cyrilzakka/clinical-trials huggingface dataset:
Suture-mediated Closure System Following Endovascular Peripheral Arterial Procedures

The purpose of this study is to evaluate the effectiveness and safety of the suture-mediated closure system produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd. following endovascular peripheral arterial procedures.

Prospective, multi-center, randomized Comparative study using the Suture-mediated Closure System produced by Suzhou Hengrui Hongyuan Medical Technology Co., Ltd.as an investigational device and the Perclose® ProGlide Suture-Mediated Closure System as a comparator.

After going through the confirmation of inclusion/exclusion criteria with signed subjects, they will have a procedure either of the two devices. The subjects should follow designated physician's instructions accurately during the clinical trial period. There are about 4 times evaluations Including screening.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18-80
2. Patients who can use 5Fr to 21Fr sheath for common femoral artery puncture for interventional catheterization or therapy
3. Informed consent signed by the patient or legal representative

Exclusion Criteria:

1. Pregnancy or lactation period;
2. Diameter of femoral artery site for puncture\< 5mm;
3. Have participated in another clinical study during the same period;
4. Known allergy to any device component, and/or contraindications of contrast agents and anticoagulants;
5. Vascular injury at the site of the approach;
6. Groin infection;
7. Morbid obesity (BMI≥40kg / ㎡);
8. Ultrasonographic assessment of the entire common femoral artery wall showed that the common femoral artery stenosis was ≥ 50%;
9. There are femoral aneurysms, arteriovenous fistulas or pseudoaneurysms in the common femoral artery;
10. Clamp vessel closures were used at the previous ipsilateral artery approach;
11. Hematoma at ipsilateral artery approach;
12. Other conditions deemed unsuitable for participation in this clinical trial by the investigator.
The Effects of Omega 3 and Vitamin E Supplementation on the Serum Antioxidant Enzymes and Gene Expressions of PGC-1a, h TERT, FOXOs and SIRTs in CAD Patients

The aim of this study is to determine the effects of omega 3 supplementation and its concurrent supplementation with vitamin E on the serum levels of antioxidant enzymes and the expressions of the PGC-1a, h TERT, FOXO1, FOXO3a , SIRT1,SIRT3, SIRT6 genes in PBMC cells in the patients with coronary artery disease


Eligibility Criteria:
Inclusion Criteria:

-

literate, willingness to participation, CAD patients 45- 65 years old, body mass index\< 30, avoidance of dietary supplements, vitamins and herbal products at least 3 months before and throughout the intervention, willing to maintain body weight during the study

Exclusion Criteria:

* people who have used vitamin E or omega 3 supplements in last 3 months, having chronic renal disease ,cancer, Hepatobilliary diseases, hematological disorders, hypo- or hyperthyroidism, diabetes, treatment with PPAR-gamma agonists or Thiazolidinediones, Smokers
Long Term Effect of Somatropin in Subjects With Intrauterine Growth Retardation

This trial is conducted in Europe. The aim of this trial is to assess the safety of long-term growth hormone treatment in growth-retarded children with intrauterine growth retardation (IUGR) enrolled in trial GHRETARD/F/1/F.


Eligibility Criteria:
Inclusion Criteria:

* Patients born with IUGR enrolled in trial GHRETARD/F/1/F
* Bone age below 14 years in boys and 12 years in girls

Exclusion Criteria:

* Bone age above 14 years in boys and 12 years in girls
Inflammation and Infection in Trauma, Role in Posttraumatic Complications

The purpose of this study is to investigate the relationship between trauma, the immune system, biochemical changes in the first 24 h and subsequent complications and mortality

The immune system plays a role in the development of complications after severe trauma, but we do not know how. Equally, biochemical changes measured in the blood after trauma (eg. bloodglucose, GC-globulin, coagulation parameters etc.) may predict the prognosis and the degree of complcations. Two significant complications are infection and organ failure, which may prolong hospitalisation and increase mortality.

In the study we collected samples from blood and body surfaces to determine changes in cytokines, biochemistry, bacterial flora, and subsequent complications. We compare the changes in between groups of the cohort.

