cyrilzakka/clinical-trials huggingface dataset:
The Safety and Efficacy of an Enzyme Combination in Managing Knee Osteoarthritis Pain in Adults

The aim of this randomized, double-blind, placebo-controlled, comparator-controlled trial was to evaluate the safety and efficacy of an enzyme combination, as Wobenzym®, in adults with moderate-to-severe osteoarthritis (OA) of the knee.


Eligibility Criteria:
Inclusion Criteria:

* Knee osteoarthritis confirmed by radiography or tomography
* Lequesne Functional Index score of 10-14
* WOMAC-A pain subscale score greater than or equal to 25

Exclusion Criteria:

* History of knee trauma
* History of joint infection
* History of joint surgery
* History of intra-articular injection (viscotherapy)
* History of gastrointestinal diseases
* Use of corticosteroids
* Use of COX-II inhibitors
* Use of glucosamine/chondroitin
* Known sensitivity to paracetamol
* Known sensitivity to non-steroidal anti-inflammatory drugs (NSAIDs)
* Known sensitivity to oral enzymes
Continuous and Non-invasive Measurements by Task Force® CORE/CARDIO in Autonomic Function Testing (AFT)

Background: The investigational device, "Task Force® CORE" (TFC, CNSystems Medizintechnik GmbH, Graz, Austria) together with the "Task Force® CARDIO" (TFCARDIO, CNSystems Medizintechnik GmbH, Graz, Austria) medical device software, is a new CE-marked medical device for continuous non-invasive determination of blood pressure (BP), cardiac output (CO) and derived parameters based on the well established CNAP® (continuous non-invasive arterial pressure) technology by CNSystems.

Aim: The primary aim of this prospective, method comparison, open study is data acquisition for the performance evaluation of the TFC during autonomic function testing in comparison with an clinically accepted reference method. Setting: The setting of the clinical investigation will be the autonomic function testing laboratory at the Department of Neurology, the University Hospital Center Zagreb.

Inclusion criteria: Patients who are over 18 years and who provide written informed consent.

Sample size: The study has an calculated sample size of 70 patients. Considering a drop-out rate of 5%, a total of 75 patients will be included.

Statistics: Descriptive statistics, values for the percentage error and correlation estimates will be derived. Furthermore, scatterplot, Bland-Altman analysis, concordance analysis of parameter changes and further comparative statistics will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (patients aged ≥ 18 years)
* Patients giving written informed consent to participate in the study.
* Patients with intact perfusion of both hands evidenced by a positive Allen's test.
* Patients with orthostatic intolerance will be included

Exclusion Criteria:

* Patients with vascular implants at the sites of non-invasive BP measurement (fingers or upper arms)
* Very low perfusion in the periphery
* Arterial vascular diseases (arteriosclerosis, Raynaud's syndrome, endarteritis obliterans, collagenosis, severely advanced vascular diseases (PAOD))
* Patients with significant edema in the fingers
* Patients with atrial fibrillation
* Patients with valvular disease of grade 2 or above
* Patients with ventricular assist devices
* Subjects not passing the Allen's test for both hands.
* Patients with a large lateral difference in BP (\> 15 mmHg for systolic BP and/or \>10 mmHg for diastolic BP) or with same arm measurement differences \> 10 mmHg in systolic or diastolic BP during assessment of lateral differences
Physician-initiated Medication Review in a Type 2 Diabetes Outpatient Clinic

Aiming to reduce polypharmacy in patients with type 2 diabetes by using physician-initiated medication reviews.

Patients will be randomised to either standard care(annual visit at outpatient clinic) or standard care plus an intervention. The intervention is a medication consultation of 30-60 minutes that consist of a medication review and increased cross-sectoral communication. Follow-up is 6 months. Primary outcome are number of medications used, secondary outcomes are health related quality of life and persistance of medication changes.

Eligibility Criteria:
Inclusion Criteria:

1. DM2
2. 12 medications in the central prescription list

Exclusion Criteria:

1. inability to give written consent (e.g., inability to understand the intervention or language barriers);
2. active cancer or palliative treatment;
3. admitted to the hospital.
Attenuation Imaging in Hepatic Steatosis

For obese and normal-weight children, the investigators assess the diagnostic performance of attenuation imaging (ATI) in the detection of hepatic steatosis in children.


