cyrilzakka/clinical-trials huggingface dataset:
Assessment of Lumen Expansion After Thrombus Extraction in Primary Percutaneous Coronary Intervention

To use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter in 40 patients during primary PCI.

Primary PCI has become the preferred therapy for ST-elevation acute myocardial infarction. The TAPAS trial data suggests that widespread adoption of manual thrombus aspiration may improve clinical outcomes for patients undergoing primary PCI.

Little data exists on the degree to which thrombus is removed during thrombectomy and how much thrombus remains with the potential for distal embolisation during stent deployment. The mechanism of lumen enlargement after thrombus aspiration is also unknown. Since angiography only provides an outline image of the vascular lumen, such questions cannot be adequately addressed by this modality alone.

The aim of this study is to use IVUS to assess (1) culprit plaque morphology and thrombus burden in patients with ST-elevation myocardial infarction; (2) the efficacy of thrombus removal with an aspiration catheter during primary PCI.

Hypotheses In this study we will assess 40 patients with STEMI. Primary PCI will be performed according to our hospital standard working protocol with thrombus aspiration and balloon dilatation of the culprit lesion if necessary prior to stent deployment. IVUS imaging will be undertaken prior to, and following, passage of the aspirations catheter to assess (1) initial and (2) residual thrombus volume. A third and final IVUS imaging run will be performed after stenting of the culprit lesion. IVUS analysis will be performed off-line to assess the lumen enlargement and volume of residual thrombus at each stage. All studies will be undertaken with the approval of the local Clinical Research Ethics.

Aspirated material will be collected and analyzed. Clinical markers such as Troponin release and left ventricular function will be assessed.

Eligibility Criteria:
Inclusion Criteria:

1. patients 18-75 years old with myocardial infarction with ST-segment elevation
2. symptoms of myocardial ischemia lasting more than 30 minutes
3. onset of symptoms within 12 hours of hospital presentation
4. ST-segment elevation of more than 0.1 mV in two or more leads on the ECG

Exclusion Criteria:

1. inability to obtain informed consent
2. use of fibrinolytic drug within 12 hours of presentation
3. comorbidity with anticipated life expectancy of \< 6 months
4. cardiogenic shock on presentation
5. major bleeding diathesis
6. history of aspirin and clopidogrel intolerance
7. critical left main stem lesions
8. severe calcfic disease precluding safe passage of the imaging catheter
9. culprit lesion within saphenous vein grafts

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Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Dysphagia, or swallowing difficulty, is a common symptom in Traumatic Brain Injury Patients. The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given stellate ganglion block. The swallowing function, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years, meeting the diagnosis of Traumatic Brain Injury;
* presence of no contraindication for Stellate Ganglion Block;
* with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
* informed consent form was obtained from the patient.

Exclusion Criteria:

* unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
* complicated with other intracranial lesions, such as stroke;
* with severe consciousness disorders caused by other diseases.
Persistence With Prolia® (Denosumab) in Postmenopausal Women With Osteoporosis

The objective of this study was to describe persistence with Prolia® 60 mg administered subcutaneously (SC) every 6 months (Q6M) at 12 and 24 months.

The study was a multi-center, single-arm, prospective, non-interventional observational study in postmenopausal women with osteoporosis who had been treated with Prolia® for osteoporosis in routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Enrollment within 4 weeks following administration of the first Prolia® (denosumab 60 mg) injection
* Received Prolia® subcutaneously for treatment of osteoporosis consistent with local (US/Canada) product label
* Subject or subject's legally acceptable representative has provided informed consent. Exclusion Criteria:
* Participation in ongoing or previous denosumab clinical trials
* Currently enrolled in another investigational device or drug study, or less than 6 months since ending another investigational device or drug study(s), or receiving other investigational agent(s)
* Contra-indicated for treatment with Prolia® according to the approved applicable local product label (US/Canada)
* Subject has any kind of disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent.
Faecal Analyses in Rheumatoid Arthritis Therapy

This study evaluates the intestinal microbiome and disease activity in patients with rheumatoid arthritis receiving immunosuppressive therapy. Patients will be analysed at two time points in reference to two predefined primary endpoints:

* Changes in intestinal microbiome
* Response to therapy

The investigators want to evaluate if successful treatment of rheumatoid arthritis coincide with specific changes in the gut flora.

