cyrilzakka/clinical-trials huggingface dataset:
Prevalence,Natural History,Prognosis Factor,QualityofLife,Health Care Consumption and Social Consequences of Symptomatic Knee and Hip Osteoarthritis in France

The aim of the project is to assemble and to follow on a 10-year period a nationwide representative sample of lower limb OA patients.

General objectives: To document the natural history and to identify predictive factors of the evolution and consequences of hip and knee OA in terms of pain, functional disability, structural damage, quality of life, autonomy, medical and health care use and cost of disease.


Eligibility Criteria:
Inclusion Criteria:

* male and female aged between 40 and 75 years
* symptomatic hip or knee, uni or bilateral OA with clinical diagnosis confirmed by a medical physician and satisfying ACR classification criteria
* Representative of prevalent cases in France at the cohort set-up time

Exclusion Criteria:

* presence of hip or knee joint replacement surgery
* comorbidities severe enough to affect quality of life significantly or likely to induce a high health care consumption independently of OA
* an history of osteotomy
* Patello-femoral osteoarthritis without tibio-femoral osteoarthritis
* Other joint diseases of the target joints
* adult under legal protection or not able to consent
Multivariate Analysis of Serum High Sensitivity C-Reactive Protein in Patients With Acute Phase Stroke

Stroke is one of main causes of death and impairment worldwide. Objective of this study is to analyze serum High Sensitivity C-Reactive Protein in acute phase stroke in patients attended at Petróleos Mexicanos Hospital Central Sur de Alta Especialidad and to correlate with stroke extension and clinical features.


Eligibility Criteria:
Inclusion Criteria:

* Patients suspected of acute phase stroke who arrive to emergency room at our hospital
* Patients affiliated to Petróleos Mexicanos medical system
* Patients of any gender
* Patients between 18 and 80 years old

Exclusion Criteria:

* Stroke provoked by angiographic procedure
* Pregnancy
* Patient under chemotherapy or radiotherapy
* Recently surgery or trauma among last 30 days
* Heparin usage
* Stroke and/ or thrombolysis history
* Active infection
* Liver disease
Qingkailing Injection Versus Puerarin Injection on Withdrawal Rate of Corticosteroids in Patients With Active Rheumatoid Arthritis

The purpose of this study is to evaluate the effect of Qingkailing injection versus Puerarin injection on withdrawal rate of corticosteroids in patients with active rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* with active RA
* without taking any other medication for the treatment of active RA in at least 4 last weeks
* aged from 18 to 75 years
* without conflict to the written, informed consent signed prior to the enrollment.

Exclusion Criteria:

* being included in other clinical trial within the last 4 weeks
* with abnormal liver or kidney function (more than 1 time above the high normal)
* with serious cardiovascular disease
* with hematologic disease
* being in pregnancy, lactation period or under a pregnancy plan
* with severe gastrointestinal disease
* with contraindication or being allergic to the test drugs
* being under the treatment of drugs within 1 previous week, that might affect the results of the trial, such as non-steroidal anti-inflammatory drugs, steroidal anti-inflammatory drugs, immunosuppressants, anti-ulcer drugs
* being not compatible for the trial medication, or other circumstances at the discretion of investigators
* without legal capacity or only with limited legal capacity.
Probability of OncotypeDx to Reallocate As Low or High Risk of Recurrence Breast Cancer Patients with Uncertain Biology

In some cases of hormone receptor positive, human epidermal growth factor receptor 2 (HER2) negative early breast cancer the benefit of adding adjuvant chemotherapy to hormonal treatment, estimated on the basis of the classical clinico-pathological parameters, is unclear. In these cases the application of a genomic test could be useful in guiding the therapeutic choice.

Oncotype Dx (ODx) is a 21-gene assay that classifies primary ER+ breast tumors into three categories of recurrence risk: High (HR), Intermediate (IR) and Low (LR).

Available data show that

1. patients with ODx low score breast cancer perform well without chemotherapy,
2. chemotherapy has an additive value to endocrine therapy in patients with ODx high score tumors, and
3. the role of chemotherapy is unknown in patients with ODx intermediate score cancer.