Eligibility Criteria:
Inclusion Criteria:

* BMI of 85th percentile or less

Exclusion Criteria:

* congenital anomaly including heart, intestine, kidney
* acute hepatitis
* congenital hepatic anomaly
CMR in Type 2 Diabetes Mellitus Patients

The study will be performed as a cross-sectional survey. 300 Type 2 diabetes patients (T2DM), with or without known cardiovascular disease, will be recruited from the diabetes outpatient clinic, Slagelse Hospital. The patients will undergo echocardiography, Cardiac magnetic resonance imaging (CMR), clinical examination and will be asked to fill out questionnaires.

This study project sets out to answer the following hypotheses:

1. Patients with T2DM have an increased risk of developing diastolic dysfunction. Using CMR, the investigators wish to measure left ventricle peak filling rate and passive atrial emptying fraction as a measure of cardiac diastolic function. The investigators hypothesize that classic T2DM markers such as levels of urinary albumin excretion, retinopathy, autonomic neuropathy, hypertension, dyslipidemia, elevated HgbA1c, T2DM duration, etc. are associated with pathological findings by CMR.
2. Patients with T2DM have impaired left ventricle myocardial perfusion as determined by gadolinium contrast CMR. The investigators hypothesize that the classic markers and risk factors mentioned above, are associated with left ventricle myocardial hypoperfusion as determined by gadolinium contrast CMR.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patient fully capable of informed consent
* Informed consent
* T2DM
* Age 18-80 (both years included)

Exclusion Criteria:

* Contraindications to CMR (pacemakers/ICD-units, cochlear implants)
* Lack of consent
* Atrial fibrillation
* eGFR \< 30 ml/min/1,73m2 (only exclusion criteria for gadolinium contrast study)
* Women of childbearing potential who are not on acceptable contraception
* Severe claustrophobia (only contraindication for CMR but can undergo echocardiography and other examinations)
* Contraindications to adenosine: history of significant bronchial asthma, 2nd or 3rd degree AV-block, severe hypotension, long QT-syndrome, unstable angina pectoris, sinus node dysfunction, incompensated heart failure
* Contraindications to glycopyrrolate: closed-angle glaucoma, prostate hyperplasia, tachycardia, bladder atony, cardia insufficiency, non-congenital pylorus stenosis and gastroparesis
The Prognostic Role of the Right Ventricle in Patients With Heart Failure or Congenital Heart Disease

The objectives are

1. to validate quantification of 2D and 3D right ventricular strian measurements of right ventricular performance in cross comparison to cardiac MRI and to evaluate its relation to right ventricular fibrosis.
2. to evaluate their prognostic value in patients with heart failure with either depressed or preserved ejection fraction.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patients with heart failure

Exclusion Criteria:

* Renal failure
* Contraindications to Cardiac MRI
Coeliac Disease in the Nord-Trøndelag Health Study (HUNT)

In this study, all citizen of Nord-Trøndelag County, Norway, above 18 years of age are invited to participate in a population-based health study, the HUNT study. Blood samples are drawn from the participants and assessed for celiac disease by a serological assay. Celiac disease is a chronic inflammatory disease of the small intestine due to dietary gluten in wheat, barley and rye. The diagnosis will be verified through endoscopic assessment and biopsies from the small intestinal mucosa. The aims of the study are 1) to establish the population-based prevalence of celiac disease; 2) to assess the consequences of the disease from patient reported outcomes, symptoms, deficiencies, and co-morbidity; 3) to study possible risk factors and environmental triggering events; 4) to identify genetic predictors and gene-environmental interactions.


Eligibility Criteria:
Inclusion Criteria:

* Participants of the forth round of the HUNT study

Exclusion Criteria:

* None
Evaluating Microneedling With CBD and Hempseed Oil for Acne Vulgaris Safety and Efficacy

This is a prospective, single center, open label study to assess the safety and effectiveness of microneedling with CBD and hempseed oil for the treatment of moderate to severe acne in adults 22-years of age or older.The objective of this exploratory study is to evaluate the safety and efficacy of HealMD's CBD with hempseed oil to reduce the appearance of moderate to severe facial acne.


