria:

* adult chronic pain patients who undergo caudal analgesia

Exclusion Criteria:

* chronic pain patients who refuse caudal analgesia
An Intervention Targeting Daily Adaptive Skills Through Executive Function Training for Adults With ASD

The current study is a single group pilot study of a novel intervention program which targets improvements in executive functions and adaptive skills in transition age young adults with high-functioning autism spectrum disorder. The main aim of the study is to test the effectiveness of the intervention using a pretest-posttest comparison. It is hypothesised that there will be an increase in executive functions and adaptive skills after the intervention.

The participants engaged in a 10-week group-based intervention program which aims to improve daily adaptive skills based on executive functions and help the transition into adulthood in young adults with ASD. Before and after the intervention, the participants and their parents completed questionnaires that measure executive functions and adaptive skills, and the participants additionally completed an assessment of social adaptive skills. The differences between pre- and post-intervention scores of the outcome measures were analyzed using Wilcoxon signed-rank tests to evaluate the effect of the program.

Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of ASD as measured by the Autism Diagnostic Observation Schedule and the Autism Diagnostic Interview-Revised
* Full-scale IQ of 70 or above as measured by the Weschler Adult Intelligence Scale

Exclusion Criteria:

* Full-scale IQ less than 70
* Uncooperative and lacking motivation to participate in the programme
* Reporting clinically significant behavioural problems, emotion regulation problems, psychotic symptoms, risk of self-harm or harm to others which can affect the participation to the programme, which is screened by the screening assessments and interviews.
Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity

This study is in patients with at least moderate obesity (Body Mass Index \[BMI\] \> 30 kg/m2 or approximately 30 or more pounds overweight) and who also produce too much insulin (insulin stores sugar as fat). Sandostatin LAR® Depot suppresses insulin, and is being developed to help with weight loss in people who find it hard to lose weight on their own because they produce too much insulin.

The main purpose of the study is to find the lowest dose of Sandostatin LAR® Depot that safely helps overweight people lose weight. The study will also compare weight loss in obese patients who receive one of three different dosages of Sandostatin LAR Depot or placebo.


Eligibility Criteria:
Inclusion Criteria:

You may qualify for this study if you:

* are between the ages of 18-70 (male or female)
* are at least moderately obese (BMI \> 30 kg/m2 or approximately 30 or more pounds overweight)
* and pass an oral glucose tolerance test (a 3 hour test to determine if your body produces too much insulin)

Exclusion Criteria:

You are not qualified for this study if you:

* have diabetes
* have been able to lose weight with diet and exercise alone
* have previously received Sandostatin LAR® Depot
Pilot Study of Budesonide for Patients With Primary Sclerosing Cholangitis

OBJECTIVES: I. Assess the safety and effectiveness of budesonide in patients with primary sclerosing cholangitis or primary biliary cirrhosis experiencing a suboptimal response to ursodeoxycholic acid.

II. Estimate the efficacy of this therapy in these patient groups as a means of evaluating the feasibility of a long-term randomized trial.

PROTOCOL OUTLINE:

Patients receive budesonide by mouth 3 times daily for a minimum of 6 months. If liver biochemistries become normal, dosage is reduced to once daily. Treatment discontinues after 1 year.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Pathologically confirmed primary sclerosing cholangitis (PSC) meeting the following criteria:

* Chronic cholestatic disease for at least 6 months
* Liver biopsy within the past 6 months compatible with the diagnosis of PSC Intra and/or extrahepatic biliary duct obstruction, beading, or narrowing

OR

Pathologically confirmed primary biliary cirrhosis (PBC) that is experiencing suboptimal response to ursodeoxycholic acid and meeting the following criteria:

* Chronic cholestatic liver disease for at least 6 months
* Positive antimitochondrial antibody
* No biliary obstruction by ultrasound, CT, or cholangiography
* Prior liver biopsy compatible with diagnosis of PBC
* Received ursodeoxycholic acid for at least 6 months

--Prior/Concurrent Therapy--

Biologic therapy:

* At least 3 months since prior D-penicillamine
* No planned transplantation for at least 1 year

Chemotherapy:

* At least 3 months (6 months for PBC) since prior cyclosporin, colchicine, azathioprine, or methotrexate
* At least 6 months since prior chlorambucil (PBC only)

Endocrine therapy: At least 3 months (6 months for PBC) since prior corticosteroids

Surgery: No prior intraductal stones or operations on the biliary tree except cholecystectomy (PSC only)

Other:

* At least 3 months since prior pentoxifylline, ursodeoxycholic acid, or nicotine (PSC only)
* At least 6 months since prior chenodeoxycholic acid (PBC only)

