cyrilzakka/clinical-trials huggingface dataset:
Effect of the EnkFiberoptic Atomizer Set on Usage of Anaesthetics During the Bronchoscopy

The aim of this prospective study is to examine the benefits und risks of administration of local anaesthetics with a special atomizing set (Enk Fiberoptic Atomizer, Cook Medical) during flexible bronchoscopy.


Eligibility Criteria:
Inclusion Criteria:

* bronchoscopy with transbronchial biopsy or cryobiopsy indicated for diagnostic purposes (suspected lung cancer, interstitial lung disease, unexplained pulmonary opacities)
* hospitalized patients
* patients aged 18 years or above
* written informed consent prior to study participation

Exclusion Criteria:

* known allergy to local anesthetics, midazolam or propofol, known epilepsy, known severe neurological or psychiatric disorder, hemodynamic instability with need for vasopressor therapy, acute or chronic decompensated heart failure, respiratory failure with the need for oxygen supplementation of more than 2 l per minute at rest (pO2 \> 55 mmHg) or pCO2 \> 50 mmHg at ambient air, known upper airway anomalies, surgery or irradiation of the upper airways in the past, contraindication for transbronchial biopsy as published by international guidelines, e. g. bleeding disorders or severe pulmonary hypertension
* women, who are pregnant or breastfeeding
* alcohol or drug abuse
* expected non-compliance
* patients unwilling or unable to give informed consent, patients with limited ability to comply with instructions for this study
* Participation on another clinical trial within the last 3 months
* subjects who are committed to an institution and/or penitentiary by judicial or official order.
* employees of the investigator cooperation companies.
Use of SV40 Vectors to Treat Chronic Myeloid Leukemia (CML)

Chronic myeloid leukemia is a serious disease which is characterized by progression from relatively quiescent stages of the disease to an aggressive phase. Although now there is highly successful medical therapy known as Gleevec (Imatinib), the treatment is not always successful and patients do develop resistance. Those patients have limited treatment options. We are developing a gene therapy model of treatment for this disease using pseudoviral particles to insert molecules of genetic material which would not allow the harmful genes causing the leukemia to function.

A novel methodology that facilitates specific silencing of genes has recently been developed. The method is based on the property of small molecules of nucleic acids (RNA) to specifically repress expression of targeted genes. These small interfering RNA (siRNA) molecules were recently demonstrated to repress, in tissue culture cells, one of the two types of the common fusion genes present in CML patients. Those studies showed that treatment with synthetic siRNA inhibited cell growth and increased the sensitivity to imatinib. These findings offer hope that a novel form of gene therapy based on this strategy may improve the treatment outcome of CML patients, particularly when used in combination with other approaches such as the tyrosine kinase inhibitor imatinib that was mentioned above.

Our group has developed an innovative vector that is most suitable to deliver siRNA molecules into human hematopoietic cells with sufficient efficacy. The vector is based on a monkey virus called simian virus 40 (SV40). The viral coat, or capsid, is produced biosynthetically. It was engineered to self-assemble in the test tube around the nucleic acids of choice, and to deliver this DNA or RNA into target cells. This vector is safer than other available viral vectors since all the viral genetic material is excluded from the final product. The vector does not elicit immune response, thus allowing repeated administration.We will start the project by testing the recently published siRNA molecules against one of the fusion genes, and several alternative siRNA molecules that we will design against the other fusion genes. The molecules will be tested for efficacy in tissue culture cell-lines, by measuring repression of the respective fusion gene, reduction in the level of the tyrosine kinase and inhibition of cell growth. The most effective siRNA molecules will be selected for further studies. The vectors will be tested on cell-lines for gene silencing and cell death as before. At the final stage we will test the best vectors for their efficacy in white blood cells obtained from CML patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CML

Exclusion Criteria:

* Under 18 years old
* Pregnant
Effect of Radiofrequency on Insulin Resistence in Obese Post Menopansal Women

insulin resistance as the prime factor linking visceral obesity with adverse metabolic changes. Analysis of abdominal obesity by imaging studies have generally reached the conclusion that it is the excess of intra-abdominal or visceral adipose tissue .Multiple environmental and genetic factors are thought to influence the manifestation of abdominal obesity. The expanded adipose tissue contributes to expose the liver to high concentrations of free fatty acids (FFA), impairing several hepatic metabolic processes leading to hyperinsulinemia .On the other side, there is an increase in the secretion of different adipokines, such as interleukin IL-6 and tumor necrosis factor-α (TNF-α), which also contributes to the insulin-resistant state .

