cyrilzakka/clinical-trials huggingface dataset:
Cemented Versus Cementless Unicompartmental Knee Arthroplasty

Unicompartmental knee replacement for selected cases of osteoarthritis is less invasive than total knee replacement. It gives better range of movement; patients stay for shorter time in the hospital and have a more natural feel than total knee replacement. Usually, the implant is fixed in the bone using bone cement. However, there are potential disadvantages of using bone cement. The operation takes longer; cement can get squeezed out into the surrounding tissues and may interfere with function. To avoid these problems, the implant can be fixed without cement. Cementless components have a special coating to encourage bone in-growth and fixation. Although the investigators believe cementless fixation will be at least as good as cemented fixation, there is a risk that it could be worse and might result in loosening.

The aim of this study is therefore to compare the outcome of cemented and cementless unicompartmental knee replacement.

Design: A prospective, randomised trial to compare the outcome of cemented and cementless unicompartmental knee replacement.

Size: 40 subjects in total will be recruited with 20 in each arm.

Methods: Patients will be recruited from the routine waiting list for unicompartmental knee replacement at the Nuffield Orthopaedic Centre. All subjects will have the procedure explained and be fully consented prior to the procedure.

Randomisation: Patients will be randomly allocated to receive either a cemented or cementless Oxford Unicompartmental Knee Replacement. This will be performed using a randomisation program based on optimisation (Minim). Subjects will be stratified according to sex and age.

Operation: All subjects will undergo the same surgical approach. 0.8mm Tantalum marker balls will be placed at standardised sites on the femur and tibia in all cases. All cemented components will be secured using the same cement. Cementless components have a hydroxy-appatite coating to facilitate bone ingrowth.

Follow-up: All patients will be followed up at 0, 3, 6, 12, 24, 60, and 120 months with clinical and radiological assessment. Clinical assessment will involve documentation with the Oxford Knee Score. Patients will undergo radiostereometric analysis and fluoroscopy to study implant migration and occurence of radiolucency, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Healthy Subjects with osteoarthritis of knee fulfilling the standard indications for an Oxford Unicompartmental Knee Replacement.
* American Society of Anaesthesiologists (ASA) Score of 1 to 3.

Exclusion Criteria:

* Subjects with severe limiting systemic illness (i.e. ASA \> 3).
* Subjects who are too large for radiostereometric analysis to be carried out.
* Subjects who have had previous open surgery or anterior cruciate ligament (ACL) reconstruction on the same knee.
Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients

The purpose of this study is to evaluate whether dietary nitrate supplementation could improve the salivary flow for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.

Thirty patients diagnosed as nasopharyngeal carcinoma will be recruited. Nitrate supplement(Sodium nitrate: 0.5 mmol/kgbodyweight,bid) or placebo(sodium chloride: 0.5 mmol/kgbodyweight,bid) will be provided to the patients from 7 days before radiotherapy to one month after the finish of radiotherapy . The salivary flow and plasma nitrate levels will be determined before the course of nitrate supplementation and radiotherapy,before the course of radiotherapy,post the course of radiotherapy immediately and one month after the finish of radiotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients with newly diagnosed stages III-IVb (UICC 2002) nasopharyngeal carcinomas, will be recruited.

Exclusion Criteria:

* Patients with local invasion or metastatic foci in salivary glands, detected by MRI and positron emission computed tomography(PET-CT) prior to treatment, were excluded, as were patients suffering from diseases, such as Sjogren's syndrome, or with a history of surgery to major salivary glands, or prior head and neck radiotherapy.
The Effect of Supplementation of Flaxseed, Hesperidin, Flaxseed and Hesperidin Together in Non-alcoholic Fatty Liver Disease: A Randomized, Controlled Study

To study the effects of Hesperidin, flaxseed and both together on lipid profile, liver enzymes, inflammatory factors and hepatic fibrosis in patients with Nonalcoholic Steatohepatitis (NASH), 100 patients who referred to Gastrointestinal (GI) clinic with steatosis grade 2 and 3 will be randomly allocated to one of following four groups: control group, hesperidin group (2 capsules Hesperidin), flaxseed group (30 gram flaxseed) or flaxseed-hesperidin group (2 capsules Hesperidin and 30 gram flaxseed) for 12 weeks; both groups will be advised to adherence the investigators' diet and exercise program too. At the first and the end of the intervention, lipid profiles, liver enzymes, some inflammatory markers, and liver fibrosis will be assessed and compared between groups.


