cyrilzakka/clinical-trials huggingface dataset:
Comparison of Autologous Platelet-rich Plasma With Hyaluronic Acid for the Treatment of Osteoarthritis of the Knee Joint

The purpose of this study is to compare the efficacy of platelet-rich plasma versus hyaluronic acid intra-articular injections for the treatment of osteoarthritis of knee joint.

The hypothesis is that PRP intra-articular injection is comparable or even better than hyaluronic acid injection.

Osteoarthritis (OA) has a significant impact on our society. The limited regenerative capacity of cartilage is part of this problem. Existing degenerative lesions lead to accelerated deterioration of the articular (joint) surface leading to end-stage arthritis. In particular, the most recent knowledge regarding tissue biology highlights a complex regulation of growth factors (GFs) for the normal tissue structure and the reaction to tissue damage. The influence of GFs on cartilage repair is now widely investigated in vitro and in vivo. Platelet Rich Plasma (PRP) is a simple, low- cost and minimally- invasive method that allows one to obtain a natural concentrate of autologous GFs from the blood, and it is increasingly applied in the clinical practice to treat knee degenerative pathology, such as chondropathy and early OA. The biological rational of PRP is that platelets contain storage pools of GFs, cytokines, chemokines and many other mediators.Although its widespread application, there are little high level studies in the literature to demonstrate the real efficacy of PRP.

The investigators hypothesized that intra-articular injections of PRP to treat knee osteoarthritis could determine pain relief and recovery of knee function with overall clinical outcome comparable or even better than viscosupplementation, which is a common injective approach applied in this kind of pathology. To this purpose the investigators designed a double blind randomized controlled trial comparing PRP vs viscosupplementation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with osteoarthritis of knee (by American College of Rheumatology Criteria) and Kellgren-Lawrence grade I \~ III
* More than 40 out of 100-mm VAS scale for pain at screening and baseline
* Participant is willing and able to give informed consent for participation in the study

Exclusion Criteria:

* Patients with Hb values \< 10 g/dl and platelet values \< 100,000/ul
* Patients with a current or medical history of autoimmune disease
* Recent fever ( within 2 weeks) or serious illness
* Local infection at the site of the procedure
* Corticosteroid injection at treatment site within 1 month
* Systematic use of corticosteroids within 2 weeks
* Female participants who are pregnant, lactating or planning pregnancy during the course of the study
* Patients who have been administered with immunosuppressants within the past 6 weeks
* Patients who are enrolled in any other clinical trials within 4 weeks
* Patients who the principal investigator considers inappropriate for participation in the clinical trial for reasons other than those listed above
Promoting Physical Activity in Patients With Type 2 Diabetes (DIAfit)

The aim of this study is to evaluate the effects of a physical activity intervention in patients with type 2 diabetes in a community setting.

The aim of this study is

1. to evaluate the effects (before and after) of a physical activity program (DIAfit program) which contains 36 sessions of structured PA and also encourages unstructured PA in an unselected population of patients with type 2 diabetes independent of the selected variant of the program
2. to compare the effects of a standard DIAfit program (3 times per week for 12 weeks) with and alternative program which suggests a more progressive PA activity intensity (starting with one PA session per week during 4 weeks and then twice a week over a period of 16 more weeks (20 weeks total). In total the program also consist of 36 sessions)

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes

Exclusion Criteria:

* Orthopedic complications
* Diabetic foot ulceration
* "Active " cardiac (ischemia during the exercise test) or stade III peripheral vascular disease
* Untreated proliferative retinopathy
* Autonomic neuropathy
* Active psychiatric, neurological, orthopedic, muscular or rheumatic disease interfering with a participation in a physical activity program
* Pregnancy
Bronchial Hyperreactivity in Children With Crohn Disease

Background: Latent pulmonary involvement is described in Crohn Disease(CD). Bronchial hyperreactivity measured by the Methacholine Challenge Test (MCT) has been evaluated in two studies involving mainly adults.Our aim was to determine the frequency of bronchial hyperreactivity in pediatric patients followed and treated for Crohn disease.

