cyrilzakka/clinical-trials huggingface dataset:
A Multicenter Cross-sectional Study of Shear Wave Ultrasound Imaging in Evaluating Supraspinatus Tendon Elasticity

The goal of this multi-center, cross-sectional, observational study is to test and compare the difference of the supraspinatus tendon's elasticity between diabetics and healthy people. The main questions it aims to answer are:

* Ultrasonic characteristics of supraspinatus tendon in diabetic patients
* Influencing factors of elastic value and thickness of supraspinatus tendon

Participants will be asked to:

* Perform ultrasound examination of the shoulder join.
* Fill in a survey with certain questions on their basic information.


Eligibility Criteria:
Inclusion Criteria:

① Age range (above 18 years old); ② Non-professional athletes; ③ No medical history of shoulder and neck pain; ④ Ultrasound examination (-).

Exclusion criteria:

① pregnant women or postpartum 1 year; ② Shoulder pain with active or passive cervical motion; ③ History of upper extremity trauma; (4) Shoulder surgery or treatment history, intra-articular injection history, use history of glucocorticoids, estrogens, quinolones and cholesterol drugs; (5) Shoulder joint fear test (shoulder joint abduction 90°, slowly increasing external rotation, the subject had a positive expression of fear); (6) Evidence of adhesive shoulder joint bursitis, such as the passive range of motion of the 2 motion planes of the shoulder joint is obviously limited; ⑦ Systemic autoimmune diseases, metabolic diseases, endocrine diseases, psoriasis; ⑧ unable to complete the relevant movements and positions; ⑨ Those who are reluctant to continue the experiment and ask to quit.
Safety and Efficacy of Recombinant Birch Pollen Allergen in the Treatment of Allergic Rhinoconjunctivitis

Safety and efficacy of recombinant birch pollen allergen in the treatment of allergic rhinoconjunctivitis


Eligibility Criteria:
Inclusion Criteria:

* Positive Skin Prick Test reaction to birch pollen
* Positive RAST result to birch pollen
* Positive Provocation Test result to birch pollen

Exclusion Criteria:

* Serious chronic diseases
* Other perennial allergies
Diets, Metabolic Profile and Gut Microbiota Among Indonesian Women in Minangkabau and Sundanese-ethnic Community

Many provinces in Indonesia have some well known traditional foods that are widely consumed, but it remains unknown whether traditional ethnic dietary patterns can confirm healthy diets. High quality diet is associated with reduced risk of metabolic diseases and modulated gut microbiota. Moreover, the relationship between dietary quality and microbiota, a potential mediator of metabolic disease, has not been studied.

This study was conducted in specific villages and hamlets that were randomly selected by multi-stage random cluster sampling in 2 provinces. The investigators randomly selected 36 villages (18 villages in each provinces) by using probability proportional to size cluster sampling to admit the total 360 women who met the criteria and consented. While Bifidobacterium, Advanced Glycation End Products (AGE) and lipid profile were examined in a subgroup of 120 participants from each province (n=240).

Field enumerators were trained to standardize 24 hours food recall, food frequency questionnaire for 1 month back, and for stool sampling technique procedure.

Anthropometric measurement was performed by performing weight and height measurement. Fasting blood sampling and fecal Bifidobacterium examination were done in collaboration with professional laboratories. Hemoglobin was assessed by using hemocue. Lipid profile was quantified using calorimetric method, fasting blood glucose (FBG) was quantified using enzymatic colorimetric method glucose oxidase - phenol aminophenazone, HbA1c was using high performance liquid chromatography (HPLC) hexokinase, malondialdehyde level was quantified using will's spectrophotometry, blood advance glycation end products was done by using enzyme linked immunosorbent assay (ELISA), carboxymethyl lysine plasma was done by ultra performance liquid chromatography-tandem mass spectometry (UPLC-MS/MS), and plasma tumor necrosis factor-alpha was done by ELISA. Fecal sample were collected in 2 pots, each contain 5-10 gram of stool, and store in cooler box (2-9 degree celcius) until sample was transported to laboratory as soon as possible to store in -80 degree celcius freezer.