So, RF technology deployed by Vanquish uses oscillating electrical current forcing collisions between charged molecules and ions, which are then transformed into heat. Since fat biophysical characteristics behave like an insulator capable of polarization, it absorbs the high RF-related heat release from the RF applicator driving specific fat necrosis and consequent lipolysis. Patients lay underneath the device while the focused-field radiofrequency heats up the underlying .

The eligible participants will be divided into two equal groups included fifty two post-menopausal women. They will be selected randomly from El kalil Ebrahem hospital in Hadaek El Maadi.

Each group will be twenty six women. Group (A) (study group) will receive radiofrequency, medical standard care for insulin resistance and regular diet habits. This group will receive 30 minutes on the abdominal area by radiofrequency, twice per week. The treatment procedure consists of placing the emitting panel over abdomen and flanks close to the skin using a spacer which standardizes distance between the panel and the body surface.

Once it is in supine position, with a pillow under their heads and with their knees in flexion. Initially, the abdominal region of each participant was divided into two equal parts- right and left-with the line Alba as reference.

Group (B) (control group) will receive regular diet habits only.

Eligibility Criteria:
Inclusion Criteria:

* • All participants post-menopausal from at least 3 years.

  * All participants' ages will be ranged from 48-60 years old.
  * All participants BMI will exceed 30 kg/m2.
  * All participants waist hip ratio will be equal or more than 0, 89.

Exclusion Criteria:

* • Surgical liposuction within the last 12 months.

  * Untreated hypo- or hyperthyroidism.
  * Uncontrolled liver, kidney or cardiovascular disease or diabetes.
  * Implanted pacemaker or metal implant.
  * History of thrombophlebitis, any hematological disease.
  * No past or present neurological and musculoskeletal disorders that will have affected health condition.
  * No smoking and drinking habits.
  * No psychological problems.
Muco-ciliary Cleansing of Lungs in COPD With and Without a Salt Particle Inhaler

Cross-over trial of the effect of a salt particle inhaler on pulmonary muco-ciliary cleansing in COPD patients as measured by lung scintigraphy.

Stable COPD patients will be examined twice with minimum two, maximum 14 days interval. In randomized order the patients will inhale from a salt particle inhaler with (active) or without (placebo) content.

Eligibility Criteria:
Inclusion Criteria:

* COPD grade 1, 2 and 3 in stable condition (less than 10% change of FEV1 ratio between investigation visits

Exclusion Criteria:

* Pregnant or lactating women
* Patients exposed to radionuclear isotopes within one month
* Patients under antibiotic treatment
* Patients with known hyper reactive airways
Investigation of the Relationship Between Salivary Histatine-5 Level and Vaginal Candidiasis in Women

The low Histatine-5 (HST-5) level of the saliva can lead to vaginal candidiasis. Because HST-5 level in the saliva can effect vaginal Ph, flora and local defence mechanisms.

Histatine-5 is secreted in the parotis and submandibular glands. İt riches histidine amino ascid and have antifungal activity. Salivary proteins and their plasma levels were found as similar in the literature.

Women with regularly menstrual cycle will enroll in the study than will separate two groups:

Study group: women with vaginal candidiasis ( diagnosed by clinic and lab.)

Control group: women ( not have any vaginal infections candida and others)

Saliva samples will be taken from two groups than HST-5 level will be analyzed. Finally HST-5 levels of the two groups will be compared .

Women with diabetes, immun deficiency, pregnancy, virgin, menopausal period , premature ovarian failure will be excluded.

Eligibility Criteria:
Inclusion Criteria: women with regularly menstrual cycle , diagnosed candidal vaginosis and not have any vaginal infection.

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Exclusion Criteria: diabetes, immun deficiency, menopause, premature ovarian failure, pregnancy, virgin

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The Impact of Early Pulmonary Rehabilitation on Multidimensional Aspect of Dyspnea in COPD Patients After Exacerbation

Acute exacerbations of chronic obstructive pulmonary disease (AECOPD) are associated with severe dyspnea and exercise intolerance. Early pulmonary rehabilitation (EPR) may lead to improvements in dyspnea and exercise tolerance, as it does in stable COPD patients.

