cyrilzakka/clinical-trials huggingface dataset:
Results at 10 to 14 Years After Microfracture in the Knee

Articular cartilage lesions are commonly occurring. In a prospective study of 1,000 knee arthroscopies focal chondral or osteochondral defects were found in 19% of the patients (Hjelle 2002). Chronic articular cartilage defects do not heal spontaneously. However, acute traumatic osteochondral lesions or surgically inflicted lesions extending into subchondral bone, e.g. by drilling (Pridie 1959), spongialization, abrasion or microfracture with an angled awl (Rodrigo 1994) causing the release of pluripotent mesenchymal stem cells from the bone marrow, may heal with repair tissue consisting of fibrous tissue, fibrocartilage or hyaline-like cartilage. The microfracture technique causes little damage to the subchondral bone plate and the risk of heat necroses caused by drilling or abrasion is eliminated. The quality of the repair tissue after these bone marrow stimulating techniques depends on various factors including the species and age of the individual, the size and localization of the defect, the surgical technique, e.g., how the subchondral bone plate is treated, and the postoperative rehabilitation protocol. Microfracture has been used in small traumatic defects in young sporting individuals (Steadman 2003) as well as in larger osteoarthritic lesions in older patients (Miller 2004, Steadman 2007). The purpose of the present study was to investigate the long-term clinical outcome 10 to 14 years after microfracture of articular cartilage defects in the knee and possible predictors of good and poor outcomes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic focal full-thickness chondral lesions verified by arthroscopic examination and a minimum of 10-year follow-up.

Exclusion Criteria:

* Exclusion criteria were joint space narrowing (\< 4 mm) on standard antero-posterior x-ray films,
* axial malpositioning,
* ligament instabilities or inability to follow the rehabilitation protocol.
Pelvic Floor Muscle Training to Treat Urinary Incontinence After Radical Prostatectomy

The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.

Urinary incontinence is a well known side effect of radical prostatectomy. The prevalence differs according to time period after the operation and the definition of incontinence used. However, a prevalence of 10-20% have been reported one year after the operation. Pelvic floor muscle training has been suggested as a treatment of urinary incontinence. The aim of this study is to evaluate the effect of pelvic floor muscle training in the treatment of urinary incontinence after radical prostatectomy.We conduct a randomized clinical trial, comparing one group(n=40) following a pelvic floor muscle training program after prostatectomy and one group (n=40) receiving only standard information.Primary outcome variable is self registration of urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Cancer prostata operated (radical prostatectomy)
* Incontinence after separation of catheter
* Understands Norwegian language

Exclusion Criteria:

* Drug/alcohol abuse
A Study of Encapsulated Cell Technology (ECT) Implant for Participants With Early Stage Retinitis Pigmentosa

The purpose of this study is to look at the safety and effectiveness of CNTF implants on vision in persons with retinitis pigmentosa, Usher type II \& III, and Choroideremia. This research is being done because there are no effective therapies for people with these retinal degenerations. They are genetic disorders that affect one's ability to see at night, and later cause tunnel vision and loss of central vision. Retinal degenerations affect the retina, a light sensitive layer of cells in the back of the eye. Slowly over time, these cells die and cause permanent loss of vision.

The implant is a small capsule that contains human retinal pigment epithelium cells. These cells have been given the ability to make CNTF and release it through the capsule membrane into the surrounding fluid. In this study, two different CNTF dose levels will be used: a high dose and a low dose in one eye, as well as a sham (or placebo) surgery in the other eye.

This study will involve about 18 visits over 2½ years for specific tests of the participant's vision and health. These visits may include visual exams, blood draw for laboratory testing, brief medical history and exam, and occasionally a questionnaire (survey), in addition to the visit for the surgical procedures. The primary effectiveness outcome for this study will be a visual field score one year after the implant surgery. There will be about 12 centers participating in this study, and up to 60 people enrolled, across the US. Each participant joining the study who has completed initial screening will then be scheduled to have a brief surgical procedure performed on each eye, one of which will include a very small cell-filled implant. Follow-up visits for repeat assessments will be required regularly to determine if the implant being tested is safe and effective for use to treat retinitis pigmentosa (RP).