Methods: Twenty-three children with Crohn disease completed a questionnaire, followed by spirometry, Methacholine Challenge Test (MCT) and determination of Fractional Exhaled NO (FENO). The control group included patients evaluated for functional cough who had negative Methacholine Challenge Test (MCT).


Eligibility Criteria:
Inclusion Criteria:

* Children with Crohn disease
* Children that can perform lung function tests (MCT)

Exclusion Criteria:

* Upper respiratory tract infection last month
* Fever or Pneumonia last month
* Smoking
* Other chronic diseases
* Other respiratory diseases
Minimally Invasive Versus Conventional Approaches in Navigated Total Knee Arthroplasty (TKA)

50 patients are randomized to two groups who receive a navigated knee prosthesis. Aim of the study is a comparison between a minimally invasive and a conventional approach. In both groups OrthoPilot computer assisted-navigation will be used. Pain intensity as well as concomitant pain medication are monitored during the first 20 postoperative days and will be compared for the two groups. Various scores are surveyed.

Accuracy of implant positioning and reconstruction of the mechanical leg axis are major requirements for achieving good long-term results in total knee arthroplasty (TKA). A minimally invasive approach might compromise the accuracy due to lacking intraoperative oversight. The purpose of this study is to compare a minimally invasive TKA approach that was performed under control of a navigation system with a standard navigated approach, with respect to patient pain and range of motion.

All patients receive a Columbus knee prosthesis and in both groups an OrthoPilot navigation system is used to control the alignment. Pain intensity using the Visual Analogue Scale (VAS) and concomitant pain medication intake are documented daily during the first 20 days after operation. As long as the patient is hospitalized the Range of Motion will also be documented daily. Knee society score, oxford score, as well as the WOMAC score are monitored pre- and postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* Indication for elective TKA
* agreement to participate in this study

Exclusion Criteria:

* Body Mass Index (BMI)\>40kg/m²
* varus or valgus deformity \>20°
* Range of Motion (ROM) \<75° flexion/extension
* concomitant diseases like: rheumatoid arthritis osteoporosis intake of cortisone diabetes former operations on the concerned knee
* infections in the operated joint during the follow-up period
* Thromboses during the follow-up period
A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.

To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

A multicentre, 1:1 randomised, double blind, double dummy, two arm parallel group phase III study comparing a dual modified release FK506E (MR4) / steroid regimen with a standard tacrolimus FK506 / steroid regimen.

Eligibility Criteria:
Inclusion Criteria:

* Patients receiving a primary, split liver or a whole liver graft from a cadaveric donor with compatible ABO blood type.

Exclusion Criteria:

* Patients receiving a multi-organ transplant or having previously received an organ transplant (including liver re-transplantation).
* Patients with severe diarrhoea, vomiting, active peptic ulcer or gastrointestinal disorder that may affect the absorption of tacrolimus.
* Patients with serum creatinine \> 200 µmol/l..
Use Peripheral Blood Proteomics to Predict the Treatment Response and Toxicities in NSCLC Immunotherapy

Peripheral blood contains enormous quantity of biological information that can improve our patient care. Investigators plan to use proteomics from serum to study its value in predicting the therapeutic response and toxicities of immunotherapy in non-small cell lung cancer (NSCLC).

An extra tube of blood for research will be collected from consented subjects prior to the initiation of anti-PD-1/L1 based immunotherapy, either single agent or in combination with chemotherapy. The blood will be coded, processed and sent for analysis. Results of analysis will be correlated with clinical data to see whether serum proteomics can be a good therapeutic predictor for future studies and treatments of NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Non Small Cell Lung Cancer (NSCLC) patients who were previously untreated receiving anti-PD1 or anti-PD-L1 therapies, either single agent or in combination with chemotherapy.
* NSCLC patients who were treated with one previous line of therapy (not containing IO) and now receiving anti-PD1 or anti-PD-L1 therapies, either single agent or in combination with chemotherapy.

