cyrilzakka/clinical-trials huggingface dataset:
T-cell Minimal Residual Disease (MRD) Evaluation Using Flow Cytometric Analysis

To determine if MRD (minimal residual disease) can be found in the blood (only) as opposed to bone marrow in children with ALL (acute lymphoblastic leukemia).


Eligibility Criteria:
Inclusion Criteria:

* Children with newly diagnosed T-cell ALL
Duloxetine As an Analgesic in Patients Without Central Sensitivity After Same Sitting Bilateral Total Knee Arthroplasty

Analgesic effect of 20mg Duloxetine was evaluated at regular short term intervals in patients without central sensitivity and undergoing bilateral single sitting total knee arthroplasty for tricompartmental osteoarthritis using standardised patient related outcome measures like the visual analogue score.

Patients who underwent bilateral, single-sitting total knee arthroplasty for tricompartmental knee osteoarthritis were evaluated preoperatively for having central sensitivity. Only patients without central sensitisation were recruited and randomised into two groups with one group given 20 mg duloxetine capsules and the other group given a starch capsule of same shape, make, and weight as a placebo. Patients were evaluated for pain at rest and movement using VAS. A 6-hourly calculation of VAS was done over the first 48 hours and the average was recorded. Subsequent measurements at 1 week, 2 weeks, 4 weeks, and 3 months after surgery was done by a blinded clinician. Additional, drug safety, NSAID consumption and overall patient satisfaction were studied.

Eligibility Criteria:
Inclusion Criteria:

* Bilateral tricompartmental knee osteoarthritis
* Underwent primary, bilateral TKA in single-sitting

Exclusion Criteria:

* American Society of Anesthesiologists physical status IV
* Hamilton Depression Scale (HAMD) and/or Hamilton Anxiety Scale (HAMA) scores \> 7
* known intolerance or allergy to any of the study drugs, alcohol, tobacco, narcotic, or opioid dependence
* patients on anticoagulants
* known hepatic/renal dysfunction
* serious cardiac/cerebrovascular comorbidities
* HbA1c≥7
* patients who were already on duloxetine or other SNRIs, monoamine oxidase inhibitors, tricyclic antidepressants, triptans, lithium, other antiepileptics, or buspirone.
Adhear Bone Conduction System

The purpose of this research study is to learn about the hearing outcomes of adult and pediatric patients who are treated with or are candidates for bone conductive devices (also termed "BAHA"). Hearing outcomes will also be assessed with a second audio processor device called the Adhear System.


Eligibility Criteria:
Inclusion Criteria:

Aims 1 and 2:

* Adult English speaking patients who are experienced users of Bone Anchored Implants (BAIs) for the indication of either single sided deafness or conductive hearing loss.
* Experienced will be defined as greater than 6 months of device use and no intermittent function of the device within 2 weeks of enrollment.
* Subjects will be limited to those who have normal hearing by bone conduction defined as a pure tone average of 25 dBHL or better at 500, 1000, 2000, \& 3000 Hz in at least one ear.

Aim 3:

* English speaking children 5 to 17 years of age and their primary guardian who present to the clinic for treatment by BAI on a headband device for the indications of single sided deafness or conductive hearing loss.
* Subjects will be limited to those who have no prior use of a BAI or bone conduction hearing device, normal hearing by bone conduction defined as a pure tone average of 25 dBHL or better at 500, 1000, 2000, \& 3000 Hz in at least one ear. For those children where this cannot be definitively established, children will be included who display clinical signs of normal bone conduction hearing beyond a reasonable doubt and may include such evidence as (but not limited to): auditory brainstem response, speech awareness thresholds, visual reinforcement audiometry, conditioning play audiometry, CT scans, etc.)

Aim 3 a \& b:

* Pediatric bilateral or unilateral conductive hearing loss patients who are between the ages of 2 and 17 years of age
* Pediatric participants who are currently managed by the University of Miami with a bone conduction device attached to a softband.

Exclusion Criteria:

Aims 1 \& 2:

* Non-English speakers
* Participants reporting allergies to adhesives or highly reactive skin.