Eligibility Criteria:
Inclusion Criteria:

* Age of 18 to 70 years
* Body Mass Index (BMI) between 25-40
* Sonographic findings compatible with hepatic steatosis (degree 2 or more)

Exclusion Criteria:

Diabetes Taking any kind of antibiotics two weeks before recruitment History of alcohol consumption pregnancy or lactation Professional athletes Other liver disease (viral/etc) Use of drugs such as calcium channel blockers, high dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs, lipid-lowering agents, metformin and vitamin E A history of Hypertension, Cardiovascular disease, Pulmonary disease, Renal disease \& Celiac disease; Cirrhosis History of Upper GI surgery / Prior surgical procedures such as jejunoileal or jejunocolic bypass, gastroplasty Following program to lose weight in recent 3 mo A history of hypothyroidism or Cushing's syndrome
Comparison Between Neuro 1 and Neuro 2 Cochlear Implant Speech Processors

The present study aims to evaluate patient satisfaction and audiological performance with their current cochlear implant speech processor, the Neuro 1, and to compare it with the satisfaction and performance obtained with the new speech processor, the Neuro 2.

Nowadays, cochlear implants (CI) are successfully used to rehabilitate severe to profound sensorineural hearing loss. Oticon Medical recently developed a new cochlear implant system, including a new implantable internal part (Neuro Zti) and a new speech processor (Neuro 1). This new speech processor automatically detects and adapts to the sound environment, increasing the ease of listening in all situations. A second version of this speech processor has very recently been developed, called the Neuro 2. The Neuro 1 and 2 share the same signal processing characteristics and the "sound" delivered to the patient is similar. However, the Neuro 2 offers better ergonomics (smaller size and weight, rechargeable batteries...). Some improvements available on the Neuro 2 may be particularly interesting for children.

The aim of the present study is twofold: 1. Compare the satisfaction of adult and pediatric users for the speech processor Neuro 1 with their satisfaction for the Neuro 2, and 2. Show that audiological outcomes are at least as good for the Neuro 2 than for the Neuro 1.

The participants come at the hospital for three visits. The Neuro 1 is evaluated during the first visit (V1). Evaluation of the Neuro 2 takes place during the second (V2, 15 days after V1) and the third (V3, 3 months after V2).

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* Native French speaker or fluent French speaker
* Patient already fitted with one or two speech processor Neuro 1 for at least 5 months

Exclusion Criteria:

* vulnerable patients, at the exception of children (pregnant women, persons under guardianship)
* No Social security affiliation
* non-compliant patient
EMPOWER-PULM (PULMonary Outcomes in Older Adults Empowered With Movement to Prevent Obesity and Weight Regain)

The purpose of this study is to improve the understanding of the effects of weight loss on the lungs in older adults. Different types of tests to understand the effects of the EMPOWER interventions on lung function will be administered.

This is a randomized clinical trial of the effects of structured aerobic exercise and a sedentary behavior intervention during weight loss on respiratory function. Site will enroll 150 older (65-85 years), obese (BMI=30-45 kg/m2), sedentary men and women from EMPOWER. EMPOWER is a 3-group design where participants will undergo a 9-month weight loss (WL) intervention (6-mo intensive phase and 3-mo reduced contact phase), followed by a 9-month self-managed follow-up phase with minimal contact. The diet element of the interventions is identical across groups, but groups differ by activity intervention: 1) moderate-intensity aerobic exercise (WL+EX); 2) intervening on SB (WL+SitLess); or 3) (WL+EX+SitLess)

Eligibility Criteria:
Inclusion Criteria:

* 65 -85 years of age
* BMI = 30-45 kg/m2
* Weight stable - no loss or gain (±5%) in past 6 months
* Sedentary
* No contraindication for safe and optimal participation in exercise training
* Approved for participation by Medical Director

Exclusion Criteria:

* Dependent on cane or walker
* Reported unintentional or intentional weight loss or gain of \>5% in past 6 months
* Participation in regular resistance training and/or \> 20 mins/day of aerobic exercise in past 6 months
* Osteroporosis (t-score \<2.3 on hip or spine scan); Severe arthritis, or other musculoskeletal disorder; Joint replacement or other orthopedic surgery in past 6 mos; joint replacement or other orthopedic surgery planned in next 2 years
* Uncontrolled resting hypertension (\>160/90 mmHg);
* Current or recent past (within 1 year) severe symptomatic heart disease, uncontrolled angina, stroke, chronic respiratory disease other than asthma or COPD, any disease requiring oxygen use, neurological or hematological disease,; cancer requiring treatment in past year, except non-melanoma skin cancers
* Serious conduction disorder, new Q waves or ST-segment depression (\>3mm), or uncontrolled arrhythmia
* Room air SpO2 (oxygen saturation) at rest or with exercise qualifying for supplementary oxygen (SpO2≤88%)
* Abnormal kidney or liver function (2x upper limit of normal);
* eFGR \< mL/min/1.73m2
* Anemia (Hb\<14 g/dl in men/\<12.3 g/dL in women);
* Uncontrolled diabetes (fasting blood glucose \> 140 mg/dl);
* Deficient levels of vitamin D (25 hydroxyvitamin D level \<20mg/mL) in those not taking a vitamin D supplement
* Smoker (No nicotine in past yr)
* No heavy alcohol use (\>14 drinks/week)
* Unstable severe depression
* Regular use of: growth hormones, oral steroids, weight loss medications\* or prescription osteoporosis medications\*
* Current participation in other research study
Dose Efficiency of Modern CT Scanners in Oncologic Scans

CT-Staging is crucial for therapy planning of patients with malignancies. Dose efficiency and image quality are important parameters for these examinations. Up to now, scientific evidence of dose efficiency of modern CT scanners is mostly derived from retrospective analyses. This prospective study systematically analyzes dose efficiency and image quality of three modern CT scanners by randomization of patients who are scheduled for a CT scan to examine the status of malignancies. After giving informed consent and randomization (1:1:1), the CT scan will be performed at one of the modern CT scanners available at our department. This will allow a systematic allocation to the different scanners.


Eligibility Criteria:
Inclusion Criteria:

* clinical suspicion of a malignancy or known / confirmed malignancy AND
* indication for contrast-enhanced CT of the body confirmed by board-certified radiologist ('justifying indication' according to German/European radiation protection law) AND
* patient (is able to give informed consent and) has given informed consent.

Exclusion Criteria:

* age \< 18 years
* known or suspected pregnancy
* contraindications for contrast agent (renal failure, allergy, hyperthyroidism)
Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3)

This study (ARD-3150-1201, ORBIT-3) will evaluate the safety and efficacy of inhaled Pulmaquin (ciprofloxacin dispersion for inhalation) compared to inhaled placebo in subjects who have a confirmed diagnosis of non-cystic fibrosis (non-CF) bronchiectasis with a history of pulmonary exacerbations and chronic P. aeruginosa infections.


Eligibility Criteria:
Inclusion Criteria:

* Verified bronchiectasis diagnosis
* Pseudomonas aeruginosa lung infection

Exclusion Criteria:

* Cystic Fibrosis
Curcumin for the Prevention of Colon Cancer

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. Curcumin may be effective in preventing the development of colon cancer.

PURPOSE: Phase I trial to determine the dose amount of curcumin that can be tolerated to help in preventing colon cancer in healthy men and women.

OBJECTIVES:

* Determine the maximum tolerated dose (MTD) of curcumin as a chemopreventive agent of colon cancer in healthy subjects.
* Determine if tolerable doses of this agent in uniformly milled formulation capsules are bioavailable in these subjects.
* Determine the pharmacokinetics of this agent and two metabolites at the MTD and next lower escalated dose in these subjects.

OUTLINE: This is a dose escalation study followed by a pharmacokinetic study.

Patients receive a single oral dose of curcumin followed by a standard fatty meal.

Cohorts of 3-6 patients receive escalating doses of curcumin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose limiting toxicities. Once the MTD is determined, additional patients are accrued to receive curcumin in the pharmacokinetic phase of the study.

