cyrilzakka/clinical-trials huggingface dataset:
A Pilot Clinical Investigation of the Efficacy and Safety of Uracyst® Versus Placebo in Patients With Interstitial Cystitis/Painful Bladder Syndrome.

This is a pilot clinical investigation. Patients who meet the eligibility criteria and provide signed informed consent will be randomized to receive either an active product (Uracyst®) or placebo intravesically via a bladder catheter weekly for 6 weeks, followed by 6 weeks of follow-up period.


Eligibility Criteria:
Inclusion Criteria:

* Are female of male patient 18 years or older
* Have been previously diagnosed with IC/PBS.
* Are willing to provide informed consent
* Available for the duration of the study including treatment and follow-up (12 weeks)

Exclusion Criteria:

* Pregnant or lactating female.
* Are currently or have previously received investigational drugs within thirty (30) days of screening.
* Previous therapy for IC/PBS
* Have any medical condition/disease that could interfere with patient compliance or interfere with interpretation of the study results.
* Are unable or unwilling to comply with protocol requirements
* Are unable to read, understand, and provide written informed consent.
Hysteroscopic Isthmocele Repair on IVF Outcome

Hysteroscopic Isthmocele repair on IVF outcome It aims to assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer.

Patients who were diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer will be assed for study eligibility. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome.

Hysteroscopic Isthmocele repair on IVF outcome Background: Uterine niche is a very common finding in women with previous caesarean section. Subfertility can be associated finding and IVF outcome can be affected by its presence. It is not yet if its treatment before IVF trial could improve the outcome of IVF cycle.

Objectives: assesse the efficacy of Hysteroscopic CS scar defect repair on the clinical pregnancy rate after embryo transfer.

Methods This prospective randomized controled will be conducted at Healthplus fertility center. The population of the study will be Patients who was diagnosed with significant caesarean section scar defect and had a previous unsuccessful ongoing pregnancy after embryo transfer of one or more euploid embryo and planning for another trial of one euploid embryo transfer. Twenty five of them will be be randomized to hysteroscopic repair before having embryo transfer. and 25 will go directly for embryo transfer. Clinical pregnancy rate is the primary outcome. Seconday outcomes are Complications following hysteroscopic CS scar repair, the need of aspiration of intrauterine fluid before embryo transfer, early pregnancy complications, Caesarean section scar dehiscence or rupture and live birth rate.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed CS scar defect by TVUS
* At least one failed trial of euploid embryo transfer
* Planning for a trial of single euploid embryo transfer

Exclusion Criteria:

* Residual myometrial thickness less than 3 mm
* Any congenital uterine abnormalities.,
* Prescence of intrauterine lesions e.g. polyp, fibroid, Endometriosis or adenomyosis, Hydrosalpinx, Chronic endometritis, Previous CS scar defect repair.
Ketogenic Diet With Radiation and Chemotherapy for Newly Diagnosed Glioblastoma

This study aims to see if reducing blood sugar and increasing ketones (a metabolic product that comes from using fats for energy) can increase survival and enhance the the effects of standard radiation and chemotherapy treatments used to treat glioblastoma multiforme (GBM). These changes occur from use of a ketogenic diet. This research has 2 goals:

1. Show that patients can tolerate the diet and maintain low blood glucose and high blood ketone levels.
2. Show if this diet enhances the effectiveness of standard treatment by prolonging survival of patients with a GBM.

The investigators propose to offer this study to patients with newly diagnosed glioblastoma multiforme (GBM) that undergo gross total resection (GTR) or subtotal resection (STR) of their tumor. Post-operatively, these patients and their families will be instructed in the implementation of the Ketogenic Diet (KD) and it will be started as soon as possible following surgery to achieve ketosis and reduction of blood sugar. Patients will receive standard chemoradiotherapy with fractionated external beam radiation (60Gy) and concurrent oral temozolomide chemotherapy followed by 12 adjuvant cycles of temozolomide chemotherapy on a standard dose schedule. Outcome measures of the study group will be compared to historic controls in the treatment arm from the European Organization for Research and Treatment of Cancer (EORTC) temozolomide study published by Roger Stupp et al, New England Journal of Medicine, March 10, 2005.