Methotrexate (MTX) and tumor necrosis factor (TNF) -inhibitors are two efficient medications for the treatment of rheumatoid arthritis. In a substantial number of cases however, these medications remain ineffective. At present, the scientific community has limited understanding of why some patients are resistant to these medications. The purpose of this study is to understand if the gut flora may associate with treatment response.

Recent studies have associated rheumatoid arthritis with intestinal dysbiosis. Specifically, the bacteria Prevotella copri, has been associated with this disease, an observation that has been supported also by mechanistic studies. In patients receiving methotrexate, normalization of dysbiosis has been associated with successful treatment.

This study is of observational character and integrated in the routine clinical care of patients with rheumatoid arthritis at the Rheumatology Clinic, Skane University Hospital, Lund, Sweden. Study participants are asked to deliver blood and fecal sampling at two time-points together with clinical evaluation of disease activity. With an estimated inclusion of 50 patients, at least 20 responders and 20 non-responders are expected to be included and to be compared to each other.

If successful treatment response in rheumatoid arthritis is associated with specific alterations of the gut flora, these results may guide future studies on the impact of dysbiosis and probiotics on this disease.

Eligibility Criteria:
Inclusion Criteria:

* Rheumatoid arthritis according to the 2010 classification criteria
* About to start methotrexate or TNF-inhibitor because of active disease

Exclusion Criteria:

* Failure to understand protocol
* A history of alcohol abuse
* Concomitant inflammatory bowel disease
* Any history of diverticulitis
* A history of failure to comply with prescribed medication
* Ongoing biological therapy
Back Deformity in Adolescents Students

1. Determine the prevalence of scoliosis and kyphosis among male adolescents in preparatory and secondary governmental schools in El Kharga city.
2. To identify factors affecting aetiology and morphology of scoliosis and kyphosis among male adolescents in governmental preparatory and secondary schools in El Kharga city.
3. To assess the effect of scoliosis and kyphosis among male adolescents in governmental preparatory and secondary schools in El Kharga city on related life style aspects.

The anterior and posterior curves of concavity are part of the physiological position of the spinal column, and are represented by cervical lordosis, thoracic kyphosis, lumbar lordosis, and new sacral and coccygeal kyphosis. Despite all these curves, the spinal column should work mechanically as a straight and rigid axis to withstand stress, and should be functionally flexible in order to allow movement. This mix of opposite behaviors (rigidness and flexibility) is the result of a complex stabilization system formed by muscles that contract and relax harmonically and absorb any impact exerted on the spinal column structure. Biomechanically speaking, the spinal column influences and is influenced by positioning and stress of the pelvic and scapular belts, and upper and lower limbs, respectively. Postural deformities and alterations should not be evaluated only in terms of bone structure, but also in terms of the functional assembly represented by the spinal column \[2\].

Adolescence is a stage of fast physical development in which the nervous system and musculoskeletal system have yet to fully develop. Changes in the physical morphology of the spine are known to cause musculoskeletal system conditions, such as non-specific back pain. Moreover, the spinal morphology as scoliosis and kyphosis.

With early identification and intervention, scoliosis may be prevented from progressing, so that it does not interfere with mobility, activity or comfort. Scoliosis has a large percentage that remains asymptomatic,\[4\] Therefore the feasibility of screening is worthwhile

Eligibility Criteria:
Inclusion Criteria:

* Male students from the 2nd and 3rd preparatory levels and 1st secondary level

Exclusion Criteria:

* female students
Study to Compare Pharmacokinetic Characteristics of Eperisone and Aceclofenac With NVP-1203

The purpose of this study is to compare the pharmacokinetics of NVP-1203 and coadministration of aceclofenac and eperisone HCl SR.

aceclofenac and eperisone(low back pain)

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers, age between 19 and 45
* BMI of \>19kg/m2 and \<28kg/m2 subject
* Informed of the investigational nature of this study and voluntarily agree to participate in this study

Exclusion Criteria:

* Use of any prescription medication within 14 days prior to Day 1
* Use of any medication within 7 days prior to Day 1
Effects of Multicomponent Physical Exercise Program and Mediterranean Diet in Alzheimer's Disease

This study is a randomized, parallel-group, single blinded controlled clinical trial. The general objective of this multicomponent physical exercise program (MPEP) associated with a Mediterranean Diet (MeDi) is to decrease the risk of falls and fractures through the improvement of the bone health and physical functions of people with Alzheimer Disease.

Patients allocated to the intervention group will perform a MPEP with a MeDi during 6 months, with a frequency of 3 sessions per week, and approximately 45-50 minutes of duration each session.

