cyrilzakka/clinical-trials huggingface dataset:
Valsartan Versus Amlodipine Effect on Left Ventricular Multidirectional Deformation and Adipocytokines Level

Aim: To evaluate the effects of Valsartan versus Amlodipine on LV deformation in relation to plasma adiponectin and leptin levels in hypertensive individuals.

Methods: LV strain measured by 2 dimensional speckle tracking echocardiography, plasma levels of adiponectin and leptin was determined in 30 healthy individuals served as control group and in 200 hypertensive patients before and after treatment for three months with either Valsartan 160 mg or amlodipine 10 mg.

Patients and methods Thirty control healthy individuals and 200 patients with uncomplicated, essential hypertension were enrolled and followed up for 3 months in a controlled randomized study. All subjects' health status was evaluated by a complete medical examination. All BP measurements were made with calibrated mercury manometers (Korotkoff I and V). Three separate measurements were taken at least 2 min apart and the average of these values was calculated. Subjects' height and weight were recorded in the fasting state with the subjects wearing only light clothes and without shoes and BMI was calculated using the equation (BMI = weight (kg)/height (m)2). Patients, of both sexes with mild to moderate essential hypertension (diastolic blood pressure \[DBP\] \>80 and ≤100 mmHg after a 2-week wash-out period, SBP systolic blood pressure\>120 and 160 mmHg). Patients were randomly assigned into two groups using a computer-generated random number: Group I treated with valsartan (160 mg/d, n = 100), Group II amlodipine (10 mg/d, n = 100). Another 30 healthy subjects are enrolled as control group (Group III). Subjects in group I and II were asked to maintain their usual dietary and physical activity habits throughout the study. Treatment tolerability was assessed at each follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Patients, of both sexes with mild to moderate essential hypertension (diastolic blood pressure \[DBP\] \>80 and ≤100 mmHg after a 2-week wash-out period, SBP systolic blood pressure\>120 and 160 mmHg). Another 30 healthy subjects are enrolled as control group.

Exclusion Criteria:

* Subjects with age \< 18 years and \>65 years and those with two and more antihypertensive medications, those with diabetes, liver or kidney diseases, angina, myocardial infarction or stroke within 6 months, congestive heart failure, neurologic or psychiatric illness, secondary hypertension, known hypersensitivity to the drugs used in the study. also those with conditions that may have caused metabolic alterations within the past year (pregnancy, abdominal surgery, weight gain or loss of more than 3 kg) are excluded.
Effect of "Therapeutic Monitoring" on Blood Glucose Control in Type 2 Diabetes

The purpose of this study is to conduct a multicenter prospective randomized controlled clinical trial, evaluating the effects of "therapeutic monitoring" on blood glucose control in type 2 diabetes.

In our study, about 480 type 2 diabetes patients will be enrolled from multiple centers in China. All participants will be randomly assigned into either the intervention group or the control group. All patients will be given basic diet, lifestyle instruction according to guidelines from home and abroad. The intervention group will be instructed to adjust the diet according to the ambulatory glucose profile (AGP) and the recorde log monitored by the continuous glucose monitoring system, thereby implementing "therapeutic monitoring". All patients will maintain the drug treatment unchanged and make the glucose level as far as possible within the target range (\>3.9 and ≤10mmol/L), and record the amount of various food, then maintain the dietary pattern and the amount unchanged until the end of the study.

The primary objective is to evaluate the effects of "therapeutic monitoring" on blood glucose control in type 2 diabetes, as measured by change in HbA1c level from baseline to 12-week follow-up in both intervention group and control group.

