cyrilzakka/clinical-trials huggingface dataset:
Phase III Study of Compound Danshen Dripping Pills to Treat Diabetic Retinopathy

The purpose of this study is to evaluate the efficacy and safety of Compound Danshen Dripping Pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis).

Compound danshen dripping pills is a kind of traditional Chinese medicine(TCM), consists of Danshen (Radix Salviae Miltiorrhizae), Sanqi (Radix Notoginseng) and borneol. This study is being conducted to evaluate the efficacy and safety of compound danshen dripping pills in patients with diabetic retinopathy(Syndrome Of Qi-Stagnation and Blood Stasis), when compared with placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosed with non-proliferative diabetic retinopathy(NPDR) and TCM syndrome differentiation of qi-stagnation and blood stasis.
2. aged 30-70 years
3. voluntary signs the informed consent

One eye met the inclusion criteria can be used as research object, if both eyes met the inclusion criteria, please record respectively, and select one eye for efficacy evaluation with reference to the following principles:

When the two eyes of fundus conditions in different clinical stage, choose the more serious one.

When the two eyes of fundus conditions in the same clinical stage, choose the eye easier for clinical operation.

Exclusion Criteria:

1. HbAlc\>8%, sustained hyperglycemia.
2. The patients who have been received the therapy of Retina laser photocoagulation or diagnosed with proliferative diabetic retinopathy (one or two eyes).
3. Diabetic retinopathy caused by type 1 diabetes mellitus.
4. Combined with glaucoma, uveitis, ocular neuropathy and severe cataract etc.
5. Combined with primarily severe diseases such as cardiovascular, hepatic，renal illness , hemopoietic system disease, and psychosis. Serum transaminase is higher than the limit of normal value of 1.5 times.
6. Diabetic nephropathy with renal failure (Azotemia or Uremia).
7. For women of child-bearing potential: pregnant or lactating or intending to become pregnant. Having any allergic reaction to some drugs.
8. Participated in other clinical trial within 3 months.
9. Used drugs for the treatment of diabetic retinopathy within 1 week.
10. Blood pressure \> 160/100 (systolic above 160 or diastolic above 100).
Boosting Executive Function With Brain Exercise

The goal of this study is to explore the impact of a 15-minute exercise break on brain function and cognitive performance in a simulated classroom setting. The main questions it aims to answer are:

1. How do short exercise breaks affect executive function in college students?
2. What changes occur in brain connectivity and microcirculation after these exercise breaks? Participants were college students who engaged in sessions of continuous sitting or sitting interspersed with exercise. The study used cognitive tasks and brain imaging techniques to measure the effects. The findings reveal improvements in cognitive performance and brain function, suggesting that short exercise breaks are beneficial in educational contexts.


Eligibility Criteria:
Inclusion Criteria:

-right-handed (how was handedness assessed; i.e., "What hand do you write with?") with normal or corrected-to-normal vision and normal color vision

Exclusion Criteria:

-reported a history of cardiovascular, metabolic, gastrointestinal, neurological, or psychiatric disorders, medical conditions requiring medical care, substance addiction, strict diets (e.g., low- carbohydrate and Mediterranean diet), pregnancy, or lactation.
ITAKOS - Italian Observation, Multicenter, Prospective Study of Ofatumumab in RRMS Patients

Study to evaluate the effectiveness of ofatumumab in Italian RRMS patients in the real-life setting.

Prospective real-world data on ofatumumab is still very limited. For this reason, the main aim of this study is to investigate the impact of ofatumumab in a population of Italian RRMS patients in routine clinical practice to evaluate if ofatumumab is able in these conditions to provide relevant clinical benefits that comprehensively encompass anti-inflammatory activity (relapses), disability accumulation, cognitive impairment, fatigue symptoms and quality of life.

This is an observational, multicenter, single-arm, prospective study. Prospective data will be collected on patients newly treated with ofatumumab over an observational period of 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Male or female outpatients ≥18 years old.
2. Patients diagnosed with RRMS (McDonald criteria 2017).
3. Patients newly treated with ofatumumab, for whom the decision to start treatment with the drug has already been taken independently from study inclusion, based on clinical practice and according to the SmPC and to AIFA reimbursement criteria and who already successfully qualified for treatment with ofatumumab (i.e., passed the screening procedure mandated by the SmPC and the Risk Management Plan (RMP) for this treatment).
4. Patient or a legal representative of the patient must provide written informed consent before any study assessment is performed.