In this study, the investigators aim to evaluate the capability of ODx to help in guiding the choice of systemic adjuvant treatment in a group of patients with ER+ and HER2- , node negative (pN0) or micrometastatic (pNmi) breast cancer with uncertain biological behavior for whom there is uncertainty about the indication of adjuvant chemotherapy.

Eligibility Criteria:
Inclusion Criteria:

* Histological diagnosis of infiltrating ductal or lobular ER+ HER2- early breast cancer adequately treated with surgery
* Nodal status: no regional lymph node metastasis (pN0) or micrometastatic regional lymph node (pN1mic)
* Uncertain biological behavior defined by all of the following parameters: ER \>20% and progesterone receptor (PgR) \>20% and Ki67 between 14% and 30% and G2
* Written informed consent

Exclusion Criteria:

* pathologic tumor stage (pT) \> 5 cm (not applicable to the internal control group)
* Prior neoadjuvant therapy
* Evidence of metastatic disease
* No axillary exploration (sentinel lymph node biopsy or axillary dissection)
* Multifocal or multicentral or bilateral tumors
Dermabond Treatment for Gastric Variceal Bleeding

The purpose of having a database is to collect data related to endoscopic ultrasound procedures performed by Indiana University EUS physicians; specifically, for the treatment of gastric variceal bleeding This data will be used for research purposes only to determine the clinical impact of endoscopic ultrasound treatment of gastric variceal bleeding. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.

Clinical outcomes research is one of the strengths of the EUS group. As a group, the physicians need a tracking system for specific treatment modalities, and data to determine the impact of endoscopic ultrasound for patients with gastric variceal bleeding. Gastric variceal bleeding is a severe complication of portal hypertension with significant morbidity and mortality with limited therapeutic options. Currently, there is no database in existence for endoscopic ultrasound clinical research for specific procedures. Also, there is limited data regarding the outcome of endoscopic sclerotherapy with cyanoacrylate in the United States.

Eligibility Criteria:
Inclusion Criteria:

Anyone receiving treatment with DermaBond for treatment gastric varices.

Exclusion Criteria:

No evidence of gastric varices.

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Comparison Of Left Ventricular Volume And Wall Stress With Dobutamine And Exercise Echocardiography

This study will compare the physiologic responses between exercise stress echocardiography and pharmacologic stress echocardiography on left ventricular volume and wall stress.

This prospective observational study will compare the physiologic responses between exercise stress echocardiography and dobutamine stress echocardiography on left ventricular volume and wall stress. Exercise and dobutamine stress testing are two widely employed diagnostic modalities that are often used, interchangeably, to detect inducible ischemia. We hypothesize that dobutamine leads to significantly lower ventricular volumes and wall stress than exercise.

Some previous studies have shown that dobutamine and exercise echocardiography have comparable sensitivities and specificities, differences exist between the hemodynamic effects produced by each modality on the cardiovascular system. These variable effects may lead to differences in left ventricular size, volume and wall stress. If divergent left ventricular effects exist(between exercise and dobutamine induced stress), then the degree of myocardial oxygen consumption, ischemic burden, and ischemic threshold observed during exercise and dobutamine stress testing may be different between these commonly used modalities of stress testing.

The potentially variable effects on the left ventricle in response to the modality used to induce stress would highlight a physiological difference between exercise and dobutamine stress testing. Differences in volumes and stress could also help explain the greater of ischemia and higher frequency of angina and ST-segment deviation which has been previously observed in some studies during exercise as compared to dobutamine echocardiography. The presence or lack of these expected hemodynamic responses may also have additional diagnostic and prognostic implications.

The study involves the collection of data among patients undergoing stress echocardiograms that are clinically indicated. This data will be retrieved from the echocardiogram and report and medical chart, including baseline clinical characteristics, exercise parameters achieved during the test.