THe secondary endpoint are 1) 1)Difference in TIR (time in range, time in target glucose range, 3.9-10.0mmol/L) at 12 weeks in both groups. 2)Fasting plasma glucose (FPG), lipids and other metabolic related components and parameters such as BMI will be measured. 3)Using questionnaires to evaluate the patients' satisfaction with Flash Glucose Monitoring System.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes defined as WHO(1999) diagnostic criteria;
* HbA1c ≥ 7% and ≤ 9% at screening; and fasting plasma glucose ≥ 7.0mmol/L, and \<13.3mmol/L;
* Duration: 3 months\~15 years;
* BMI: 24\~ 28 kg/m2;
* Using 1-3 oral medications when enrolled, and the treatment pattern was stable for at least 3 months and can maintain during this study period;
* Sign the informed consent. Details please see the study protocol.

Exclusion Criteria:

* There are serious diabetic complications, heart, brain, liver and kidney diseases, allergic diseases and organic diseases;
* The subject is currently pregnant, intends to become pregnant or is unwilling or unable to contraception during the study (female only);
* The subject has symptoms or signs of skin lesions, scab, redness, infection or edema at the sensor application site that may affect the accuracy of sensor application or interstitial glucose measurements;
* The subject has a concomitant disease and the investigator believes it will affect the study or pose a risk to the safety or benefit of the subject or research worker.
* An X-ray, MRI, or CT examination is scheduled during the study period, and the appointment could not be changed to before the study started or after the study ended;
* Take aspirin \> 200 mg / day, and the drug may be added during the entire study period; Details please see the study protocol.
UTERINE EVALUATION FOR THE IDENTIFICATION OF PATHOLOGY. This Study Will Compare the Intrauterine Pathology Detection Rate Between Standard of Care Hydrosonography, and a New Visual Saline Infusion Device Providing Direct Visualization of the Uterus.

This is a prospective, single center, multiple arm cohort study intended to compare the diagnostic accuracy of a Visual Saline Infusion Device (VSI) device, vs standard of care Hydrosonography in reproductive aged women to identify pathology in the uterus.

This is a prospective, single center, multiple arm cohort study intended to compare the diagnostic accuracy of a Visual Saline Infusion Device (VSI) device, vs standard of care Hydrosonography in reproductive aged women to identify pathology in the uterus.

Patients who are enrolled in the study will have a 1) Hydrosonography, and 2) Visual Saline Infusion procedure performed.

The Visual Saline Infusion Device is a 2.7mm, steerable tip catheter with a camera and illumination at the distal end. The device is intended to evaluate the intrauterine space in an office based, outpatient setting using minimal volume of fluid (3-5cc's).

This study will recruit up to 100 women from a fertility center in Los Angeles.

Eligibility Criteria:
Inclusion Criteria:

1. Patients requiring a uterine cavity evaluation
2. Premenopausal women between ages of 18-45

Exclusion Criteria:

1. Positive test or history of any of the following conditions:

1a. Chlamydial pelvic infection

1b. Gonorrheal pelvic infection. 2. Positive Pregnancy Test 3. IUD currently in place
Periodontal Disease and Cardiovascular Disease

To access the influence of triclosan dentifrice on the progression of periodontal disease in patients with coronary heart disease.


Eligibility Criteria:
Inclusion Criteria:

* A minimum of 12 uncrowned teeth other than 3rd molars
* Age 18 to 75 years
* Informed consent

Exclusion Criteria:

* Prosthetic heart valves
* Prosthetic joint replacement
* Previous infective endocarditis
* Requirement for antibiotic cover for dental treatment
* Current treatment with warfarin
Comparison of a Multifocal Contact Lens to a Traditional Multifocal Contact Lens

The purpose of the trial is to compare the performance of two multifocal contact lens systems/products in established presbyopic subjects.


Eligibility Criteria:
Inclusion Criteria:

* Be at least 35 years of age.
* Best-corrected visual acuity of at least 20/40 in each eye.
* Spectacle add from +1.50D and +2.50D (inclusive).
* Able to be fit in available study sphere powers (Plano to -4.00D).
* Currently wearing soft contact lenses at least 5 days a week.
* Other protocol inclusion / exclusion criteria may apply.