Exclusion Criteria:

* Patients not capable of making medical decisions
* Any patients who do not meet the inclusion criteria
Description of Treatment Patterns and Population Characteristics of Pre-dialysis CKD Patients in the Czech Republic

The decision making in the Czech nephrology offices depends on the local common practice which is likely to be heterogenous. In other words, the same patient would be indicated to different therapy and regimen at different sites. To date, the practices and treatment paths have not been described. The aim of the present epidemiological research is to characterize the population of CKD patients at the point of treatment choice and to outline the motivation of nephrologist to initiate particular therapy.

This is epidemiological (observational) cross-sectional survey. Data for the research will be obtained from clinical records and patient´s questionnaires and transcribed into electronic case report forms (eCRF) by physician anonymized using subject ID.

This observational research will not impose any additional procedures, assessments, or changes in addition to the routine management of subjects.

The research does not aim to follow treatment with a single medicinal product. The management of patients will be described in general terms. Names of active substances will be collected rather than the names of individual products.

Eligibility Criteria:
Inclusion Criteria:

* Adult patient of 18 years and older
* Signed consent with processing of personal data as per the GDPR and the applicable national legal requirements
* Chronic kidney disease (CKD) category 4 to 5 characterized by GFR \< 30 ml/min/1.73m2 for at least 3 months

Exclusion Criteria:

* Patients on chronic dialysis
* Patient waiting for kidney transplant
* Patient requiring indication of dialysis (e.g., life-threatening changes in fluid, electrolyte, and acid-base balance, serositis, pruritus, inability to control blood pressure, lethargy or other changes in mental status, symptoms of uraemia, GFR \< 10 ml/min/1.73 m2)
* Patient with altered mental state unable to fill patient questionnaires
A Long-Term Monitoring Study of the IMT-002 Patients

This is a 5-year study of patients implanted with the Implantable Miniature Telescope (IMT by Dr. Isaac Lipshitz) under Protocol IMT-002. All patients implanted with the telescope prosthesis who enrolled in the IMT-002 trial were asked to participate in this study to monitor long-term safety. Patients will undergo examinations at six-month intervals up to a total of 5 years following implantation.

Every 6 months, manifest refraction, visual acuity, intraocular pressure, slit lamp examination, endothelial cell density, device failures, complications and adverse events will be assessed.

Eligibility Criteria:
Inclusion Criteria:

* Patients must have participated in the IMT-002 trial.
* Patients must be able to understand and comply with the requirements of the clinical study, and be able to abide by the requirements and restrictions of the study.
* Patients must be able to provide voluntary informed consent, and must sign and be given a copy of the written Informed Consent form.

Exclusion Criteria:

* Patients who have not participated in the IMT-002 trial.
A Study Comparing the Effects of Famotidine Pretreatment and of Food on the Relative Bioavailability of BMS-986165 in Healthy Volunteers

The primary purpose of this study is to evaluate the effects of food and pH on the relative bioavailability (BA) of the tablet formulation of BMS-986165 in healthy volunteers


Eligibility Criteria:
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Body mass index of 18.0 kg/m\^2 to 32.0 kg/m\^2, inclusive, and body weight ≥ 50 kg, at screening
* Male and female paritcipants, aged 18 years, or age of majority, to age 55 years, inclusive
* All female subjects must have a negative serum or urine pregnancy test

Exclusion Criteria:

* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease.
* History of administration of live vaccines within 60 days before screening until clinic discharge
* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population

Other protocol-defined inclusion/exclusion criteria could apply
Markerless Image Guidance Using Intrafraction Kilovoltage X-ray Imaging

This trial will investigate the feasibility of the Markerless Tumour Tracking technology.

Markerless Tumour Tracking will be integrated with existing treatment machines to provide real-time monitoring of tumour motion during treatment delivery. Eligible patients will be implanted with fiducial markers, which act as the ground truth for evaluating the accuracy of Markerless Tumour Tracking. The patients will undergo the current standard of care radiotherapy, with the exception that kilovoltage x-ray images will be acquired continuously during treatment delivery to enable Markerless Tumour Tracking.