One hundred and six patients admitted in a university hospital with AECOPD were randomized after discharge to either EPR for 8 weeks (EPR group) or usual care (UC) (UC group). All patients carried out the following initially and after 8 weeks: spirometry, 6minute walk test (SMWT), and a symptom-limited incremental cycle cardiopulmonary exercise test (CPET), and different dyspnea dimensions evaluation as following: Dyspnea intensity during incremental exercise using Borg scale, dyspnea 12 questionnaire and COPD assessment test (CAT) to assess sensory perceptual, affective distress, and symptom impact domains respectively.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized COPD patients with a diagnosis of AECOPD with no clinically significant arterial hypoxemia at rest or on exercise (resting percutaneous oxygen saturation (SpO2) \> 90% or a sustained decrease of \< 4% during exercise) were recruited. Diagnosis of COPD, AECOPD and spirometric assessment of airflow limitation severity was based on Global Initiative for Chronic Obstructive Lung Disease (GOLD)

Exclusion Criteria:

* Patients with a prior diagnosis of other cardiorespiratory conditions (i.e., bronchial asthma, interstitial lung diseases, primary pulmonary hypertension, chronic congestive heart failure), as well as other conditions such as orthopedic, muscular and peripheral vascular diseases that could cause or contribute to breathlessness and exercise intolerance and/or could interfere with carrying out of exercise testing, were excluded.
Aerobic vs Core Stability Exercise Training Program in Women With Endometriosis

To compare the effects of aerobic and core stability exercise training program on pain, sleep and quality of life in women with endometriosis.


Eligibility Criteria:
Inclusion Criteria:

* Age 24-45

  * Diagnosed patients with endometriosis
  * Pain lasting more than 6 months
  * Chronic pelvic pain
  * Infertility
  * Patients with dysmenorrhea.

Exclusion Criteria:

* Patients with the tubo- ovarian abscess.

  * Concomitment use of hormonal drugs.
  * Any malignancy
  * Impaired sensation..
  * Patients with Gynecological hemorrhage
Remifentanil Versus Morphine for Sedation of Premature Neonates With Respiratory Distress Syndrome

In this randomised controlled study we intended to compared intubation conditions and the continuous infusion of remifentanil (n=10) and morphine (n=10) in mechanically ventilated premature neonates (28-34wk) regarding the time to be awake and, the time until extubation after interruption of the opioid administration.

Intubation and mechanical ventilation are majors component of intensive care for premature neonates with respiratory distress syndrome (RDS) and is associated with physiologic, biochemical, and clinical responses indicating pain and stress in prematures. Although morphine is one of the most used drugs for premedication and for sedation and analgesia during mechanical ventilation in the treatment of RDS its pharmacological profile precludes several limitations mostly due to its much delayed onset of action what makes the drug not suitable as premedication and due to its prolonged duration of action mainly in prematures. Unlike morphine, remifentanil has an unique pharmacokinetic properties with a rapid onset of action and, a fast decrease in plasma concentration after interruption of administration due to a context-sensitive half-time of 3.2 minutes. So, it could be the ideal opioid for neonates who are especially sensitive to respiratory depression by opioids

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 28 and 34 wk
* Clinical and radiological features compatible with respiratory distress syndrome that required an elective tracheal intubation and surfactant therapy.

Exclusion criteria:

* The presence of major congenital malformations
* Birth weigh less than 1000g
* Previous or concurrent use of opioid for any reason (cesarean section with general anaesthesia)
* Hemodynamic instability before the indication of tracheal intubation
* Refuse of the parents to enroll the neonate in the study protocol
Efficacy and Safety of IBI351 in Combination With Chemotherapy in Advanced Non-squamous Non-small Cell Lung Cancer Subjects With KRAS G12C Mutation

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy in advanced non-squamous NSCLC with KRAS G12C mutation.