Exclusion Criteria:

* Requires concurrent ocular medication.
* Eye injury or surgery within twelve weeks immediately prior to enrollment.
* Currently enrolled in an ophthalmic clinical trial.
* Evidence of systemic or ocular abnormality, infection or disease likely to affect successful wear of contact lenses or use of their accessory solutions.
* Previous refractive surgery.
* Astigmatism \> 1.00D.
* Currently wearing Proclear Multifocal, Frequency 55 Multifocal or Biomedics EP contact lenses.
* Other protocol inclusion / exclusion criteria may apply.
A Clinical Study to Evaluate the Sensitizing Potential of LEO 43204 Gel

This is a randomized, single-center, controlled, within-subject comparison study assessing the sensitization potential of the investigational product, LEO 43204 gel under open conditions in healthy volunteers.

LEO 43204 Gel and Vehicle Gel will be applied to adjacent sites on the infrascapular area of the back. Evaluation of dermal reactions at the application sites will be assessed clinically using a visual scale that rates the degree of erythema, edema and other signs of cutaneous irritation.

Following induction, subjects will have a 10 to 14-day Rest Phase, after which they will enter the Challenge Phase, which consists of one 48-hour application to a naive site on the opposite side of the back. Observations at the naive site during Challenge and the patterns of reactivity during the Induction Phase will provide a basis for an interpretation of contact sensitization.

A total of 10 applications will be made over a period of approximately 6-8 weeks.


Eligibility Criteria:
Inclusion Criteria:

1. Are free of any systemic or dermatologic disorder, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
2. Fitzpatrick skin types I-IV (due to lack of safety data for the investigational product in darker skin types);
3. Complete a Medical Screening form as well as a Medical Personal History form;

Exclusion Criteria:

1. Have any visible skin disease at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction;
2. Are not willing to refrain from using topical/systemic analgesics for 72 hours prior to and during the study (daily use of 81 mg aspirin is acceptable and occasional use of acetaminophen will be permitted);
3. Are using systemic/topical corticosteroids for 3 weeks prior to and during the study, or systemic/topical antihistamines for 72 hours prior to and during the study;
4. Are using medication which, in the opinion of the investigative personnel, will interfere with the study results, including anti-inflammatory medications;
5. Are unwilling or unable to refrain from the use of sunscreens, cosmetics, creams, ointments, lotions, or similar products on the back during the study;
6. Have psoriasis and/or active atopic dermatitis/eczema;
7. Have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site;
Study of the Correlation Between Specific Genes and Cognitive Dysfunction After Surgery

The purpose of this study is to determine whether a certain clock-gene (HPER3) with the 5/5 genotype carries a higher risk of post-operative cognitive dysfunction.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing non-cardiac and non-neurological surgery in either regional or general anesthesia

Exclusion Criteria:

* daily use of major tranquilizers or antipsychotic medication
* known disease of the CNS
* score less than 24/30 points in MMSE
PET-guided Radiotherapy for Patients With Small Cell Lung Cancer.

There is a prospective risk-adapted evaluation of the optimal dose of radiotherapy for definitive radiotherapy of locally advanced small cell lung cancer within the corridor recommended as standard therapy according to the current interdisciplinary S3 guideline of the German Cancer Society/Cancer Aid/AWMF

The main objective of this study is to determine whether patients with SCLC who have a metabolically active residual tumor in the fluorodeoxyglucose (FDG) PET/CT scan after two to three cycles of induction chemotherapy have a similarly low local recurrence rate with higher dose. There is a prospective risk-adapted evaluation of the optimal dose of radiotherapy for definitive radiotherapy of locally advanced small cell lung cancer within the corridor recommended as standard therapy according to the current interdisciplinary S3 guideline of the German Cancer Society/Cancer Aid/AWMF. Allocation to PET boost, if confirmed vital tumor rest by PET CT and biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Histopathologic confirmation
* Limited disease

Exclusion Criteria:

* Other histology than small cell lung cancer
* Further tumor diagnosis
* ECOG 3 or worse
* Extensive disease
* stage IV
Combination of Vitamin C and N-Acetylcysteine to Improve Functional Outcome After Rotator Cuff Repair