Eligibility Criteria:
Inclusion Criteria:

* Clinical suspicion of multiple trauma
* Age \>/= 18 years
* Direct referral from scene of accident

Exclusion Criteria:

* Major burn injury
* HIV positiv
* Pregnancy
The Ventriloquist Puppet Method for Children Under The Inhaler Treatment

This study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on anxiety and fear level of children aged 4-6

Although treatment methods appropriate to the disease are applied in respiratory system diseases, healthcare professionals must cooperate with the child and family regarding compliance with the treatment (oral, nebulizer, inhaler) and management of the disease. Children may experience anxiety and fear from the moment they enter the hospital. They may react to being in the hospital and medical procedures such as crying, running away, or withdrawing. Age, previous negative hospitalization experiences, and fear of getting sick are factors that shape children's medical fears. The majority of children have 'a little' or 'a lot' of fear about medical procedures. Children have adaptation problems to the inhaler treatment and often reject it. To provide effective treatment, compliance of the child and family with the treatment and suitable application techniques are crucial. In this process, it is important to minimize the anxiety and fear of children and ensure that they receive the treatment in the best possible way. Therapeutic approaches such as distraction cards, musical toys, and puppets during the preparation of the child for the procedure before the treatment can increase the child's compliance with the treatment and reduce the level of anxiety. In a study, puppet shows were useful in reducing the fears of children with 'a lot' fear. In another study, finger puppets as a play enhanced communication with children with cancer and were suitable for use in the hospital environment. It has been concluded that the use of puppets is beneficial because it gives children the opportunity to express themselves freely. An effort should be made to reduce the child's anxiety and fear by taking a therapeutic approach not only for invasive procedures but also for non-invasive procedures. Therapeutic approaches can be applied to the child and family before, during, and after treatment. This study aimed to determine the effect of preparation with the ventriloquist puppet method before inhaler treatment on the anxiety and fear levels of children aged 4-6.

Eligibility Criteria:
Inclusion Criteria:

* Children between the ages of 4-6,
* Children receiving inhaler therapy,
* Children and families who can speak Turkish,
* Children and families who volunteer to participate in the research,

Exclusion Criteria:

* Children with cognitive or mental problems,
* Children with life-threatening conditions,
* Children with hearing, vision and/or speech impairments
Study to Learn About How the Study Medicines Called PF-07976016 and PF-06882961 Are Taken Up by the Body, and if Either of Them Change How the Body Processes the Other Medicine in Otherwise Healthy Adults With Overweight or Obesity

The purpose of this study is to see how two study medicines, PF-07976016 and danuglipron, taken together affect the level of each other in the blood of participants who have overweight or obesity.

The total number of weeks of the study is up to approximately 22 weeks (5.5 months).


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant, non-breastfeeding female, 18 to 65 years of age
* BMI 25 to 40 kg/m2 and a total body weight \> 50 kg (110 lb)
* Willing and able to comply with all study procedures including staying a research unit for up to 95 days

Exclusion Criteria:

* Any medical or psychiatric condition or laboratory abnormality, or recent serious illness or hospitalization, that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study including diagnosis of type 2 diabetes mellitus, type 1 or secondary forms of diabetes
* Use of any prohibited prior or concomitant medication(s)
* Presence of specified abnormalities on diagnostic assessments including clinical laboratory tests
* A positive urine drug test.
* History of alcohol abuse or repeated binge drinking and/or any other illicit drug use or dependence
* Use of tobacco/nicotine containing products in excess of the equivalent of 5 cigarettes/day or 2 chews of tobacco/day
Preoperative Hormone Therapy for Postmenopausal Women With ER+ Clinical Stage T2-4 Tumors

This phase II trial studies how well exemestane before surgery works in treating postmenopausal patients with newly diagnosed estrogen receptor positive stage II-III breast cancer. Estrogen can cause the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by blocking the use of estrogen by the tumor cells.