Eligibility Criteria:
Study inclusion / exclusion criteria:

Criteria for patients to qualify for the study include, but are not limited to:

* Over 18 years of age, and less than 65 years of age
* Diagnosis of retinitis pigmentosa, Usher Syndrome Type 2 or 3 or Choroideremia
* Visual acuity no worse than 20/63
* Experience with at least two full threshold Humphrey Visual Field 30-2 tests, one completed within the year prior to enrolling in this study

The following criteria will exclude patients from the study:

* Pregnant or lactating females, or females planning to become pregnant during the study or not using an acceptable method of contraception.
* Retinitis pigmentosa caused by a classic syndrome, including Usher Type I
* Other eye diseases including advanced cataract.
* Chronic systemic disease requiring continuous treatment with systemic steroids, immunosuppressive medications or insulin.
Association Between Early Childhood Caries, Low Birth Weight and Nutritional Risk Factors: (Cohort Study)

The aim of this study is to assess the ECC experience in children aged from 12 to 36 month with low birth weight children in comparison to normal birth weight.

Dental caries is on the top list of most widespread chronic diseases in addition to be a major public health issue. Dental caries is the single most common chronic childhood disease; it is 5 times more common than asthma, 7 times more common than hay fever and 14 times more common than chronic bronchitis. Deciduous tooth decay was ranked as the 12th most prevalent condition, affecting 560 million children in the 2015 Global Burden of Disease Study.

Low birth weight and premature birth are highly related to infant mortality, perinatal infections and the poor growth and development of children. Some risk groups have been identified, and attention should be focused on them so that preventive and health promotion measures are taken in an attempt to reverse this situation. One of these risk groups is composed of children born prematurely. Prematurity may be a predisposing factor for the development of caries.

There is a strong relationship between birth weight and infant mortality and morbidity and chronic diseases later in life. Many studies discussed the association between birth weight and dental caries however the results were conflicting. Knowledge of the association between low birth weight and the risk factors of ECC and the associated nutritional risk factors will improve the preventive and health promotion measures for this population.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children.
* Children aged from 12 to 36 month.

Exclusion Criteria:

* Refusal of participation from the parents.
* Medically compromised children
* Major illness
* Child with special needs
* Any systemic disease that may affect caries experience.
* Any congenital deformity that may affect caries experience.
Treatment With High Dose Methotrexate in Patients With Eosinophilic Fasciitis

Evaluate the effect of high dose MTX on skin induration in patients with eosinophilic fascia.

Eosinophilic fasciitis (EF)is a fibrosing skin disorder extensively involving the deep fascia. The aim of this pilot study is to evaluate the effect of high dose MTX on skin induration in patients with EF. In addition, we study the effect of this treatment on joint mobility, peripheral blood eosinophilia, functional ability, and pulmonary function. By administering high dose MTX intravenously every four weeks with a Leukovorin rescue, we hope to induce a more pronounced and sustained effect on the involved skin with less (long-lasting) side effects.

Eligibility Criteria:
Inclusion Criteria:

* Eosinophilic fasciitis as defined by clinical judgement of an expert,
* Histologically confirmed with a skin-fascia-muscle biopsy, and in additon:

  * Either the presence of a modified skin score according to Zachariae of 8 or higher (0-18), regarded as a generalised eosinophilic fasciitis or the presence of severe contractures due to eosinophilic fasciitis lesions.

