cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Exercise on Quality of Life and Physical Function in Patients With Knee Osteoarthritis

The overall contribution of this study is to increase the knowledge of the efficacy of strength and aerobic exercise on knee related quality of life, knee pain, and physical function in patients with knee osteoarthritis (OA). Knee OA is one of the most important diseases within musculoskeletal conditions affecting a considerable number of people worldwide. This randomized controlled trial will involve one intervention group delivered strength exercises and one group delivered aerobic exercise (ergometer cycling). The two intervention groups will be compared to a control group undergoing usual care. Cost-effectiveness analysis will be performed comparing the three groups. The study is funded from The Research Council of Norway.

The trial aimed to recruit 207 study participants randomly allocated to three arms. The participants had to have symptomatic knee osteoarthritis verified by grade 2-3 using the Kellgren and Lawrence radiographic classification system, and they had to have knee pain most of the days the last month and fulfil 2/3 of the ACR clinical criteria. Participants with other serious comorbidities or self-reported BMI \>35 were included.

The interventions consisted of structured strength training program over 12-14 weeks, and a structured stationary cycling program for 12-14 weeks.

Primary outcome was the KOOS knee-related quality of life subscale at the 1 year follow-up. Secondary outcomes were other patient reported outcomes, muscle strength, and peak oxygen consumption at the 4-month and 1 year follow-up, and over time (1-year).

Eligibility Criteria:
Inclusion Criteria:

* Women and men aged 35-70 years
* Clinical knee OA according to the American College of Rheumatology Clinical Criteria
* Kellgren and Lawrence radiographic OA grade 2 and 3 (mild to moderate radiographic OA)

Exclusion Criteria:

* Severe knee OA according to the Kellgren and Lawrence classification (grade 4)
* Other known major musculoskeletal impairments in the lower extremities or the back or prostheses in any joint of the lower extremities
* Known coronary heart diseases or cancer
* Body mass index \> 35
* Scheduled for surgery in any joint
* Known mental or psychologic diseases
* Known drug abuse
* Persons who already perform sports related moderate physical activity more than two times a week
* Contraindications for magnetic resonance imaging (specific point list at Oslo University Hospital, radiographic department)
* Not speaking Norwegian language
Follow-up of Patients With Uveal Melanoma Adapted to the Risk of Relapse (SALOME)

Biomarkers search for early diagnosis of liver metastases in patients with uveal melanoma who benefit from a follow-up tailored to their personalized risk of relapse.

High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule :

(i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines).

(ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucleated cells will be isolated and preserved for bio-markers research.

* M0 : during the first medical oncology visit.
* At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120).
* At the diagnosis of metastasis.
* At each significant event during the metastatic disease (surgery, treatment response or progression).

Eligibility Criteria:
Inclusion Criteria:

1. Patient aged of 18 years or more.
2. Patient with uveal melanoma with high metastatic relapse risk defined as :

   * T2b/c/d ou ≥ T3,
   * or chromosom 3 or chromosom 8 abnormality by CGH array.
3. Completion of treatment of the primary tumor ≤ 2 months.
4. Patient able to comply with the schedule of visits and blood samples of the study.
5. Signed informed consent form or legal representative.

Exclusion Criteria:

1. Patient without french social insurance.
2. Any social, medical or psychological condition making the research process impossible.
A Phase 2 Trial of Antisense Nucleotide to PKC-Alpha (LY900003, ISIS 3521) Plus Gemcitabine and Carboplatin in Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer.

The purposes of this study are to determine the following:

Whether LY900003 plus gemcitabine and carboplatin can make your tumor smaller or disappear, and for how long.

If treatment with LY900003 plus gemcitabine and carboplatin can help you live longer.

The safety of LY900003 plus gemcitabine and carboplatin and any side effects that might be associated with the combination of these three drugs.

How LY900003 is distributed and broken down by your body when it is given with carboplatin and gemcitabine.