Eligibility Criteria:
Inclusion Criteria:

* Is willing to comply with all trial procedures and intends to provide written Informed Consent for participation in this trial.
* Patients undergoing external beam radiotherapy.
* Histologically proven Stage I NSCLC or oligometastatic lung metastases (3 or less).
* MRI/4D-CT prior to insertion of fiducial markers.
* Patient must be able to have fiducial markers placed in the lung (if on anticoagulants, must be cleared by LMO or cardiologist).
* ECOG performance status 0-2.
* A maximum of three metastases to the lung from any non-haematological malignancy. Multiple metastases will be treated separately.
* 1 cm ≤ Tumour diameter in any dimension ≤ = 5 cm.
* The distance between the tumour centroid and the top end of the diaphragm is \<=10 cm.

Exclusion Criteria:

* Patient has low respiratory performance as evaluated by the physicians.
* Previous high-dose thoracic radiotherapy.
* Less than one fiducial marker implanted in the lung.
* Fiducial markers are too far from the tumour centroid (\>9 cm).
* Cytotoxic chemotherapy within 3 weeks of commencement of treatment, or concurrently with treatment. Hormonal manipulation agents are allowable (e.g. aromatase inhibitors, selective oestrogen receptor modulators, and gonadotropin releasing hormone receptor modulators).
* Targeted agents (such as sunitinib, bevacizumab and tarceva) within 7 days of commencement of treatment, or concurrently with treatment.
* Women who are pregnant or lactating.
* Unwilling or unable to complete quality of life questionnaires.
Gastrointestinal Transit Time in Patients With Guillain-Barré Syndrome

Constipation is a common condition among patients with Guillain-Barré Syndrome. It is believed, that the constipation is caused by autonomic neuropathy. However, the severity of the constipation, and its relation to autonomic function have not previously been studied.


Eligibility Criteria:
Inclusion Criteria:

* Guillain-Barré Syndrome
* Ability to swallow the capsules used to assess GITT
* Ability to give meaningful informed consent to participate in the study

Exclusion Criteria:

* Major abdominal disorders
* Severe acute comorbidity
* Known cancer
* Pregnancy
* Other known neurological disorder
* Use of laxatives one week before inclusion. (Patients will be excluded if medication with laxatives is started during the one week GITT measurement)
Efficacy and Safety of Levocetirizine and Fexofenadine in Reducing Symptoms of Seasonal Allergic Rhinitis

No information was yet available over the effect of levocetirizine in children under 12 years. The aim of this double-blind, placebo-controlled study was to assess the efficacy and safety of levocetirizine in children from 6 to 12 years old with perennial allergic rhinitis due to house dust mites.


Eligibility Criteria:
Inclusion Criteria:

* adults 18 to 55 years both inclusive
* suffering at least 2 years of seasonal allergic rhinitis due to grass pollen
* positive RAST and/or positive skin prick test
* comply with study restrictions

Exclusion Criteria:

* known alcohol or drug addiction or abuse
* known allergy/intolerance to lactose, cellulose, cornstarch
* presence of nasal anatomical deformities leading to \> 50% obstruction
* ENT infection within 30 days of the study
* use of disallowed medication
* ongoing desensitization
* known cardiac, renal or hepatic dysfunction
* presenting allergic bronchial asthma
* use of cimetidine
* intending to donate blood during the trial
Music Pacing in Pediatric Exercise Testing

Study hypothesis: Music pacing improves the quality of exercise testing in children.

Children tend to cycle in a non-constant pace during exercise testing, which might make the test less reliable.

20 boys will perform two exercise tests on a cycle ergometer. One test will be done with constant tempoed music, and the other without. Different parameters will be checked including pedaling cadence, aerobic fitness, level of work load obtained.


Eligibility Criteria:
Inclusion Criteria:

* male sex
* currently and generally healthy

Exclusion Criteria:

* presence of chronic disease/ medication use
* BMI above 85%
* trained/competitive cyclists
Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot

the investigators want to obtain a functional and radiological outcome of peroneus brevis, tertius and extensor digitorum longus muscles lengthening together with calcaneal osteotomies in the treatment of the spasmodic flat- foot.