Exclusion Criteria:

* Age \< 18 yrs
* Contraindications to MTX: AST/ALT level \> 2 times upper limit of normal, WBC count \< 3.5 x 109/l or platelet count \< 150 x 109/l, serum creatinine \> 130 micromol/l or clearance \< 50 ml/min, confirmed by two repeated tests within one month.
* Chronic liver disease, insulin dependant diabetes mellitus, alcohol abuse
* Restrictive pulmonary disease (total lung capacity or vital capacity \< 40% of predicted) or interstitial lung disease (KCO \< 60% of predicted)
* Pregnancy or child bearing potential without adequate contraception
* The presence of any serious co-morbidity or malignancy
* Use of other anti-folate drugs than MTX
The Effect of Ischaemic-reperfusion on the Endogenous Fibrinolysis in Man

Heart attacks are usually caused by a blood clot blocking an artery supplying blood to the heart. Current treatments are designed at relieving this blockage as quickly as possible to minimise damage to the heart muscle. However in restoring the supply of blood local damage known as "ischaemia-reperfusion injury" may occur. The aim of this study is to assess how clot forming and clot dissolving pathways are affected during this process, and examine the role of a natural inflammatory hormone, bradykinin. This will help us to understand the mechanism by which ischaemia-reperfusion injury may occur and to devise new treatments for heart attacks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 18-65 years of ages, non-smokers.

Exclusion Criteria:

* Any concurrent illness or chronic medical condition. Concurrent use of vasoactive medication. Smoking history.
Sleep-related Breathing Disorders in Cardiological Outpatients

The purpose of this study is to determine the prevalence of sleep-related breathing disorders (SRBD) in clinically stable cardiologic outpatients of a German university clinic by means of polygraphy.

Furthermore, the practicability of the underlying diagnostic process in clinical application is assessed as well as the sensitivity and specificity of polygraphy as compared to the reference standard of polysomnography. Another aim is to determine the individual cardiovascular risk profile by pulse wave analysis and risk classification according to European Society of Hypertension (ESH) and European Society of Cardiology (ESC), "ESH/ESC risk".


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Present chronic cardiovascular disease (incl. but not limited to: ischemic heart disease, arterial hypertension, heart failure, atrial fibrillation)
* Current clinically stable state (incl. patients after a cardiovascular-related, emergency hospital admission and subsequent recompensation towards the end of their hospital stay

Exclusion Criteria:

* Age \<18 years
* Acute life-threatening disease (incl. but not limited to:instable angina pectoris, acute bronchial asthma, heart failure New York Heart Association (NYHA) stage IV, myocardial infarction, exacerbated chronic obstructive pulmonary disease (COPD), Malignant disease requiring treatment)
* Pregnancy and/or lactation
* Any medical, psychological or other condition impairing the patient's ability to provide informed consent
Effect of Probiotics in Childhood Abdominal Pain

The purpose of this study is to assess the effect of probiotics in childhood recurrent abdominal pain. Patients will be randomly assigned to receive L. reuteri or placebo for 4 weeks with a follow up phase of additional 4 weeks.

Prospective randomized double-blind placebo-controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Healthy children

Exclusion Criteria:

* Any chronic or organic illness
Evaluation of Quality of Life and Survival With MS-20 in Patient With Advanced Hepatocellular Carcinoma (FDA IND 74572)

To evaluate Quality of Life (QoL) score of MS-20 versus placebo in advanced HCC patients using European Organization for Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire.


Eligibility Criteria:
Inclusion Criteria:

Subjects may be included in the study only if they meet all of the following criteria:

1. Subject aged ≧ 20;
2. Histologically documented, unresectable advanced HCC. For patients with difficulty in obtaining histological diagnosis, a "clinical diagnosis" of HCC is acceptable if all the following criteria are met:

   * Chronic hepatitis B or C with evidence of liver cirrhosis;
   * Presence of hepatic tumor(s) with image findings (sonography, CT scan) compatible with HCC and no evidence of gastrointestinal tumors;
   * Elevated serum α-fetoprotein level ≧ 400 ng/ml;
3. Cancer of the Liver Italian Program (CLIP) score of 3-4;
4. Liver transaminase ≦ 5 times upper normal limits (UNL);
5. Patient fulfilling any of the follow conditions:

   * Refuse to receive aggressive cancer therapy after explained to the subjects the benefits and risks;
   * Progressive malignant disease after previous radiotherapy, percutaneous ethanol injection, radiofrequency ablation, transarterial embolization, transarterial chemoembolization, systemic chemotherapy, immunotherapy, or any experimental therapy, or unable to tolerate such therapy;
   * No treatment of high priority is available;
6. ECOG performance status of 0 - 2;
7. Patients are willing and able to comply with study procedures and sign informed consent.