Eligibility Criteria:
Inclusion Criteria:

* Age 30-80 years
* Normal sinus rhythm on electrocardiogram
* Normal left ventricular systolic function on baseline echocardiogram

Exclusion Criteria:

* Patients with stress-induced wall motion abnormalities
* Left ventricular hypertrophy
* Evidence of prior myocardial infarction
* More than mild valvular heart disease
* Prior cardiac surgery
* Poor technical quality of echocardiogram
Mobilition With Movement and Soft Tissue Mobiiztion in Tennis Elbow

Lateral epicondylitis or tennis elbow is one of the most common lesions of the arm. This injury is a major challenge, as it is difficult to treat, prone to recurrence and may last for several weeks or months, with an average duration of a typical episode which has been reported to be between six months to two years. This is an RCT study. Subjects who fulfilled inclusion criteria will be taken for the study. Before conducting the actual method for subjects, lateral epicondylitis evaluation is done. First day before treatment, pain evaluation were done by using Numeric Pain Rating Scale. Muscle power was assessed by MMT (Manual Muscle Testing) and the function level are tested by Patient-Related Tennis Elbow Evaluation (PRTEE) questionnaire and asked to mark the results. Subjects will be divided into 2 groups randomly by lottery method. Each group consists of 15 patients. Group A will be given MWM; Group B will be given soft tissue mobilization. Both groups will be given with the above said methods for alternative days in a week as per 3 sessions per week for 4 weeks. At the end of program subjects will be reassessed by recording muscle strength, pain intensity and functional level. Finally pre and post recordings will be compared and analyzed statistically.


Eligibility Criteria:
Inclusion Criteria:

* Tennis players.
* Age group between 15-30 years.
* Positive specific tests.(cozen and mills test)
* Subjects having lateral epicondylitis pain for at least 4 weeks, muscle power for wrist muscle should be increase with activity against resistance, average pain level of 3-cm or more on a 10-cm Numerical pain rating scale

Exclusion Criteria:

* Any neurological disorder.
* Other elbow deformity or joint pathology. fracture of upper limb
Efficacy and Safety Study of Sorafenib Plus Pravastatin to Treat Advanced Hepatocarcinoma

The purpose of this study is to evaluate the overall survival (OS) in order to assess the efficacy and safety of pravastatin as adjuvant treatment to sorafenib.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have been diagnosed with advanced hepatocarcinoma (HCC), confirmed histologically or with non-invasive criteria, according to the clinical practice guidelines by the American Association for the Study of Liver Diseases (AASLD) during a maximum period of 15 days prior to the baseline visit.
* Males and females, over 18 years of age.
* Patients who have not previously received treatment with sorafenib.
* Have an ECOG ≤ 2.
* Liver function: Child A and B7.
* Life expectancy greater than 12 weeks.
* Adequate kidney function: serum creatinine concentration less than or equal to 1.5 times the upper limit of normal (ULN).
* Sign the written informed consent before starting any procedure, including randomization.

Exclusion Criteria:

* Patients who routinely (more than 3 times a week) take some sort of statin.
* Patients with hypersensitivity to statins.
* Pregnant or breastfeeding women.
* Peripheral neuropathy: grade 2 or higher
* Patients who have been diagnosed, within the previous 5 years, with another type of tumor, except for non-melanoma skin cancer, or in situ carcinoma of the cervix or the urinary bladder.
* Patients receiving chemotherapy or radiotherapy for another type of tumor.
* Patients with heart failure greater than NYHA grade II, hypertension that is uncontrolled with medication, uncontrolled arrhythmias or AMI within the previous six months.
* A history of perforation or hemorrhage due to a gastroduodenal ulcus within the last month.
* Greater hemorrhagic diseases.
* Asthmatic patients uncontrolled with medication.
* Any other contraindication associated to the use of statins.
* Physical or psychological inability to participate in the trial.
* Treatment with another investigational drug or participation in another clinical trial within 6 months prior to inclusion in the study.
Multicenter Selective Lymphadenectomy Trial (MSLT)

Subjects must be diagnosed with melanoma. All subjects receive Wide Excision (WEX) of their melanoma. If the melanoma meets study requirements, the subject is randomized to receive either (1) no further surgical procedures as part of the study or (2) a Selective Lymphadenectomy with the possibility of a Complete Lymphadenectomy. Subjects are then followed for 10 years.