This Phase Ib/III study evaluates the efficacy and safety of IBI351 in combination with chemotherapy. There will be five cohorts of subjects, all of whom have KRAS G12C mutation and have advanced or metastatic NSCLC. Those five cohorts (A, B,C ,D and E) are treated with IBI351, IBI351+Sintilimab,IBI351+pemetrexed+cis-platinum/carboplatin,IBI351+Cetuximab, or IBI351+pemetrexed+cis-platinum/carboplatin respectively.

IBI351 is an orally available small molecule inhibitor of KRAS G12C.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of nonsquamous NSCLC with KRAS G12C mutation
2. Unresectable or metastatic disease
3. Adequate organ function
4. Not received any systemic antitumor therapy for locally advanced or metastatic non-squamous NSCLC previously.

Exclusion Criteria:

1. History of intestinal disease or major gastric surgery or inability to swallow oral medications
2. Prior therapy with agents targeting KRAS G12C mutation (e.g., AMG 510).
3. Active brain metastases.
Intravitreal Bevacizumab in Agioid Streaks

The purpose of this study is to investigate the safety and efficacy of intravitreal bevacizumab in patients with choroidal neovascularization associated with angioid streaks.

To investigate the safety and efficacy of intravitreal bevacizumab in a patient with choroidal neovascularization associated with angioid streaks. One of the most serious ocular complication of angioid streaks is the occurrence of choroidal neovascularization (CNV) and because of the implication of the macula, this complication usually leads to central vision loss.

During the past, laser photocoagulation, first, and photodynamic therapy (PDT), more recently, have been used as treatment for this kind of CNV. The outcome of these therapies was often variable and sometimes disappointing for the stabilization of visual acuity and lesion size in CNV secondary to AS.

Five patients (six eyes) with CNV secondary to AS participated in this retrospective interventional case series. All patients were scheduled for three monthly IVB injections (1.25 mg). Two eyes had been previously treated with photodynamic therapy (PDT), and four received IVB as first choice treatment. IVB was repeated in case of recurrence after the three monthly IVB schedule. Ophthalmic evaluations included: best corrected visual acuity (BCVA) determination (ETDRS), optical coherence tomography (OCT), fluorescein and indocyanine green angiographies. Main outcome measures were BCVA improvement, reduction of leakage from CNV and diminution of central retinal thickness (CRT). Patients were followed-up for 30 months. Patients were 3 males and 2 females aged 44 to 67 years (mean 51.6 +/- 9.07 SD), who received a mean number of 4.33 IB treatments (+/-1.5; min: 3, max: 7). The mean retreatment interval was 3 months (+/-1.36; min: 2, max: 6).

Four eyes (66.6%) showed a BCVA improvement (mean 3.4 lines) from baseline and two eyes (33.3%) did not show any change in visual acuity from baseline to last follow-up. Mean BCVA rose significantly from 22.5+/-14.4 letters at baseline to 35.8+/-21.5 letters at 30 months (p=0.025). Angiographic examinations showed reduction or cessation of the CNV leakage in all patients. OCT findings demonstrated slight CRT diminution (mean 41.6 µm). No intraocular pressure changes were observed after the IVB injection, which did not cause any systemic complication. No injection related back pain or IVB-induced ocular complication was reported.

Eligibility Criteria:
Inclusion Criteria:

* presence of an active CNV
* visual loss
* increased retinal thickness

Exclusion Criteria:

* no actively leaking CNV by FAG
* normal retinal thickness
* satisfactory visual acuity
Effects of Statins on the Pharmacokinetics for Midazolam in Healthy Volunteers

The purpose of this study is to investigate whether statins have any influence on cytochrome P450 (CYP) 3A4 enzyme activity using a probe drug midazolam.


Eligibility Criteria:
Inclusion Criteria:

* Volunteers in good health according to their medical history, a physical examination and standard laboratory tests

Exclusion Criteria:

* Subjects who have been using any continuous medication or herbal supplements.
Comparison of Retinal Oxygenation and Retinal Vessel Diameters in Healthy Subjects and Patients With Diabetic Retinopathy or Retinal Vein Occlusion Between DVA and Oxymap

To date two different instruments are commercially available to measure retinal oxygen saturation and retinal vessel diameters: Dynamic Vessel Analyzer (DVA) and Oxymap. Retinal oxygen saturation analysis is based on spectroscopic evaluation of retinal fundus images. Up to now no data comparing both instruments for the measurement of retinal oxygen saturation and vessel diameter are available in the literature.