During the study, 4 evaluations will be carried out to assess the effects of the interventions on bone mineral density, gait, balance, and fall risk: ((1) Baseline (pre-intervention); 2) 1st post-intervention after 1 month; 3) 2nd post-intervention after 3 months; 4) Final, 3rd post-intervention after 6 months


Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes older than 50 years
* Have a diagnosis of AD
* Present mild or moderate cognitive impairment (Mini-mental State Examination (MMSE) score between 11 and 23 points included)
* Acceptance to participate in the study (enrollment in the study and signing of informed consent)

Exclusion Criteria:

* Other associated pathologies that do not allow physical exercise due to having severe functional disability or being insecure (neurological diseases, severe cardio-respiratory pathology, etc.).
* Impossibility to carry out the evaluation tests.
* Falls and other incidents with severe consequences that cause disability and/or that do not allow the intervention to continue.
* Attendance at the MPEP is less than 75% in the total of the sessions between assessments. (Criterion applied to each period between assessments).
* Not performing the MPEP sessions for 2 or more consecutive weeks.
* Participate in another intervention program outside of this study, especially an exercise program (important intervention bias for the control group).
Efficacy Study of a Computer Decision Support System to Treat Depression

The purpose of this study was designed to test the feasibility and effectiveness of implementing a Computerized Decision Support System for depression (CDSS-D) during acute care in a primary care setting.

The research project was designed to test the feasibility and effectiveness of implementing a Computerized Decision Support System for depression (CDSS-D) during acute care in a primary care setting. The basic experimental design was a two-group, two-site study design. Three different clinics with a total of 4 primary care physicians agreed and provided informed consent and participated in the study. Half of the physicians used the CDSS-D to treat patients with MDD and the other half provided Usual Care (UC) treatment.

The intervention, CDSS-D, incorporated a pre-existing depression treatment algorithm (Texas Medication Algorithm Project for Depression, Trivedi et al) with computer decision support programming, providing the treatment group physicians with a computerized algorithm.

Eligibility Criteria:
Inclusion Criteria:

* Outpatients aged 18 and over
* Met Criteria for Non-Psychotic Major Depressive Disorder
* Had a baseline HRSD-17 score of at least 14

Exclusion Criteria:

* Patients with a current Axis I diagnosis of somatization disorder, anorexia nervosa, bulimia, or obsessive-compulsive disorder
* Patients with current alcohol or substance dependence
* Women with a positive pregnancy test or who are lactating
* Women of child-bearing potential who are not practicing a clinically accepted method of contraception
* Patients with general medical conditions that contraindicate antidepressant medications
* Patient whose clinical status requires inpatient or day hospital treatment
Mechanism Research of Tinnitus Based on Electroencephalogram and Acoustic Therapy Intervention

This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.

Tinnitus is one of the most common auditory disturbances in human. The treatment of tinnitus is always not effective, and the standardized treatment of tinnitus has been lacking. With the development of neuroimaging, neuroelectrophysiology and animal models of tinnitus, the central mechanism of tinnitus has been gradually revealed. The possible mechanisms of tinnitus are the increase of spontaneous discharge rate and synchronization of auditory central neurons caused by hearing deprivation, the change of brain topological structure, the reorganization of auditory cortex, and the disorder of limbic system and auditory central regulation of tinnitus patients. EEG, as an important means to study the cerebral cortex, has become an important technical support for the research on the central mechanism of tinnitus. Changes in activity in auditory brain areas associated with tinnitus have been observed using EEG/ERPs, and non-auditory brain areas such as the limbic system and frontal cortices have also been associated with tinnitus mechanisms. This project aims to systematically and deeply study the central mechanism of tinnitus using electroencephalogram, and further study the treatment mechanism of tinnitus in combination with sound treatment strategies, so as to provide a research basis for clinical treatment of tinnitus.

Eligibility Criteria:
Inclusion Criteria:

1. 18-30 years old, male or female;
2. PTA (0.5,1,2kHz) ≤25dB HL;
3. Tinnitus is a major problem faced by patients (except healthy volunteers);
4. tinnitus course \> for 3 months;
5. Healthy, no history of other ear diseases, no history of hearing impairment;
6. There are no other medical, psychological or social problems that need urgent treatment, and no other problems that interfere with tinnitus-related treatment;
7. Voluntary tinnitus treatment, and have enough time to cooperate with treatment.