Whether LY900003 affects the way gemcitabine and carboplatin are distributed and broken down by your body.

Definition: The phase 2 study will provide important information regarding effects of LY900003 on safety and efficacy of patients treated with gemcitabine and carboplatin. LY900003 will be given at approximately 2 mg/kg/day for the first 14 days of a 21-day cycle. The dose and schedule for LY900003 administration are based on results of prior studies of LY900003 and are currently being used in other studies of LY900003. Gemcitabine will be administered on Days 1 and 8 at 1250 mg/m2 and carboplatin will be given on Day 1 at AUC 5.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Non-Small-Cell Lung Cancer.
* Stage IV or Stage IIIB disease.
* ECOG Performance Status of 0 or 1.
* Adequate organ function
* One unidimensionally measurable lesion.

Exclusion Criteria:

* Prior therapy for NSCLC.
* Serious concomitant disorders.
* Untreated CNS metastases.
* Uncontrolled, active infection.
* Previous LY900003/ISIS trial participation.
Messages About Reduced Nicotine in Combusted Tobacco Products

The investigators will conduct a message-exposure experiment with nationally representative samples of smokers, dual-users (cigarettes and e-cigarettes), and young adult non-smokers (aged 18-29).

Experimental messages will address the reduction of nicotine in cigarettes. Participants will also complete a follow-up survey after 2 weeks, measuring their recall of the messages and behaviors since message exposure.

A national probability-based sample will be recruited to include 900 current exclusive smokers, 450 dual users, and 450 young adult (18-29) non-smokers, evenly split between men and women.

The study will be conducted using a self-administered, online questionnaire via proprietary, web-assisted interviewing software.

Participants are randomized to one of four conditions:

* reduced nicotine messages
* modified risk messages
* a combination of reduced nicotine message and modified risk message
* control messages with no cigarette-related content

Participants will take part in two sessions: in session 1 (estimated at about 15 min) participants will see the messages and report immediate outcomes including risk perceptions.

In session 2, which will take place 2 weeks after session 1, participants will complete a brief 5-minute survey measuring their recall of the messages and behaviors since message exposure.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years old or older:
* Belonging to one of three groups of participants; 900 current exclusive smokers, 450 dual users (cigarettes and e-cigarettes), and 450 young adult (18-29) non-smokers, evenly split between men and women.
* Enrolled in existing nationally representative panel where recruitment is based

Exclusion Criteria:

- None.
Ofloxacin vs. Gentamicin as Prophylaxis Prior Transrectal Biopsy of Prostate

Prostate biopsy is usually conducted transrectal, ultrasonography guided. Since the area is not sterile, infection can be induced during the procedure.

Prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of infections. Quinolones are considered preferred treatment but there is already an increase in resistance rates. TMP-SMX can not be used empirically due to a high percent of resistant uropathogens. One of the options is aminoglycosides, especially gentamicin. Advantages: very low resistance rate in the community, high concentration is urinary tract, slow clearance, no resistance developed under treatment, chip and with very few side effects.

Prostate biopsy is usually conducted as an ambulatory transrectal needle aspiration, ultrasonography guided. The area is not sterile, with high concentration of gram-negative and anaerobic pathogens, infection can be induced during the procedure to the urinary tract, and even cause bacteremia.

Prior studies concluded that prophylaxis antibiotic against gram-negative bacteria decreased significantly the amount of infections and hence it is accepted to give prophylaxis antibiotics which will cover especially gram-negative bacteria. Other studies show decrease in infections percent in patients that received prophylaxis opposed to those who did not, from 5-30% to less than 1%. Yet, there was no significant difference between those who received one dose and those who were treated for 3-5 days. Quinolones are considered preferred treatment since they can be given orally, but there is already an increase in resistance rates. TMP-SMX can not be used empirically due to a high percent of resistant uropathogens. One of the options is aminoglycosides, especially gentamicin. Advantages: very low resistance rate in the community, high concentration is urinary tract, slow clearance, no resistance developed under treatment, chip and with very few side effects.