Patients are followed at 24, 36, 48, and 72 hours.

PROJECTED ACCRUAL: A total of 3-24 patients will be accrued for the dose escalation phase and then 12 additional patients will be accrued for the pharmacokinetic phase of this study within 3 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Healthy men and women age 18 and over

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* WBC greater than 4,000/mm3
* Hemoglobin greater than 12 g/dL
* Platelet count greater than 120,000/mm3

Hepatic:

* ALT/AST less than 1.5 times upper limit of normal (ULN)
* Alkaline phosphatase less than 1.5 times ULN
* Bilirubin less than 1.5 mg/dL

Renal:

* Creatinine less than 1.7 mg/dL

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior cancer except surgically resected basal cell or squamous cell skin cancer
* No history of peptic ulcer disease, gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors
* No history of unreliability or noncompliance (missing pretreatment appointment more than twice)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* At least 14 days since prior steroids

Radiotherapy:

* Not specified

Surgery:

* Not specified

Other:

* At least 14 days since prior curcumin (turmeric) rich foods
* At least 14 days since prior nonsteroidal antiinflammatory drugs (NSAIDs)
* No chronic medications (i.e., daily for more than 28 days) except for oral contraceptives
* No concurrent coumadin or other anticoagulants
Impact of Telehealth Care

Heart failure is associated with high incidence and mortality rates, limited physical activity, decreased quality of life, and increased healthcare expenses. Implementing a Telehealth Care (TC) HF program could address these challenges while improving patient outcomes.

Telemonitoring for heart failure patients reduces all-cause and cardiovascular mortality by enabling early intervention during clinical deterioration, improving outcomes even for those recently discharged. Moreover, a reduction in the percentage of days lost due to unplanned cardiovascular hospital admissions is evident. Furthermore, the rapid expansion of telehealth care and telemedicine services during the COVID-19 pandemic optimized the management and care quality of heart failure patients through telemonitoring .

Eligibility Criteria:
Inclusion Criteria:

* Inpatients diagnosed with heart failure were enrolled, with patients automatically selected daily by the electronic medical record system. A list of ward visits was obtained based on the first three digits of the International Classification of Diseases 10th edition diagnosis codes; the ICD-10 code I50 was applied for selection.

Exclusion Criteria:

* Other diagnosis
Personalized Home Respiratory Rehabilitation Program for Subjects with Systemic Sclerosis with Early Lung Disease

Systematic sclerosis (SSc) is a potentially severe disease characterized by various visceral involvements including lung. The investigators hypothesize that a respiratory rehabilitation program specifically designed for people with systematic sclerosis with early lung disease could help to decrease respiratory deficiencies, improve aerobic capacity and prevent activity limitations and participation restrictions.

Before testing the effectiveness of such a program, a pilot study is needed to assess its feasibility and optimize its content.

Participants will have 1 supervised session in the outpatient rehabilitation department. Each patient will then perform the home personalized exercises program for 3 months.

The feasibility of the program will be assessed at 3 months using patients' adherence to the program (assessed by the number of lost to follow-up, the number of questionnaires not completed, the amount of aerobic activity and the amount of home personalized exercises, treatment burden, adverse effects and quality of life.

SSc is responsible for a reduced life expectancy. The prognosis depends on the presence of severe visceral damage and more particularly on the presence of interstitial lung damage, pulmonary arterial hypertension or specific cardiac damage which represent the 3 main causes of mortality in SSc.

The importance of rehabilitation in SSc has been confirmed by the latest INSERM Collective Expertise 2019). The objectives of functional rehabilitation in SSc are to prevent and/or reduce the specific (cutaneous, oral, cardiorespiratory, musculoskeletal) and non-specific (exercise deconditioning, fatigue, anxiety and depression) impairments frequently characterizing the evolution of the disease. Based on the latest practice recommendations for the diagnosis and treatment of idiopathic pulmonary fibrosis, people with a confirmed diagnosis of idiopathic pulmonary fibrosis and significant exercise and activity limitations should follow a respiratory rehabilitation program.