Exclusion Criteria

Subjects will be excluded from the study for any of the following reasons:

1. Patient with history of HCC rupture;
2. Medical condition requiring anticoagulant or anti-platelet drugs;
3. Patients with brain metastases;
4. Patient unable to receive oral medication;
5. Patients with significant renal function impairment (creatinine\>1.5mg/dl), severe cardiac disease, e.g. angina pectoris, myocardial infarction, cardiac arrhythmia, congestive heart failure (New York Heart Association Functional Classification III and IV) or physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that might render the subject at high risk from treatment;
6. Female subjects of childbearing potential who:

   * are lactating; or
   * have positive pregnancy test (urine) at V2;
7. Active infection or on antiretroviral therapy for HIV disease;
8. Patient with known hypersensitivity to any component of the study medication (soy bean or soy product).
Pharmacokinetics of Liposomal Amphotericin B in Critically Ill vs. Non-critically Ill Hematological Patients: Exploration of Covariates

This prospective study will compare the pharmacokinetic exposure to liposomal amphotericin B between critically ill patients and non-critically ill (hematology) patients in an early and late exposure day.

This phase IV, open label, non-randomized, monocenter pharmacokinetic study will be carried out in critically ill and non-critically ill (hematology) patients receiving multiple dose treatment with L-AmB.

The pharmacokinetic exposure to liposomal amphotericin B in plasma, urine, BAL and ascitic fluid will be compared between the two population groups in an early and late exposure day.

Correlating covariates will be identified to provide a rationale for optimal dosing strategy in critically ill patients.

Eligibility Criteria:
Inclusion Criteria:

* Treatment with L-AmB
* Admitted to an ICU or Hematology ward

Exclusion Criteria:

* DNR 2 or 3
* Pregnant or lactating women
* Previous documentation of intolerance/sensitivity to L-AmB
Oral Nemonoxacin in Treating Elderly Patients With CAP

This study was to evaluate the safety and efficacy of oral nemonoxacin in treating elderly patients (aged ≥ 65 years) with community-acquired pneumonia (CAP).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65 years
* Clinical diagnosis of CAP
* Evidence of inflammatory exudates or infiltrates on chest X-ray

Exclusion Criteria:

* Suspect viral pneumonia, aspiration pneumonia, ventilator-associated pneumonia or hospital-acquired pneumonia
* History of hypersensitivity to quinolone or fluoroquinolone
Supplementary Implants Supporting Conventional Removable Dental Prosthesis (RDPs) in Kennedy Class I

In this study the additional effect of supplementary implants in patients with Kennedy Class I in terms of patient-reported outcome measures (PROMs) and cost-benefit-analyses comparing costs of maintenance care will be investigated


Eligibility Criteria:
Inclusion Criteria:

* Subjects must have voluntarily signed the informed consent before any study action, are willing and able to attend scheduled follow-up visits, and agree that the encoded data will be collected and analyzed
* Males and females with at least 18 years of age
* intraoral situation with bilateral edentulous areas located posterior to the remaining natural teeth (Kennedy class I) in the upper or lower jaw
* remaining dentition includes a first premolar, canine or incisor as the most posterior tooth

Exclusion Criteria:

* Uncontrolled systemic disease that would interfere with dental implant therapy;
* Patients who smoke \> 10 cigarettes per day or tobacco equivalents;
* Patients with alcohol and/or drug abuse;
* Patients with chronic pain;
* Patients with untreated periodontitis and / or inadequate oral hygiene (Plaque Index \< 30%);
* Medical conditions requiring chronic high dose steroid therapy or anti-resorptive treatment;
* Conditions or circumstances, in the opinion of the investigators, which would prevent completion of study participation or interfere with analysis of study results such as history of non-compliance or unreliability.
Evaluation of the WATCHMAN Left Atrial Appendage (LAA) Closure Device in Patients With Atrial Fibrillation Versus Long Term Warfarin Therapy

This was a prospective, randomized, multicenter study to provide additional information on the safety and efficacy of the WATCHMAN LAA Closure Technology. The purpose of the PREVAIL study was to confirm the efficacy endpoint as demonstrated in the PROTECT AF pivotal study and to further demonstrate that the WATCHMAN LAA Closure Technology is safe and effective in subjects with non-valvular atrial fibrillation who require anticoagulation therapy for potential thrombus formation.