Eligibility Criteria:
Inclusion Criteria:

1. The patient consents to be in the study.
2. The patient must have invasive melanoma with: 1) Clark Level III and Breslow Thickness greater than or equal to 1.00 mm; or 2) Clark Level IV or V with any Breslow thickness. A confirmation of diagnosis and thickness must be made by the institutional pathologist.
3. The primary cutaneous melanoma site must be on the head, neck, trunk, extremity, scalp, palm of the hand, sole of the foot, or subungual skin.
4. The patient's biopsy must have been completed no more than 10 weeks before the initial visit to the clinic. (Surgery must be scheduled within three months of the biopsy.)
5. The patient must be between 18 and 75 years old.
6. The patient must have a life expectancy of at least 10 years from the time of diagnosis, excluding the diagnosis of melanoma.

Exclusion Criteria:

1. The patient had a prior wide excision of the primary with a diameter of excision greater than or equal to 3.0 cm and the shortest margin from the tumor edge to the excision edge was measured by a pathologist to be greater than or equal to 1.5 cm; or the patient had an elliptical excision and a margin beyond the tumor edge was greater than or equal to 1.5 cm at the narrowest margin.
2. The primary cutaneous melanoma involves the eye, ear, mucous membranes.
3. The patient has clinical evidence of satellite lesions, in-transit, regional nodal or distant metastases.
4. The patient has a second primary invasive melanoma.
5. The patient has had any type of solid tumor or hematologic malignancy during the past 5 years. Exceptions are if the patient has been treated for T1 lesions (e.g., squamous cell carcinoma of the skin, basal cell carcinoma or in situ carcinoma of the uterine cervix) during the past 5 years, but has not received treatment within the last 6 months.
6. The patient has had prior skin grafts, tissue transfers or flaps, or lymph node dissections that may alter the lymphatic drainage pattern from a primary cutaneous melanoma to the adjacent regional lymph node basins.
7. The patient has had previous chemotherapy, immunotherapy or radiation therapy.
8. The patient has had an organ transplantation and is receiving immunosuppressive agents as a result of the transplantation.
9. The patient has taken oral or parenteral steroids or immunosuppressive drugs within the last 6 months.
10. The patient has any known primary or secondary immune deficiencies.
11. The patient has another medical condition that will affect life expectancy.
12. The patient is pregnant.
13. Evidence that the patient cannot undergo selective lymph node dissection for any reason.
OPTIONS: A Patient-Centered HIV Prevention Decision Aid for PrEP Uptake for Women With Substance Use in Treatment Settings

To develop and test the effect of a patient-centered HIV prevention decision aid on HIV pre-exposure prophylaxis (PrEP) uptake among women with substance use disorders (SUD) in treatment.

To test the effect of the informed decision aid intervention on PrEP uptake among women with substance use disorders in treatment. Investigators hypothesize that compared to those receiving standard harm reduction information, women receiving the decision aid will have a significant increase in PrEP uptake at 6 and 12 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* Self- identification as female (i.e., cis- or trans- women), age ≥18, HIV negative status (confirmed with APT date from rapid testing procedures), and entering or receiving treatment at our partnering site, the APT Foundation, Inc. (a drug treatment center).

Exclusion Criteria:

* Women on PrEP at baseline, unable or unwilling to provide informed consent, threatening to staff, pregnant, or experiencing symptoms of physiological withdrawal that interfere with ability to provide informed consent
Text Messaging and Atopic Dermatitis

Atopic dermatitis is a common problem faced by patients of all ages and backgrounds. Treatment regimens and specific therapies may be time consuming and multiple studies have documented a parallel decrease in compliance as time after an office visit increases. The adolescent population is an extremely challenging sub-group of patients in terms of complying with a treatment regimen. Not only are they striving for independence and thus lacking supervision of a regimen by a parent, but their complex thinking skills are immature, leading to forgetful behavior. By introducing a reminder system for these vulnerable patients that is easily incorporated into their daily lives, the investigators propose that patients will have better compliance at applying their medication and thus improving their atopic dermatitis. Text-messaging via cell phones has become very popular among teenagers and adults and provides a non-obtrusive method of sending a treatment reminder.

