cyrilzakka/clinical-trials huggingface dataset:
Post Market Study of the 3DKnee™ With E-plus Insert

The purpose of this study is to evaluate the use and efficacy of the 3DKnee™ System using Vitamin E UHMWPE tibial inserts for total knee replacement surgery.

Total knee replacement surgery is widely accepted as effective treatment for degenerative joint disease (DJD), osteoarthritis and rheumatoid arthritis. Relief of patient pain and return of mobility are the primary goals that can be accomplished by this surgery. Currently available prosthetic designs accomplish these goals and the surgery has been defined as one of the most successful operations available to improve the quality of life for patients with DJD. This study will evaluate subjects who are candidates for a total knee replacement and meet the indications for use criteria for the 3DKnee™ System with vitamin E UHMWPE tibial inserts (VE).

Eligibility Criteria:
Inclusion Criteria:

* Subject must be a candidate for a total primary knee replacement.
* Subject must have knee joint disease related to degenerative joint disease, including osteoarthritis or traumatic arthritis
* Subject has a BMI ≤ 40.00 kg/m2
* Subject is likely to be available for evaluation for the duration of the study
* Subject is able and willing to sign the informed consent and follow study procedures
* Subject is not pregnant
* Subject must be between age 40 and age 75 at the time of consent

Exclusion Criteria:

* Subject has had a prior total or uni-knee replacement on this knee in the past (no revisions allowed in study)
* Subject has avascular necrosis of the femoral condyles, post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities or rheumatoid arthritis
* Subject has an active cancer or is a survivor for \<5 years except for squamous cell or basal cell skin cancer
* Subject has a chronic disease(s) where, in the opinion of the investigator, the disease will interfere with the patient's ability to follow the protocol
* Subject is currently a documented substance abuser (alcohol or other addictions)
* Subject has an infection, or history of infection (within the last 3 months), acute or chronic, local or systemic
* Subject has a history of muscular, neurological or vascular deficiencies which compromise the affected extremity
* Subject has a BMI \> 40.00 kg/m2
* Subject has loss of ligamentous structures
* Subject has high levels of physical activity and is unwilling to modify levels of physical activity commensurate with recommendations
* Subject has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease)
* Subject is a prisoner
* Subject is pregnant
* Subject has known materials sensitivity (to metals)
* Subject is younger than 40 years (\<40) or older than 75 years (\>75) at the time of consent
The Influence of Advanced Age, Obesity and Diabetes Type on Course and Outcome of Pregnancy With Diabetes Mellitus.

Results of this project will enable investigators to get information and to compare maternal and pregnancy characteristics and perinatal outcomes of women with different types of Diabetes Mellitus and to identify the independent risk factors for adverse perinatal outcomes. Particularly, the impact of the advanced age, obesity, and type of diabetes on the course and outcome of pregnancy will be evaluated.

The prevalence of obesity and metabolic diseases (such as type 2 diabetes mellitus, dyslipidaemia, and cardiovascular diseases) has increased in recent years, in both industrialized and developing countries. Diabetes mellitus (DM) is one of the most common disorders which occurred during pregnancy. Approximately 15% of pregnancies worldwide are thought to be affected by preexisting or gestational insulin-dependent (type 1) or independent (type 2) diabetes mellitus (DM).

The utility of mid- and third trimester ultrasound parameters will be assessed for prediction of intrapartal events and perinatal outcomes in patients with diabetes mellitus. The importance of mid-trimester uterine artery blood flow and foetal biometry will be investigated for prediction of intrapartal events and perinatal outcomes in patients with diabetes mellitus. Moreover, an investigation of the utility of third trimester (measured at 30 and 34 weeks of gestation) ultrasound scan will be carried out for prediction of intrapartal events and perinatal outcomes in patients with diabetes mellitus. Additionally, researchers will assess the relationship between the cerebro-placental ratio (CPR) and intrapartum and perinatal outcomes in pregnancies complicated by different types of Diabetes mellitus to determine if the CPR measured at 30 and 34 weeks of gestation is predictive of adverse obstetric and perinatal outcomes. At the end, investigators will evaluate the role of the addition of the UAPI to the CPR, alone or as CPUR \[cerebro-placental-uterine ratio (CPUR)\], in the improvement of the ability of CPR to predict APO at the end of pregnancy in any subgroup of diabetic patients. Finally, this project will enable precise intervention and resource saving as well as provide evidence for preventable targets development.

Eligibility Criteria:
Inclusion Criteria:

* All pregnant women with diabetes mellitus (18 yo and older).