Exclusion Criteria:

1. Pulsatile tinnitus;
2. Acute tinnitus;
3. Tinnitus is associated with severe hearing loss;
4. Tinnitus accompanied by vertigo;
5. Tinnitus accompanied by headache;
6. Tinnitus is accompanied by somatic symptoms, such as neck pain and temporomandibular joint disorder;
7. Post-traumatic tinnitus;
8. Tinnitus is associated with serious psychiatric complications;
Provigil in Conjunction With SSRIs for the Treatment of Mild or Moderate Depression With Attendant Symptoms of Sleepiness and Fatigue.

The main purpose of this study is to determine if Provigil® (modafinil) at a dose of 200 mg once daily is safe and effective for treating symptoms of sleepiness and fatigue associated with Major Depressive Disorder when added to a SSRI.

Approximately 100 male and female outpatients, who are between the ages of 18 and 65, will be enrolled at four sites in the United States. This study consists of two parts. The first part consists of 6 weeks of open label treatment with a selected SSRI \& double blind treatment with Provigil or placebo (inactive medication).

After the six week double blind treatment phase all patients will enter a four week open label treatment phase with Provigil. The dose of Provigil is not to exceed 400 mg and cannot be less than 100 mg per day. They will continue taking the prescribed SSRI.

Eligibility Criteria:
Inclusion Criteria:

* Major Depressive Disorder
* MADRS score ≥ 15 at both screen \& baseline.
* Significant fatigue as evidenced by FSS ≥4 at both screen \& baseline.
* Excessive sleepiness as evidenced by ESS ≥ 10 at both screen \& baseline.

Exclusion Criteria:

* Treatment refractory depression
* Serious or unstable medical condition.
* Pregnancy
* Primary diagnosis of another Axis I or II disorder
* Alcohol or substance abuse or dependence within the past 12 months.
Effect of Adductor Canal Block vs. Placebo on Muscle Strength, Mobilisation and Pain After Total Knee Arthroplasty

The purpose of this study is to evaluate the effect of adductor canal block (ACB) vs. placebo on muscle strength, mobility and pain on the first postoperative day after total knee alloplastic (TKA).

Patients will be included on the first day after TKA surgery and randomized in two groups. Each group will receive 2 ACB with a 1 hour interval, one ACB with an active drug, Ropivacaine, and another ACB with a placebo drug, Saline.

At T0, arm ACB_active/placebo will receive the active ACB with Ropivacaine followed by the placebo ACB at T60 (60 minutes after T0).

At T0, arm ACB_placebo/active will receive the placebo ACB with Saline followed by the active ACB with Ropivacaine at T60 (60 minutes after T0).

Outcome measurements will be made at T60, 1 hour after the first ACB, and the difference in outcome between the groups will be compared.

Baseline values will be measured prior to the first ACB. Final measurements at T120 (120 minutes after the initial ACB), will determine if the differences between the groups are eliminated, since both groups then have received an active ACB.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had a Total Knee Arthroplasty surgery within 2 days (1.postoperative day on inclusion)
* Written informed consent.
* ASA 1-3

Exclusion Criteria:

* Non-cooperative patients
* Patients who have already had a peripheral or central block post surgery.
* Patients who are not able to perform a TUG test pre surgery.
* Patients who do not understand or speak Danish.
* Patient who are allergic to the drugs used in this research.
* Patients with alcohol- or drug abuse - determined by investigator.
* Patients with peripheral sensory neuropathy in their lower extremities.
* Pregnant patients.
Fermented Grape Combined With Fruits and Vegetables Drink on Anti-aging and Anti-inflammatory

60 subjects were recruited and divided into placebo group and fermented grape drinks group.

In this study, using a fermented grape drinks made of fermented grapes with fruit and vegetable powder to explore whether it can improve the skin's condition and achieve anti-inflammatory effects. Sixty subjects were recruited and divided into placebo group and fermented grape drinks group. After drinking for 8 weeks, skin test and blood biochemical analysis were performed.

Eligibility Criteria:
Inclusion Criteria:

1. Dry skin.
2. Rough skin
3. Large pores
4. Dark yellow complexion
5. Sagging skin

Exclusion Criteria:

1. Skin disorders
2. Liver diseases
3. Kidney diseases
4. Allergy to cosmetics, drugs, or foods
5. Pregnant and lactating women
6. People who had any cosmetic procedures before 4 weeks of the study
7. Area of facial spot over 3 cm2
8. Vegan
9. People who took collagen supplements in the past 3 months.