Eligibility Criteria:
Inclusion Criteria:

* healthy reproductive women aged 19-50 years old
* having both parents from the same ethnicities (Minangkabau or Sundanese)
* willing to participate voluntarily signed a written informed-consent.

Exclusion Criteria:

* not being pregnant or lactating
* not having symptoms of gastrointestinal disturbance such as diarrhea, dysentery, constipation more than 3 days, and/or abdominal pain for the last 2 weeks
* not having nausea or vomiting or lost appetite for the last 2 days
* no history of malignancy
* not consuming antibiotics in the last 1 week before fecal collection
* not consuming alcohol more than 3 times a week
Comparison of Two Different Heart-lung Machine Filling Methods: Precoating Versus Colloidal Fluids

The study is a single-center, randomized, un-blinded treatment study in which patients (\>78 years) with the use off a heart-lung machine were provided into two study arms.

Patient wit "precoating" have a filling of the machine with their own blood. In the comparator arm, a standard priming is used.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 78 years
* CPB

Exclusion Criteria:

* Hb \<12 mg/dl
* Off pump surgery
Correlation Between Preoperative Refraction and Anterior Segment Parameters with ICL Vault

This prospective non-comparative interventional study aims to analyse the pre-operative factors affecting the range of optimal ICL vaulting. the main question is what is the correlation between age, gender, spherical equivalent, white to white, anterior chamber volume and depth and postoperative vault? participants will do preoperative investigations ( specular microscopy, pentacam and biometry ) then refractive surgery (ICL implantation) followed by follow-up visits to assess the post-operative ICL vault and visual outcome.

Procedure: Refractive error correction by implantable contact lens ( ICL) will be preceded by a Preoperative assessment of the patient's anterior segment using specular Microscopy, pentacam and biometry and full ophthalmic examination.

Post-operatively, visual acuity evaluation, intraocular pressure, and anterior and posterior segments examination using a slit lamp will be done on days 1 and 3 and then repeated after 1 month and 6 months Assessment of ICL vault measurement using pentacam scheimpflug imaging after 1 and 6 months will be done then a correlation between the ICL vault and the patient's refractive error and preoperative anterior segments parameters will be evaluated

Eligibility Criteria:
Inclusion Criteria:

* Age:21 - 45 years old.
* High Myopia or Myopic astigmatism.
* Patients with stable preoperative refraction for the previous 12 months.
* Aqueous depth (ACD internal) = 2.8 mm or greater from the endothelial side using pentacam.
* Patients who are not fit for LASIK.
* No previous intraocular surgeries.

Exclusion Criteria:

* Patients with endothelial cell count \< 2800 cells /mm2
* Patients with corneal opacities
* Patients with preoperative glaucoma, cataract, and retinal disease.
* Patients with any systemic diseases especially collagen diseases.
Brief Mindfulness Intervention for Chronic Pain in Ukraine

This is a pragmatic randomized controlled trial comparing a single 15-minute mindfulness-based intervention to usual care for patients with chronic pain in Ukraine being seen in a pain clinic.


Eligibility Criteria:
Inclusion Criteria:

* Physician-confirmed chronic pain-related diagnosis

Exclusion Criteria:

* Cognitive impairment preventing completion of study procedures.
* Other unstable illness judged by medical staff to interfere with study treatment.
A Phase II Study of Topotecan in Children With Recurrent Wilms Tumor

In spite of the overall success of treating Wilms tumor, certain patients still have poor clinical outcomes. The sub-optimal outcomes for patients with anaplastic histology and recurrent Wilms tumor warrant the identification of new therapeutic agents. The objective of this trial is to estimate the response rate to two cycles of intravenous topotecan in children with recurrent Wilms tumor of favorable histology that is refractory to standard curative therapy.

Topotecan administered intravenously over 30 minutes daily for 5 consecutive days for 2 consecutive weeks, with a two-day rest given in between the five-day treatment blocks. The topotecan dose started at 1.8 mg/m2/dosage and adjusted to attain a target systemic exposure of 80 plus or minus 10 ng-hr/ml.each cycle consists of 28 days and subsequent cycles can be administered upon hematological recovery. Patients with a CR, PR, or SD, can continue to receive up to a total of six cycles. Patients with PD are removed from the study.