Aim 3:

* Pediatric participants who are non-English speakers.
* Children who have previous experience with a BAI or bone conduction hearing device will not be included for study.
* Pediatric participants reporting allergies to adhesives or highly reactive skin.

Aims 3a \& 3b:

* Pediatric participants who are non-English speakers.
* Pediatric participants reporting allergies to adhesives or highly reactive skin.
Myopia Preventing With Distance-image Screen

This study is for testing the efficacy and safety of distance-image screens for preventing myopia in children for 12 month. Each subjects would be asked to paired test the ocular parameters between before and after 12-month distance-image screens.

This study is for testing the efficacy and safety of distance-image screens intended usage for preventing myopia in children with reading after a 6-meter-distant-image device. It was a prospective study. The investigators would like to recruit 100 volunteers, aged 6 years 16 in Beijing.

All the volunteers will be complete examined their ocular parameters before using the distant-image screen in a random order for at least 2 hours daily for 12 month. The changes of ocular axial length and refractive error were both calculated before and after 12-month usage for paired t-test.

Eligibility Criteria:
Inclusion Criteria:

* (1) Must be 6\~12 years old;
* (2) Must be best corrected visual acuity \< logMAR: 0.1;
* (3) Spherical Equivalence (SE) must be -1.00\~ + 6.00 Diopter (D),
* (4) Spherical Equivalence (SE) must have changed \> 1.25 Diopter (D) in the recent 2 years;
* (5) Must be astigmatism \<1.75 Diopter (D);
* (6) Must be anisometropia \<1.75 Diopter(D).

Exclusion Criteria:

* (1) Strabismus disease;
* (2) Amblyopia disease;
* (3) Cataract disease;
* (4) Glaucoma disease;
* (5) Severe dry eye disease;
* (6) Cannot use distance-image screen for 12 month;
* (7) Other severe diseases that would effect the use of distance-image screen.
Potential of Gayo Arabica Coffee Skin

The purpose of this study was to assess the effectiveness of gayo arabica coffee skin extract cream in the prevention of skin aging


Eligibility Criteria:
Inclusion Criteria:

* Women.
* have skin aging condition aged 30-60 years.
* Willing to participate in research based on research protocols.
* Before the research begins, research subjects are willing to sign informed consent and participate in the research until completion according to the research provisions from initial examination, re-control, and treatment until completion).

Exclusion Criteria:

* History of allergy to one of the ingredients in the cream.
* have a skin disorder and are undergoing treatment for skin disease.
* Undergoing treatment and use of facial cream in the last 1 month.
* History of allergy to coffee.
Transcutaneous Carbon Dioxide Monitoring Post Cardiac Surgery: Incidence and Severity Resp Insufficiency

The purpose for the investigators study is to investigate the severity and incidence of respiratory insufficiency using transcutaneous carbon dioxide (TcPCO2) monitoring as an adjunct to the current standard of care for early detection of inadequate ventilation in post-operative surgical in-patients undergoing cardiac surgery after discharge from intensive care unit (ICU) or post anesthesia recovery unit (PACU).

This observational study is to determine the baseline carbon dioxide and severity of respiratory distress and acute respiratory failure (ARF)/respiratory arrest in the post cardiac surgery patients in the first 24 hours on a monitored telemetry floor.

Eligibility Criteria:
Inclusion Criteria:

* ASA Class 1, 2, 3, or 4 men and women who are having cardiac surgery by one of the participating surgeons

Exclusion Criteria:

1. Subject has participated in a trial with any experimental drug or device trial within 30 days prior to enrollment in the study, or has ever been enrolled in this study;
2. Subject has a condition that would require an extensive amount of time off of 13 Roberts during the first 24 hours of admission to the telemetry unit. (e.g., hemodialysis);
3. Subject has a condition or allergy which would prohibit placing the probe on the earlobes;
4. Subject is unable to undergo any procedure required by the protocol;
5. Subject has any other condition or factor which, in the Investigator's opinion, might increase the risk to the subject; or
6. If female, subject is non-lactating, and is either:

   * Not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile due to bilateral tubal ligation, bilateral oophorectomy, or hysterectomy; or
   * Of childbearing potential but is not pregnant as confirmed by negative serum pregnancy test at time of screening.
Megestrol Acetate Plus LNG-IUS in Young Women With Early Endometrial Cancer

To see if megestrol acetate plus Levonorgestrel-releasing intrauterine system (LNG-IUS) will not be inferior to returning the endometrial tissue to a normal state than megestrol acetate alone in patients with early endometrial cancer.

