cyrilzakka/clinical-trials huggingface dataset:
Cardioneuroablation for Recurrent Vasovagal Syncope and Bradyarrhythmias: The CNA-FWRD Registry

The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation.

The CNA-FWRD Registry is an international prospective observational multicenter registry of patients with symptomatic vasovagal syncope and bradyarrhythmias managed under routine care by medical therapy and radiofrequency catheter ablation of ganglionated plexi or permanent pacemaker implantation. Major inclusion criteria for enrollment are history of VVS or symptomatic bradyarrhythmia, age \< 60 years, and evaluation by a physician and discussion about potential candidacy for radiofrequency cardioneuroablation or permanent pacemaker implantation for medically refractory symptoms.

For analysis purposes, patients awaiting the intervention will remain in the "control group" and will cross-over to the "procedural group" after successful completion of radiofrequency cardioneuroablation procedure. The follow-up for the procedure group will start at completion of CNA procedure, but patients who eventually do not get the procedure will stay in the control group until the end of the study, with similar follow-up performed as for the patients undergoing RFCA procedure. If a patient in the control group undergoes permanent pacemaker placement, then the day after the procedure the patient will be removed from the control group for follow up.

Eligibility Criteria:
Inclusion Criteria:

* symptomatic vasovagal syncope or symptomatic bradyarrhythmia refractory to behavioral and medical measures
* age \< 60 years

Exclusion Criteria:

* age \> 60 years
* intra-/infra-Hisian AV block
* intrinsic sinus node disease
* history of supraventricular tachycardia
* history of ventricular tachycardia
* presence of structural heart disease related
* prior history of catheter ablation
* presence of inheritable arrhythmic conditions
* orthostatic hypotension on HUTT test
* abnormal thyroid function levels
* Proven indication for permanent pacemaker implantation
Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)

To establish standard therapy for patients with advanced-stage low grade B-cell lymphoma

Since currently there is no standard therapy for untreated advanced-stage low-grade B-cell lymphoma, Phase 2/3 study was planned. Comparison(s): An intensified bi-weekly version by shortening the intervals of both rituximab and CHOP therapies using G-CSF, compared to the tri-weekly R-CHOP regimen.

Eligibility Criteria:
Inclusion Criteria:

1. Histological confirmed, low-grade B-cell lymphoma except mantle cell lymphoma and histologic transformation to DLBCL
2. CD20-positive
3. Ann Arbor CS III or IV
4. Lymphoma cell count in PB≦10,000/mm3
5. 20\<=age\<=69
6. ECOG PS 0-2
7. Bidimensionally measurable disease \>1.5cm in a single dimension by CT scans
8. No prior chemotherapy, radiotherapy, interferon-alfa, or antibody therapy
9. Normal BM, hepatic, renal, cardiac, and pulmonary function
10. Written informed consent

Exclusion Criteria:

1. CNS involvement
2. Glaucoma
3. DM treated by insulin
4. Uncontrollable HT
5. AP, AMI
6. Positive HBs antigen
7. seropositive to HCV
8. seropositive to HIV
9. Interstitial pneumonitis, pulmonary fibrosis, or emphysema
10. Severe infection
11. Liver cirrhosis
12. Double cancer
13. Pregnant or lactating
14. Patients who desire auto PBST after CR
15. Patients treated with major tranquilizer or antidepressant
Vitamin C for the Prevention of UTI in Women Who Undergo Elective GYN Surgeries

This open-label randomized trial aims at assessing the role of Vitamin C pills in the prevention of catheter-associated urinary tract infections in women undergoing elective gynecological surgeries.


Eligibility Criteria:
Inclusion Criteria:

Non pregnant women at least 18 years of age visiting the Preadmission unit (PAU) or the OBGYN floor (7N), presenting for elective GYN surgery at the American University of Beirut Medical Center (AUBMC).