Eligibility Criteria:
Inclusion Criteria:

* Patients going under transrectal biopsy of prostate with sterile urine culture.

Exclusion Criteria:

* Urine culture not sterile
Resilience and Quality of Life in Patients With Gynaecological Carcinomas and Chronic Gynaecological Diseases

The intended pilot project aims at evaluating the feasibility and acceptability of questionnaires about resilience and quality of life in two different patient groups (either with a gynaecological carcinoma ora chronic gynaecological disease). The results provided by this pilot study will build the basis of an upcoming, larger project including these questionnaires and the main objective of assessing resilience. More precisely, the study aims at answering the following questions. How is the overall resilience and quality of life in the target population at one assessment point? Are the instruments used in this pilot feasible for the target population when assessing resilience and quality of life?


Eligibility Criteria:
Inclusion Criteria:

* female,
* \>18 years old,
* german speaking

exclusion criteria:

- insufficient study language skills
Prevention of Arrhythmia Device Infection Trial (PADIT)

The goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce CIED infection rate compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics used are approved for use and readily available.

This is a randomized prospective cluster crossover trial to track outcomes of high infection risk patients undergoing arrhythmia device procedures. Centres will be randomized to either conventional antibiotic therapy or incremental antibiotic therapy. Patients will not be randomized. Centres will be randomized to one therapy and then cross over to the next after 6 months. At one year they will randomize again and then cross over for the final time at 18 months. During each treatment period the randomized antibiotic therapy will be used on all centre patients undergoing a device implant procedure.

Ethics approval has been obtained in all sites for waiver of consent with notification of the study (i.e. data collection is taking place to track infection rates). A third of sites obtain consent after the procedure for collection of data (but not for care, since either arm is the standard of care).

Eligibility Criteria:
Inclusion Criteria:

1. Age \>= 18 years
2. Received one of the following procedures:

   1. A second or subsequent procedure on the arrhythmia device pocket:

      ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement
   2. Pocket or lead revision
   3. System upgrade (insertion or attempted insertion of leads)
   4. New cardiac resynchronization therapy device implant (pacemaker or ICD)
3. Patient is not known to have device infection at the time of the surgery
A Prospective Study of Cabazitaxel in Patients With Non Seminomatous Germ-cell Tumors

Cabazitaxel is a new generation taxane with a high capacity for blood-brain barrier crossing and limited peripheral neuro-toxicity, two major potential advantages in patients with advanced NSGCTs.

Cabazitaxel has a broader in vitro spectrum of activity than docetaxel. Taxanes have demonstrated activity in pre-treated GCTs and are now part of standard treatment, but cabazitaxel has not yet been tested in patients with NSGCT.


Eligibility Criteria:
Inclusion Criteria:

* Male patients aged 15 years or older
* Evidence of advanced NSGCT documented either by pathology or by elevated tumor markers (AFP or hCG) and a compatible clinical presentation
* Primary site located in either the testis, the retroperitoneum or the mediastinum
* Progressive disease after at least 2 lines of chemotherapy for advanced NSGCT (ie, non-stage I)
* In case of brain metastases, confirm that patients should be stable / controlled with corticosteroid/anti seizures agents
* No other progressive carcinoma within previous the 5 years, except for basal-cell carcinoma of the skin
* Life expectancy \>/= 3 months
* Adequate hematologic function :
* Hemoglobin \>/= 10.0 g/dL
* Absolute neutrophil count \>/= 1.5 x 10 \^ 9/L,
* Platelet count \>/= 100 x 10 \^ 9/L,
* Adequate organ function
* Serum creatinine \< 1.5 x ULN. If serum creatinine 1.0 - 1.5 x ULN, creatinine clearance calculated (or measured) according to CKD-EPI formula (see Appendix B) \> 60 mL/min
* AST/SGOT and ALT/SGPT \</= 1.5 x ULN
* Bilirubin \</= 1.5 x ULN
* Information delivered to patient and informed consent form signed by the patient or his legal representative
* Patient affiliated to a social security system or beneficiary of the same