Note: Gross Total Resection (GTR), Subtotal Resection (STR), temozolomide (Temodar), and radiation therapy are routine care for GBM and are not an investigational component of this study.

Study end-points:

Primary: Ketogenic diet (KD) tolerance and compliance in brain tumor patients. The diet will be considered tolerable if the patient chooses to remain compliant. Compliance is monitored by the dietician using self reporting of diet, blood glucose and blood ketone levels.

Secondary: Overall survival, time to recurrence, health and therapy-related quality of life. Overall survival and progression free survival will be measured and compared to the historic controls who received chemoradiotherapy in standard dose scheduling.

Laboratory correlate: Molecular/immunohistochemical analysis of tumors that do and do not respond to a KD.

Eligibility Criteria:
Inclusion Criteria:

* adult patients, 18 - 80 years of age,
* a single enhancing lesion of the brain with MRI appearance consistent with GBM
* Pathologic confirmation of GBM
* Zubrod Performance Scale (ZPS) \< 2
* Must be able to undergo MRI imaging with gadolinium
* Must have access to a computer and the internet (to use KetoCalculator© on-line Database)

Exclusion Criteria:

* unable to undergo MRI with gadolinium
* genetic disorders of fat metabolism
* patients receiving sodium valproate (may cause false ketone reading in urine)
* diabetes
* enrolled in another treatment trial for GBM
Efficacy of a Non-invasive Pelvic Floor Muscle Trainer for Treatment of Stress Urinary Incontinence

The goal of this clinical trial is to assess the efficacy and usability of the electromyography component of the company's pelvic health product in a patient population with stress urinary incontinence. The main questions it aims to answer are:

Does treatment with the device under study improve symptoms of stress urinary incontinence as measured by the ICIQ?

Participants will be given one of the devices under study, in addition to educational materials on use of the device, and a treatment schedule. Participants will perform a standardized biofeedback-mediated pelvic floor muscle training program with the study device 10 minutes a day, five times a week for 4 weeks. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).

This will be a prospective cohort study of women \> 18 years of age with symptoms of stress urinary incontinence, recruited via an online recruitment tool.

After screening, patients meeting inclusion criteria will be given a study brochure, and then given instructions on how to indicate desire to participate in the study. The patient will then be contacted for study participation, including explanation of study and details and completion of Informed Consent. Participants will then complete a pre-treatment urinary incontinence symptom questionnaire(ICIQ).

After completion of the above, the participants will then be given one of the devices under study, in addition to educational materials on use of the device, and a treatment schedule. Participants will perform a standardized biofeedback-mediated pelvic floor muscle training program with the study device 10 minutes a day, five times a week for 4 weeks. There will be a mid-study check in to assure all devices are functioning appropriately. At the end of the study, participants will complete a post-treatment urinary incontinence symptom questionnaire(ICIQ).

Endpoint of the study will be change in stress urinary incontinence symptoms as measured by the ICIQ. The ICIQ will be collected at 2 time points: before study entry, and at study close.

Eligibility Criteria:
Inclusion Criteria:

* Female
* 18 years of age or older
* Documented symptoms of predominantly stress urinary incontinence as determined by the ICIQ questionnaire

Exclusion Criteria:

* History of pelvic or lower back surgery

Pregnancy or less than 12 months post partum

History of physician-supervised PFMT

History of Kegel exercises greater than once a month

History of prior operative delivery

Self-reported history of pelvic organ prolapse stage II or greater
New Protein Bar for Physically Active People

Post-exercise nutrition is an important factor in a nutrition plan for physically active subjects. Focusing on that, the Serbian group is developing protein bars enriched with sports supplements. Slovenian partner group will investigate the effect of new protein bar consumption on body composition, biochemical parameters, and muscle regeneration after training. The new bar will be compared with a commercially available bar.

The clinical study will be performed on 10 elite handball players from Slovenia handball club. It will be designed as a crossover study. Half of the participants will consume the new bar for five days and the other half will consume the control bar. After the five-day washout period, the groups will consume the bar which was not consumed in the first period.