Exclusion Criteria:

* Any women with the following:

  1. Nephrolithiasis
  2. Congenital anomaly or neurogenic bladder
  3. Allergy to ascorbic acid
  4. Who require therapeutic anticoagulant medicine during the 6 weeks after surgery
  5. Surgery did involve a fistula repair or a vaginal mesh removal
  6. Positive Urinalysis in the PAU
  7. Recurrent UTI's
  8. Diabetes
  9. G6PD
  10. Hemochromatosis
  11. Renal disorders

Patients already taking Vitamin C supplementation will also be excluded from the study.
Brazilian Green Propolis Extract (EPP-AF) as an Adjunct Treatment for Hospitalized COVID-19 Patients (BeeCovid2)

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) promotes challenging immune and inflammatory phenomena. Though various therapeutic possibilities have been tested against coronavirus disease 2019 (COVID-19), the most adequate treatment has not yet been established. Among candidate adjunct treatment options, propolis, produced by honey bees from bioactive plant exudates, has shown potential against viral targets and has demonstrated immunoregulatory properties.

To evaluate the efficacy and safety of oral propolis as an adjunct treatment for SARS-CoV-2 infection, we designed a randomized, double-blind, placebo-controlled trial (Bee-Covid2) (The Use of Brazilian Green Propolis Extract (EPP-AF®) in Patients Affected by COVID-19).

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years;
* Diagnosis of coronavirus infection confirmed by polymerase chain reaction - reverse transcriptase testing;
* Symptoms started within 14 days of the randomization date

Exclusion Criteria:

* Pregnant or lactating women;
* Known hypersensitivity to propolis;
* Propolis use less than 30 days from the randomization date;
* Active cancer;
* Human immunodeficiency virus carriers;
* Patients undergoing transplantation of solid organs or bone marrow or who were using immunosuppressive medications;
* Bacterial infection at randomization, sepsis or septic shock related to bacterial infection at randomization;
* Impossibility of using the medication orally or by nasoenteral tube;
* Known hepatic failure or advanced heart failure (New York Heart Association \[NYHA\] class III or IV).
* End Stage Renal Disease (ESRD).
Ocular Signs and Symptoms in Glaucoma Patients Switched From Latanoprost 0.005% to Preservative Free Tafluprost Eye Drops

The purpose of this study is to investigate if changes in ocular signs and symptoms occur in patients with ocular hypertension or glaucoma when they switch from latanoprost 0.005% (Xalatan) to preservative free Tafluprost eye drops.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of ocular hypertension or open angle glaucoma for which the patient has been using latanoprost 0.005% as his/her prior medication. - Evaluable patients must have ocular surface related symptoms and/or signs with their prior medication.
Evaluation of the Analgesic Effect of Midazolam and Ketamine as an Additive to Intrathecal Bupivacaine in Patients Undergoing Cesarean Section

Objective :To compare the analgesic effect of intrathecal midazolam and ketamine as an additive to bupivacaine in patients undergoing cesarean section .

Methods:Following Ethics Committee approval and informed patients consent, Ninety patients 18-45 yr old ASA physical status I or II, scheduled for cesarean section under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally . Time to first requirement of analgesic supplement, Sensory block onset time, maximum sensory level , onset of motor block, duration of blockade, hemodynamics variables, the incidence of hypotension, ephedrine requirements, bradycardia ,hypoxemia \[Saturation of peripheral oxygen (SpO2)\<90\], postoperative analgesic requirements and Adverse events, such as sedation, dizziness , Pruritus and postoperative nausea and vomiting were recorded. Patients were instructed preoperatively in the use of the verbal rating scale (VRS) from 0 to 10 (0no pain, 10maximum imaginable pain) for pain assessment. If the VRS exceeded four and the patient requested a supplement analgesic, diclofenac Na supp 100 mg was to be given for post-operative pain relief as needed . For breakthrough pain(VRS \>4) if time of administration of diclofenac Na less than 8h,Pethidine 25 mg IV was given.

The patients were randomly allocated to one of three groups of 30 each. The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free ,the midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam and the placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .

Eligibility Criteria:
Inclusion Criteria:

* patients with American Society of Anesthesiologists(ASA) physical status I and II, undergoing elective cesarean section

Exclusion Criteria:

* significant coexisting disease such as hepato-renal and cardiovascular disease
* any contraindication to regional anesthesia such as local infection or bleeding disorders
* allergy to ketamine or midazolam
* long-term opioid use or a history of chronic pain.
Fetuin A as a Predictor of Deterioration of Renal Function in Hypertonic Patients

Commonly used parameters (creatinine, estimated glomerular filtration rate, and urine albumin/creatinine ratio) for prediction of decline of renal function are sensitive for advanced kidney impairment. Modified human urine Fetuin A (urine Fetuin A) with specific modification in urine (Fetuin A) can earlier predict the progression of kidney disease in patients with diabetes. Studies evaluating urine Fetuin A in hypertonic patients are still lacking.

Arterial hypertension and diabetes are the most common cause of chronic kidney disease. Commonly used parameters for the evaluation of renal function (plasma creatinine, estimated glomerular filtration rate, and urine albumin/creatinine ratio) are sensitive to advanced kidney disease. Parameters predicting early kidney impairment are still lacking. Modified human urine Fetuin A with specific modification in urine (urine Fetuin A) presents a new biomarker that seems to be promising in the early prediction of kidney disease in patients with diabetes without microalbuminuria. Studies evaluating urine Fetuin A in hypertonic patients are still lacking.

Eligibility Criteria:
Inclusion Criteria:

* Arterial hypertension treated by at least one antihypertensive agent

Exclusion Criteria:

* Diabetes mellitus of any type, defined as fasting glucose \>7,0 mmol/l or any glycemia \>11,0 mmol/l, or HbA1c\>48 mmol/mol
* Decompensated arterial hypertension defined as office blood pressure \>180/110 mmHg or on Ambulatory Blood Pressure Monitoring (ABPM)
* Patient with renal replacement therapy
* Present rheumatoid disease (rheumatoid arthritis, systemic lupus, sclerodermia, dermatomyositis, Inflammatory Bowel Disease, etc.), positivity of antinuclear antibody (ANA) / extractable nuclear antigen (ENA) screening
* Acute infection defined as C-Reactive Protein (CRP) \>50 mg/l
* Severe impairment of liver function defined as cirrhosis, Alanine Transaminase or ASpartate Transferase (ALT or AST) \>10 µkat/l
* Terminal incurable illness
The Oncological Safety and Cosmetic Outcome of Areola Sparing Mastectomy : a Single Arm, Prospective, Cohort Study

To balance the oncological safety and cosmetic outcome is the basic principle of modern breast surgery. To preserve the nipple-areolar complex shows attractive cosmetic advantage but concerns regarding local recurrence make the oncological safety of nipple sparing mastectomy a controversial issue. Since the involvement of areolar pigmented skin by cancer is rare compared to that of nipple, we designed the current study to investigate the oncological safety and cosmetic outcome of Areola Sparing Mastectomy.

Primary breast cancer originated from areolae is rare. We hypothesized that nipple and areola are two separate anatomy tissue and have different oncological impact on the treatment of breast cancer. Areola Sparing Mastectomy (ASM) is a innovative procedure that involves of removal of nipple and preservation of areola the pigmented skin of which would improve the cosmetic outcome of mastectomy and lead to a illusion of congenital crater nipple in some patients.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed invasive or in situ breast cancer.
* cTis-2N0-1M0.
* Indicated for total mastectomy and desire immediate breast reconstruction.

Exclusion Criteria:

* cT3-4 or cN2-N3 breast cancer.
* Retraction of nipple or areola.
* Involvement of subcutaneous layer by cancer on ultrasound or MRI.
Sildenafil Citrate for Treatment of Growth-restricted Fetuses

The aim of this study is to assess the effect of Sildenafil citrate therapy on neonatal outcomes in women with fetal growth restriction.


Eligibility Criteria:
Inclusion Criteria:

* Maternal age ranging from 20-40 years.
* Gestational age 28-37 weeks.