Secondary Objectives include:

* To describe the anti-tumor activity of topotecan in children with recurrent Wilms tumor of anaplastic histology.
* To assess the relation between CYP3A4/5 genotype and the pharmacokinetics and pharmacodynamics of topotecan.
* To assess the relation between ABCG2 genotype and the pharmacokinetics and pharmacodynamics of topotecan.

Eligibility Criteria:
Inclusion Criteria:

* Favorable histology Wilms tumor that has recurred or progressed after primary treatment and at least one standard salvage treatment regimen OR anaplastic histology Wilms tumor that has recurred or progressed after primary treatment
* Age\< 21 years of age at the time of study entry
* Adequate bone marrow function
* Adequate liver function
* Adequate renal function
* Adequate performance status

Exclusion Criteria:

* Subject is pregnant
* Subject is lactating
* Renal tumors other than Wilms tumors
Angiography Combination Laparoscopy in Patients With Obscure Gastrointestinal Bleeding

There were many approaches for patients with obscure gastrointestinal bleeding (OGIB). Capsule endoscopy (CE), double-balloon endoscopy, deep small-bowel spiral enteroscopy, laparoscopy, computed tomography and angiography have been recommended as investigation. However, of these techniques, the evaluation and management of patients with OGIB remains a formidable challenge. We compared the diagnostic yield and long-term outcomes of patients with OGIB randomized to angiogram combination laparoscopy or angiogram alone.

Consecutive patients who presented with OGIB to the second people's hospital of GuangDong province between January 2003 and November 2008 were recruited. This study was approved by the ethical committee of the Second people's Hospital of GuangDong Province and was designed according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. All patients gave written informed consent before beginning the study. As a standard protocol, all patients presented with melena or hematochezia would receive at least 2 times upper gastrointestinal endoscopy before admission. Patients who had nondiagnostic upper GI endoscopy were also offered at least 2 times colonoscopy before admission. All gastrointestinal endoscopies were performed by experienced endoscopists (hanning Wang). OGIB were defined as patients who had nondiagnostic upper endoscopy and colonoscopy.

Patients who were \< 18 years, pregnant, in moribund conditions, or with terminal malignancy were excluded. Patients with contrast allergy and impaired renal function (serum creatinine \> 150 µmol/l) were also not eligible for this study. All patients were randomized to receive either mesenteric angiography alone or angiography combination laparoscopy in a 1:1 ratio. Randomization was performed computer-generated list using a randomly permuted block design. To ensure concealed randomization, the randomization code was put in opaque envelope and kept by researchers not performing angiography or angiography combination laparoscopy. Both patients and investigators were unaware of the randomization sequence.

Eligibility Criteria:
Inclusion Criteria:

- melena or hematochezia receive at least 2 times upper gastrointestinal endoscopy nondiagnostic upper GI endoscopy were also offered at least 2 times colonoscopy endoscopies were performed by experienced endoscopists.

Exclusion Criteria:

- \< 18 years, pregnant moribund conditions terminal malignancy contrast allergy impaired renal function (serum creatinine \> 150 µmol/l)
Nocturnal/Diurnal Intraocular Pressure-Lowering Effect of Netarsudil Ophthalmic Solution

To evaluate effect of Netarsudil Ophthalmic Solution 0.02% on Nocturnal and Diurnal Intraocular Pressure.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or older.
2. Ocular hypertension or open-angle glaucoma in both eyes.
3. Unmedicated intraocular pressure \> 17 mmHg in one or both eyes and \< 30 mmHg in both eyes.
4. Corrected visual acuity in each eye equivalent to 20/200 or better.
5. Able and willing to give signed informed consent and follow study instructions.