The goal of this clinical trial is to learn if vitamin C and N-acetylcysteine work to improve shoulder functional score after rotator cuff repair. It will also learn about the safety of vitamin C and N-acetylcysteine. The main questions it aims to answer are:

Do vitamin C and N-acetylcysteine improve the shoulder functional score of participants? Do vitamin C and N-acetylcysteine improve healing of rotator tendon? Researchers will compare vitamin C and N-acetylcysteine to a placebo (a look-alike substance that contains no drug) to see if vitamin C and N-acetylcysteine works to improve shoulder functional score after rotator cuff repair.

Participants will:

Take vitamin C and N-acetylcysteine or a placebo every day for 45 days. Visit the OPD three times at 2 week, 6 month and 12 month after surgery for checkups and tests.


Eligibility Criteria:
Inclusion Criteria:

* All patient who undergone arthroscopic primary rotator cuff complete repair.
* Clinical history and symptom consistent with rotator cuff tear.
* MRI confirmation of rotator cuff tear.

Exclusion Criteria:

* Non-reparable or partial rotator cuff repair.
* High grade fatty degeneration of the rotator cuff (Goutallier III, IV)
* At least one torn tendon with retraction to the glenoid (stage 3 of Patte classification)
* Rotator cuff retear.
* Isolated subscapularis tear.
* Patient who loss follow up.
* Patent who cannot respond questionnaire.
* Patient who allergy to vitamin C or N-acetylcysteine.
COVID-19: SARS-CoV-2 Detection in Saliva, Oropharyngeal and Nasopharyngeal Specimens

The aim of this study is to compare the SARS-CoV-2 detection rate using either a Saliva, oropharyngeal swabs or nasopharyngeal swab method for specimen collection.

The reference test to evaluate patients with suspected respiratory infection caused by virus is a real-time reverse transcription-polymerase chain reaction (RT-PCR) from a nasopharyngeal swab (NPS). However, other specimen collection methods like oropharyngeal swabs (OPS) and a saliva specimen collection have also been accepted by the Centers for Disease Control and Prevention for SARS-CoV-2 testing during the current coronavirus disease 19 (COVID-19) pandemic. It is unclear how much the SARS-CoV-2 detection rate differs when using different sampling methods and the aim of this study is to compare the expected COVID-19 detection rate using saliva, oropharyngeal swabs or nasopharyngeal swab in a public setting.

We, therefore, aim to investigate the detection rate of SARS-CoV-2 in Saliva, oropharyngeal swab, and nasopharyngeal swab specimen samples collected in symptomatic and non-symptomatic individuals tested for COVID-19 in a public test center during the COVID-19 pandemic.

Individuals referred for outpatient COVID-19 testing center will be invited to participate in a prospective clinical study. They will have saliva, OPS, and NPS specimen collection performed at the same time and analyzed separately for SARS-CoV-2. The rate for SARS-CoV-2 detection in saliva, OPS, and NPS will be compared using a logistic regression mixed-effect analysis. A Sample Size Calculation estimated that a sample of 18,000 participants would be needed for the trial with 80% power at a significance level of 5%.

Eligibility Criteria:
Inclusion Criteria:

* volunteers, who are attending the COVID-19 test facilities to obtain a RT-PCR test.
* oral and written informed consent to participate before entering the study.

Exclusion Criteria:

* Failure to understand and provide informed consent.
* Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs.
Computer-Based Training in Cognitive Behavior Therapy

The computer-based training program (CBT for CBT) focuses on teaching basic coping skills, presenting examples of effective use of coping skills in a number of realistic situations in video form, and providing opportunities for patients to practice and review new skills while receiving substance abuse treatment.