This study will develop preliminary data regarding the efficacy and safety of exemestane in the preoperative treatment of postmenopausal women with ER+ or PR+ tumors. This trial is also designed to develop a predictive model to correlate expression of the known isoforms of ER and progesterone receptor (PR) and the aromatase enzyme with response to estrogenic deprivation using exemestane.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed breast cancer
* ER positive (+)
* Primary tumor 2-4 regional lymph nodes 0-2 (T2-4N0-2); patients may have metastatic disease, provided local-regional surgery is clinically indicated
* Clinical stage II/III
* Postmenopausal- defined as having had a previous bilateral oophorectomy or, for women with no prior hysterectomy, the absence of spontaneous menstrual cycles for more than 1 year
* Newly diagnosed
* Patients with prior non-breast malignancies are eligible if they have been disease free for \>= 5 years before study entry; patients with squamous or basal cell carcinoma of the skin that has been effectively treated, carcinoma in situ of the cervix that has been treated by surgery only, or lobular carcinoma in situ (LCIS) of the ipsilateral or contralateral breast that has been treated by surgery only are eligible, even if the cancer was diagnosed within 5 years before randomization
* Serum creatinine =\< 1.5 x institutional upper limit of normal (ULN)
* Hemoglobin within normal limits for institution
* Absolute granulocyte count \>= 1500
* Platelet count \>= 100,000
* Serum glutamic oxaloacetic transaminase (SGOT), aspartate aminotransferase (AST) or serum glutamate pyruvate transaminase (SGPT), alanine aminotransferase (ALT) =\< 2.5 x ULN
* Total bilirubin \< 2 x ULN for institution
* Alkaline phosphatase \< 2 x the ULN

Exclusion Criteria:

* Completely resected
* Prior hormone or chemotherapy
* Unable to take oral medication
* Patients who have nonmalignant systemic disease (cardiovascular, renal, hepatic, etc.) that would preclude their being subjected to protocol therapy
AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.

This PMCF study is designed as prospective, multi-center study to collect real-life data.

The rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients who will undergo an endovascular intervention within standard-of-care (SOC) where at least 1 of the following devices from AndraTec were used:

The LOKUM-Quest guidewire, The LOKUM AMPLATZ guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA balloon, the AltoSa-XL GEMINI PTA Balloon, the OPTIMUS CoCr Stent , the OPTIMUS-CVS PTFE-Covered stent.


Eligibility Criteria:
Inclusion Criteria:

- Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.

Patient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study (depending on the used device during the procedure) Patient is \>18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study Patient is eligible for treatment with

* the Lokum L-Quest guidewire
* and/or the Lokum Amplatz guidewire
* and/or the Slider Hydrophilic Nitinol Guidewire
* and/or the AltoSa-XL PTA balloon
* and/or the AltoSa-XL Gemini balloon catheter
* and/or the Optimus-XL CoCr Bare Metal Stent
* and/or the Optimus-XL CVS PTFE Covered Stent, as described in the IFU for each device.

Exclusion Criteria:

* Application in coronary, cerebral arteries and central circulatory system
* Known contraindication to peripheral arterial and visceral vasculature treatment - Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.
* Known contraindication and/or allergy to (a component of) an investigational device
* Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding
* Life expectancy of less than twelve months
* Any planned surgical intervention/procedure within 30 days of the study procedure
* Any patient considered to be hemodynamically unstable at onset of procedure
* Patient is currently participating in another investigational drug or device study that has not completed the entire follow-up period.

Device-related exclusion criteria (not applicable for guidewire):

* Known contraindications given in the IFU of Optimus CoCr and Optimus-CVS PTFE- Covered Balloon-Expandable Stent which includes treatment of renal arteries, aneurysms adjacent to site of stent implantation and neurovascular treatment
* Known contraindications given in the IFU of AltoSa-XL-PTA and AltoSa-XL-Gemini Balloon catheter:

  * patients with a contraindication for anti-platelet/anti-coagulant therapy
  * patients with excessive vessel tortuosity
  * dilatation of in-stent restenosis and highly calcified stenosis
  * patients with perforated vessels evidenced by extravasation of contrast media
  * patients with a known hypersensitivity to nylon
Comparing Senobi and Jacobsons Exercises in COPD