Eligibility Criteria:
Inclusion Criteria:

* Male or non-pregnant, non-lactating female, 22 years of age or older. Females of childbearing potential must agree to the use of a reliable method of contraception throughout the study.
* Have a Global Acne Severity Scale Score of 3 (Moderate), 4 (Severe), or 5 (Very severe).
* Have no plans to begin a new skincare routine or medical treatment program (Accutane) through the course of the study.
* Willing to abstain from any aesthetic or surgical procedure in the treatment area for the duration of the study.

Exclusion Criteria:

* Significant history or current evidence of any uncontrolled chronic or serious disease or medical condition that would, in the judgment of the investigator, would put the subject at undue risk or compromise the study assessments.
* Employees of the Investigator or research center or their immediate family members.
* Inability to understand the requirements of the study and the relative information and are unable or not willing to comply with the study protocol.
* The use of Accutane (Isotretinoin) within 6-months.
* The use of topical or oral therapies that include benzoyl peroxide, azelaic acid, salicylic acid, and hydroquinone 30 days prior to study entry.
* Exposure to any other investigational drug/device within 30 days prior to study entry.
* Sunburned at time of anticipated treatment. Subject must also be willing to avoid significant sun exposure throughout participation
* Recent facial plastic surgery, aesthetic treatment, or dermatological treatment at treatment sites that would interfere with ability to receive microneedling.
* Facial hair that would interfere with the visualization of treatment sites.
* Subject with abnormal vision assessments.
* Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g. due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.
Effects of 5-Aminolevulinic Acid on Glucose Metabolism

This study is designed to evaluate efficacy of 5-aminolevulinic acid in subjects with type 2 diabetes on medication.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetic patients on medication
* HbA1c ≤ 9.0% (as JDS values, which is equivalent to HbA1c ≤ 9.4% as NGSP values)
* On stable treatment of diabetes for at least the last 3 months
* With permission to attend the clinical trial from the primary doctor

Exclusion Criteria:

* On insulin therapy
* BMI ≤ 18 kg/m2 or ≥ 30 kg/m2
* History of porphyria, hemochromatosis, or viral hepatitis
* Pregnant or nursing a child
* Heart disease
* Renal or hepatic dysfunction
* Participation in any clinical trial within 90 days of the commencement of the trial
Evaluation of the Dosing Regimen of Vancomycin in Pediatric Patients

In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine.

In this retrospective registry the investigators wish to verify whether the current dosing regime of vancomycin is leading to the appropriate pharmacokinetic targets in pediatric patients. Therefore data will be collected from all pediatric patients hospitalized in University Hospitals Leuven between January 2012 and April 2014 who were treated with vancomycine. Patient files will be screened for relevant information. Individual patients can be included multiple times if vancomycin has been administered more than once.

Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients hospitalized in the University Hospitals Leuven between January 2012 and April 2014, treated with vancomycin

Exclusion Criteria:

-
Study of the Quality of Sleep of Parents of Premature Children Compared to Parents of Full-term Children

This study evaluate the incidence of sleep disorders in parents of premature children hospitalized in unit care of neonatalogy or intensive unit care of neonatalogy, compared to parents of full-term child in maternity.


Eligibility Criteria:
Inclusion Criteria:

* Couple of parents of children born before term (between 25 and 36 weeks) and hospitalized at the CHRU de Brest.
* Parents of healthy full-term children born at Brest CHRU (\> 37 weeks) without neonatal hospitalization.
* Having formulated their agreement

Exclusion Criteria:

* Parents whose child died in the neonatal period.
* Couple whose one parents are minors at the birth of the child.
* Parents of children with malformation and /or genetic anomaly.
* Parents with known addiction, depressive syndrome or known psychiatric condition before birth.
* Single parent family.
* Non-French speaking parents.
* Refusal of participation of one of the parents.
Systemic Chemotherapy, Lenvatinib Plus Sintilimab for ICC With Distant Metastasis

This study were designed to verify the better method of survival for ICC with distant metastasis. Since the traditional method for ICC with distant metastasis. was GEMOX(first-line treatment from NCCN guideline), our previous study found similar results from FOLFOX (second-line treatment from NCCN guideline) compared with GEMOX.