At baseline, at the end of every intervention and washout period, the blood samples will be withdrawn, and the body composition will be analyzed.

The analyzed biochemical parameters will be basic serum parameters, such as fasting glucose, total cholesterol, LDL, HDL, triglycerides, aspartate aminotransferase (AST), alanine aminotransferase (ALT), C-reactive protein (CRP), and parameters related to the muscle regeneration and inflammation, such as creatine kinase, lactate dehydrogenase, insulin-like growth factor (IGF), tumor necrosis factor alpha (TNF-alpha), interleukin 6 (IL-6), monocyte chemoattractant protein 1 (MCP-1).

In the second part of the study, the acute effect of consuming each bar after training will be tested. Each participant will consume both bars on separate days. The mentioned parameters will be assessed after training and immediately and 3h after bar consumption.

Eligibility Criteria:
Inclusion Criteria:

* daily high-intensity physical activity

Exclusion Criteria:

* smoking, cardiovascular, neurological, skeletal muscle disease, allergies
Evaluation of iPRF With Vit.D As an Adjunct to Non-Surgical Therapy in the Treatment of Stage III Periodontitis

a clinical trial will be made to investigate the effect of locally applied injectable prf (iPRF) plus vitamin D on the periodontal pockets in stage III periodontitis patients

in this clinical trial, the treatment of periodontal pockets in stage III periodontitis patients will be evaluated. the study participants will be divided in 3 groups:

First group \>\> will be treated with professional mechanical plaque removal (PMPR) only.

second group \>\> will be treated with PMPR + locally applied iPRF.

Third group \>\> will be treated with PMPR + locally applied iPRF + vitamin D.

Then the results will be compared after 6 months of the treatment (clinically and radiographically).

Eligibility Criteria:
Inclusion Criteria:

1. Patients with healthy systemic condition.
2. Adult patients ˃ 18 years old.
3. Patients with Stage III periodontitis.
4. Patients accept 3-month follow-up period (cooperative patients).
5. Patients provide an informed consent.

Exclusion Criteria:

1. Presence of prosthetic crowns.
2. Extensive interproximal restorations.
3. Periodontal therapy within the last 12 months.
4. Having undergone surgical periodontal therapy or undergoing orthodontic treatment.
5. Ongoing drug therapy that might have an impact on the clinical signs and symptoms of periodontitis.
6. The use of antibiotics or anti-inflammatory drugs 3-month prior to the procedure and till the end of 6-month of follow-up.
7. Smokers.
8. Pregnant females.
VR-3D Movie-based Education

Atrial fibrillation (AF), which is the most common cardiac arrhythmia in adults, is associated with a high risk of stroke and other thromboembolic complications. The usage of oral anticoagulation (OAC) may prevent the incidence of the thromboembolic events in the majority of patients. The current guidelines for the management of AF patients highlight the important role of patients' education, since the clinical benefit from OAC treatment may be achieved by the effective cooperation between patients and physicians. It has been suggested, that compliance may be increased by the novel e-solutions introduced into the daily clinical practice. Due to the improvement in advanced technologies, the virtual reality (VR) three-dimensional (3D) movie stands for a future alternative in e-medicine. The aim of the OCULUS study was to examine whether the 3D movie-based knowledge transfer is effective in teaching patients about the consequences of AF and pharmacological possibilities in reducing the risk of stroke.

The OCULUS is a prospective, single centre study. The study will include hospitalized patients, who are over 18 years old. The only exclusion criteria of the study is the previously diagnosed dementia. The study is based on the questionnaire designed by the authors of the study, enclosing questions about sex, age, education, current job, AF history and knowledge about consequences of AF and the possibility of stroke prevention due to the OAC therapy. Subsequently, the brief VR-3D will be shown using the oculus glasses and a smartphone. The movie's plot informs about the risk of stroke and importance of the OAC therapy to prevent the incidence of the thromboembolic complications of AF. Consequently, patients will be asked several questions, including what was the movie about, whether AF can affect patient's life in a negative way, is it possible to reduce the risk of stroke and by what kind of drugs. Similar questions will be asked to the patients immediately after the movie, one week and one year later, via the Telephone follow-up.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* signed written informed consent

Exclusion Criteria:

* previously diagnosed dementia
Adrenaline Injections to Children Born at Elective CS

Children born after elective C-section have a greater risk of respiratory problems and hypoglycemia - most likely due to a lower concentration of stress hormones compared to children born vaginally. Hypothesis: can we eliminate or reduce the risk of respiratory distress and hypoglycaemia by administrating adrenaline to the newborn.