--Patient Characteristics--

Life expectancy: At least 3 years

Hematopoietic: Not specified

Hepatic:

* Alkaline phosphatase at least 2 times upper limits of normal
* No chronic hepatitis B infection
* No hepatitis C infection
* No autoimmune hepatitis
* Bilirubin no greater than 4 mg/dL (PBC only)

Cardiovascular: No severe cardiopulmonary disease

Other:

* No concurrent advanced malignancy
* At least 3 months since prior inflammatory bowel disease requiring specific treatment except maintenance therapy (PSC only)
* No anticipated need for transplantation within 1 year
* Not pregnant
* No liver disease of other etiology such as:

Chronic alcoholic liver disease

Hemochromatosis

Wilson's disease

Congenital biliary disease

Cholangiocarcinoma

No recurrent ascending cholangitis requiring hospitalization more than 2 times per year (PSC only)

At least 1 year since prior active peptic ulcer

No recurrent variceal bleeds

No spontaneous encephalopathy

No diuretic-resistant ascites
Lumbar Erector Spinae Plane Block and Fascia Iliaca Compartment Block After Total Hip Arthroplasty

Compare the analgesic efficacy of ultrasound-guided lumbar erector spinae plane block (L-ESPB) versus fascia iliaca compartment block (FICB) in patients scheduled for total hip arthroplasty.

Ultrasound-guided erector spinae plane (ESP) block is a recent regional anesthetic technique. It was first described by Forero et al. in 2016 for acute and chronic thoracic pain management. Local anesthetic (LA) is injected between the erector spinae muscle and the vertebra's transverse process, leading to the spread of LA cephalad, caudally, and through the paravertebral space.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 30-75 years from both sexes.
2. ASA I-III scheduled for unilateral hip surgery under spinal anesthesia.

Exclusion Criteria:

1. Patients' refusal.
2. Patients who were unable to co-operate with researchers.
3. History of allergy to local anesthetics.
4. Local infection at the site of the block.
5. Patients with bleeding and coagulation disorders.
6. Patients with renal, hepatic, cardiac decompensation, or spine deformities.
7. Patients receiving opioids for chronic analgesic therapy
8. Body mass index \> 35 kg/m2
In-Field Detection of Intracranial Pressure

This is a research study to develop a noninvasive test using ultrasound to determine when urgent, life-saving treatment is needed for those with severe traumatic brain injuries.


Eligibility Criteria:
Healthy Volunteer Inclusion Criteria:

* Adults 18 or older
* Able to provide legally effective consent

Healthy Volunteer Exclusion Criteria:

* Intracranial disease, neurologic symptoms, or eye pathology

Patient Inclusion Criteria:

* Adults age 18 or older
* Confirmed or suspected severe traumatic brain injury
* Able to provide legally effective consent

Patient Exclusion Criteria:

* Significant bilateral ocular trauma
Ultra Low Dose CT for CACS and AC of SPECT

The aim of the study is to compare the CACS obtained from standard dose CT to the CACS obtained from ultra-low-dose scans. Additionally, the usefulness of ultra-low-dose CT for AC of myocardial perfusion SPECT will be assessed.


Eligibility Criteria:
Inclusion Criteria:

* Patients referred for myocardial perfusion SPECT
* Male and Female subjects ≥18 years of age,
* Written informed consent

Exclusion Criteria:

* Pregnancy or breast-feeding
* CACS of 0 after inclusion of 10 patients with CACS 0
* Stents or implanted cardiac devices (valves, pace makers, ICD)
* Coronary artery bypass grafts
Efficacy and Safety of Pemigatinib in Participants With Solid Tumors With FGFR Mutations or Translocations (FIGHT-208)

The purpose of this study is to evaluate the efficacy and safety of pemigatinib in participants with previously treated locally advanced/metastatic or surgically unresectable solid tumors harboring activating FGFR mutations or translocations.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed solid tumor malignancy that is advanced or metastatic (Stage IIIB or IV) or is surgically unresectable.
* Radiographically measurable disease (per RECIST v1.1 or RANO for primary brain tumors).
* Documentation of an FGFR1-3 gene mutation or translocation.
* Objective disease progression after at least 1 prior therapy.
* Not eligible or able to participate in any other Incyte-sponsored clinical trial.

Exclusion Criteria:

* Advanced/metastatic bladder cancer or advanced/metastatic cholangiocarcinoma.
* Prior receipt of a selective FGFR inhibitor.
* Current evidence of clinically significant corneal or retinal disorder.
* History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues.
Alrex® Versus Patanol in the Treatment of Seasonal Allergic Conjunctivitis(SAC)

This study is to evaluate the safety and efficacy of Alrex (LE ophthalmic suspension, 0.2%) versus Patanol (olopatadine hydrochloride ophthalmic solution, 0.1%) in the temporary relief of the signs and symptoms of Seasonal Allergic Conjunctivitis (SAC).


