cyrilzakka/clinical-trials huggingface dataset:
Adjunctive Right Atrial Ablation for Persistent Atrial Fibrillation

Persistent atrial fibrillation (PerAF) can induce right atrial (RA) enlargement. Our previous study demonstrated patients with PerAF and RA enlargment may benefit from adjunctive RA ablation. Therefore, we conduct this multicenter, prospective, randomized study to confirm the value of adjunctive RA ablation.

Long-term persistent atrial fibrillation (PerAF) may induce right atrial (RA) enlargement and subsequently atrial functional tricuspid regurgitation (AF-TR) at the absence of structural valvular lesion, abnormal right ventricular geometry and function. Enlarged RA and significant AF-TR may aggravate atrial remodeling and contribute to AF sustaining. Previous studies showed that RA enlargement was closely related to the recurrence of AF after catheter ablation. However, unlike the left atrium, the RA mechanism has been poorly studied and generally excluded from the therapeutic target. In an animal model of right heart disease, the RA enlargement associated with re-entrant activity serves as the prominent mechanism of AF genesis. Using sophisticated mapping techniques, recent study has confirmed that up to one-third of AF drivers are located in the right atrium. Furthermore, our previous case report also showed that the majority of patients with right atrial appendage-driven AF have concomitant RA enlargement. Therefore, it is plausible to hypothesize that the presence of RA enlargement represents the necessity of adjunctive RA ablation. Currently, the value and timing of RA intervention are still under debate. Therefore, the purpose of the present study was to testify whether patients with PerAF and RA enlargement may benefit from adjunctive RA ablation

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as persistent atrial fibrillation according to the latest clinical guidelines;
* Ineffective or intolerable to ≥1 anti-arrhythmia drug treatment.

Exclusion Criteria:

* Uncontrolled congestive heart failure;
* History of severe valve disease and/or prosthetic valve replacement;
* Myocardial infarction or stroke within 6 months;
* Severe congenital heart disease;
* EF \<40%;
* Contrast agent allergy;
* The use of anticoagulant drugs is contraindicated;
* Severe lung disease;
* Left atrial thrombus confirmed by preoperative esophageal ultrasound;
* Contraindications for cardiac catheterization;
* Atrial fibrillation ablation;
* Have performed any cardiac surgery within 2 months;
* Poor general health;
* Life expectancy \< 6 months.
The Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in France

This study seeks to determine the effectiveness of the interferon-free ABBVIE REGIMEN ± ribavirin (RBV) in participants with chronic hepatitis C (CHC) virus in clinical practices across France.


Eligibility Criteria:
Inclusion Criteria:

* Treatment-naïve or -experienced participants with confirmed CHC, genotype 1 or 4
* Participants receiving or who will receive the interferon-free ABBVIE REGIMEN ± RBV according to product label
* RBV prescribed in line with the current local label

Exclusion Criteria:

* Participant is not participating or intending to participate in a concurrent interventional therapeutic trial
HER-2 Expression in Pancreatic Duct Adenocarcinoma

Pancreatic duct adenocarcinoma is a highly aggressive carcinoma that is associated with a poor prognosis. Detection of novel biological markers that are specifically over expressed in pancreatic duct adenocarcinoma and their subsequent targeting by anti cancer therapeutic modalities may improve patient's survival.

Pancreatic duct adenocarcinoma (PDAC) is a deadly neoplasm that showed current increase in its occurrence. There are many challenges in PDAC; the tumor is frequently associated with perineural invasion and angioinvasion, these lead to early metastasis.Another important challenge is that the tumor is associated with extensive fibrosis that prevents arrival of chemotherapeutic agents. Most modern anti-cancer therapeutic modalities depend on the biologic signature of the tumor. Human epidermal growth factor receptor-2 (HER-2) is a cell surface protein that is associated with enhanced cellular proliferation. HER-2 has been detected and successfully targeted in many human carcinomas as breast and gastric cancers. we aimed to evaluate the potential cancer-promoting effect of HER-2 in PDAC, in order to detect any possible benefits of its targeting by future therapeutic modalities.