Our current study were conducted for further investigation to verify the better method for with distant metastasis.

ICC (Intrahepatic CholangioCarcinoma) patients with metastasis has a short survival time and poor prognosis after diagnosis. Treatment methods was few and far from satisfaction. The treatment recommended from NCCN guideline was GEMOX (Systemic Chemotheray) and clinical trials. Our previous study has demonstrate FOLFOX (Systemic Chemotheray based on Oxaliplatin#5- fluorouracil) has a similar survival and tumor response compared with GEMOX. Further study was needed to intensive confirmation of the result. We designed this study to demonstrate the hypothesis. Metastasis ICCs were recruited and screened by our criteria. All patients were treated with FOLFOX (Systemic Chemotheray based on Oxaliplatin#5-fluorouracil ), lenvatinib (one of tyrosine kinase inhibitors) plus sintilimab (one of PD-1 antibody).

Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of Intrahepatic CholangioCarcinoma (ICC)
* With distant metastasis
* Patients must have at least one tumor lesion that can be accurately measured according to mRECIST criteria.
* With no previous treatment
* No Cirrhosis or cirrhotic status of Child-Pugh class A only
* Not amendable to surgical resection ,local ablative therapy and any other cured treatment
* The following laboratory parameters:

Platelet count ≥ 60,000/μL Hemoglobin ≥ 8.5 g/dL Total bilirubin ≤ 30mmol/ L Serum albumin ≥ 32 g/L ASL and AST ≤ 6 x upper limit of normal Serum creatinine ≤ 1.5 x upper limit of normal INR ≤ 1.5 or PT/APTT within normal limits Absolute neutrophil count (ANC) \>1,500/mm3

Exclusion Criteria:

* Evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy
* Known history of HIV
* History of organ allograft
* Known or suspected allergy to the investigational agents or any agent given in association with this trial.
* Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy
* Evidence of bleeding diathesis.
* Patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry.
Comparison of Different Massages Tecniques on Chronic Pelvic Pain

The aim of this study is to investigate and compare the effectiveness of transverse friction and Thiele massage on pain, quality of life and sexual functions in female patients with chronic pelvic pain. The study will be performed on 20 female patients with pelvic floor muscle tenderness, who applied to the Urology Clinic in Istanbul and were diagnosed with chronic pelvic pain.


Eligibility Criteria:
Inclusion Criteria:

Clinical Diagnosis of Pelvic floor muscle tenderness, Clinical Diagnosis of Chronic Pelvic Pain Syndrome

Exclusion Criteria:

Neurological pathologies ( such as hemiplegia, epilepsy, multiple sclerosis and parkinson's disease) Urogynecological surgery in the last 6 months, Severe pelvic prolapse, Pelvic malignancy and pelvic radiotherapy.
The Effect of Ultrasound Guided Visual Biofeedback Performed by Midwifes on the Duration of the Active Second Stage of Labor

The goal of this randomized controlled trial is to investigate whether using of coached sonographic pushing will decrease the length of the second stage of labor and the rate of operative deliveries.

Researchers will compare women who undergo the traditional coached pushing to women who undergo visual biofeedback coached pushing.


Eligibility Criteria:
Inclusion Criteria:

* Singleton pregnancy
* Nulliparous
* 37-42 weeks of gestation
* Under neuroaxial analgesia
* Reached the second stage of labor
* An estimated fetal weight between 2500-4000 grams

Exclusion Criteria:

* Women who arrived in active labor and delivered before being assessed by a physician.
* Women with contra-indications for vaginal birth
Treating Heart Failure With Enhanced External Counterpulsation (EECP)

Enhanced external counterpulsation (EECP) is an outpatient coronary artery disease (CAD) therapy that involves the cyclical inflation/deflation of cuffs wrapped around the lower extremities. However, the possible benefits of EECP in patients with heart failure (HF) (New York Heart Association \[NYHA\] classes II to IV) and cardiomyopathy are unclear.