Exclusion Criteria:

* Patients receiving anti cancer therapy within 4 weeks prior to enrolment
* Previous radiotherapy within 4 weeks prior to enrolment
* Serious uncontrolled concurrent medical illness
* History of severe hypersensitivity reaction (\>/= grade 3) to polysorbate 80 containing drugs or to other taxanes
* Concurrent or planned treatment with strong inhibitors or strong inducers of cytochrome P450 3A4/5 (see Appendix A). A one week wash-out period is necessary for patients who are already on these treatments.
* Patient with reproductive potential not implementing accepted and effective method of contraception for up to 6 months after the last dose of cabazitaxel.
* Active Grade \>/= 3 peripheral neuropathy
* Patients who have had a major surgery within 4 last weeks prior enrolment
* Uncontrolled cardiac arrhythmias, angina pectoris, and/or hypertension. History of congestive heart failure (NYHA III or IV) or myocardial infarction within last 6 months is also not allowed
Colour Coded Duplex Ultrasound of Native Arterio-venous Fistula for Haemodialysis With Venous Pressure Measurement Using Controlled Compression Ultrasound as a Predictor for Shunt Maturation in the Early Postoperative Phase

Prospective observational ultrasound study of native arterio-venous fistula for haemodialysis with venous pressure measurement using controlled compression ultrasound.


Eligibility Criteria:
Inclusion criteria:

* Patients after creation of a native arterio-venous fistula at the cephalic vein for hemodialysis access;
* Informed consent.

Exclusion criteria:

* Former creation of a native arterio-venous fistula at the same arm;
* Known upper extremity occlusive arterial disease;
* Situation when ultrasound examination is not suitable: extreme swelling of the arm, post-operative pain, hematoma, local infections.
Mindfulness Training Versus Low (FODMAP) Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols Diet

The study aims to compare the effect of mindfulness-based awareness training in Irritable Bowel Syndrome (IBS) (MB-IBS-EAT) with the dietary standard of care (low fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet) on patient's IBS symptoms

This pilot study will be a randomized parallel trial comparing MB-IBS-EAT done over an 8-week period to a standard low FODMAP diet. The low FODMAP diet is currently employed by clinicians as a treatment for IBS, but response rates are poor, without documented long-term benefit. This finding supports the need for better, longer lasting interventions.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 and over
* Meets Rome IV criteria for diagnosis of Irritable Bowel Syndrome (IBS)
* Has legal and mental capacity to understand and sign an informed consent document
* Access to a computer or smart device with internet

Exclusion Criteria:

* Pregnancy
* Active malignancy in the previous five years
* Current or prior history of alcohol or drug abuse as defined by clinician
* Any history of eating disorder such as anorexia or bulimia
* Taking yoga or with prior history of mindfulness therapy within 3 months of enrollment
* Currently on a fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP) diet
* Psychiatric illnesses other than depression or anxiety disorder
* Nausea or vomiting
The Attitudes and Beliefs of Hispanic/Latino Individuals Toward Prescription Opioids and Non-Medical Opioid Use

To better understand how people think and feel about prescribed pain medication, including opioids.

OBJECTIVES:

Primary Objectives:

1. To examine the general attitudes and beliefs of Hispanic/Latino individuals about the use of prescription opioids. The primary outcomes include the responses to questions 13-28 from the Opioid Attitudes and Beliefs survey.