Study objectives: To compare retinal oxygenation and retinal vessel diameters in healthy subjects and patients with diabetic retinopathy or retinal vein occlusion between 2 commercially available systems (DVA, Oxymap T1)

Study design: Open pilot study

Study population:

30 healthy volunteers, age 18-80 years 30 type 2 diabetic patients with mild or moderate non-proliferative diabetic retinopathy, age 18-80 years 30 patients with retinal vein occlusion, age 18-80 years

Topically administered medication:

Tropicamide (Mydriaticum "Agepha"®, Agepha, Vienna, Austria), dose: 1-2 drops per study day for dilation of the pupil Oxybuprocainhydrochloride combined with sodium fluorescein (Thilorbin®, Alcon Pharma GmbH, Freiburg, Germany), dose: 1 drop in one eye for measurements of intraocular pressure Nonylacidvanillylamide combined with Nicotinic-acid--ß-butoxyethylester (Finalgon®, Boehringer Ingelheim RCV GmbH \& Co KG, Vienna, Austria): topical on the earlobe

Methods:

Dynamic vessel analyzer Oxymap T1 Blood pressure and pulse rate measurement Applanation tonometry Oxygen and carbon dioxide partial pressure measurement in arterialized blood from earlobe

Main outcome variables:

Difference of oxygen saturation of retinal vessels between DVA and Oxymap T1

The motive for this investigation is to compare data between 2 commercially available instruments for the measurement of retinal oxygen saturation and retinal vessel diameter in healthy subjects as well as in patients with ocular disease associated with altered retinal oxygenation. Comparative data from both systems are currently not available. Data from this study will allow the comparison of studies performed with different systems. All oxygen measurement procedures are non-invasive and painless. Hence, the risk/benefit ratio appears to be acceptable.


Eligibility Criteria:
Inclusion criteria healthy volunteers

* normal ophthalmic findings, ametropia \< 3 dpt
* men and women aged between 18 and 80 years

Exclusion Criteria:

Any of the following will exclude a subject from the study:

* participation in a clinical trial in the 3 weeks preceding the study
* symptoms of a clinically relevant illness in the 3 weeks before the first study day
* pregnancy
Abdominal aBscess Catheter Sclerotherapy (ABCS)

This is a single center, two arm phase I/II clinical trial exploring the use of chemical sclerosants (ethanol and povidone iodine) in decreasing the time needed for catheter drainage for patients with non-fistulous intraabdominal abscesses. The target study sample size is 60 patients, 30 in each arm and abscess size is to be a minimum of 3cm in all 3 dimensions. The primary outcomes of interest will be tolerability and need for catheter reinsertion by one week post intervention.

This is a two-arm prospective phase I/II clinical trial to assess the safety of a protocol of catheter-based drainage and povidone iodine or ethanol sclerotherapy of non-fistulous intraabdominal abscesses. The study aims to enroll approximately 60 total subjects with 30 per arm. The abscess should be intraperitoneal with a minimum diameter of 3cm in all three dimensions and devoid of suspicion for relation to a fistula. The described technique above will be employed to place a drainage catheter of minimum 14F in caliber and obtain an antimicrobial sample. Saline lavage will be performed by irrigating the abscess and aspirating the contents until the character of the instilled and aspirated fluid are similar. Following this step the cavity will be drained in full and a volume of approximately equal to the cavity of povidone iodine or ethanol will be instilled through the catheter with the catheter turned off to drainage. After approximately two minutes the drain will be opened to gravity and two minutes of additional time will be allotted to drain any excess povidone iodine or ethanol. The catheter will then be removed, and the site dressed with gauze and film dressing. The patient will then be followed clinically in the hospital for at least 48 hours and by phone check in for 7 days.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged over 18years
* Cross-sectional imaging (CT, US, MRI) showing an intraabdominal abscess measuring at last 3cm in each dimension without fistula to the bowel or skin.
* Provision of signed and dated informed consent form
* Stated willingness to comply with all study procedures and availability for the duration of the study

Exclusion Criteria:

* Pregnancy or lactation
* Known allergic reactions to povidone iodine or ethanol
* Hemodynamic instability