Eligibility Criteria:
Inclusion Criteria:

1. Cases of PDAC who underwent radical operations.
2. Tissue blocks with sufficient material.
3. Cases with available clinical data.

Exclusion Criteria:

1. Cases of pancreatic carcinoma other than PDAC.
2. Patients who received preoperative chemotherapy or radiotherapy.
3. Patients with PDAC who were diagnosed by tru-cut biopsies only and didn't undergo radical operations.
4. Cases with insufficient/destructed material.
5. Patients with inadequate clinical data.
Is it Safe to do Endometrial Injury in the Same ICSI Cycle: A Randomized Controlled Trial

Endometrial injury is one of the interventions suggested to improve the endometrial receptivity by enhancing the decidualization process, and so increasing the pregnancy rate

In assisted reproductive techniques , specially ICSI, several approaches have been put forward to improve the endometrium, including endometrial injection of granulocyte colony-stimulating factor or platelet-rich plasma. Endometrial injury is one of the interventions suggested to improve the endometrial receptivity.

Endometrial injury, also known as endometrial scratching, is the intentional damage of the endometrium, usually using a pipelle, aiming at increasing the implantation rate. The exact mechanism of action is still vague ,many hypotheses have been advocated, including enhanced decidualization, which is stimulated by the local injury. Moreover, endometrial injury stimulates an inflammatory response, which in turn adjusts gene expression.

The value of endometrial injury is a controversial issue, there is no agreement on the exact time to perform endometrial scratching, so in the current study, we investigated the safety and efficacy of performing endometrial injury in the follicular phase of the same ICSI cycle.

Eligibility Criteria:
Inclusion Criteria:

* Age \<40 year.
* BMI 20-35 kg/m2.

Exclusion Criteria:

* Age \>40 year
* BMI \> 35
* Uterine cavity abnormalities
* poor quality embryos
* Poor responders
* Diagnosed sever endometriosis
* Sever male factor
* Declined to participate
A Study to Learn More About TIVDAK in Women With Cervical Cancer That Has Come Back

TIVDAK is used for the treatment of cervical cancer that has come back after chemotherapy. Chemotherapy is a treatment that uses medicines to stop the growth of cancer cells. This is done either by killing the cells or by stopping them from growing. The purpose of this study is to learn about possible side effects of TIVDAK, specially to any side effect that is related to the eye. A side effect is anything a medicine does to your body that is not part of how the medicine treats disease.

* This study is seeking for participants who: Are willing to take all the required eye tests
* Have not received TIVDAK before
* Do not have any active eye issues.

Participants will receive TIVDAK once every 3 weeks as an infusion that will be injected into the vein. Participants will visit an eye care provider at 3 stages:

* before starting the treatment,
* before each of the first 9 infusions
* then monthly for 3 months after they stop taking TIVDAK. Treatment with TIVDAK will continue until it is not working anymore against the participant's cancer.


Eligibility Criteria:
Inclusion criteria:

1. Must have recurrent or metastatic cervical cancer with disease progression on or after chemotherapy
2. Treating physician has determined that treatment with Tivdak is appropriate for the participant according to US Prescribing Information
3. Must sign an informed consent form indicating that the participant understands the purpose and procedures required for the study and are willing to participate
4. Must be willing to undergo repeated ocular assessments as required by the study and regular clinic visits according to local standard practice of the study site
5. Must agree to use effective contraception according to the US Prescribing Information

Exclusion criteria:

1. Active ocular disease at baseline per investigator assessment
2. Previous treatment with Tivdak
3. Previous administration of an investigational drug within 30 days
4. Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may, in the investigator's judgment, increase the risk of study participation or make the participant inappropriate for the study.
5. Patients who are breastfeeding, pregnant, or planning to become pregnant based on criteria as indicated in the US Prescribing Information
6. Known allergies, hypersensitivity, or intolerance to Tivdak or its excipients
Knowledge of Young Adults About Genital Herpes

Despite sex education in schools and prevention campaigns concerning sexually transmitted infections, genital herpes remains frequent infection. In 2016, according to the World Health Organization, more than 490 million people worldwide were living with a genital herpes infection.

the aim of the study is to describe knowledge of adults aged 25 to 35 about genital herpes (symptoms, transmission, prevention).

Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Aged 25 to 35
* Having sex or not
* Agreeing to participate in the study

Exclusion Criteria:

- Not agreeing to participate in this study
Relationship Between Dyslipidemia and The Response of Diabetic Macular Edema to Intravitreal Injection of Anti Vascular Endothelial Growth Factor Agents

Diabetic retinopathy (DR) is considered the main etiology of blindness among working-age adults, and Diabetic macular edema (DME) is the main reason for vision loss related to DR . Retinal oedema is responsible for retinal micro-structural alterations, retinal atrophy of photoreceptors and ganglion cell disorders . In addition, it might be considered consensual that the best improvements in VA could be accomplished when retinal oedema is managed. In the context of a chronic and progressive disease, DME has to be faced as a state to control as effectively and rapidly as possible . Vascular endothelial growth factor (VEGF) is a protein that promotes the growth of new blood vessels. It also makes the blood vessels more leaky. Anti- VEGF medicines stop the growth of these new blood vessels. This prevents damage to the retinal light receptors and loss of central vision. The DME treatment has been shifted from the laser photocoagulation to anti-VEGF therapy . The advantages of anti-VEGF therapy in decreasing DME and improving patient's vision have been reported in many studies . Ranibizumab, in addition to aflibercept, have been reported as the first line therapies among the other anti-VEGF . There are several data demonstrating the efficiency of ranibizumab in treatment of patients with DME . On the other hand, there are studies that revealed poor response of some patients to anti-VEGF therapies even after 3 or more injections Non-modifiable risk factors for diabetic retinopathy are gender and DM duration.

Modifiable risk factors contributing to the development of diabetic retinopathy are elevated blood sugar levels, blood pressure, and dyslipidemia which is the imbalance of lipids such as cholesterol, low-density lipoprotein cholesterol, (LDL-C), triglycerides, and high-density lipoprotein (HDL). This condition can result from diet, tobacco exposure, or genetic . Hard exudates are thought to be induced by the leakage of lipids from dysfunctional retinal capillaries . Therefore, theses were formulated that higher levels of total cholesterol, LDL-C and triglycerides could be considered biomarkers of the development of hard exudates in DM patients . Aim of the work

- Correlate between dyslipidemia and the response of patients with diabetic macular oedema to intravitreal anti-VEGF injection


Eligibility Criteria:
Inclusion Criteria:

* patients with type II DM and center involving DME with central foveal thickness more than 280 um.

Exclusion Criteria:

1. Evidence of macular ischemia
2. Evidence of macular traction
3. Previous intravitreal injections
4. Previous macular laser therapy
5. Previous pars plana vitrectomy
Qatar Universal Diabetes Outcomes (QUDOS) Study

QUDOS is a cross-sectional population study aiming to answer key questions about diabetes and its complications in Qatar as well as identify factors associated with the development and progression of diabetes complications.

QUDOS aims to gain a better understanding of diabetes in primary and secondary care over a period of 24 months.

A range of patients with diabetes will be sampled (including those with Type 1 diabetes as this group is under-studied in Qatar). This will be important in designing appropriate intervention plans that will improve diabetic patients' health conditions to prevent or delay the onset of complications and will provide a strong foundation for longitudinal study.