The study aims to evaluate the effects of Senobi versus Jacobsons muscular relaxation exercises on pulmonary functions, dyspnea, and sleep quality in chronic obstructive pulmonary disease. The study design will be a randomized clinical trial. The study will be completed in 10 months after the approval of the synopsis from the Ethical Committee of RCRS and AHS. A non-probability convenient sampling technique will be used to recruit the individuals into two groups. Group A had undergone Senobi exercises and Group B engaged in Jacobsons Muscular relaxation exercises along with conventional treatment of COPD.

It will be a randomized clinical trial with 40 participants, aimed to compare the effects of Senobi and Jacobsons muscular relaxation exercises on pulmonary functions, dyspnea, and sleep quality in COPD patients. Participants were chosen through convenient sampling at Sarwet Anver Medical Complex Lahore. Participants were divided into Groups A and B. Group A had undergone Senobi exercises and Group B had engaged in Jacobsons muscular relaxation exercises. The pulmonary function was assessed by spirometer the calculated values will be FVC (Forced vital capacity) and FEV1(Forced expiratory volume in one second). The dyspnea will be assessed by a 6-minute walk test and at the end of the walk state of breathlessness will be evaluated by the Modified Borg Dyspnea Scale. The sleep quality will be assessed by the SATED sleep questionnaire The exercises were evaluated after 6 weeks of interventions. Data was analyzed using SPSS software version 2.5.

Spirometry assesses the amount and speed of air that can be inhaled and exhaled. Key measurements include Forced Vital Capacity (FVC). The maximum volume of air forcefully exhaled after a full inhalation. Forced Expiratory Volume in 1 second (FEV1): The volume of air exhaled in the first second of the FVC test, indicates how quickly the lungs can be emptied.

The modified Borg dyspnea score is a variation of the CR10 scale, with a range from 0 to 10, where 0 signifies the absence of breathlessness and 10 indicates the highest level of breathlessness. Participants assess their dyspnea after the 6-minute walk distance (6MWD) test, capturing the peak intensity of breathlessness experienced throughout the entire walking test. This scoring system provides a subjective measure of the individual's maximal perceived dyspnea during physical activity.

The SATED scale includes specific quantitative criteria for four of the five sleep-related dimensions that have been reliably linked to health outcomes. It evaluates five important aspects of sleep. These include the following dimensions: sleep satisfaction, sleep efficiency, sleep duration, timing of sleep, and alertness during waking hours.

Eligibility Criteria:
Inclusion Criteria:

Both genders

* Age 35-50 years
* Diagnosed COPD patients of stage 2-3 according to gold criteria (moderate)

Exclusion Criteria:

* Patients with neurological disorders
* History of fractures (68)
* History of other pulmonary complications
Efficacy Study of Temperature Controlled Laminar Airflow (TLA)-Treatment in Perennial Allergic Asthma

The purpose of this study is to determine whether nocturnal environmental control with Temperature controlled Laminar Airflow (TLA) is effective as add on treatment in patients with perennial allergic asthma.

Exposure to inhaled allergens is a pathogenetic factor in allergic asthma. However, physical, chemical and combined methods aiming to reduce airborne allergen levels have shown little or no effect in reducing asthma symptoms in people who are sensitive to perennial allergens.Aims and objectives: This study aims to investigate treatment with Temperature controled Laminar Airflow (TLA) with a very low particle concentration directed to the breathing zone in subjects with allergic asthma during night sleep. The hypothesis is that the decreased allergen exposure during the night will have an effect on quality of life and bronchial inflammation.