Eligibility Criteria:
Inclusion Criteria:

* Patients with heart failure (NYHA II-IV)

  1. with optimal medical therapy
  2. caused by ischemic or non-ischemic cardiomyopathy
* EECP-Therapy and Treatment in the Cardio Centrum Berlin or Charité - University Medicine Berlin
* Aged 18 to 100 years
* Offered patient information and written informed consent

Exclusion Criteria:

* Participation in another interventional trial
* Acute coronary syndrome \< 4 weeks prior to enrollment
* Operation \< 4 weeks prior to enrollment
* Stroke \< 4 weeks prior to enrollment
* Clinically significant disease with hospitalization
* Aortic valvular heart disease ≥ moderate
* Aortic aneurysm
* clinically relevant severe cardiopulmonal diseases
* Resting RR \> 160/90mmHg
* Thrombose, Thrombophlebitis \< 8 weeks prior to enrollment
* Peripheral artery occlusive disease ≥ Stadium II
* Acute Heart failure
* Pathological bleeding tendency
* Arrhythmias, which interfere with Triggering of the EECP
* Other diseases, that inhibit EECP-Treatment (e.g. Spinal disc herniation)
* Accommodation in an institution due to an official or judicial order
* Women: pregnancy or lactation
A Study to Evaluate Oral Formulations of Tedizolid Phosphate in Healthy Participants (MK-1986-043)

The goal of the study is to learn what happens to different oral formulations of tedizolid phosphate (MK-1986) in a healthy person's body over time. Researchers want to know if there is a difference in the absorption and elimination of different oral formulations from the healthy person's body.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18.5 and ≤34 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
* Has a history of clinically significant cancer (malignancy)
EMPower Mechanisms

Primary Biliary Cholangitis (PBC) is a chronic liver disease that can cause fatigue, itching, brain fog, and emotional distress, all of which can lower quality of life. While the standard treatment, ursodeoxycholic acid (UDCA), helps slow the disease, it does not relieve these symptoms. Research shows that mind-body practices-such as breathing exercises, meditation, and gentle movement-can help improve mental and physical well-being in people with chronic conditions, but their benefits for PBC are not yet well understood.

This study will test a 10-week online wellness program designed for women with PBC. The program will include guided breathing, meditation, and movement exercises, plus optional weekly group sessions and educational videos. Some participants will also receive nutrition guidance on the Mediterranean diet to see if it adds extra benefits.

The study will evaluate feasibility via recruitment, adherence, and retention. To assess acceptability, participants will provide feedback through surveys and interviews. The study will also explore early signs of effectiveness by measuring changes in symptoms like anxiety, depression, fatigue, and stress, as well as biological markers, brain activity, physical function, and data from wearable devices.

The results will help determine whether an online mind-body program, with or without nutrition support, could be a simple and effective way to help people with PBC manage their symptoms and improve their quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Primary Biliary Cholangitis (PBC) as confirmed by a study Hepatologist using accepted clinical criteria
* Have been on stable medical therapy for PBC for ≥3 months
* Score ≥3 on a 1-10 numeric rating scale for two of: depression, anxiety, fatigue, sleep disturbance, cognitive impairment
* Are able to communicate in English
* Have access to an Internet-connected device in their home
* Can commit to up to 60 minutes of study activities 5 days per week

Exclusion Criteria:

* Unable to provide informed consent
* Have decompensated cirrhosis including hepatic encephalopathy
* Are post-liver transplant
* Current severe substance use or psychiatric disorder judged to interfere with study testing or program participation
* Are receiving compassionate care
* Have a clinical condition that makes the intervention unsafe or infeasible (e.g. unable to follow instruction) or unsafe environment for virtual participation
* Practices mind-body practices more than the study dose
* Have contraindications for MRI
* Have colour blindness
* Are unable to attend baseline testing