Exclusion Criteria:

* Cases of multiple pregnancies
* Cases of long-term use of corticosteroids
* Cases complicated by congenital fetal abnormalities or aneuploidy.
Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use

To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.

This study is a prospective, bilateral eye, double-masked, randomized, 1-month cross-over, daily-wear design involving two different FRP lens types. Each lens type will be worn for approximately one month.

Eligibility Criteria:
Inclusion Criteria:

1. Is at least 18 years of age and no older than 35 years, and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Self-reports having a full eye examination in the previous two years;
5. Self-reports spending on most days at least 6 hours cumulative (not necessarily in one single stretch) using digital devices such as a computer, laptop, tablet, e-reader, smartphone;
6. Has healthy eyes with no health condition or medication that contra-indicate contact lens wear, in the opinion of the investigator;
7. Anticipates being able to wear the study lenses for at least 8 hours a day, 6 days a week;
8. Habitually wears soft frequent replacement contact lenses, for the past 3 months minimum (NOTE: The habitual contact lens brand was restricted such that no more than one third were to be Biofinity Energys brand (or their equivalent private label brand name) and no more than one third were to be Alcon brand);
9. Has refractive astigmatism no higher than -0.75DC in each eye;
10. Can be fit and achieve binocular distance vision of at least 20/30 Snellen (Available lens parameters are sphere +6.00 to -6.00D, 0.25D steps).

Exclusion Criteria:

1. Is participating in any concurrent clinical or research study;
2. Has any known active ocular disease and/or infection that contraindicates contact lens wear;
3. Has a systemic or ocular condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect contact lens wear or a study outcome variable;
5. Has known sensitivity to the diagnostic sodium fluorescein used in the study;
6. Self-reports as pregnant, lactating or planning a pregnancy at the time of enrolment;
7. Has undergone refractive error surgery or intraocular surgery.
Personalized Blood Pressure Care Using IoMTs and Artificial Intelligence

In this RCT, up to 100 adults classified as pre-hypertensive will be randomized to either an artificial intelligence (AI) based lifestyle intervention group or an active control group with a 1 to 1 ratio. Both groups will receive an identical activity tracker (Samsung Galaxy Watch) and BP monitor (Omron Evolv). The AI intervention group will receive automated and personalized lifestyle recommendations based on their lifestyle (e.g. sleep, exercise and diet) and blood pressure (BP) data, involving an automated analytics engine using statistics and machine learning. The active control group will not receive these lifestyle recommendations. The investigators aim to assess objectively the effectiveness of the AI-based personalized lifestyle recommendations on the patients BP.


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* SBP between 130 mmHg to 139 mmHg or/and DBP between 80 to 89 mmHg in a research office
* speaking and reading English
* having an iPhone 8 or newer or an Android x or newer

Exclusion Criteria:

* currently taking antihypertensive medication
* self-reported diagnosis of coronary heart disease, medical condition or other physical problem necessitating special attention in an exercise program (e.g., cancer, eating disorder, uncontrolled diabetes)
* current participation in a lifestyle modification program or research study
* self-report of being currently pregnant
Insulin Resistance and Androgen Deprivation Therapy

Prostate cancer is the most common malignancy amongst men in United States. Androgen deprivation therapy (ADT) with long acting gonadotropin releasing hormone agonists is routinely used as adjuvant therapy in intermediate and high risk localized or locally advanced prostate cancer. Since ADT induces insulin resistance and diabetes, it is important that cellular and molecular effects of ADT are investigated to define precisely the mechanisms involved in the pathogenesis of insulin resistance. Pioglitazone, a known insulin sensitizer, may provide amelioration of insulin resistance in these patients.

Investigators plan to conduct a prospective, randomized, double-blind, placebo-controlled trial in 44 men with nonmetastatic prostate cancer who are receiving ADT with long acting GnRH agonist (study group). Study subjects will undergo insulin clamp, subcutaneous fat biopsy, muscle biopsy, have a blood sample taken and fibroscan performed prior to randomization of study drug. They will then be randomized to 30 mg pioglitazone or placebo tablet daily for 6 months. Blood samples will be drawn 2 and 4 months following the initiation of the study drug. The final study visit will be at 6 months. Subjects will undergo clamp, fat biopsy, muscle biopsy, blood sampling, fibroscan and will be discharged from the study.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer, non-metastatic
* Have been on ADT with long acting GnRH agonist continuously for last 3 months, AND planning to continue ADT for at least 6 months

Exclusion Criteria:

* Used pioglitazone in last 6 months
* Heart Failure NYHA Class 3 or 4
* Known to have osteoporosis at this time.
* history of bladder cancer
* Hemoglobin \<8 g/dl
* eGFR \<15 ml/min/1.73m2
* liver enzymes (ALT or AST) \>3 times the upper limit of normal
Diagnostic Criteria of ARDS at High Altitudes in Western China

The severity of ARDS in high altitude areas was classified according to the Berlin standard high altitude area Oxygenation.