After diagnosed of endometrioid endometrial cancer (EEC) by hysteroscopy, patients will be enrolled. Age, waist circumstances, blood pressure, basic history of infertility, blood pressure, serum lipid level and side effects will be collected. Blood tests, including fasting blood glucose (FBG), postprandial blood glucose (PBG), fasting insulin (FINS), SHBG, sex hormone levels, blood lipids and anti-müllerian hormone(AMH) will be performed before treatment to evacuate their metabolic conditions.

Patients are randomized to 1 of 2 treatment groups. Patients will receive MA (megestrol acetate) 160 mg by mouth daily for at least 3 months on Arm I. Patients will receive MA 160 mg plus LNG-IUS insertion for at least 3 months on Arm II. Then an hysteroscope will be used to evaluate the endometrial condition every 3 months, and the findings will be recorded. For patients with EEC, complete response (CR) is defined as the reversion of endometrial disease to proliferative or secretory endometrium; partial response (PR) is defined as regression to simple or complex hyperplasia without atypic or atypical hyperplasia; no response (NR) is defined as the persistence of the disease; and progressive disease (PD) is defined as the progression of endometrial lesions. Continuous therapies will be needed in PR, NR or PD.

As the reason of the low response rate of LNG-IUS alone in EC patients (nearly 50%), and the potential limitation of LNG-IUS to focal cancer lesion in endometrial cavity, the investigators did not add LNG-IUS alone as a single control group.

After completion of study treatment, 2 months of maintenance treatment will be recommended for patients with CR, and participants will be followed up for 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Primarily have a confirmed diagnosis of endometrioid endometrial cancer based upon hysteroscopy
* MRI parameters shows there's no myometrial invasion, extension beyond corpus, or enlarged lymph nodes
* Have a desire for remaining reproductive function or uterus
* Need to be able to undergo correlative treatment and follow-up

Exclusion Criteria:

* Acute liver disease or liver tumor (benign or malignant) or renal dysfunction
* Pregnancy or suspicion of pregnancy
* Have a history of EAH or EC and have disease relapse during Merina insertion
* Under treatment of high-dose progestin therapy more than 3 months in recent 6 months
* Congenital or acquired uterine anomaly including fibroids if they distort the uterine cavity
* Confirmed diagnosis of malignant tumor in genital system
* Acute severe disease such as stroke or heart infarction or a history of thrombosis disease
* Hypersensitivity or contradiction to any component of this product
* Ask for removal of the uterus or other conservative treatment
* Smoker(\>15 cigarettes a day)
The Effectiveness and Safety of Levosimendan in Patients With Severe Aortic Stenosis and Heart Failure Undergoing Transcatheter Aortic Valve Replacement

A study to evaluate the effectiveness and safety of levosimendan compared with placebo in subjects with severe aortic stenosis and heart failure undergoing transcatheter aortic valve replacement

The number of subjects undergoing transcatheter aortic valve replacement to treat aortic stenosis have been increasing in recent decades. Levosimendan, an innovative inotrope, is powerfully evidenced to have the function to improve cardiac output and hemodynamic parameters. However, there is no specified study concentrated on the role of Levosimendan in surgical procedure such as transcathter aortic intervention. This double-blind, randomized, placebo-controlled study is aimed to investigate the effectiveness and safety of Levosimendan in adults having severe aortic stenosis combined with heart failure undergoing transcatheter aortic valve replacement. Therefore, the purpose of this trial is to explore whether the improvement of cardiac and renal performance can be rendered by intra-operative Levosimendan infusion.