Eligibility Criteria:
Key Inclusion Criteria:

* Paroxysmal, persistent or permanent non-valvular AF
* Eligible for long-term warfarin therapy
* Eligible to come off warfarin therapy
* Calculated CHADS2 score of 2 or greater. Also patients with a CHADS2 score of 1 may be included if any of the following apply:

  * Female age 75 or older
  * Baseline LVEF ≥ 30 and \< 35%
  * Aged 65-74 and has diabetes or coronary artery disease
  * Aged 65 or greater and has congestive heart failure

Key Exclusion Criteria:

* Contraindicated/allergic to aspirin
* Indicated for clopidogrel therapy or has taken clopidogrel within 7 days prior to enrollment
* History of atrial septal repair or has an ASD/PFO device
* Implanted mechanical valve prosthesis
* NYHA Class IV CHF
* Resting heart rate \> 110 bpm
* Participated previously in the PROTECT AF or CAP Registry studies

Key Echo Exclusion Criteria:

* LVEF \< 30%
* Existing pericardial effusion \> 2mm
* High risk PFO
* Significant mitral valve stenosis
* Complex atheroma with mobile plaque of the descending aorta and/or aortic arch
* Cardiac tumor
Health-economic Evaulation of Interventional Pain Mangement

To establish the cost per QALY (Quality Adjusted life Years) gained all patients that are referred to a specialized interventional pain clinic are assessed by Euroqol EQ-5D to measure the health-related quality of life at the first visit and then during the following year. Quality of life is calculated from EQ-5D by using hte TTO-validated UK-value set. With this and calculations of the cost we will be able to calculate the cost per QALY-gained which makes it possible to compare interventional pain managment to other treatments for pain patients.


Eligibility Criteria:
Inclusion Criteria:

* All patients

Exclusion Criteria:
Efficacy and Safety of Tanzânia Association in the Treatment of Erectile Dysfunction Associated With Benign Prostatic Hyperplasia

The purpose of this study is to evaluate the efficacy and safety of Tanzânia association in adults with erectile dysfunction associated with Benign Prostatic Hyperplasia.


Eligibility Criteria:
Inclusion Criteria:

* Ability to confirm voluntary participation and agree to all trial purposes by signing and dating the informed consent forms;
* Male participants aged 18 years or more;
* Sexually active participants with a defined partner who have averaged 1 attempt at sexual intercourse per week in the past month;
* Diagnosis of Benign Prostatic Hyperplasia;
* Diagnosis of erectile dysfunction;
* Patients with score between 6 and 25 points in the erectile function questionnaire;
* IPSS (International Prostate Symptom Score) greater or equal to 8 points;

Exclusion Criteria:

* Known hypersensitivity to the formula components used during the clinical trial;
* History of alcohol and/or substance abuse within 2 years;
* Diagnosis of other diseases or conditions in the urinary tract, including but not limited to: cancer, neurogenic bladder; urinary incontinence, recurrent infection, urethral stricture, bacterial prostatitis;
* Clinical evidence of prostate cancer;
* Hypogonadism or absent sexual desire;
* Severe psychiatric or psychosocial disorders;
* Primary erectile dysfunction;
* Polyneuropathy, neurodegenerative diseases, trauma or spinal cord injuries, central nervous system tumors or other conditions that may affect erections;
* Anatomical penile deformation that can significantly impair erection, including but not limited to: angulation, cavernous fibrosis, Peyronie's disease.