Will between January 2018 and December 2018 in lanzhou, and so on more than 1500 meters above sea level in qinghai region 10 intensive care patients with ARDS, respectively according to the standard in Berlin, Berlin, diagnosis of high altitude ARDS calibration standards and zhang the plateau region in western China put forward by the diagnosis of ALI/ARDS severity classification, observation group patients were ICU mortality, within 28 days, ICU mortality did not use breathing machine time, mechanical ventilation, ICU length of hospital stay, and the differences in hospitalization days.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18
* the primary disease of ARDS caused by systemic infection, shock, severe pneumonia, aspiration and trauma
* blood gas analysis showed a progressive decline in pulmonary ventilation function
* PEEP≥5cmH2O Exclusion criteria
* Receive a large amount of hormone shock therapy in a short period of time
* Died within a short time (\< 24h) after mechanical ventilation
* Lack of data
* No chest imaging data
A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors

This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous \[IV\] infusion at Weeks 0, 2, and 6, then once every 8 weeks \[Q8W\]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)
* Naive to treatment with any anti-TNF inhibitor therapy (including TNF inhibitor biosimilars)
* An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment
* Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budenoside multi-matrix system (MMX), probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period
* Use of highly effective contraception during and at least 24 weeks after the last dose of study drug

Exclusion Criteria:

* A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps
* Prior or planned surgery for UC
* Past or present ileostomy or colostomy
* Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, efalizumab, and tofactinib)
* History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies; fusion proteins, or murine proteins; hypersensitivity to etrolizumab or any of its excipients
* Chronic hepatitis B or C infection, Human deficiency virus (HIV) or tuberculosis (active or latent)
Impact of Bright Light Therapy on Prader-Willi Syndrome

This is a placebo controlled clinical trial to assess the utility of light therapy as a sufficient treatment for excessive daytime sleepiness in patients with Prader-Willi Syndrome

This is a prospective, placebo controlled, open label clinical trial that examines light therapy as a treatment for excessive daytime sleepiness in patients with Prader-Willi syndrome. Subjects are assessed for changes in mood, behavior, body weight, and hyperphagia during visits. All visits are conducted remotely. There are a total of 8 visits occurring over the course of 8 weeks. After the first visit, all study visits occur on a weekly basis.

Individuals between the ages of 6-18 years old with diagnosis of PWS confirmed by genetic testing will be screened for enrolment by the study team.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of PWS confirmed by genetic testing
* Score of 12 or above on the Epworth Sleepiness Scale (ESS).

Exclusion Criteria:

* Subjects with an eye condition that could be negatively affected by bright light such as patients with a history of retinal damage or patients needing photosensitizing medications
* A history of previous treatment with LT
* Patients presenting with active psychosis or mania
Homeopathic Drug Provings

In a homeopathic drug proving a homeopathically prepared substance is administered to healthy volunteers in order to produce the symptoms specific to that substance and thereby reveal its inherent curative powers. During a homeopathic drug proving the goal is to provoke temporary symptoms (or "artificial illness") associated with the homeopathic medication. These symptoms are then arranged to form a symptom pattern or 'remedy picture' which is specific to that particular homeopathic substance and provides the basis for a better understanding of the possible effects of that homeopathic remedy in patients.

The duration of these homeopathic drug provings are six week per subject (42 days). The central investigational tool of the homeopathic drug proving is the journal kept by each subject from DAY 1-35. The subject describes the symptoms they experience in their own words in the journal daily. During the 7 day run-in phase, the subject notes in their journal their current state of health, the daily rhythm of their life, and any other signs or symptoms that occur on a daily basis. This will also enhance familiarity with self-observation and the recording of signs and symptoms. After completion of this run-in phase an evaluation including journal check will occur on DAY 7. During the following 4 weeks (observation periods DAY 8-14, 22-28; wash-out period DAY 15-21 and 29 - 35) the subject documents all signs or symptoms that occur in his/her journal on a daily basis. During this period, subject interviews will take place on DAY 15, DAY 21. DAY 29 and DAY 36. During the 7 day follow up (post observation period, DAY 36-42) the subject will be contacted to check if any additional symptoms and/or adverse events occurred.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years and \< 75 years
* General state of good health
* Continuation of the usual habits and patterns of daily living
* Written informed consent obtained and willingness to comply with the requirements of the study