Eligibility Criteria:
Inclusion Criteria:

1. Signed (by the subjects or their legally acceptable representatives) informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
2. Severe aortic stenosis

   1. Mean transaortic gradient ≥ 40 mmHg(at rest or stress)
   2. Aortic peak velocity ≥ 4m/s;
   3. Arotic valve area \<0.8 cm2 and/or aortic valve area index\< 0.5cm2/m2
3. Cardiac dysfunction

   1. LVEF≤50% (estimated by Simpson)
   2. NT-proBNP≥1500ng/L；
   3. Symptoms of dyspnea and fatigue when at rest or after slight exertion (New York Heart Association ≥ Ⅲ -Ⅳ)
   4. Intermittant fluid retention and/or symptoms induced by low cardiac output at rest, but lack of hemodynamic instability

Exclusion Criteria:

1. Decompensated acute cardiac failure due to hemodynamic instability
2. A historty of torsade de points ventricular tachycardia
3. Known allergic reaction or sensitivity to Levosimendan or excipients
4. Received levosimendan within 1 week prior to the planned clinical trial
5. Serum potassium \< 3.5 mmol/L and \> 5.5 mmol/L before the drug study
6. Systolic blood pressure \< 90mmHg at baseline
7. Estimated glomerular filtration rate (eGFR) ≤30 mL/min/1.73m2.
8. Unable to participate in study for being critically ill asssed by clinicians
9. Other concomitant severe morbidities leading to poor prognosis and decreased mortality, such as malignant tumor and disease involving other vital organs; life expectancy less than 1 year.
Behavioral Plant-Based Dietary Intervention in Latinos

The Aims of this study are 1) to develop a traditional plant-based diet that is palatable and acceptable to the Latino population and which contains the appropriate calorie and macronutrient composition needed to lose weight and improve metabolic function and; 2) to develop a culturally sensitive \[based on previous literature and stakeholder input\] lifestyle intervention program, that will be delivered by community health workers \[CHWs\], that focuses on consuming a traditional plant-based diet and overcoming the barriers to incorporating this dietary therapy as part of the family lifestyle but with a focus on the adult participant with obesity. Ultimately, in Aim 3 the investigators will conduct a 16-week randomized controlled trial (RCT) in 40 Latino adults with obesity \[20 control, 20 treatment\] to evaluate the intervention's: i) clinical efficacy; ii) fidelity of the implementation by CHWs; and iii) acceptance by CHWs and study participants.


Eligibility Criteria:
Inclusion Criteria:

* Self-reported Hispanic and/or Latino heritage
* Body Mass Index (BMI) 30-42 kg/m²
* HbA1c ≤ 6.4%

Exclusion Criteria:

* Previous diagnosis of diabetes
* Unstable weight (≥4% during the last 2 months prior to study enrollment)
* Severe cardiovascular disease within the 6 months prior to study enrollment
* Severe organ system dysfunction
* active substance abuse with alcohol or drugs
* Severe anemia
* Pregnant or breastfeeding
* Use of medications that are known to affect the study outcome measures
* Persons who are not able to grant voluntary informed consent
Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair

To investigate the influence of limb remote ischemic preconditioning (LRIP) on mortality, hospitalization costs and quality of life in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.

Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators have revealed that limb remote ischemic preconditioning (RIPC) would reduce intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.Few groups have investigated the long term influence of limb remote ischemic preconditioning.Therefore, the investigators evaluated the impact of limb remote ischemic preconditioning on mortality, hospitalization costs and quality of life during elective abdominal aortic aneurysm repair in a prospective, randomized, controlled, single blind setting.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of abdominal aortic aneurysm
* Must be received open abdominal aortic aneurysm repair

Exclusion Criteria:

* age \>80 years old
* Acute coronary syndrome or myocardial infraction within 3 months
* Chronic obstructive pulmonary emphysema
* angina pain within 48 hours of repair procedure
* ejection fraction less than 40%
* poor pulmonary function (PaO2 \<60mmHg)
A Study to Evaluate the Product Performance of the PureVision®2 High Definition (HD) Contact Lens

The objective of this study is to evaluate the product performance of PureVision2 HD contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings
* Subjects must be myopic or hyperopic and require lens correction in each eye
* Subjects must own a pair of spectacles and the spectacle prescription must have been updated or confirmed as correct within the last 2 years.