Exclusion Criteria:

1. Patients outside the approved label of ofatumumab.
2. Pregnant and lactating women.
3. Patients with any clinical condition that may interfere with the subject's ability to cooperate and comply with the study procedures based on investigator's judgement.
4. Patients cannot participate in this non-interventional study if they also participate in an interventional trial.
5. Treatment with ofatumumab prior to inclusion in this study or after 7 days from baseline visit.
Importance of Patient Selection for Treatment of Infected Total Knee Prosthesis

The infection of a total knee replacement often imposes changing implants. The change in two step is currently considered the gold standard. The change in one step is a much debated attitude: strictly contra-indicated for some professionals, but others agree to reserve these for favorable suspected cases selected. Several criteria have been proposed in the literature: age, condition, duration of infection, known bacterium responsible, not virulent and sensitive to antibiotics, no fistula, no significant bone destruction. But these criteria are poorly validated, standing over an experience of surgical teams rather than high-level scientific studies. Some authors have proposed to achieve change in one step systematically. The results of these cohorts on healing the infection does not seem very different from the changes in two steps. But it is most often single-center series, uncontrolled, with small numbers.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Patient having surgery for the management of knee infection after change in one step of a knee replacement prothesis in the participating services between 2000 and 2010.

Exclusion Criteria:

* Patients under 18 years
Reproductive Health and Family Planning

The aim of this study is to measure the knowledge and attitude levels of women who play a key role in society on reproductive health and family planning, and to determine the changes in their attitudes and behaviors after face-to-face training with virtual reality application.

In a three-month period, using the virtual reality application prepared for the individuals in the Experimental 1 group, it will be explained for an average of 40 minutes in a time period where they are suitable, through the trainings prepared according to the subjects. The literature will be scanned and appropriate educational materials will be created, and animations will be used to support education. The trainings for the Experiment 1 group will continue in accordance with the training titles according to the weeks, using virtual reality glasses. Modern family planning methods will be shown in detail through virtual reality glasses, three dimensions of the methods will be shown and supported by videos.

By using the training room of the family health center specified for the individuals in the Experimental 2 group, training content covering the subjects of reproductive and health and family planning methods will be prepared, and the days when women are suitable will be determined, and each training will be given for 40 minutes with face-to-face classical training method. Educational subjects will be continued in parallel with Experiment 1 group by using Ministry of Health hand brochures and training materials for Experiment 2 group.

Eligibility Criteria:
Inclusion Criteria:

-Being over 20 years old

* Married,
* Being literate,
* Not using modern family planning methods

Exclusion Criteria:

-Being under 20 years old

* not being married
* Not volunteering to participate in the study
* Using modern family planning method
* Not being able to attend the trainings at any stage of the research
PD-L1 and BRAF Expression in Nasopharyngeal Carcinoma

The prognostic value of programmed death-ligand 1 (PD-L1) and BRAF expression in nasopharyngeal carcinoma (NPC) is not well-defined. In this study the investigators investigated alterations in PD-L1, BRAF and EGFR by using immunohistochemistry analysis in a cohort of consecutively enrolled NPC patients.

NPC is a common type cancer in Macau and Southern China. The role of PD-L1 in NPC remains controversial. There many reasons behind these inconsistent findings. We used the SP263 antibody with the standard cut off value of 1% and 5%, which is frequently used for lung cancer and other cancer types. We also plan to include over 150 patients, which will be the largest study in NPC. This will help us to gain insights in NPC.

Eligibility Criteria:
Inclusion Criteria:

* Above 18 years of age
* Locally advanced (stage IIIB) or metastatic (stage IV) NPC
* Fresh-frozen tissue samples were available were included
* After treatment with curative surgery or radiotherapy in Macau
* With follow up data were available

Exclusion Criteria:

• Enrolment in studies that prohibit any participation in this observational study
Clinical Study for Palliative/Preventive Treatment of Chronic Back Pain

Randomized, controlled, double-blind, double-blind clinical trial, with three parallel arms depending on the product consumed (experimental product dose 1 and dose 2 and placebo product) and single-center, to measure the efficacy of a botanical supplement on the prevention of non-joint pain.

Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product dose 1 or dose 2, or placebo, depending on the group to which they have been assigned).

The product to be consumed is a Botanical Extract. Participants will consume the product for 84 days. It should be taken half an hour before breakfast, two capsules per day.

The study subjects will have to make 5 visits to the laboratory. On the first and last visit, they will have their blood drawn, their sleep quality will be evaluated and they will complete a series of questionnaires to evaluate their quality of life and type of back pain. In the rest of the visits they will only have to take the tests on paper.

Eligibility Criteria:
Inclusion Criteria:

* Men and women between 20 and 65 years of age.
* The subjects must have localized myofascial pain in the back area (cervical, dorsal and lumbar), with an evolution time of at least 3 months.
* The pain must present an initial score of at least 30 mm in the pain evaluation by means of the VAS scale.
* The pain must be episodic.
* BMI 18.5 - 29.9 kg/m2.
* Subjects should not be treated with narcotic drugs or steroidal anti-inflammatory drugs. steroidal anti-inflammatory drugs or immunosuppressants.