Eligibility Criteria:
Inclusion Criteria:

* All children born at elective section with gestational age more than 37 + 0

Exclusion Criteria:

* Children in whom a serious malformation was found during pregnancy assuming this malformation will lead to very early death or respiratory problems.
* Serious malformations (ex.anencephalia) will be excluded at birth
* Other malformations will be estimated by investigator whether it will lead to exclusion.
Natalizumab and Chronic Inflammation

In this study the investigators will assess the ability of Natalizumab, a medication given to treat multiple sclerosis (MS), to restore blood brain barrier integrity and repair subtle leakages of the blood brain barrier (BBB).

The investigators will image a cohort of persons with relapsing remitting multiple sclerosis (pwRRMS) using dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) and selective inversion recovery quantitative magnetization transfer imaging (SIR-qMT). pwRRMS will be imaged at baseline and at month-3 and month-12, after starting treatment with natalizumab. Changes in ktrans, a measure of BBB permeability derived from DCE-MRI, and in pool saturation ratio (PSR) a measure of myelin integrity derived from SIR-qMT will be computed to assess the ability of natalizumab to fully restore BBB integrity.

As a corollary aim, the investigators will assess changes in quality of life (QoL) measurements and the relation between those measurements and those derived from the above detailed quantitative MRI methods. QoL will be measured using the Visual Analogue Scale. This questionnaire entails 13 questions regarding the perceived effect of Tysabri, but also level of pain, fatigue, anxiety, depression before and during treatment with natalizumab. The answer to each question is rated on a color-coded bar the range of which is between 0 to 100.

Eligibility Criteria:
Inclusion Criteria:

1. multiple sclerosis
2. clinical eligibility to treatment with Natalizumab
3. no previous exposure to Natalizumab treatment

Exclusion Criteria:

1. inability to perform an MRI with contrast
2. inability to undergo a paper-pencil questionnaires and blood work
Assessement of the Knoweldge ,Attitudes,Practices of Diabetic Kidney Disease Among Diabetic Patients

This research aims to evaluate the levels of knowledge , attitudes and practices, of diabetic kidney disease among diabetic patients.

Diabetic kidney disease is defined as patients with diabetes mellitus who have persistent proteinuria for at least three consecutive measurements per year, or a decrease in GFR (\<90 ml/min/1.73m²) .Diabetic kidney disease is a severe microvascular complication frequently associated with both type 1 and type 2 diabetes mellitus, is a leading cause of renal failure. The condition can also lead to accelerated cardiovascular disease and macrovascular complications.

In Egypt, DM is a dilemma and a fast-expanding concern. According to the International Diabetes Federation (IDF), the prevalence of DM among Egyptian adults is 15.2%, which may be an underestimation.Public awareness, knowledge, and preventive practices are crucial in mitigating the onset and progression of diabetic nephropathy. Gaining insights into the general population's awareness, knowledge, attitudes, and practices (A-KAP) pertaining to this condition is crucial for the development of effective educational campaigns and preventative strategies.

Eligibility Criteria:
Inclusion Criteria:

* • Diabetic patients (either type 1or 2 DM ) with age above 18yrs old.

Exclusion Criteria:

* • CKD patients due to cause other than diabetes.

  * Patients who refuse participation in the study.
Factors Influencing Nocturnal Symptoms After Refractive Surgery.

By comparing the parameters of the two groups of patients with glare at night after refractive surgery and those without glare at night, the influence of preoperative related parameters on postoperative glare was analyzed.