Exclusion Criteria:

1. Glaucoma with pseudoexfoliation or pigment dispersion component, history of angle closure, narrow angles.
2. Intraocular pressure ≥ 30 mmHg.
3. Use of ocular medications within 30 days.
4. Known hypersensitivity to any component of the test formulations or to medications used routinely during a clinical eye examination.
5. Previous eye surgery (other than cataract).
6. Ocular trauma within 6 months.
7. Clinically significant ocular disease that might interfere with the study.
8. Central corneal thickness greater than 620 µm.
Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes

This trial is conducted in Japan. The aim for this trial is to investigate the pharmacodynamics and pharmacokinetics of insulin detemir and insulin NPH in Japanese subjects with type 1 diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus
* HbA1c (glycosylated haemoglobin) maximum 9.0%
* Duration of diabetes at least 1 year
* Body Mass Index (BMI) maximum 25.0 kg/m\^2

Exclusion Criteria:

* Recurrent severe hypoglycaemia
* Proliferative retinopathy or maculopathy requiring acute treatment as judged by the Investigator
* Impaired hepatic function
* Impaired renal function
* Cardiac problems
* Uncontrolled treated / untreated hypertension
* Hepatitis B surface antigen, Hepatitis C antibodies or HIV (human immunodeficiency virus) antibodies, positive
* Known or suspected allergy against the trial products or related products including the components
* Previous history of serious allergy or anaphylactic reaction
* Any disease or condition which the Investigator feel would interfere with the trial participation or evaluation of the results
* Severe late-phase diabetic complications including nephropathy
* Blood donation of more than 400 mL (inclusive) in total within the last 12 weeks or more than 200 mL (inclusive) in total within the last 3 weeks
* Known or suspected alcohol and illicit substance abuse or dependence
* Pregnancy, breast-feeding (within a year after labour) or the intention to become pregnant
* The receipt of any investigational drug within the last 12 weeks prior to this trial
* Current or anticipated treatment with systemic corticosteroids
Nevada Environmental Tobacco Smoke and Health Study

Workplace exposure to secondhand cigarette smoke or environmental tobacco smoke (ETS)is widespread, effecting between 19 and 49% of the U.S. workforce. The first part of this study is designed to test whether exposure to ETS in the workplace effects a person's risk of developing chronic diseases such as cardiovascular disease and cancer. The second part of this study is designed to test whether antioxidant supplementation in this group of ETS exposed individuals can reduce their risk of developing chronic disease.

The study will look at 375 non-smokers who either work on a casino floor or as bartenders or cocktail servers. Initial baseline data will be collected (questionnaires and blood samples taken) and the subjects will be randomized into one of three groups, placebo, low antioxidant supplementation and high antioxidant supplementation. They will be followed over a two-year period, coming in for follow-up testing every six months. Statistical analysis will be conducted to see whether this group of ETS exposed individuals has a greater risk of developing chronic disease and whether the use of antioxidant supplements can moderate any risks.


Eligibility Criteria:
Inclusion Criteria:

Non-smoker Work in a casino - on the casino floor or work as a bartender or cocktail server for at least 1 year Do not take antioxidant supplements Healthy - not diagnosed with any major chronic diseases.

Exclusion Criteria:

Blood pressure SBP\>200,\<85 DBP\>100, \<40 Pulse \>120, \<45 Cholesterol \>400 Triglycerides \>700 Blood Cotinine \>10 ng/ml BMI \>35
Phase I Randomized, Open-label, Parallel-controlled, Pharmacokinetic and Safety Study of BR201 Injection Versus Cosentyx in Healthy Male Subjects

This is a randomized, open-label, controlled Phase I study of BR201 administered by subcutaneous injection. This study will characterize the pharmacokinetic, safety and immunogenicity of BR201 versus Cosentyx（Secukinumab ） in healthy male subjects after a single dose.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign informed consent form；
* Healthy men 18-50 years of age at time of consent；
* Body weight of ≥50 kg and ≤ 80 kg and BMI ≥19 and ≤ 26 kg/m2.