Exclusion Criteria:

* Obese patients (BMI \>30 kg/m2).
* Patients with medical disorders: cardiac diseases, pulmonary diseases, liver disease, renal disease, previous history of seizures, hearing loss.
* Drug interactions, such as users of any vasodilator agents, omeprazole, clarithromycin and amoxicillin.
* Fetal distress.
* Pregnancy of multiple fetuses.
* Congenital fetal malformation or chromosomal abnormalities.
* Diastolic blood pressure more than 110 mmHg.
* Hypersensitivity to the drug.
Doppler-guided Endoscopic Treatment in Peptic Ulcer Bleeding

The present study is a randomized controlled trial (RCT) that examines if the outcome of peptic ulcer bleeding could be improved by use of doppler-guided endoscopic treatment.

This study evaluates if performance of a control endoscopy with doppler-guided endoscopic treatment is associated with an improved outcome in term of lower rate of rebleeding and lower rate of bleeding-related mortality. A potential risk of increased risk of complications (in particular perforation) among patients treated with control endoscopy is also evaluated. Outcomes are prospectively registered based on patient records.

Eligibility Criteria:
Inclusion Criteria:

* Peptic ulcer bleeding from ulcers classified as Forrest I-IIb

Exclusion Criteria:

* Severe comorbidity with a remaining life expectancy below 30 days
HIV Prevention Program for Patients Receiving Care at a Sexually Transmitted Diseases Clinic

This study will determine the effectiveness of a two-step HIV prevention program in reducing risky sexual practices and decreasing the incidence of sexually transmitted diseases (STDs).

Numerous factors influence one's sexual choices, including social support and pressure, internal feelings and beliefs, and knowledge about the subject. Data indicate that people who are well-informed about the risks associated with certain sexual behaviors are more likely to protect themselves than those who are less informed. This study will determine whether an intervention comprising information, motivation, and behavioral skills components is more effective than an information-only workshop in changing sexual behavior for HIV prevention.

At study entry, participants will undergo a physical exam, various STD tests, and a rapid HIV test, which can provide test results within several hours. While waiting for their test results at the study clinic, participants will complete a computerized questionnaire assessing their thoughts, feelings, and behaviors regarding sexual activities. Participants will also be exposed to one of two brief health promotion interventions: a motivational, one-on-one counseling session or a DVD on safer sex. After receiving their test results, participants will be asked to complete a brief postassessment questionnaire about their attitudes toward their test results and the intervention.

Two-thirds of the participants will then be invited to attend an intensive, 4-hour safer sex workshop. These participants will be randomly assigned to one of two workshops: an information-only workshop or a workshop that includes information, motivation, and behavioral skills components. Participants who choose not to participate in the workshop will complete the study after receiving their STD and HIV test results. Participants who participate in the workshop will return to the clinic at 3, 6, and 12 months after the workshop to complete another questionnaire about sexual behaviors and give a urine sample for STD testing.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis or symptoms of an STD within 3 months prior to study entry OR have had unprotected vaginal or anal intercourse with one or more of the following: two or more sexual partners, a partner with two or more partners, an anonymous partner, an injection drug-using partner, or a partner with an STD
* Able to understand English

Exclusion Criteria:

* Psychosis or impaired mental status that would prevent participant from providing informed consent
* Have been tested for HIV within 3 months prior to study entry
* HIV infected
An Exploratory Open Label Study of EPI-743 (Vincerinone TM) in Children With Autism Spectrum Disorder

The investigators hypothesize that EPI-743 may provide clinical benefit to children with Autism Spectrum Disorder.

An Exploratory Open Label Phase 2 Study of EPI-743 (Vincerinone TM) in Children with Autism Spectrum Disorder

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of Autism Spectrum Disorder as defined by the DSM-V criteria for ASD and a gold-standard diagnostic evaluation for ASD such as the Autism Diagnostic Observation Schedule (ADOS) and/or the Autism Diagnostic Interview - Revised (ADI-R)
2. Male or female, 3 years to 14 years of age
3. Abnormal glutathione cycle biomarkers (GSH/GSSG in plasma\<8.0)
4. Language impairment (as defined by the CELF-2 or CELF-4 screener)
5. Ability to complete language assessment (using either CELF or PLS)
6. Subject or subject's guardian able to consent and comply with protocol requirements
7. Abstention from use of Coenzyme Q10, vitamin E, lipoic acid, folinic acid, other forms of folic acid above recommended daily allowance (RDA), and idebenone 2 months prior to treatment with EPI-743 and for duration of study
8. Stable regimen of medication and supplements for 2 months prior to enrollment and duration of the study