Eligibility Criteria:
Inclusion criteria：

* Age ≥18 years old；
* Stable diopter (diopter change less than 0.5D in the past 2 years);
* Best corrected distance visual acuity (CDVA) of 1.0 or better；
* Anterior chamber depth (ACD) ≥2.8 mm;
* Corneal endothelial cell density (ECD) ≥ 2 000 cells/mm.

Exclusion criteria:

* History of ocular trauma or surgery;
* Suspected keratoconus;
* Previous history of other ocular diseases such as corneal inflammation or edema, glaucoma, uveitis, retinal detachment, macular degeneration, cataract, amblyopia, etc.;
* History of severe dry eye；
* Patients with systemic diseases, such as hyperthyroidism or autoimmune diseases; or severe mental disorders, such as anxiety and depression.
Trial of Concurrent Versus Sequential Tamoxifen With Radiotherapy in Breast Cancer Patients

Two hundred and sixty patients with breast cancer will be accrued into the study. After inclusion in the study, all the patients will be randomized into two arms. Arm 1 will receive Tamoxifen given concurrently with radiotherapy while in Arm 2 radiotherapy will be given followed by tamoxifen sequentially. The patients will be stratified for the following factors: a) BCS (Breast conservative surgery) versus MRM (modified radical mastectomy) and b) central lung distance (CLD) \> 2 cm.

Patients in both arms will continue tamoxifen for a period of 5 years. The patients will be evaluated by high-resolution computed tomography (HRCT) (baseline and at 2 years), serum transforming growth factor (TGF) beta levels (baseline and at 6 months) and diethylenetriaminepentaacetic acid (DTPA) aerosol clearance half life (baseline and at 6 months).


Eligibility Criteria:
Inclusion Criteria:

* Patients with large operable lesions (pT/cT \> 5 cm) or locally advanced breast cancers undergoing modified radical mastectomy or breast conservative surgery-(BCS) who need adjuvant post operative radiotherapy
* Patients post mastectomy requiring radiotherapy because of nodal positivity
* Completed planned chemotherapy schedule
* ER and/or PR positive patients
* Patients decided to be put on tamoxifen
* Patients reliable for follow up

Exclusion Criteria:

* Patients with BCT who have pT1 or pT2 breast lesions (N0,N1)
* Patients for palliative radiotherapy to the chest wall/breast/supraclavicular fossa
* Any patient requiring radiation to the axillary or internal mammary area
* Recurrent disease or metastatic disease
* Patients on concurrent chemotherapy and radiation
Immunogenicity and Safety of DTP/HB/Hib (Bio Farma)Compared to DTP/HB Given Simultaneously With Hib(Registered)Vaccine

The main objective of this study was to evaluate the protectivity and safety of DTP/HB/Hib (Bio Farma) vaccine compared to DTP/HB and Hib vaccine given simultaneously.

This trial was randomized, single blind, prospective intervention study. Total 220 subject (6-11 weeks of ages) followed this trial, divided into 2 groups, each group consists of 110 subjects.

Eligibility Criteria:
Inclusion Criteria:

* Infant 6-11 week of age
* Infant born after 37-42 week of pregnancy
* Infant weighing more than 2.5 kg at birth
* Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form
* Parents commit themselves to comply with the indication of the investigator and with the schedule of the trial
* Mother at least graduate from elementary school
* Received Hepatitis B vaccine (Bio Farma) at birth

Exclusion Criteria:

* Child concomitantly enroll or schedule to be enroll in another trial
* Evolving moderate or severe illness, especially infectious diseases or fever (axillary temperature \>=37.5 Celsius on Day 0)
* Known history of allergy to any component of the vaccine component (e.g.formaldehyde)
* History of uncontrolled coagulopathy or blood disorder contraindicating intramuscular injection
* Known history of congenital or acquired immunodeficiency (including HIV infection)
* Child who has received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived product or long term corticotherapy (\>2 weeks)
* Other vaccination within the 7 days prior to inclusion with the exception of BCG and poliomyelitis
* Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objective
* Infant with a known history of diphteria, tetanus, pertussis, Hib, Hepatitis B infection