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are diagnosed with acute SAC and experience at least grade 4 ocular itching and at least grade 2 bulbar conjunctival injection (redness) in each eye due to seasonal allergy at Visit 1.

Exclusion Criteria:

* Subjects who have a known hypersensitivity to the study medications or their components or contraindications to ocular corticosteroids.
* Subjects who use any of the disallowed medications throughout the duration of the study and during the period indicated prior to Visit 1.
* Subjects who have intraocular pressure (IOP) greater than 21 mm Hg in either eye or any type of glaucoma.
* Subjects who have a history of any severe/serious ocular pathology or medical condition that could result in the subject's inability to complete the study or affect the subject's safety or trial parameters.
Mindfulness-based Treatment to Prevent Smoking Relapse

Background: Smoking causes a variety of health problems and causes burden to healthcare systems. Even when support is provided, local data suggest that around 50% of biochemically confirmed quitters resume smoking within 6 months of participating in a smoking cessation program. Mindfulness-based intervention is a promising option because accumulating evidence from randomized controlled trials support its use among smokers. Our team aims to determine if mindfulness-based interventions can prevent relapse in smokers who recently quit smoking. A pilot trial is needed to determine the feasibility of recruitment, randomisation and acceptability of the intervention in these patients Method: Forty participants, who just quitted smoking, will be randomised in a 1:1 ratio to the 8week mindfulness-based relapse prevention (MBRP) program and to usual care.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* self-reported smokers
* can speak and read Cantonese and Chinese
* willing to participate in at least 7 of the 8 sessions of the MBRP program

Exclusion Criteria:

* pregnancy (they will have different motivations for quitting smoking)
* significant physical illness or severe cognitive impairment that prevents communication, such as blindness or severe hearing loss, because mindfulness exercise instructions are given verbally and reading materials are given out after each class
* history of psychotic disorders or symptoms, because MBRP is not confirmed safe or effective in this group of patients
* suicidal tendency as detected by PHQ-9 (see below)
* we will not exclude participants with mood disorders for the reasons stated in the introduction, but participants with drug changes for their mood disorders in the last 3 months will be excluded (ethics approval and informed consent will be obtained for assessing patients' medical records, CMS of the hospital authority or e-health, to confirm drug information)
* active illicit drug use and
* past mindfulness course or practices in the previous 12 months
Study to Evaluate Safety, Tolerability and Pharmacokinetics of Increasing Repeated Oral Doses of Ambroxol Lozenges in Healthy Male Volunteers

The main objectives of the present study are to determine pharmacokinetics of ambroxol in healthy male volunteers following repeated administration of lozenges of 20 mg ambroxol for four days


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs, 12-lead Electrocardiogram (ECG), clinical laboratory tests
* Age ≥21 and Age ≤50 year
* BMI ≥18.5 and BMI ≤29.9 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including vital signs and ECG) deviating from normal and of clinical relevance
* Any evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Surgery of the gastrointestinal tract (except appendectomy)
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
* Intake of drugs with a long half-life (\> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
* Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within two months prior to administration or during the trial
* Actual smoker
* Alcohol abuse (more than 40 g/day)
* Drug abuse
* Blood donation (more than 100 mL within four weeks prior to administration or during the trial)
* Excessive physical activities (within one week prior to administration or during the trial)
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of trial site
* A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval \>450 ms)
* A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalaemia, family history of Long QT Syndrome)
Use of Repetitive Facilitative Exercise Program in Established Stroke

The purpose of this study is to assess whether a novel therapy approach (repetitive facilitative exercise (RFE)) is more effective than conventional rehabilitation in facilitating the recovery of upper extremity function following stroke.


Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 years
* Having a single ischemic or hemorrhagic hemispheric stroke of more than 6 months duration
* The ability to selectively demonstrate active extension of at least 10 degrees at the metacarpo-phalangeal joint and the interphalangeal joints and 20 degrees at the wrist
* Capable of effectively participating in the study

Exclusion Criteria:

* Upper extremity contracture/pain that interfere with study technique
* Pre-existing upper extremity neurologic or orthopedic disorders
* Unstable medical condition
* BMI \> 35
* Active treatment of condition during 3 months prior to enrollment in study (botulinum toxin, therapy, tendon release, etc.)
* Language or cognitive/perceptual deficits or scheduling problems that would limit participation
* Inability to provide informed consent