Exclusion Criteria:

1. Allergy to EPI-743 or sesame oil
2. Allergy to vitamin E
3. Clinical history of bleeding or abnormal baseline PT/PTT
4. Use of anticoagulant medications
5. Participation in any other interventional study within 90 days of treatment.
6. Use of antipsychotic medications
7. Moderate to severe positive response on ABC irritability subscale on questions: Injures self on purpose, is aggressive to other children or adults (verbally or physically), deliberately hurts himself/ herself, and/or does physical violence to self
8. Severe impairment as defined as a Vineland Adaptive Behavioral Scales composite standard score of \<40
9. Patients with genetic disease that gives rise to ASD (e.g. Rett syndrome, Down syndrome, fragile x syndrome)
10. Abnormal liver function tests two times the upper limit of normal or renal insufficiency with creatinine levels two times the upper limit of normal
Water Bolus Volumes During Continuous Exercise in Heat

Hydration is important to all individuals including occupational workers who complete physical activity in the heat. Current best practice guidelines suggest drinking a cup of water every 15-20 minutes during activity in a hot environment, but research shows this may not be ideal for best maintaining hydration. The goal of this study is to determine if larger, more frequent water boluses better maintain hydration than smaller, less frequent water boluses during moderate intensity physical activity in the heat.


Eligibility Criteria:
Inclusion Criteria:

* Male
* 18-39 y old
* Self-reported to be healthy

Exclusion Criteria:

* Female
* Not within defined age range
* History of any cardiovascular, neurologic, or metabolic disease
* Current tobacco use or regular use within the last 2 years.
* Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
* Inability to follow the rules of the protocols or understand the consent form
68Ga-DOTATATE PET/CT in Neuroendocrine Tumor

Somatostatin receptor(SSTR) was expressed in neuroendocrine tumor cells and SSTR-targeting molecular imaging(68Ga-DOTATATE PET/CT) could be a promising technique to evaluate the primary tumor and metastatic lesions of neuroendocrine tumors with higher accuracy. This prospective study is going to investigate whether radiolabeled somatostatin analogs 68Ga-DOTATATE PET/CT may be valuable for diagnosis, risk stratification, and prognostic evaluation of neuroendocrine tumors and compared it with 18F-FDG PET/CT.

Neuroendocrine tumor(NET)can be derived from endocrine glands, endocrine tissues and endocrine cells from any parts of body. Due to its occult onset and heterogeneity, it is hard to be detected by conventional imaging like CT and it is often at late stage when diagnosed. New imaging modality such as 18F-FDG PET/CT have been well-accepted as a practical way to evaluate the aggressive of tumor. 18F-FDG PET/CT has been used to improve the efficacy in assessing the extent and severity of NET, but the diagnostic accuracy of 18F-FDG PET/CT decreased in low proliferation tumor cells and inflammation. Recent studies showed somatostatin receptor (SSTR) was expressed in NET cells and SSTR-targeting molecular imaging-68Ga-DOTATATE PET/CT could be a promising technique to evaluate the extent of NET with higher accuracy. Especially in some well differentiated tumor, 18F-FDG PET/CT can be negative, while 68Ga-DOTATATE PET/CT can be positive. However, the results can be varied in these two imaging modalities and characterized this disease at multiple levels such as clinical presentation, biologic characteristics, treatment response, and clinical outcome.This prospective study is going to investigate whether 68Ga-DOTATATE PET/CT may be superior to 18F-FDG PET/CT for diagnosis, risk stratification, and prognostic evaluation of NET.

Eligibility Criteria:
Inclusion Criteria:

* suspected or confirmed untreated NET patients previously performed 18F-FDG PET/CT signed written consent.

Exclusion Criteria:

* pregnancy breastfeeding known allergy against TATE any medical condition that in the opinion of the investigator, may significantly interfere with study compliance.