Exclusion Criteria:

* Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, mental or cardiovascular and cerebrovascular diseases) with clinical significance;
* Use of IL-17 or other monoclonal antibodies in the last 6 months;
* Positive for anti-IL-17 antibodies at screening;
* Evidence of tuberculosis infection;
* With active infection at screening or have been hospitalized for a serious infection during the 8 months prior to screening or use of antibiotics within 2 weeks of enrollment;
* Anti-IL-17 antibody active ingredient, excipients or latex allergy;
* With severe bleeding factors that affect venous blood collection or unwilling to undergo venipuncture;
* Use drug treatment (including prescription drugs, over-the-counter drugs, health product etc.) within 14 days before screening;
* Surgery within 2 months prior to screening; or plan to have surgery during the study period;.
* Have received live vaccines within 6 months prior to screening, or have used any vaccines within 4 weeks prior to screening, or plan to be vaccinated during the trial.;
* History of malignant neoplasms；
* Hepatitis B and/or Hepatitis C; or HIV antigen/antibody positive; or Treponema pallidum antibody positive; .
* Blood donation or massive blood loss (\> 400 ml) within 3 months or blood loss (\> 200 ml) within 1 month before signing the informed consent; or plan to donate blood during the trial;
* Have a history of drug or substance abuse before screening; or positive drug abuse test results on the day of check-in;
* Acute disease occurred or with concomitant medication from the screening to use of the study drug.;
* Have pregnancy plan or sperm donation plan during the whole trial period and within 6 months after the completion of the study;
* Other conditions considered inappropriate to be included in this study.
Controlled Phonation and Vocal Rest Programs After Acute Vocal Exertion in Healthy Adults

The proposed research will investigate the most effective strategy to reduce vocal exertion reported by speakers in noisy environments. Repeated vocal exertion can lead to voice problems and therefore identifying effective strategies can lead to better prevention of acquired voice disorders. This study will compare the effects of vocal rest and controlled phonation both before and after vocal exertion. The investigators hypothesize that vocal rest and controlled phonation will mitigate the negative effects of vocal exertion.


Eligibility Criteria:
Inclusion Criteria:

* within age range

Exclusion Criteria:

* Voice Disorders
* Strong gag reflex
* Craniofacial disorders
* Cognitive Impairments
* Head and Neck Cancer
* Hearing Difficulties
* Dentition problems that prevent an oral scope being placed in mouth
Electrical Cardioversion As a Predictor in Postoperative Preservation of Sinus Rhythm

The aim of this study is to evaluate benefits of electric cardioversion in the early and long-term postoperative period in patients after radiofrequency catheter isolation of pulmonary veins. Parameters of the left atrium will be evaluated by transthoracic echocardiography and electroanatomic mapping. Preservation of the sinus rhythm will be assessed by 24-hour electrocardiographic monitoring.

The main question that is planned to be answered is:

Does a reverse remodeling of the left atrium and/or a decrease in the progression of the fibrosis zone occur after performing electrical cardioversion (and before subsequent catheter ablation) in patients with persistent and long-standing persistent atrial fibrillation (AF)? Can performed electrical cardioversion serve as a predictor of AF freedom in this group of patients?

Participants will undergo a follow-up examinations (echocardiography, ECG, 24-hour ECG monitoring) at the 3rd, 6th and 12th months after catheter ablation. Based on the results of these examinations, the recurrence rate of AF will be estimated.

Two groups of patients will include both persistent and long-standing persistent AF. Experimental group will include patients who underwent electrical cardioversion before the intervention, and active comparator group will include those patients who did not undergo it. The experimental group will be subdivided into a persistent AF patients who were successfully cardioverted in sinus rhythm and persistent AF patients who failed to restore sinus rhythm during DC at the time of catheter ablation. Analysis and comparison of subgroups will be performed.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent signed by the patient to participate in the study.
* Persistent atrial fibrillation resistant to antiarrhythmic drugs for 6 months or more
* The size of the left atrium is less than 55 mm, volume is less than 130 ml, volume index (LP) is less than 55 ml/m2

Exclusion Criteria:

* Reversible causes of atrial fibrillation (hyperthyroidism, pericarditis, myocarditis).
* Patients in need of myocardial revascularization and/or heart valvular disease correction.
* Any previous intervention (including MAZE surgery, thoracoscopic ablation; implanted occluder of the auricle of the left atrium.).
* Patients with severe concomitant pathology requiring correction.
* Contraindications for administration of anticoagulant therapy.
* Documented presence of a blood clot in the cavity of the left atrium or other reasons preventing the insertion of catheters into the left atrium.
* BMI of 40 or more