The value of a specific respiratory rehabilitation program for people with SSc is then a matter of interest. A pilot study is needed to assess the feasibility and optimize the content of a rehabilitation program. The investigators aimed to study the feasibility of a personalized home-based respiratory rehabilitation program in people with SSc with early lung disease.

Eligibility Criteria:
Inclusion Criteria:

* Systemic sclerosis according to ACR/EULAR 2013 criteria
* Lung involvement, with FCV \> 70% on PFT

Exclusion Criteria:

* Inability to understand French
* Pregnancy or breastfeeding
* Arterial pulmonary hypertension \> 35 mmHg and unexplained dyspnoea or arterial pulmonary hypertension \> 40 mmHg
* Major musculoskeletal impairment incompatible with physical activity
* other pulmonary disease decreasing FCV
* Pathological EKG
* Oxygen saturation at rest or during physical activity \< 90%
* FCV \< 70%
Omission of Controlled Cord Traction During Active Management of Third Stage of Labor

This is a comparative study which will be conducted in Ain Shams University Maternity hospital to assess the individual and specfic role of controlled cord traction as a part of active management of third stage of labor

300 patients will be randomized into two groups with controlled cord traction and withoout. The primary outcome will be sever postpartum haemorrhage

Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* term pregnancy

Exclusion Criteria:

* episiotomy
* operative vaginal delivery
* known coagulation defect
* Acute complication during labor e.g. eclampsia
Ticagrelor CytoSorb Hemoadsorption

TISORB is a study to show that the CytoSorb device removes ticagrelor from blood during surgery in patients who need emergency surgery on their heart. The hypothesis of TISORB is that removal of ticagrelor by the CytoSorb device during surgery will decrease the risk for surgical bleeding from ticagrelor.


Eligibility Criteria:
Inclusion Criteria:

Cardiothoracic surgery requiring cardiopulmonary bypass ≤ 48 hours following the last dose of ticagrelor.

Exclusion Criteria:

Any cardiothoracic surgery \> 48 hours after last dose of ticagrelor.
Pain Effect on Attention Using an Ipad Game App

Cognitive performance will be studied over time using an iPad game interface called the nine choice human game (5CH) in normal volunteer subjects before during and after experimentally induced thermal (cold or warm) pain or control (no intervention).

Purpose: to assess the effects of pain on performance in a computer game interface of attention and memory and reliability of the repeated testing.

Rationale: The perioperative period may alter the ability to play an iPad game through changes in attention or memory as result of surgery, anesthesia, pain or medications. This study will describe and quantify and isolate any short term reduction in ability to focus and pay attention to the presence of thermal (cold or warm) pain.

Objectives: Determine if cognitive function is altered from thermal pain (cold or warm) using simple computer/ipad games of attentional performance and cognitive function.

Design and Outcomes: In group 1: no interventions will be used and the subjects will play the ipad game at baseline, 5 minutes later and 10 minutes later. In group 2: The subjects will play the ipad game, then 5 minutes later a thermal probe at 47 degrees C for 90 seconds on the arm or leg will be used while the game is being played. Following 10 minutes of recovery, the subject will play the game again, 5 minutes later the subject will have the foot placed in 10 degree water bath or body temperature water bath while the game is played, and the game will be played 10 minutes later after the foot is warm and dry. Visual analog scale (VAS) pain score from 0-10 will be used to assess discomfort. The subject will be able to stop the game or withdraw at any point. The primary outcome measures will be median cue duration (MCD) in the 9CH game. Secondary outcome measures will be number of correct, incorrect, omissions, time to finish trials, and time to quit for the 9CH. A total of 60 subjects will be studied, 20 subject warm probe/cold water, 20 subjects warm probe/body temperature water, and 20 normal subjects with no intervention.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male and non-pregnant female volunteers between the ages of 18-55.

Exclusion Criteria:

* Any reported learning disabilities, psychomotor impairment including diagnosis of ADD/ADHD, seizures, debilitating neurologic disorders (muscular dystrophy, multiple sclerosis, etc.), genetic diseases, heart disease, stroke, or memory deficits; anything that would impair the ability to hold the iPAD and perform the computer gaming tasks (i.e. blindness, color blindness, upper extremity dysfunction or pain). Also any history of cold induced impaired circulation, cold agglutinins or Raynaud's or insensitivity to cold.