Exclusion Criteria:

* Severe or terminal illnesses.
* Subjects with pain associated with trauma.
* Subjects with pain associated with chronic conditions (rheumatoid arthritis, herniated discs, ankylosing herniated disc, ankylosing spondylitis, etc.).
* Subjects with known allergy to any of the components of the investigational product. the investigational product.
* Subjects undergoing physiotherapy treatment during the course of the study. development of the study.
* Pregnant or lactating women.
* Inability to understand the informed consent.
CPAP in Diabetes Type 2 Patients With Sleep Apnea

Aim: To assess if six months of treatment with CPAP associated with conventional drug therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome SAHS)

Main objective:

To assess the effect of 6 months of CPAP treatment associated with conventional drug therapy on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)

Eligibility Criteria:
Inclusion Criteria:

* subjects 18 to 75 years old; diagnosis of type 2 diabetes mellitus; treatment with diet; oral antidiabetics or insulin stable in the last month; levels of HbA1c\> 7.5% (if not supported clinic two controls to confirm with a difference not exceeding 0.5%); overweight or obese (BMI ≥ 25 kg/m2)

Exclusion Criteria:

* professional drivers, risk profession or respiratory failure; excessive daytime sleepiness is very high (Epworth scale\> 18); morbid obesity (BMI\> 40 kg/m2); CPAP treatment
Demonstrate the Value of Using Hypnosis in Chimiotherapy- Induced Chronic Neuropathies

Chimiotherapy produces neuropathies injuries to 30% to 70% cases. A third of those patients keeps suffering from this side effects disabilities and their quality of life is seriously affected.

Hypnosis, as a non-invasive tool without physical side effects, might be used to relieve them.

the purpose of this trial based on our own experience, is to demonstrate the value of using hypnosis and self-hypnosis in chimiotherapy- induced chronic neuropathies.

The aim will be to sustainably improve the quality of life by expanding self-management of pain and motor function side effect.


Eligibility Criteria:
Inclusion Criteria:

* Minimum age :18 years
* Chemiotherapy- induced chronic neuropathies for at least 2 months with a DN4 score \>4
* Failure of classic treatment used to relief neuropathic
* Having stopped chemotherapy treatment and being in complete or partial response or in tumoral stability
* Without any planed chemiotherapy during the study
* Having signed a written informed consent.
* French efficient understanding
* With health insurance coverage
* availability during all the study
* With efficient contraception for women of childbearing age

Exclusion Criteria:

* No participation to another study at the same time
* Suffering from neuropathy before having chemotherapy
* Other disease that may cause neuropathy
* deafness
* Any medicine that could cause neuropathy
* Neurological or psychiatrical disease past or present
* Mental retardation
* Allergy to EMG's electrodes
* Unable to consent, under tutelage or curatorship or judiciary safeguard
* Pregnant or nursing woman
Expanded Quantitative Urinary Culture (EQUC) vs Standard Culture (SUC) Techniques in the Clinical Care

This purpose of this study is to see if expanded urine culture techniques used in the laboratory improve the clinical care of women over standard urine culture techniques.

The investigators request permission to recruit 225 women who respond "yes" to the question "do you feel you have a urinary tract infection". All participants will provide baseline urine specimens obtained by transurethral catheter (to avoid vulvo-vaginal contamination) and will complete a UTISA questionnaire to assess their current urinary tract symptoms. Participants will be randomized to the SUC treatment algorithm or the EQUC treatment algorithm. Treating physicians will receive either the SUC results or the EQUC results from the clinical laboratory and the results will be part of their clinical record. Treating physicians will follow the Loyola FPMRS treatment algorithm. Women in the study will also give consent for us to contact them using email, text messaging or phone call within 7-10 days after "treatment plan" has been implemented. The treatment plan options will include no treatment if the culture results show no pathogenic bacteria. All participants will be queried 7-10 days after their treatment plan (by email or text) "do you feel you continue to have a urinary tract infection". Women who respond "yes' will be asked to return for a second urine specimen which is our standard protocol. The second urine specimen will be analyzed using EQUC culture techniques only. Again, a treatment plan will be developed by the attending physician and the patient participant will be queried 7-10 days after the plan is implemented.

Eligibility Criteria:
Inclusion Criteria:

* A "yes" answer to the screening question "do you feel you have a UTI"?
* Non-pregnant women ages 18 years or older
* Agreement to respond to a text or email question 7-10 days after treatment plan for their UTI (note: the treatment plan may include "no treatment").