Secondary

1. To evaluate Hispanic/Latino individuals' reports of personal experiences with the use of opioids. The corresponding outcomes are the responses to questions 1-12 from the Opioid Attitudes and Beliefs survey.
2. To find out any potential reasons why some Hispanic/Latino individuals may refuse to use clinically indicated opioid prescriptions. These outcomes are the responses to questions 14-15 from the Opioid Attitudes and Beliefs survey.
3. To explore factors associated with participant's comfort with the use opioid analgesics for their pain. The outcome will be the association between participants' responses to question 2 and their characteristics such as age, gender, race, level of education, extent of acculturation, knowledge of opioids, or previous opioid use.

Eligibility Criteria:
Inclusion criteria:

1. Aged 18 years or older.
2. Ability to understand, read, write, or speak English and/or Spanish.
3. Ability to give informed consent.
4. Willingness to participate in the survey.

Exclusion criteria:

1. Refusal to participate in the study
The Effect of Naftopidil for the Double-J Stent Discomfort

This study is To confirm the efficacy of Naftopidil for reducing discomfort of ureteral stent after urinary stone surgery.

1. Enrollment

   1. patients underwent Double-J ureteral stent indwelling after urological surgery during less than 15 days
   2. patients aged more than 20 years
2. Randomization

   1. naftopidil 75 mg qd or placebo until Double-J stent removal
   2. Standard treatment with pain-killers on demand were also applied.(aceclofenac)
3. Follow-up to the day of Double-J stent removal (Evaluation should be done at stent removal)

Eligibility Criteria:
Inclusion Criteria:Patients to be undergone double-J stent indwelling

* \>= 20 years
* undergoing unilateral retrograde double J (DJ) stent placement planned for 5-15 days indwelling

Exclusion Criteria:

* after percutaneous nephrolithotomy, open or laparoscopic ureterolithotomy presence of ureteral stone
* renal insufficiency (serum Cr \> 1.4)
* febrile urinary tract infection (fever \> 38.0°C, evidence of urinary infection )
* pregnancy or breast feeding
* solitary kidney
* hypersensitivity to Naftopidil
* current use of any alpha blocker, calcium channel blocker, corticosteroid moderate or sever cardiovascular or cerebrovascular disease
* hepatic dysfunction
* prior history of pelvic surgery or irradiation
* prior history of transurethral resection of bladder tumor or prostate surgery
* significant active medical illness which in the opinion of the investigator would preclude protocol treatment
* genetic disorder such ad galactose intolerance, lapp lactase deficiency, glucose-galactose malabsorption
Safety and Effectiveness of Wavefront-guided LASIK for the Correction of Mixed Astigmatism

To demonstrate that wavefront-guided LASIK with measurements from iDesign is safe and effective in the treatment of mixed astigmatism.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age at the time of pre-operative exam
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* Demonstration of refractive stability
* Anticipated post-operative stromal bed thickness of at lest 250 microns
* Willing and capable of returning for follow-up examinations for the duration of the study

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
* Concurrent use of topical or systemic medications that may impair healing
* History of any medical conditions that could affect wound healing
* History of prior intraocular or corneal surgery, active ophthalmic disease,or other ocular abnormality
* Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
* Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
Phase I/II Study of OPB-31121 in Patients With Progressive Hepatocellular Carcinoma

The purpose of this study is:

Phase1: To evaluate the safety and determine the recommended dose (RD) Phase2: To evaluate the efficacy


Eligibility Criteria:
Inclusion Criteria:

* Patients with histopathologically or clinically confirmed diagnosis of hepatocellular carcinoma
* Patients with Child-Pugh classification A or B
* Patients unresponsive to standard therapy or for whom standard therapy is intolerable, or for whom there is no appropriate therapy
* Patients who are able to take oral medication
* Patients age 20 to 79 years (inclusive) at time of informed consent
* Patients with an ECOG performance status score of 0-2
* Patients have the eligible organ function.

Exclusion Criteria:

* Patients with a primary malignant tumor
* Patients with a history of liver transplant
* Patients with brain metastases
* Patients with a complication of uncontrolled
* Patients with a psychiatric disorder that might cause difficulty in obtaining informed consent or in conducting the trial