One of the most common foot complaints is the "flatfoot" deformity. Clinical evaluation of flatfeet primarily focuses on differentiation between the two main types: flexible and rigid. The rigid flatfoot deformity is an uncommon diagnosis (occurring one-third as often as the flexible type) but often is symptomatic and requires treatment". Multiple causes of rigid flatfeet have been identified such as rheumatoid arthritis, tarsal coalitions (being the most common cause) that are excluded from that research. Triple arthrodesis is used for treatment of rigid flat foot but the patient satisfaction is not good as there is some stiffness in the foot .but here the investigators want to know what is the effect of extensor digitorum longus, peroneus brevis and tertius lengthening together with osteotomies in alignment of spasmodic flat- foot. In patient with rigid flat- foot or spasmodic flat- foot will often have the hind-foot alignment to the outside. Alignment of the heel influences how weight-bearing stress is applied to the foot, ankle, knee and hip. So, these patients may benefit from the calcaneal osteotomies and extensor digitorum longus, peroneus brevis and tertius lengthening to improve that alignment.

Eligibility Criteria:
Inclusion Criteria:

* Painful, incorrectable pes Plano valgus after failure of conservative treatment
* Age: patients with skeletally mature foot as proved by x-ray

Exclusion Criteria:

* coalition bar
* Ankle subtalar joint arthritis.
* Previous foot fractures.
* Severe trophic skin disorders
* Standard contraindications to any surgery such as poor circulation, concurrent infection, other co-morbidity".
Cardiopulmonary Adaptations to High-intensity Interval Training (HIIT) in COPD

The aim of this prospective randomised controlled trial in which the impact of high intensity interval training (HIIT) on pulmonay blood volume, pulmonary gas exchange during exercise, and lung tissue mass.

The primary objective is to investigate whether 6 months of supervised HIIT leads to an increase in pulmonary blood volume in patients with COPD with a concomitant improvement in pulmonary gas exchange.

Key objectives are to determine whether an increase in pulmonary blood volume is associated with the formation of new lung tissue. Other secondary objectives include investigating the effect of supervised HIIT on formation of lung tissue, symptom severity, pulmonary gas exchange at supine rest and on pulmonary blood volume at rest. Finally, exploratory objectives include investigating the effects of HIIT on lung function, V̇O2peak, functional outcomes, body composition, blood samples and cardiac output.

Participants will be randomly allocated (1:1) stratified by sex to either

1. 24 weeks of HIIT training consisting of 3 weekly supervised exercise sessions or
2. A control group who will not undergo HIIT training. The control group will be encouraged not to change their exercise or eating habits.

The participants will visit the clinic pre- and post the intervention. Exercise habits, adverse events, hospital admisseions, infections and medications will be assessed by phone at week 4, 8, 12, 16, 20 and at follow-up visit. All participants will undergo 24-h accelerometry for five consecutive days to measure posture allocation and daily physical activity behavior. The devices will be attached just before the randomization, after one month, at 12 weeks and just before the 6 months testing.


Eligibility Criteria:
Inclusion criteria

* Men and women
* Age \>=40 and \<80 years
* COPD (GOLD stage I to III)
* Modified Medical Research Council score (mMRC) of 0 to 3
* Resting arterial oxygenation \> 90% Exclusion criteria
* Symptoms of ischaemic heart disease
* Known heart failure
* Unable to complete or understand HIIT training
* Claudication
* Symptoms of disease within 2 weeks prior to the study
* Participation in pulmonary rehabilitation within 3 months
* Known malignant disease
* Pregnancy
* Unstable cardiac arrhythmic disease
* Renal or liver dysfunction

  * Known chronic kidney or liver disease
  * Elevated creatinine, urea, alanine transaminase (ALAT), aspartate transaminase (ASAT), bilirubin, basic phosphatases at blood test
* Completion of pulmonary rehabilitation within the last 3 months