Exclusion Criteria:

* Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Any systemic disease affecting ocular health.
* Using any systemic or topical medications that will affect ocular physiology or lens performance.
* Allergic to any component in the Biotrue multi-purpose solution
Mineral Nano Pathology

Hip arthroplasty is a treatment widely used in most inflammatory, traumatic and degenerative conditions of this joint. The longevity of implants may be disappointing in some cases, despite the promising results obtained during in vitro simulations. Early loco-regional or systemic dissemination, known since the 1990s, of wear particles from these prosthesis may reduce their life span.

The analysis of the particles in the synovial fluid and in the articular tissues by electron microscopy after digestion or directly by optical microscopy, will improve the knowledge on the mechanisms of wear.

This category 3 study is based on the case-control model and will be conducted in a national reference center (hospital la Croix-Rousse- Lyon). It will include a population of adult patients.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient,
* Patient including French,
* Patient witness: to be hospitalized in the orthopedic department of the Croix-Rousse hospital for a first hip prosthesis
* Patient test: to be hospitalized in the orthopedic department of the Croix-Rousse hospital for the removal of a hip prosthesis

Exclusion Criteria:

* Patient protected by law (guardianship, curatorship, safeguard of justice).
* Pregnant or lactating woman
* Patient with suspicion of infection on prosthesis
* Patient opposing his participation in the study
Improving Practice Patterns for the Treatment of Hypertension

To improve the quality of hypertension care in our facility, while concurrently, examining the relative contribution of each aspect of a multi-factorial intervention designed to improve hypertension care.

This project was a randomized trial designed to examine the relative contribution of three quality improvement interventions of increasing intensity on BP control in veterans. Providers in each stratum and their eligible patients were randomized to one of three study arms. The providers randomized to the first arm received education alone, and were considered the controls. Providers randomized to the second arm received both provider education and a hypertension alert. The third arm included provider education, a hypertension alert, and patient education. Patients were eligible for inclusion if they were aged 21- 90 years and filled their medications with the VA pharmacies. Between July and December 2003, we determined patient eligibility using a search strategy using data from the Mid South Quality Improvement Data warehouse, which is downloaded monthly from Veterans' Health Information System and Technology Architecture (VistA).

Eligibility Criteria:
Inclusion Criteria:

Patients were eligible for inclusion if they were aged 21- 90 years and filled their medications with the VA pharmacies. Seen in 2003 and had a primary care visit coded as hypertension using International Classification of Diseases Ninth Revision; Clinical Modification (ICD 9-CM) (24) of 401.1 or 401.9 and who were prescribed only one antihypertensive medication

Exclusion Criteria:

More than one antihypertensive medication Refuse consent to review medical record Pregnant Prisoners
Skin Cancer Oncology Radiation Evidence Registry

To collect and analyze long term safety and efficacy outcomes of patients undergoing radiotherapy for non-melanoma skin cancer. A target of 400 VMAT-treated sites is set which is estimated to be identified in approximately 350 participants. Participants referred for radiotherapy for the management of non-melanoma skin cancer.

The Registry will collect information on key clinical indications and patient reported outcomes to assess the safety and efficacy of VMAT radiotherapy. Data that will be collected includes baseline data of demographic, relevant medical history, photographs, treatment schedule, and treatment outcomes. Data may be collected retrospectively in regard to previous relevant medical history, prior treatments and outcomes as well as prospectively, including treatment schedule and treatment outcomes of radiotherapy treatment.

The Registry aims to assess the safety and outcomes of treatment for up to 5 years. This Registry will be the first of its kind in the US and will provide a basis for a number of potential research publications. The Registry will also give insights into treatment delivery and potentially facilitate future improvements in patient care.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age
* Diagnosed with a treatable non-melanoma skin cancer by referring medical practitioner
* Eligible to be treated using widefield (\>50cm2) VMAT radiotherapy as determined by RO
* Patient has provided written informed consent.

Exclusion Criteria:

♦ Patients who do not consent to their involvement in the Registry.