We propose to conduct a randomized, controlled 6-week trial to evaluate the impact of a text message-based reminder program on adherence to health maintenance behaviors among adolescents diagnosed with Atopic Dermatitis. After obtaining informed consent, subjects will be randomized into either an intervention or control group. Subjects in the intervention group will receive a daily text message with a tailored message regarding atopic dermatitis, while control group subjects will receive a weekly text message with information on local weather, sport or news without any reference to atopic dermatitis. Of note, the decision to send a weekly text message to the control group reflects the expectation that a message will be sent, although the frequency and content of the message will not be revealed.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-17 inclusive
* Capable of giving informed consent/assent. Of note, all subjects will sign an assent form and parents will sign a parent consent form.
* Diagnosed with Atopic Dermatitis by a physician (self report)
* IGA score fo 2 or greater
* Currently using at least one prescribed topical therapy for atopic dermatitis
* Have a mobile phone capable of receiving text messages
* Able to retrieve text messages from mobile phone
* Able to adhere to study visit schedule and other protocol requirements.

Exclusion Criteria:

* Younger than 10 years of age or 18 years and older at the time of enrollment
* No diagnosis of atopic dermatitis by a physician
* IGA score of 0 or 1
* Currently on no prescribed topical treatment for atopic dermatitis
* UV therapy or climatotherapy is a part of treatment for atopic dermatitis
* Does not have a mobile phone capable of receiving text messages
* Unable to retrieve text message
* Non-English speaking individuals (text messages are in English)
Dexmedetomidine on Postoperative Cognitive Dysfunction and Serum Tau-217 Protein.

To assess the effect of Dexmedetomidine on serum Tau-217 protein and its relation to the incidence and severity of postoperative cognitive dysfunction in elderly patients undergoing major surgery under general anesthesia.

to assess the effect of dexmedetomidine on serum Tau-217 protein through measuring serum Tau-217 protein preoperative and postoperative period and comparing the 2 measurements , assessing the cognitive dysfunction in the elderly patients and comparing the correlation between the cognitive dysfunction with serum tau-217 level also assessing the neuroprotective effect of dexmedetomidine on postoperative cognitive dysfunction and its relation with serum Tau-217 level.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \> 65 years old, both genders, Basal Metabolic Index range 18.5 to less than 35 American Society of Anesthesiologists I - III with Glasgow Coma Scale 14-15 undergoing major surgery under general anesthesia.

Exclusion Criteria:

* Patients will be excluded if they refused the enrollment in our study, Glasgow Coma Scale\<14 or if there is severe cardiac, liver or renal disease, patients have Alzehimer's Disease or any of the psychotic diseases, poorly educated patients and if there is any sensitivity to given drugs
Ultrasound (US) Guided External Ventricular Catheter Placement

To assess the accuracy the SOLOPASS® System US based in the placement of external ventricular drain into the cranial cavity. This study will aim at evaluating the proposed efficacy of the device in targeting the brain ventricles and decrease multiple brain passes, incorrect deployment and malfunctioning of the drain.


Eligibility Criteria:
Inclusion Criteria:

* Decision made to perform the procedure by the primary consultant
* Age 18 or older
* Neuro ICU stay
* Newly diagnosed hydrocephalus
* Has a recent CT within the past 24 hrs
* Normal platelets and coagulation profile
* No active infection or currently on antibiotics
* The targeted fluid compartment has more than 50 percent CSF vs blood by CT scan imaging

Exclusion Criteria:

* Age \<18
* Not in Neuro ICU setting
* Previous placement of a ventricular catheter
* More than 50 percent of the fluid compartment is filled with blood by CT scan
* Time to include in the trial prohibited by clinical personnel