Method: This is a multicentre, double blind, randomized 52 week parallel trial comparing active TLA treatment with Placebo. For ethical reasons the randomization is 2 to 1 for active and placebo treatment, respectively. A 2 weeks run-in period is inserted between inclusion and randomization, during which the patient shall get familiar with the use of the patient asthma diary and to adhere to the requirements of the study participation. First 12 weeks an unchanged maintenance medication will be kept and week 13-52 medication will be modified to obtain asthma control according to international guidelines (GINA). After inclusion, run-in, randomization and baseline measurements active/placebo treatment with AA will be implemented over 52 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Consent to participate voluntarily. Willing and able to comply with the study specific procedures. Signed Informed Consent prior to any study procedure.
* Perennial allergic asthma, male and female, age 7 through 70 years, at time of randomization.
* A miniAQLQ/PAQLQ score of ≤ 5.5.
* Sensitive to pet allergen and/or house dust mites as demonstrated by changed to RAST 0.70 or positive skin prick test (wheal reaction similar to histamine control).
* Daily maintenance dose of at least ICS ≥200µg/day of budesonide or ≥100µg/day of fluticasone since at least 6 months
* Features of partly controlled asthma according to GINA

Exclusion Criteria:

* Current smoker (Non-smoker is defined as abstinent since \> 1 year). Children: Parents'indoor smoking.
* Participation in another allergen avoidance program
* Participation in drug trial the preceding 3 months
* Multiple chemical sensitivity (e.g. paint, petrol, perfumes) as primary etiology
* Allergen injection or sublingual treatment in the preceding 2 years
* ICS ≥1200µg/day of budesonide or 1000µg/day of fluticasone
* Significant cardiovascular disease
* Participation in the present trial of a family member within the same household

Other protocol-defined exclusion criteria may apply
Oral Findings In A Group of Egyptian Children With Attention Deficit Hyperactivity Disorder

Attention-deficit/hyperactivity disorder is the most common childhood neuro-developmental disorder that is characterized by inattention, hyperactivity, and impulsivity. These symptoms last till adulthood in 65% of cases. ADHD has been reported to have a worldwide prevalence of 5.3% and it is more common in boys than in girls (Ghanizadeh 2008; Serra-Negra et al. 2012 and Shooshtari et al. 2013) The symptoms of ADHD are generally treated through behavioral therapy, with or without pharmacological intervention. Medications prescribed are commonly divided into stimulant or non-stimulant drugs. The stimulant medications (such as methylphenidate and amphetamines) have been implicated in adverse oral effects, such as xerostomia and gingival enlargement. The current evidence is controversial regarding the severity and prevalence of dental caries, dental trauma, periodontal diseases, oral habits and tooth wear among patients with ADHD (Chau et al. 2017).

In the Arab world, few studies have been published on ADHD. Accordingly, in the Arab society and Egypt there are limited data regarding the oral findings of children with ADHD. Owing to the sparsity of these data, this study will be conducted to evaluate different oral characteristics of Egyptian children with ADHD.

Due to lack of published studies about the oral findings of Egyptian Children with ADHD, this study will be conducted to cover this point.

Eligibility Criteria:
Inclusion Criteria:

* - Egyptian children 3-6 years old diagnosed with ADHD.
* Patients taking medications for the treatment of ADHD or not.
* Both male and female patients will be included.

Control Group:

A matched group of healthy children aged 3-6 years old.

Exclusion Criteria:

* - Non-Egyptian children.
* Patients having systemic disorders, such as cerebral palsy or Down's syndrome.
* Patients complaining from any systemic disease
Physiotherapy Treatment for Chronic Achilles Tendinopathy

Laser treatment with the proper dosage has been found effective in the treatment of chronic Achilles tendinopathy, and animal research indicate that a combination of cryotherapy followed by LLLT could yield an even better result.

Thus, the main purpose of this project is to test if the addition of low level laser therapy can enhance the treatment result of exercise and cryotherapy in patients with chronic Achilles tendinopathy, yielding less pain and higher function.


Eligibility Criteria:
Inclusion Criteria:

* Achilles tendinopathy with a minimum duration of three months, pathological appearance of the Achilles tendon with thickened tendon and structural changes of the tendons matrix.

Exclusion Criteria:

* Cortisone injection within the last 6 months, systemic inflammatory disease, previous suture/surgery of the Achilles tendon, pregnancy or familial hypercholesterolemia.