Exclusion Criteria:

* Women currently on antibiotics
* Patients who cannot communicate or read in English
* Patients under the age of 18
* Pregnant patients
* Women with an indwelling catheter and intermittent self-catheterization
* Men
* Urine obtained via the "clean catch method" (i.e. voided urine)
* Women who refuse to be catheterized
* Women who cannot or will not agree to respond to an email or text message 7-10 days after treatment plan is initiated.
Long-Term Immune Persistence of GSK Biologicals' Combined Hepatitis A & B Vaccine Injected According to a 0,6 Month Schedule

The aim of this study is to evaluate the long-term persistence of hepatitis A and B antibodies at Years 6, 7, 8, 9 and 10 after subjects received their first two doses primary vaccination schedule of combined hepatitis A/hepatitis B vaccine.

This protocol posting deals with objectives \& outcome measures of the extension phase at year 6 through to 10.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

To evaluate the long-term antibody persistence, volunteers will be bled at Years 6, 7, 8, 9 and 10 after the first vaccine dose of the primary vaccination course to determine their anti-HAV and anti-HBs antibody concentrations.

If a subject has become seronegative for anti-HAV antibodies or lost anti-HBs seroprotection concentrations at the long-term blood sampling time point (i.e. Years 6, 7, 8, 9 or 10), he/ she will be offered an additional vaccine dose.

Eligibility Criteria:
Inclusion Criteria:

* Subjects participating in this study should have participated in the primary study with combined hepatitis A/ hepatitis B vaccine.
* Written informed consent will be obtained from each subject and/ or parent or guardian of the subject before the blood sampling visit of each year.
Antiplatelet Therapy in Acute Mild-Moderate Ischemic Stroke

The risk of early recurrence or progression of acute ischemic stroke is very high, even in patients treated with aspirin. The Chance study show that clopidogrel plus aspirin treatment reduced the risk of recurrent stroke in patients with transient ischemic attack (TIA) or minor ischemic stroke (NIHSS ≤ 3) within 24 hour onset and was not associated with increased hemorrhage events, compared with aspirin monotherapy. However, it is not known whether the dual antiplatelet treatment could reduce the risk of early recurrence or progression in patients with acute mild to moderate ischemic stroke (4 ≤ NIHSS ≤ 10). The investigators hypothesise that clopidogrel-aspirin treatment will be superior to aspirin monotherapy in this group of patients.

The ATAMIS study is a multicentre, prospective, randomised, open-label, controlled trial with a target enrollment of 3,000 patients from 60 centres of the Northeast China. Eligible patients are as follows: (1) definite acute ischemic stroke; (2) neurological deficit: 4 ≤ NIHSS ≤ 10; (3) time from onset to drug treatment: within 48 hours.

Patients in the clopidogrel-aspirin group will receive a 300mg loading dose of clopidogrel, followed by clopidogrel 75 mg/d and aspirin 75 mg/d from day 2 to day 14, and followed by clopidogrel 75 mg/d or aspirin 100 mg/d from day 15 to day 90.

Patients in the aspirin-alone group will receive 100-300 mg aspirin from day 1 to day 14, followed by aspirin 100 mg/d from day 15 to day 90.

The primary efficacy end point is early neurological deterioration assessed as a change of NIHSS: no change of NIHSS within 14 days.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Acute ischemic stroke that can be randomized within 48 hours of symptoms onset
* neurological deficit: 4 ≤ NIHSS ≤ 10
* CT or MRI scan ruling out hemorrhage or other pathology
* the first onset of ischemic stroke or previous stroke with no obvious sequelae (mRS≤1)
* Signed informed consent by patient self or legally authorized representatives

Exclusion Criteria:

* intracranial hemorrhage and hemorrhagic cerebral infarction
* Thrombolysis for ischemic stroke
* Allergy to clopidogrel and/or aspirin
* History of stroke with serious sequelae
* Severe systemic disease (such as severe infection, severe hepatic and renal dysfunction)
* Clear indication for anticoagulation (atrial fibrillation, mechanical cardiac valves, deep venous thrombosis, pulmonary embolism)
* History of intracranial hemorrhage
* Planned treatment with nonsteroidal anti-inflammatory drugs to affect platelet function
* Anticoagulation within 10 days
* Gastrointestinal bleed or major surgery within 3 months
* Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
* Planned surgery or intervention to stop antiplatelet therapy
* Ischemic stroke induced by angiography or surgery
* Pregnancy or childbirth within the previous 4 weeks
* Patients who have been treated with any other investigational drug within 3 months of enrollment
* Severe noncardiovascular comorbidity with life expectancy \<3 months
Cross-over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel 1.5 mg

A single dose, two treatments (Postinor-2 and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 14 days between the two study periods. Treatment groups are balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis.

Exclusion Criteria:

* History of illnesses or any organic abnormalities that could affect the results of the study.
* History of tobacco or alcohol abuse or regular use of recreational or therapeutic drugs.
* Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.