Exclusion Criteria:

* Any major life changes e.g. moving, getting married or divorced etc.
* Current or expected medical treatment or surgery during this homeopathic drug proving
* Surgery within the past four weeks prior to enrollment into the homeopathic drug proving
* Use of homeopathic medicines \> 30 C or contraceptive pills in the month prior to enrollment into the homeopathic drug proving
* Alcohol or drug abuse
* Pregnancy or nursing (or anticipating pregnancy during this homeopathic drug proving)
* Incompetence, or inability of understanding the nature, meaning and consequences of the homeopathic drug proving or inadequate completion of the journal form DAY 1-7.
* Participation in another clinical trial at the same time or within the last 4 weeks.
A Comparison of Oxycodone/Naloxone and Oxycodone After Laparoscopic Hysterectomy

Objectives:

Primary objective:

* To demonstrate that the treatment with OXN PR tablets up to 72 hrs after surgery is superior to the treatment with OxyPR with regards to constipation in subjects with postoperative pain after laparoscopic hysterectomy based on interviews 24h, 72 h and 1 week postoperatively.

The secondary objectives:

* Analgesic effect (including registration during the first 24 hrs)
* To asses the frequency of pain rescue mediation use (in the double-blind phase, 0-72 hrs)
* Frequency of nausea and vomiting
* Frequency of other adverse events
* Appetite
* Mobilization

The exploratory objectives:

* Overall patient satisfaction at 24, 72 hrs and 1 week


Eligibility Criteria:
Inclusion Criteria:

1. Females 18 -70 years
2. Elective, non-malignant laparoscopic gynecological surgery in general anesthesia : hysterectomy/ myomectomy, ASA 1, 2 and 3
3. Subjects willing and able to participate the study and have provided informed consent form -

Exclusion Criteria:

1. Previous recent or regular opioid use (WHO step I pain treatment allowed)
2. Any situation where opioids are contraindicated.
3. Any history of moderate to severe hepatic impairment.
4. Any history of severe respiratory depression with hypoxia and/or hypercapnia
5. Any history of severe chronic obstructive pulmonary disease, cor pulmonal, acute severe bronchial asthma
6. Subjects with evidence of non-opioid induced paralytic ileus
7. Subjects with evidence of severely impaired pulmonary function, myxoedema, hypothyroidism
8. Subjects with evidence of Addison's disease (adrenal cortical insufficiency), toxic psychosis,cholelithiasis, prostate hypertrophy, alcoholism, delirium, pancreatitis, hypotension, hypertension, pre-existing cardiovascular diseases, head injury (due to the risk of increased intracranial pressure), epileptic disorder or predisposition to convulsions, or patients taking MAO inhibitors.
9. Any history of hypersensitivity to Oxycodone / Naloxone or to any of the excipients.
10. Active alcohol or drug abuse and/or history of opioid abuse.
11. Subjects with evidence of clinically unstable disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that, in the Investigator's opinion, preclude entry into the study.
12. Subjects who have received an investigational medicinal product within 30 days of study entry (defined as the start of the Screening Period).
Pilot to Assess DBE as a Rescue Technique for Failed PEJ

Is DBE(double balloon enteroscopy)-assisted DPEJ(direct percutaneous endoscopic jejunostomy) a viable option in patients who have failed conventional DPEJ placement and who otherwise would require surgical jejunostomy or parenteral nutrition.

DBE-assisted DPEJ is a viable option in patients who have failed conventional DPEJ placement and who otherwise would require surgical jejunostomy or parenteral nutrition.

Eligibility Criteria:
Patients:

Patients who have failed conventional DPEJ tube placement will be offered participation in the study. DBE-assisted DPEJ will be performed on a subsequent day following failed DPEJ. Patients who do not wish to undergo an attempt at DBE-assisted DPEJ will follow-up with their primary caregiver for alternative means of feeding tube placement (e.g., surgical jejunostomy).

Inclusion criteria:

1. Age \> 18 years old
2. Appropriate indication for DPEJ tube placement and Nutrition consult approval
3. Absence of bleeding disorder
4. Platelet count \> 50,000 and INR \< 1.5
5. Ability to give informed consent