The broad objectives of the study are:

QUDOS 1: Aims to recruit 1,700 diabetic patients (including 200 with type 1 diabetes mellitus (independent of healthcare setting)) attending the hospitals and primary care and to collect the following data:

* Demographics: age, sex, ethnicity, socio-economic background, smoking status;
* Anthropometrics: vital signs, height, weight, body fat percentage, fat mass, neck and waist circumference;
* Medical History: medications, complications, comorbidities, latest HbA1c and lipid profiles and family medical history;
* Routine laboratory data;
* Lifestyle: diet, physical activity,;
* Sleep: quality and daytime sleepiness;
* Cognition and Mental Health: depression, anxiety, stress and memory;
* Diabetes microvascular complications: diabetic neuropathy, urine albumin/creatinine ratio; routine retinal screening data.
* Gut microbiome from a stool sample

QUDOS 2: To further characterise 500 patients, from the total 1500 patients with T2DM recruited in QUDOS 1, who accept to continue with QUDOS 2 (a more detailed study and assessment).

This phase aims to concentrate on the following aspects:

* Obstructive sleep apnoea;
* Sleep duration and quality;
* Diet;
* Objective physical activity;
* Stress;
* Quality of Life;
* Depression and anxiety;
* Perceived control of health;
* Detailed neuropathy screening;
* Cardiovascular function;
* Cognitive function;
* Biological samples.

Eligibility Criteria:
Inclusion Criteria:

1. Type 1 and Type 2 diabetes mellitus;
2. Male or Female;
3. Resident in Qatar;
4. MENA birthplace and family origin;
5. 18-70 years old;
6. Capable to give informed consent and complete the study.

Exclusion Criteria:

1. Known pregnancy or planning pregnancy during the duration of study; 2. Congenital disorders; 3. Terminal illness; 4. Enrolled in a clinical trial involving medication; 5. Uncontrolled mental illness preventing participation; 6. Those who have already experienced a definitive microvascular complication:

i. End-stage renal disease; ii. Major amputation; iii. Blindness.
Testing for COVID-19 Infection in Asymptomatic Persons

Intensive action has been taken around the globe to fight the corona virus SARS-COV-2 (COVID-19) pandemia. Clinical symptoms of the infection appear to be variable, from basically asymptomatic infections and mild, flu-like symptoms up to severe respiratory insufficiency, requiring mechanical ventilation at the intensive care unit, and death. Broad testing for COVID-19 infection has been proven difficult in clinical practice and hampered by limited resources. Urgently needed epidemiological data on the rate of silent, asymptomatic infections in the population and the percentage of individuals that have already developed immunity are still missing. Within this study we therefore plan to (i) determine the proportion of asymptomatic COVID-19 virus carriers in (a) German Cancer Research Center (DKFZ) employees, who work and are present at the center during the time of extended minimum operation and (b) in all DKFZ employees before onboarding when extended minimum operation has been terminated. We plan to (ii) develop a high-throughput assay for COVID-19 testing as well as (iii) a serum-based COVID-19 antibody assay. Finally, we will (iv) analyze for a possible correlation between oral microbiome and COVID-19 infection status.


Eligibility Criteria:
Inclusion Criteria:

DKFZ employee

Exclusion Criteria:

Non DKFZ employee
Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.

Safety issues are addressed in the Adverse Events section

Eligibility Criteria:
Inclusion Criteria:

* Patients with either known or highly suspected focal areas of disruption of the blood brain barrier (BBB) (eg, primary and secondary tumors, focal inflammatory or demyelinating disorders) and/or abnormal vascularity in the CNS, who are scheduled to undergo a routine contrast-enhanced MRI of the CNS.
* Patients with untreated brain tumors should constitute a minimum of 50% of the study population and patients with treated brain tumors will be limited to a maximum of 20% of the study population

Exclusion Criteria:

* Is a female patient who is pregnant or nursing.
* Is a female of childbearing potential and did not have a negative urine pregnancy test the same day as the administration of gadobutrol or comparator treatment.
* Has received any investigational product within 30 days prior to enrolling in this study.
* Has been previously enrolled in this study or any other study using gadobutrol.
* Has any contraindication to the MRI examinations.
* Has a history of severe allergic or anaphylactoid reaction to any allergen including drugs and contrast agents.
* Has received any contrast agent within 24 hours prior to gadobutrol contrast administration, or is scheduled to receive any contrast agent within 72 hours after the gadobutrol study.
* Is considered to be clinically unstable or his/her clinical course during the study period is unpredictable (eg, due to previous surgery, acute renal failure).
* Has been treated with high dose (\>55 cobalt Gy equivalent) photon radiation or global radiotherapy for CNS lesions at any time before entering the study.
* Is scheduled to receive chemotherapy or radiotherapy during the study period.
* Is expected or scheduled to have a change in any treatment or procedure between the comparator and gadobutrol MRIs that may alter their interpretation.
* Is scheduled or is likely to require a biopsy or surgery within the 72 hours after the gadobutrol MRI procedure, or is scheduled for or has undergone such interventions between the comparator and gadobutrol studies.
* Has severe cardiovascular disease.
* Has any contraindication to OptiMARK according to the package insert.
* Has more than 30 brain lesions detected by any prior imaging examination.
Irinotecan Plus Cisplatin vs Pemetrexed Plus Cisplatin as 2nd Line in NSCLC Stage IIIB/IV

This trial will compare the efficacy of irinotecan/cisplatin and pemetrexed/cisplatin in the second-line treatment of patients with stage IIIB/IV NSCLC

Non-platinum-based doublets including the newer drugs can be used instead of platinum-based regimens in the first line treatment of patients with advanced NSCLC. Docetaxel or pemetrexed have been proven effective as second-line treatment of patients with NSCLC. In a study conducted by our group the combination of irinotecan/cisplatin demonstrated higher response rates over cisplatin monotherapy in patients progressing after first-line docetaxel/gemcitabine. Moreover, pemetrexed has been combined with the platinums (ie, cisplatin, carboplatin, and oxaliplatin) in NSCLC to yield clinical activity similar to that of other platinum-based doublets. The efficacy of different platinum-based combinations in patients pretreated with non-platinum based first-line chemotherapy is not known.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed NSCLC
* Age 18 -75 years
* Performance status (WHO) \<2
* Patients progressing after first-line docetaxel/gemcitabine treatment
* Adequate bone marrow (absolute neutrophil count \>1000/mm3, platelet count \>100000/mm3, hemoglobin \> 9 gr/ mm3)
* Adequate liver (bilirubin \<1.5 times upper limit of normal), renal (Creatinine clearance \> 50mg/min) and cardiac (LVEF \>50%) function
* Presence of measurable disease (according to RESIST criteria)
* Informed consent

Exclusion Criteria:

* Psychiatric illness or social situation that would preclude study compliance'
* Other concurrent uncontrolled illness.
* Other invasive malignancy within the past 5 years except nonmelanoma skin cancer
Evaluation of Proprioception in Patients With Total Hip Replacement

Disturbances of balance and postural stability are frequent in patients with coxarthrosis due to the damage to the mechanoreceptors, characteristic of arthritic degeneration, and muscular hypotrophy of the affected limb.

The aim of the study is to evaluate with adequate instrumentation the alterations of proprioception and postural control in patients with hip osteoarthrosis and the effectiveness of joint reconstruction in improving any deficit.


Eligibility Criteria:
Inclusion Criteria:

* Primary Osteoarthrosis
* BMI \< 35 kg/m\^2
* Able to stand in monopodalic support without aids / support

Exclusion Criteria:

* History of previous hip or knee replacement
* Orthopedic trauma within the previous 6 months
* Pathologies that can interfere with balance: neurological (of the central nervous system, neuropathies, movement disorders), vestibular, visual, cognitive disability, consumption of alcohol / drugs / psychoactive drugs in the 24 hours prior to the test