In this behavioral trial 120 methadone maintained cocaine abusing individuals will be randomly assigned to either treatment as usual in a community-based clinic OR treatment as usual plus 8 hours of access to the 'CBT for CBT' computer program over a period of 8 weeks. Primary outcomes will be retention in treatment and reduction in cocaine use (percent days abstinent, confirmed by urine toxicology screens). The patients' ability to demonstrate coping skills through a computerized role-play evaluation will be a secondary outcome. A six-month follow-up will assess durability and/or delayed emergence of effects.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* methadone maintained for at least 3 months
* meet current DSM-IV criteria for cocaine use disorder
* fluent in English or at least a6th grade reading level
* can commit to at least 8 weeks of treatment and willing to be randomized to treatment

Exclusion Criteria:

* untreated bipolar or schizophrenic disorder
* current legal case pending (pending incarceration during 8 weeks of study)
Liposomal Irinotecan With TAS102 and Bevacizumab for Patients With Metastatic Colorectal Cancer

This study is being done to see if combining liposomal irinotecan with TAS102 and bevacizumab confers clinical benefit for patients with treatment refractory metastatic colorectal cancer.

This prospective phase II, single arm, single site trial will evaluate the efficacy of the combination of liposomal irinotecan (nal-IRI), TAS102, and bevacizumab for the treatment of patients with mismatch repair proficient, metastatic or unresectable colorectal cancer that has previously been treated with 5-fluorouracil, oxaliplatin, irinotecan and if RAS wild-type an anti-EGFR agent. A total of 25 patients will be accrued at UW Carbone Cancer Center. Subject enrollment will occur over 12 months with the total duration of the trial expected to be 3 years.

Primary Objective

* To determine the progression free survival (PFS) of patients with metastatic colorectal cancer treated in the treatment refractory setting with liposomal irinotecan in combination with TAS102 and bevacizumab.

Secondary Objectives

* To evaluate the objective response rate (ORR) of liposomal irinotecan in combination with bevacizumab and TAS102.
* To assess the safety and tolerability of these regimens in this setting.
* To determine the impact of the timing of irinotecan use in prior lines of therapy on the ORR and PFS observed with these nal-IRI containing treatment regimens

Eligibility Criteria:
Inclusion Criteria:

* Patients must be ≥ 18 years of age
* Eastern Cooperative Oncology Group (ECOG) performance must be 0 or 1.
* Patients must have a histologically or cytologically confirmed diagnosis of colorectal adenocarcinoma and be metastatic or unresectable.
* The cancer must be mismatch repair proficient.
* Patients must have had prior treatment with 5-fluorouracil, oxaliplatin, irinotecan containing regimens. If RAS wild-type must have received prior anti-EGFR therapy with either cetuximab or panitumumab. If RAS wild-type and HER2 positive then must have had a prior HER2 targeted therapy.

Exclusion Criteria:

* Uncontrolled concurrent medical illness that would not allow for the completion of the planned therapy.
* Patients whose cancers possess BRAF V600 mutations are excluded.
* Patients must stop the use of strong inducers/inhibitors of CYP3A4 at least 2 weeks before initiating therapy.
* Patients must not have mismatch repair deficient or microsatellite instability high cancers.
* Patients must not have received prior TAS102.
Esmolol Effects on Heart and Inflammation in Septic Shock

Beta adrenergic system, over-activated in septic shock patients, is a key modulator of the inflammatory response. Experimental works demonstrated that Esmolol, an highly selective beta-1 blocker, reduces heart rate and regulates the inflammatory response. A recent mono centric, double blind, randomized clinical work in septic shock patients has shown that Esmolol administration is safe and reduces effectively heart rate. However there are only sparse data on 1) regional and micro-circulation, 2) inflammation modulation in human resuscitated septic shock patients treated by esmolol.


Eligibility Criteria:
Inclusion Criteria:

* septic shock patients following the definition of the Surviving Sepsis Campaign
* femoral and central venous catheters for thermodilution monitoring
* fluid optimization
* with a cardiac index \> 3 l/min/m2
* Heart Rate \>100 /min

Exclusion Criteria:

* Cardiogenic shock
* Bradycardia
* History of Severe Asthma
* Indications against esmolol